Traditional Chinese medicine composition with antidepressant, anxiolytic, antifatigue and sleep-aiding effects and preparation method thereof

Abstract

The present application relates to the technical field of medicine, in particular to a traditional Chinese medicine composition with the effects of anti-depression, anti-anxiety, anti-fatigue and sleep aid and a preparation method thereof.The traditional Chinese medicine composition comprises raw malt, dried tangerine or orange peel, cassia seed, chrysanthemum, Chinese date kernel, lily and baked licorice, and the components have the effects of soothing liver and relieving depression, tranquilizing, sleep aid, relieving anxiety and fatigue, and the combination of the single medicine materials in the prescription has the best synergistic effect.In addition, the traditional Chinese medicine composition has the advantages of simple preparation, low cost, safety, no toxic side effects, convenience for carrying and taking, controllable quality and remarkable effect.

Description

Technical Field

[0001] This invention relates to the field of pharmaceutical technology, specifically to a traditional Chinese medicine composition and its preparation method that has antidepressant, anti-anxiety, anti-fatigue and sleep-aiding effects. Background Technology

[0002] As social competition intensifies and people experience increasing pressure, the incidence of depression continues to rise. The World Health Organization estimates that 350 million people worldwide suffer from depression, and the disease is affecting increasingly younger people, with an incidence rate as high as 11%. The number of people who commit suicide due to depression reaches 1 million every year, and this number is increasing year by year, posing a serious threat to society.

[0003] Depression has a complex etiology and pathogenesis. Currently, clinical treatment primarily relies on Western medicine, but most drugs suffer from slow treatment duration, low cure rates, and significant side effects. For example, antidepressants such as sertraline, paroxetine, selegiline, and amitriptyline show that 30% of patients do not experience effective symptom relief after taking these medications. Selective serotonin reuptake inhibitors (SSRIs), with fluoxetine (Prozac) as a representative drug, are currently the most commonly used antidepressants in clinical practice. Clinical studies have shown that SSRIs broadly enhance serotonin levels; however, patients taking SSRIs experience many adverse reactions related to their pharmacological effects, such as nausea, diarrhea, agitation, anxiety, insomnia, or sexual dysfunction. Furthermore, most antidepressants have a slow onset of action, and long-term use can easily lead to drug dependence; some drugs also have withdrawal symptoms. Therefore, there is an urgent need to develop antidepressants with rapid onset of action and fewer side effects. The use of traditional Chinese medicine in the treatment of depression presents a promising opportunity for development.

[0004] Traditional Chinese medicine (TCM) theory categorizes what modern medicine calls "depression" as a type of "yu syndrome," considering it a disease caused by emotional distress and stagnation of Qi (vital energy). This syndrome is mainly manifested as depressed mood, emotional instability, distending pain in the hypochondrium, irritability, frequent crying, a feeling of obstruction in the throat, insomnia, and other complex symptoms. Compared to Western medicines with their single action and numerous side effects, TCM treatment for depression typically has the advantage of systemic regulation, stable efficacy, long-lasting effects, fewer adverse reactions, low relapse rate, holistic physical and mental regulation, and suitability for long-term use. However, the clinical application of TCM compound antidepressants is limited, and they suffer from drawbacks such as slow onset of action and uncertain efficacy. Therefore, developing safer, more effective, faster-acting, and comprehensive TCM antidepressant compositions is of great significance for the clinical treatment of depression. It is necessary to provide a safe, effective, and definitively effective TCM composition. Summary of the Invention

[0005] Therefore, the present application aims to provide a traditional Chinese medicine composition with the effects of anti-depression, anti-anxiety, anti-fatigue and sleep aid and a preparation method thereof.

[0006] The present application provides a traditional Chinese medicine composition comprising the following components in the weight parts: 15-25 parts of raw malt, 12-18 parts of dried tangerine or orange peel, 10-15 parts of cassia seed, 8-13 parts of chrysanthemum, 8-20 parts of sour jujube kernel, 10-20 parts of lily and 8-12 parts of fried licorice root.

[0007] In the traditional Chinese medicine composition provided by the present application, raw malt is the monarch drug, which plays the role of soothing the liver and promoting qi. Dried tangerine or orange peel is the minister drug, which plays the role of regulating qi and relieving the middle. Cassia seed, chrysanthemum, sour jujube kernel and lily are the auxiliary drugs, which play the roles of clearing heat, relieving restlessness, calming the heart and nourishing the liver and soothing the mind. Fried licorice root is the ministerial drug, which relieves the urgent and harmonizes the drugs. Compared with other traditional Chinese medicine compositions, the traditional Chinese medicine composition provided by the present application can effectively improve the effects of anti-depression, anti-anxiety, anti-fatigue and sleep aid due to the reasonable selection of each drug and the appropriate drug amount, thereby achieving a better technical effect.

[0008] In some embodiments, the composition comprises the following components in the weight parts: 18 parts of raw malt, 12-18 parts of dried tangerine or orange peel, 13 parts of cassia seed, 10 parts of chrysanthemum, 10-20 parts of sour jujube kernel, 10-20 parts of lily and 10 parts of fried licorice root.

[0009] Within the above concentration range, the traditional Chinese medicine composition can better improve the effects of anti-depression, anti-anxiety, anti-fatigue and sleep aid due to the mutual cooperation between the components, thereby achieving a more accurate technical effect.

[0010] In some specific embodiments, the composition is composed of the following components in the weight parts: 18 parts of raw malt, 15 parts of dried tangerine or orange peel, 13 parts of cassia seed, 10 parts of chrysanthemum, 12 parts of sour jujube kernel, 15 parts of lily and 10 parts of fried licorice root.

[0011] or the following components in the weight parts: 18 parts of raw malt, 12 parts of dried tangerine or orange peel, 13 parts of cassia seed, 10 parts of chrysanthemum, 10 parts of sour jujube kernel, 10 parts of lily and 10 parts of fried licorice root.

[0012] or the following components in the weight parts: 18 parts of raw malt, 18 parts of dried tangerine or orange peel, 13 parts of cassia seed, 10 parts of chrysanthemum, 20 parts of sour jujube kernel, 20 parts of lily and 10 parts of fried licorice root.

[0013] The influence of the above-mentioned concentration of traditional Chinese medicine composition on anti-depression, anti-anxiety, anti-fatigue and sleep aid of mice is verified by experiments. The results show that the traditional Chinese medicine composition has obvious improvement effect on chronic unpredictable mild stimulation (CUMS) induced hepatic depression and qi stagnation type depression in mice. The prevention of the traditional Chinese medicine composition can significantly reverse the depression-like behavior of CUMS mice, reverse the decrease of norepinephrine (NE) and 5-hydroxytryptamine (5-HT) content in hippocampus of CUMS mice, and improve the pathological distribution change of Nissl body and BDNF in hippocampus. The traditional Chinese medicine composition has significant therapeutic effect on anxiety induced by metaclopramide in mice, significantly reduces the activity distance and speed of the mice in the dark box, and the total distance and average speed of the mice in the central field of the open field. The traditional Chinese medicine composition significantly improves the fatigue tolerance of mice, and significantly increases the sleep latency and sleep time of mice induced by sodium pentobarbital. Further experiments show that the traditional Chinese medicine composition has obvious synergistic effect, and the effect of anti-depression, anti-anxiety, anti-fatigue and sleep aid is best, so that more accurate technical effect is obtained.

[0014] The application provides a preparation method of the traditional Chinese medicine composition, which comprises the following steps:

[0015] Step 1: obtaining extract and residue by solution soaking, heating and reflux extraction of raw malt, dried tangerine or orange peel, cassia seed, chrysanthemum, Chinese date kernel, lily and prepared licorice;

[0016] Step 2: obtaining extract and residue by solution soaking, heating and reflux extraction of the residue in step 1;

[0017] Step 3: obtaining extract and residue by repeating step 2, and obtaining the traditional Chinese medicine composition by combining the extracts obtained in steps 1-3, and then reducing pressure, concentrating and freeze-drying.

[0018] In some embodiments, in steps 1-3, the solution is independently selected from ethanol, water or 0-95 vol% ethanol aqueous solution, and the volume of the solution is 5-20 times of the total mass of the raw malt, dried tangerine or orange peel, cassia seed, chrysanthemum, Chinese date kernel, lily and prepared licorice. In the ethanol aqueous solution, the concentration of ethanol can be any value in the range, for example, 10 vol%, 20 vol%, 50 vol%, 70 vol%, 90 vol% and the like, and preferably 70 vol%.

[0019] In some specific embodiments, the volume of the solution is 10 times of the total mass of the raw malt, dried tangerine or orange peel, cassia seed, chrysanthemum, Chinese date kernel, lily and prepared licorice.

[0020] In other embodiments, in steps 1-3, the soaking time is 12 h, and the heating and reflux extraction time is 2 h. In other embodiments, in steps 1-3, the soaking time is 12 h, and the heating and reflux extraction time is 2 h.

[0021] The application provides application of the traditional Chinese medicine composition and / or the traditional Chinese medicine composition prepared by the preparation method in preparation of an antidepressant, anxiolytic, antifatigue and / or sleep-aiding product.

[0022] The application provides an antidepressant, anxiolytic, antifatigue and / or sleep-aiding product, which comprises the traditional Chinese medicine composition and / or the traditional Chinese medicine composition prepared by the preparation method.

[0023] In some embodiments, the product comprises a pharmaceutical preparation.

[0024] In some embodiments, the dosage form of the product comprises, but is not limited to, an oral preparation, an injection preparation, a transdermal absorption preparation and the like.

[0025] In some embodiments, the dosage form of the product comprises any one or more of a tablet, a capsule, a granule, a pill, a powder, a bolus, a syrup, an oral solution and an oral suspension.

[0026] In some embodiments, the pharmaceutical preparation is in the form of an injection preparation, which comprises, but is not limited to, a pharmaceutically acceptable injection dosage form such as an injection solution, an injection suspension, an injection emulsion, an injection powder and the like.

[0027] In some embodiments, the pharmaceutical preparation is in the form of a transdermal absorption preparation.

[0028] The traditional Chinese medicine composition provided by the application has the antidepressant, anxiolytic, antifatigue and sleep-aiding effects, and comprises raw malt, dried tangerine or orange peel, cassia seed, chrysanthemum, Chinese date kernel, lily and honey-fried licorice, and has the following beneficial technical effects compared with the prior art.

[0029] 1. The traditional Chinese medicine composition of the application is a compound prepared from the homology of medicine and food, i.e., raw malt, dried tangerine or orange peel, cassia seed, chrysanthemum, Chinese date kernel, lily and honey-fried licorice, and is used for treating liver depression and qi stagnation, mild to moderate depression, anxiety, fatigue and various sleep disorders. The raw malt is used as the monarch drug for soothing the liver and promoting qi, the dried tangerine or orange peel is used as the minister drug for regulating qi and tonifying the center, the cassia seed is used for clearing the liver and improving eyesight, moistening the intestines and defecation, the chrysanthemum is used for dispelling wind and clearing heat, soothing the liver and improving eyesight, the Chinese date kernel is used for nourishing the liver, calming the heart and tranquilizing the mind, the lily is used for nourishing yin, moistening the lung, clearing the heart and tranquilizing the mind, and all of them are used as the auxiliary drugs, and the honey-fried licorice is used for harmonizing the drugs and relieving the urgent condition, and the seven kinds of traditional Chinese medicines are used together to achieve the effects of soothing the liver, relieving depression, tranquilizing the mind, aiding sleep, relieving anxiety and fatigue.

[0030] 2. The composition of the application has the effects of soothing the liver, relieving depression, tranquilizing the mind, aiding sleep, relieving anxiety and fatigue. Systematic pharmacological studies show that the traditional Chinese medicine composition has the multiple effects of antidepressant, anxiolytic, antifatigue and sleep-aiding, and the combination of the single medicinal materials in the prescription has the best synergistic effect, and the effect is better than that of the extract of the single medicinal material and the extract of the combination of the partial single medicinal materials.

[0031] 3、The Chinese medicine composition of the present application not only has a therapeutic effect on depression, anxiety, fatigue and sleep disorders, but also has the characteristics of good safety of the same origin of medicine and food, and supports its use for the prevention and treatment of the above diseases, has the potential value of health security moving forward, slow disease management and promoting national health. BRIEF DESCRIPTION OF DRAWINGS

[0032] Figure 1 Results of Nissl staining of mouse hippocampal CA1 region are shown;

[0033] Figure 2 Results of immunohistochemistry of BDNF protein expression in mouse hippocampus are shown. DETAILED DESCRIPTION

[0034] The present application provides a Chinese medicine composition with anti-depression, anti-anxiety, anti-fatigue and sleep aid efficacy and a preparation method thereof, and those skilled in the art can refer to the content herein to appropriately improve the process parameters. It is particularly pointed out that all similar substitutions and changes are obvious to those skilled in the art, and they are considered to be included in the present application. The method and application of the present application have been described by preferred embodiments, and relevant personnel can obviously modify or appropriately change and combine the method and application herein without departing from the content, spirit and scope of the present application, to realize and apply the present application technology.

[0035] The present application provides a Chinese medicine composition with anti-depression, anti-anxiety, anti-fatigue and sleep aid efficacy and a preparation method thereof. The present inventors have found, through in-depth research and creative labor, a Chinese medicine composition with clear efficacy for depression and anxiety and higher safety and a preparation method thereof, and the Chinese medicine composition also has anti-fatigue and sleep aid effects, while fatigue and insomnia are the most prominent somatic symptoms of depression and anxiety. The combination of single medicinal materials in the composition of the present application has the best synergistic anti-depression effect, which is superior to the extract of single medicinal materials and the extract of the combination of part of single medicinal materials.

[0036] The numerical ranges and parameters involved in the present application have been presented as accurately as possible in the specific embodiments. However, any numerical value inevitably contains a standard deviation due to individual test methods in nature. Therefore, unless otherwise explicitly stated, it should be understood that all numerical ranges or specific data used in the present disclosure can have a certain reasonable deviation within a certain range, for example: ±10%, ±5%, ±1% or ±0.5%.

[0037] Some cases are described in the examples and comparative examples of the present application. The examples show some implementations of the present application. However, this does not mean that the effects of the present application can only be achieved in these cases. In fact, any concentration of the components between the two end point values shown in the examples (especially examples 1-3) can achieve good anti-depression, anti-anxiety, anti-fatigue and sleep-aiding effects, and the best case is example 1. In each of the comparative examples, only some cases with poor effects in the tests are listed, and in addition to this, many attempts have been made during the development process, such as using different medicinal flavors or using different amounts of medicine, but the effects of these attempts are not as good as examples 1-3, and therefore will not be described here.

[0038] The test materials used in the present application are all ordinary commercially available products. The raw traditional Chinese medicine materials used in the experiments of the present application, raw malt, dried tangerine or orange peel, cassia seed, chrysanthemum, Chinese date kernel, lily and licorice, are purchased from Beijing Tong Ren Tang (Group) Co., Ltd. The present application will be further described below in conjunction with examples.

[0039] Preparation of traditional Chinese medicine extract in example 1

[0040] 1. Preparation of extract of combination 1 (whole formula)

[0041] Take 18 g of raw malt, 15 g of dried tangerine or orange peel, 13 g of cassia seed, 10 g of chrysanthemum, 12 g of Chinese date kernel, 15 g of lily and 10 g of licorice; soak in 70% ethanol (1:10, m:V) at room temperature for 12 h, heat reflux for 2 h, filter, collect the filtrate, and extract the residues with distilled water under the same conditions for 2 times, each time for 2 h of heating reflux extraction, filter the extract, and collect the filtrate. Combine the filtrates of the three times, reduce pressure and concentrate, vacuum freeze-dry to obtain the extract of combination 1.

[0042] Method and dosage of taking: 1 dose each time for adults, 2 times a day.

[0043] 2. Preparation of extract of combination 2 (different compatibility ratio of whole formula)

[0044] Take 18 g of raw malt, 15 g of dried tangerine or orange peel, 13 g of cassia seed, 10 g of chrysanthemum, 12 g of Chinese date kernel, 15 g of lily and 10 g of licorice; soak in 70% ethanol (1:10, m:V) at room temperature for 12 h, heat reflux for 2 h, filter, collect the filtrate, and extract the residues with distilled water under the same conditions for 2 times, each time for 2 h of heating reflux extraction, filter the extract, and collect the filtrate. Combine the filtrates of the three times, reduce pressure and concentrate, vacuum freeze-dry to obtain the extract of combination 1.

[0045] Method and dosage of taking: 1 dose each time for adults, 2 times a day.

[0046] 3. Preparation of extract of combination 3 (different compatibility ratio of whole formula)

[0047] Take raw malt 18 g, dried tangerine or orange peel 18 g, cassia seed 13 g, chrysanthemum 10 g, Chinese date kernel 20 g, lily 20 g and charred licorice 10 g; soak in 70% ethanol (1:10, m:V) at room temperature for 12 h, heat to reflux for 2 h, filter, collect the filtrate, and extract the residue with distilled water under the same conditions for 2 times, each time heat to reflux for 2 h, filter the extract, and collect the filtrate. Combine the three filtrates, concentrate under reduced pressure, and freeze-dry under vacuum to obtain the combination 3 extract.

[0048] Method and dosage of taking: 1 dose each time, 2 times a day for adults.

[0049] 4. Preparation of combination 4 (raw malt + dried tangerine or orange peel + cassia seed + chrysanthemum + Chinese date kernel + charred licorice) extract

[0050] Take raw malt 18 g, dried tangerine or orange peel 15 g, cassia seed 13 g, chrysanthemum 10 g, Chinese date kernel 12 g and charred licorice 10 g; soak in 70% ethanol (1:10, m:V) at room temperature for 12 h, heat to reflux for 2 h, filter, collect the filtrate, and extract the residue with distilled water under the same conditions for 2 times, each time heat to reflux for 2 h, filter the extract, and collect the filtrate. Combine the three filtrates, concentrate under reduced pressure, and freeze-dry under vacuum to obtain the combination 4 extract.

[0051] Method and dosage of taking: 1 dose each time, 2 times a day for adults.

[0052] 5. Preparation of combination 5 (raw malt + dried tangerine or orange peel + cassia seed + chrysanthemum + lily + charred licorice) extract

[0053] Take raw malt 18 g, dried tangerine or orange peel 15 g, cassia seed 13 g, chrysanthemum 10 g, lily 15 g and charred licorice 10 g; soak in 70% ethanol (1:10, m:V) at room temperature for 12 h, heat to reflux for 2 h, filter, collect the filtrate, and extract the residue with distilled water under the same conditions for 2 times, each time heat to reflux for 2 h, filter the extract, and collect the filtrate. Combine the three filtrates, concentrate under reduced pressure, and freeze-dry under vacuum to obtain the combination 5 extract.

[0054] Method and dosage of taking: 1 dose each time, 2 times a day for adults.

[0055] 6. Preparation of combination 6 (raw malt + dried tangerine or orange peel + cassia seed + Chinese date kernel + lily + charred licorice) extract

[0056] Take raw malt 18 g, dried tangerine or orange peel 15 g, cassia seed 13 g, Chinese date kernel 12 g, lily 15 g and charred licorice 10 g; soak in 70% ethanol (1:10, m:V) at room temperature for 12 h, heat to reflux for 2 h, filter, collect the filtrate, and extract the residue with distilled water under the same conditions for 2 times, each time heat to reflux for 2 h, filter the extract, and collect the filtrate. Combine the three filtrates, concentrate under reduced pressure, and freeze-dry under vacuum to obtain the combination 6 extract.

[0057] Method of taking and dosage: 1 dose each time, 2 times a day for adults.

[0058] 7. Preparation of extract of combination 7 (raw malt + dried tangerine peel + chrysanthemum + Suanzaoren + Baihe + Zhigancao)

[0059] Take raw malt 18 g, dried tangerine peel 15 g, chrysanthemum 10 g, Suanzaoren 12 g, Baihe 15 g and Zhigancao 10 g; soak in 70% ethanol (1:10, m:V) at room temperature for 12 h, heat reflux for 2 h, filter, collect the filtrate, and extract the residues with distilled water under the same conditions for 2 times, each time heat reflux for 2 h, filter the extract, and collect the filtrate. Combine the filtrates of the 3 times, concentrate under reduced pressure, vacuum freeze-dry to obtain the extract of combination 7.

[0060] Method of taking and dosage: 1 dose each time, 2 times a day for adults.

[0061] 8. Preparation of extract of combination 8 (raw malt + cassia seed + chrysanthemum + Suanzaoren + Baihe + Zhigancao)

[0062] Take raw malt 18 g, cassia seed 13 g, chrysanthemum 10 g, Suanzaoren 12 g, Baihe 15 g and Zhigancao 10 g; soak in 70% ethanol (1:10, m:V) at room temperature for 12 h, heat reflux for 2 h, filter, collect the filtrate, and extract the residues with distilled water under the same conditions for 2 times, each time heat reflux for 2 h, filter the extract, and collect the filtrate. Combine the filtrates of the 3 times, concentrate under reduced pressure, vacuum freeze-dry to obtain the extract of combination 8.

[0063] Method of taking and dosage: 1 dose each time, 2 times a day for adults.

[0064] 9. Preparation of extract of combination 9 (dried tangerine peel + cassia seed + chrysanthemum + Suanzaoren + Baihe + Zhigancao)

[0065] Take dried tangerine peel 15 g, cassia seed 13 g, chrysanthemum 10 g, Suanzaoren 12 g, Baihe 15 g and Zhigancao 10 g; soak in 70% ethanol (1:10, m:V) at room temperature for 12 h, heat reflux for 2 h, filter, collect the filtrate, and extract the residues with distilled water under the same conditions for 2 times, each time heat reflux for 2 h, filter the extract, and collect the filtrate. Combine the filtrates of the 3 times, concentrate under reduced pressure, vacuum freeze-dry to obtain the extract of combination 9.

[0066] Method of taking and dosage: 1 dose each time, 2 times a day for adults.

[0067] 10. Preparation of extract of raw malt

[0068] Take raw malt 18 g; soak in 70% ethanol (1:10, m:V) at room temperature for 12 h, heat to reflux for 2 h, filter, collect the filtrate, and the residue is extracted with distilled water under the same conditions for 2 times, each time heat to reflux for 2 h, filter the extract, and collect the filtrate. Combine the filtrates of the 3 times, concentrate under reduced pressure, and freeze-dry under vacuum to obtain the extract of Combination 10.

[0069] Method and dosage of taking: 1 dose each time for adults, 2 times a day.

[0070] 11. Preparation of extract of pericarpium citri reticulatae

[0071] Take pericarpium citri reticulatae 15 g; soak in 70% ethanol (1:10, m:V) at room temperature for 12 h, heat to reflux for 2 h, filter, collect the filtrate, and the residue is extracted with distilled water under the same conditions for 2 times, each time heat to reflux for 2 h, filter the extract, and collect the filtrate. Combine the filtrates of the 3 times, concentrate under reduced pressure, and freeze-dry under vacuum to obtain the extract of Combination 11.

[0072] Method and dosage of taking: 1 dose each time for adults, 2 times a day.

[0073] 12. Preparation of extract of semen cassiae

[0074] Take semen cassiae 13 g; soak in 70% ethanol (1:10, m:V) at room temperature for 12 h, heat to reflux for 2 h, filter, collect the filtrate, and the residue is extracted with distilled water under the same conditions for 2 times, each time heat to reflux for 2 h, filter the extract, and collect the filtrate. Combine the filtrates of the 3 times, concentrate under reduced pressure, and freeze-dry under vacuum to obtain the extract of Combination 12.

[0075] Method and dosage of taking: 1 dose each time for adults, 2 times a day.

[0076] 13. Preparation of extract of flos chrysanthemi

[0077] Take flos chrysanthemi 10 g; soak in 70% ethanol (1:10, m:V) at room temperature for 12 h, heat to reflux for 2 h, filter, collect the filtrate, and the residue is extracted with distilled water under the same conditions for 2 times, each time heat to reflux for 2 h, filter the extract, and collect the filtrate. Combine the filtrates of the 3 times, concentrate under reduced pressure, and freeze-dry under vacuum to obtain the extract of Combination 13.

[0078] Method and dosage of taking: 1 dose each time for adults, 2 times a day.

[0079] 14. Preparation of extract of semen ziziphi spinosae

[0080] Take semen ziziphi spinosae 12 g; soak in 70% ethanol (1:10, m:V) at room temperature for 12 h, heat to reflux for 2 h, filter, collect the filtrate, and the residue is extracted with distilled water under the same conditions for 2 times, each time heat to reflux for 2 h, filter the extract, and collect the filtrate. Combine the filtrates of the 3 times, concentrate under reduced pressure, and freeze-dry under vacuum to obtain the extract of Combination 14.

[0081] Method of taking and dosage: 1 dose each time, 2 times a day for adults.

[0082] 15. Preparation of Lily Extract

[0083] Take Lily 15g; soak in 70% ethanol (1:10, m:V) at room temperature for 12h, heat reflux for 2h, filter, collect filtrate, and extract the residue with distilled water under the same conditions for 2 times, each time heat reflux for 2h, filter the extract, and collect the filtrate. Combine the 3 filtrates, concentrate under reduced pressure, freeze-dry under vacuum to obtain Combination 15 extract.

[0084] Method of taking and dosage: 1 dose each time, 2 times a day for adults.

[0085] 16. Preparation of Fried Licorice Extract

[0086] Take Fried Licorice 10g; soak in 70% ethanol (1:10, m:V) at room temperature for 12h, heat reflux for 2h, filter, collect filtrate, and extract the residue with distilled water under the same conditions for 2 times, each time heat reflux for 2h, filter the extract, and collect the filtrate. Combine the 3 filtrates, concentrate under reduced pressure, freeze-dry under vacuum to obtain Combination 16 extract.

[0087] Method of taking and dosage: 1 dose each time, 2 times a day for adults.

[0088] Preparation of Granules of Traditional Chinese Medicine Composition (Combination 1) in Example 22

[0089] Ingredients: raw malt 18g, dried tangerine or orange peel 15g, cassia seed 13g, chrysanthemum 10g, Chinese date kernel 12g, lily 15g, and fried licorice 10g;

[0090] Take raw malt 18g, dried tangerine or orange peel 15g, cassia seed 13g, chrysanthemum 10g, Chinese date kernel 12g, lily 15g, and fried licorice 10g; soak in 70% ethanol (1:10, m:V) at room temperature for 12h, heat reflux for 2h, filter, collect filtrate, and extract the residue with distilled water under the same conditions for 2 times, each time heat reflux for 2h, filter the extract, and collect the filtrate. Combine the 3 filtrates, concentrate under reduced pressure, concentrate to a relative density of 1.20-1.40 (25°C), dry, pulverize into fine powder, add 1:1-1:3 dextrin, mix uniformly, granulate, dry, and sieve to 20-30 mesh. Fill into double aluminum packaging bags.

[0091] Preparation of Tablets of Traditional Chinese Medicine Composition (Combination 1) in Example 3

[0092] Ingredients: raw malt 18g, dried tangerine or orange peel 15g, cassia seed 13g, chrysanthemum 10g, Chinese date kernel 12g, lily 15g, and fried licorice 10g;

[0093] Take raw malt 18g, dried tangerine or orange peel 15g, cassia seed 13g, chrysanthemum 10g, Chinese date kernel 12g, lily 15g and fried licorice 10g; soak in 70% ethanol (1:10, m:V) at room temperature for 12h, heat to reflux for 2h, filter, collect the filtrate, and extract the residue with distilled water under the same conditions for 2 times, each time heat to reflux for 2h, filter the extract, and collect the filtrate. Combine the filtrates of the three times, concentrate under reduced pressure, concentrate to a relative density of 1.20-1.40 (25°C), dry, and crush into fine powder. Put the above mixture of raw and auxiliary materials into a one-step granulator, add starch, lactose and microcrystalline cellulose (1:1:2) to granulate and dry. After measuring the moisture content <2%, sieve the granules through a 20-30 mesh sieve, add 0.1-1% micronized silica gel and magnesium stearate, and mix well. Use 8#-9# punch to press the tablets, and control the tablet pressing force at 20-40 Newton. Put the pressed tablets into a coating machine, coat with moisture-proof and light-proof coating, and control the weight gain at 2%-4%.

[0094] Effect Example 1 Comparison of the Anti-depression Effects of Different Traditional Chinese Medicine Compositions

[0095] Experimental animals: ICR mice, male, 18-22g, purchased from Changchun Yis Experimental Animal Technology Co., Ltd.

[0096] Test samples: compositions 1-16 prepared in Example 1, according to the human clinical dose, convert into mouse dose according to the body surface area method, take the corresponding dose of traditional Chinese medicine composition, add distilled water to prepare a solution for intragastrical administration.

[0097] Experimental instruments: mouse swimming device: a glass container with a diameter of 14cm and a height of 19cm. Mouse tail suspension box: 30x25x30cm, Shanghai Xinsuo Company. Electronic balance: Shanghai Shunyu Hengping Scientific Instrument Co., Ltd. Dehydrator: DIAPATH. Embedding machine: Wuhan Junjie Electronics Co., Ltd. Pathological section machine: Shanghai Leica Instrument Co., Ltd. Tissue slice machine: Zhejiang Jinhua Kodie Instrument Equipment Co., Ltd. Microscope: OLYMPUS JAPAN

[0098] Grouping and administration: after the mice are adapted to the environment for 7 days, the mice are randomly grouped into 19 groups, which are blank control group, model group, fluoxetine group (10mg / kg), compositions 1-16 groups, n=12 for each group. All the mice are administered by intragastrical administration, 0.1mL / 10g body weight, once a day, for 35 days. The blank group and the model group are administered with distilled water by intragastrical administration. The model group, the fluoxetine group and the administration groups are subjected to chronic unpredictable mild stress every day, and detected after 35 days.

[0099] Construction of the mouse model of depression: the mouse model of depression was constructed by chronic unpredictable mild stress. Chronic unpredictable mild stress included water deprivation for 24 h, food deprivation for 24 h, water and food deprivation for 24 h, tail pinch for 10 min, black and white reversal, cold water swimming (10℃) for 10 min, hot water swimming (45℃) for 10 min, 45°cage tilting for 12 h, tail suspension for 5 min, restraint for 2 h, wet bedding for 24 h, etc. Two stimuli were randomly applied to the mice for 1 h every day, and each stimulus did not appear repeatedly.

[0100] Index detection 1, sucrose preference test (SPT):

[0101] Forty-eight hours before the test, all mice were given 1% sucrose drinking water to adapt to the sucrose drinking water. In the first 24 h, two bottles of 1% sucrose drinking water were placed in each cage; in the second 24 h, one of the bottles was replaced with regular drinking water. During the test, the mice were deprived of water and food for 12 h, and each mouse was given one bottle of 1% sucrose drinking water and one bottle of regular drinking water. The weights of the two bottles were precisely measured before the water was given. After 2 h, the positions of the two bottles were exchanged. After 4 h, the two bottles were taken out and the weights were precisely measured again. The percentage of the mice's sucrose water preference was calculated by the formula. Increase rate = (experimental group - model group) / model group x 100%. The results are shown in Table 1.

[0102] Table 1 Results of sucrose preference test in mice (X ± SD)

[0103]

[0104] Note: # is compared with the blank control group, #p<0.05, ##p<0.01; * is compared with the model group, *p<0.05, **p<0.01.

[0105] According to the experimental results in Table 1, it can be found that the sucrose water preference rate of the model group was significantly lower than that of the blank control group (p<0.01), indicating that the mouse model of depression was successfully constructed. Compared with the model group, the sucrose water preference rate of mice in compositions 1-9 was significantly improved (p<0.01 and p<0.05), and the sucrose water preference rate of mice in compositions 10-16 was improved, but the difference was not statistically significant. This indicates that compositions 1-9 have an antidepressant effect, and compositions 1-3 have a significant advantage in antidepressant effect compared with compositions 4-9, and composition 1 has the best antidepressant effect. It is suggested that the traditional Chinese medicines in compositions 1-3 have a synergistic effect, and the compatibility ratio of composition 1 is the best, and its antidepressant effect is stronger than that of any single component in the composition.

[0106] Index detection 2, tail suspension test (TST):

[0107] The mouse tail was stuck on the mouse tail hanging support 2 cm from the tail tip, and the mouse head was hung in a soundproof dark box 50 cm from the ground. The activity of the mouse was analyzed, and the behavior of the mouse in the soundproof dark box for 6 min was recorded. The immobile time of the last 4 min was recorded. The decrease rate = (model group-experimental group) / model group x 100%. The results are shown in Table 2.

[0108] Table 2 Results of the mouse tail suspension test (X ± SD)

[0109]

[0110] Note: # is compared with the blank control group, #p<0.05, ##p<0.01; * is compared with the model group, *p<0.05, **p<0.01

[0111] According to the experimental results in Table 2, it can be found that the immobile time of the mice in the model group was significantly prolonged (p<0.01) compared with the blank control group, indicating that the mouse model of depression was successfully constructed. The immobile time of the mice in compositions 1-9 was significantly reduced (p<0.01 and p<0.05) compared with the model group, and the immobile time of the mice in compositions 10-16 also had a reduction phenomenon, but the difference was not statistically significant. The immobile time of compositions 1-3 had a significant advantage compared with compositions 4-9, and the immobile time of composition 1 was the shortest. It is suggested that the traditional Chinese medicines in compositions 1-3 have a synergistic anti-depression effect, and the compatibility ratio of composition 1 is the best, and its anti-depression effect is stronger than the individual application of any component in the composition.

[0112] Index detection 3, forced swimming test (FST):

[0113] The mouse was placed in a 18 cm diameter and 40 cm high organic glass tube. The water depth was 15 cm, and the water temperature was 23-25℃ in the soundproof dark box. The mouse was swimming for 6 min, and the activity of the mouse was recorded. The total immobile time of the mouse in the last 4 min was calculated. The mouse floated on the water surface and made necessary movements to keep its head above the water surface to maintain breathing, which was judged as immobile. At the end of the swimming test, the mouse was taken out of the water and dried with a hair dryer. The decrease rate = (model group-experimental group) / model group x 100%. The results are shown in Table 3.

[0114] Table 3 Results of the forced swimming test of mice (X ± SD)

[0115]

[0116] Note: # is compared with the blank control group, #p<0.05, ##p<0.01; * is compared with the model group, *p<0.05, **p<0.01

[0117] According to the experimental results of Table 3, it can be found that the forced swimming rest time of the model mice was significantly prolonged (p<0.01) compared with the blank control group, indicating that the mouse model of depression was successfully constructed. Compared with the model group, the forced swimming rest time of mice in compositions 1-9 was significantly reduced (p<0.01 and p<0.05), and the rest time of mice in compositions 10-16 was reduced, but the difference was not statistically significant. The swimming rest time of compositions 1-3 had significant advantages compared with compositions 4-9, and the swimming rest time of composition 1 was the shortest. It is suggested that the traditional Chinese medicines in compositions 1-3 have synergistic anti-depression effect, and the compatibility ratio of composition 1 is the best, and its anti-depression effect is stronger than the individual application of any component in the composition.

[0118] Expression detection experiment of NE and 5-HT in the hippocampus of mouse brain:

[0119] After the behavioral index detection of mice was completed, the hippocampus of mice was stripped on ice and stored in a 1.5 mL EP tube. Then, the expression levels of 5-HT and NE in the hippocampus of mice were measured immediately using mouse 5-hydroxytryptamine ELISA kit and mouse norepinephrine ELISA kit double antibody sandwich method. The specific operation was strictly performed according to the manufacturer's instructions of the kit, and the content of 5-HT and NE in the hippocampus of mouse brain was calculated according to the standard curve method. The results are shown in Table 4.

[0120] Table 4 Effect of composition 1 on the concentration of NE and 5-HT in the hippocampus

[0121]

[0122] Note: # is compared with the blank control group, # p<0.05, ## p<0.01; * is compared with the model group, * p<0.05, ** p<0.01

[0123] According to the experimental results of Table 4, it can be found that the levels of 5-HT and NE in the hippocampus of mice in the model group were significantly reduced (p<0.01), and the administration of composition 1 could significantly increase the concentrations of 5-HT and NE in the hippocampus of model mice (p<0.01), suggesting that the anti-depression effect of composition 1 is related to the regulation of the content of 5-HT and NE in the hippocampus of mouse brain.

[0124] Histopathological morphology detection experiment of Nissl bodies in the hippocampus of brain:

[0125] Nissl staining was used to detect the morphology and number of Nissl bodies in the hippocampus of mice. The detailed steps were as follows: the brain tissue of mice was fixed with 4% paraformaldehyde solution, paraffin sections were prepared with a thickness of 4 mm, and after deparaffinization to water, the sections were stained with Nissl staining solution (Beyotime, China) at 37°C for 40 min. Then, the sections were dehydrated with anhydrous ethanol, permeabilized with xylene twice for 5 min each time, and mounted with neutral balsam. After completion, imaging was performed under a light microscope, and the number of cells was quantitatively analyzed using ImageJ 1.45 analysis software. The results are shown in Table 5, Figure 1 .

[0126] Table 5 Number of Nissl staining positive cells in CA1 region of hippocampus of mice (X ± SD)

[0127]

[0128] Note: # is compared with the blank control group, #p<0.05, ##p<0.01; * is compared with the model group, *p<0.05, **p<0.01.

[0129] According to the experimental results in Table 5 and Figure 1 It can be found that the number of neurons in the hippocampus of mice in the blank group is large, the arrangement is close, the cell morphology is complete, the clear structure is rich in Nissl bodies. Compared with the blank group, the hippocampal neurons of the mice in the model group were arranged loosely, the number was significantly reduced, and the Nissl substance was reduced or dissolved (p<0.01). Compared with the model group, the number of Nissl bodies in the hippocampus of mice in the composition 1 group was significantly increased (p<0.01), which indicated that the composition 1 could increase the number of Nissl bodies in the hippocampus of mice with depression.

[0130] Pathological detection experiment of BDNF distribution in hippocampus in brain of mice

[0131] The distribution of BDNF in the hippocampus of mice was analyzed by immunohistochemistry. First, the whole brain tissue of the mice was fixed, paraffin-embedded, and cut into 5 μm sections. After deparaffinization to water, the section tissue was placed in a repair box containing citric acid antigen repair buffer (PH 6.0), heated to boiling with medium fire for 8 min, stopped for 8 min, then converted to low heat for 7 min, naturally cooled, placed in PBS (PH 7.4) solution, and de-stained for 5 min each time. After washing three times, the section was placed in a 3% hydrogen peroxide solution and incubated at room temperature in the dark for 25 min. 3% BSA solution was added in the group circle, covering the entire tissue, and blocked for 30 min. Then the primary antibody was added, and the primary antibody information was Cell Signaling Technology; #47808; 1:1000; USA, incubated at 4°C overnight. The next day, the secondary antibody was added and incubated at 37°C for 50 min. After washing three times, the newly prepared DBA color developing solution was added, and the color developing was stopped after water washing for 20 min. The section was re-stained with hematoxylin for 3 min, dehydrated and mounted. The BDNF positive area in the hippocampus was measured by quantitative image analysis through microscope imaging and ImageJ 1.45 analysis software. The results are shown in Table 6, Figure 2 .

[0132] Table 6 Immunohistochemical results of BDNF in the hippocampus of mice

[0133]

[0134] Note: # is compared with the blank control group, #p<0.05, ##p<0.01; * is compared with the model group, *p<0.05, **p<0.01

[0135] According to the experimental results in Table 6 and Figure 2 It can be found that compared with the blank group, the percentage of BDNF positive area in the CAI region of the hippocampus of the model group mice was significantly reduced (p<0.01). Compared with the model group, the percentage of BDNF positive area in the CAI region of the hippocampus of the composition 1 group mice was significantly increased (p<0.01), indicating that the composition 1 group can increase the percentage of BDNF positive area in the CAI region of the hippocampus of the depressed mice.

[0136] Effect Example 2 Comparison and evaluation of the anti-anxiety effects of different traditional Chinese medicine compositions.

[0137] Experimental animals: KM mice, male, 18-22 g, purchased from Changchun Yis Experimental Animal Technology Co., Ltd.

[0138] Test samples: compositions 1-16 prepared in Example 1, according to the human clinical dose, the mouse dose was calculated according to the body surface area method, the corresponding dose of traditional Chinese medicine composition was weighed, distilled water was added, and a solution was prepared for intragastrical administration.

[0139] Experimental instruments: Mouse open field instrument: Beijing Ubi-soft Biological Technology Center. Animal light-dark shuttle box: Shanghai Xinsoft Information Technology Co., Ltd.

[0140] Grouping and administration: After the mice were adapted to the environment for 7 days, the mice were randomly divided into 19 groups, namely blank control group, model group, diazepam group, composition 1-16 group, 12 mice in each group. The blank group and the model group were given distilled water by gavage, and the positive group was injected intraperitoneally with diazepam (2 mg·kg -1 , 0.25 mL per mouse). The administration group was given the corresponding drug according to the dose every day, and the administration was continued for 7 days.

[0141] Construction of anxiety model: Except for the blank group, the mice in other groups were subcutaneously injected with meclozine (8 mg·kg -1 , 0.2 mL per mouse) for 3 consecutive days to prepare the anxiety model. The number of times and time of the model animals entering the light box were significantly reduced compared with the blank group animals, indicating that the modeling was successful.

[0142] Light-dark box shuttle (OFT) experiment:

[0143] After 1 hour of administration on the 2nd and 5th day, the mice were placed into the animal light-dark shuttle box from the light room with their backs to the shuttle hole. The total distance and average movement speed of the mice in the dark room within 5 minutes were recorded, and the average value of two measurement results was taken for statistics. The drop rate = (model group-experimental group) / model group x 100%. The results are shown in Tables 7 and 8.

[0144] Table 7 Results of dark box movement distance determination experiment (X ± SD)

[0145]

[0146] Note: # is compared with the blank control group, #p<0.05, ##p<0.01; * is compared with the model group, *p<0.05, **p<0.01

[0147] Table 8 Results of dark box movement speed determination experiment (X ± SD)

[0148]

[0149] Note: # is compared with the blank control group, #p<0.05, ##p<0.01; * is compared with the model group, *p<0.05, **p<0.01

[0150] According to the experimental results of Table 7, Table 8, it can be found that: compared with the blank group, the activity distance and speed of the mice in the dark box of the model group increased significantly (P<0.01), suggesting that the mouse anxiety model was successful; compared with the model group, the composition 1 group can significantly reduce the activity distance and speed of the anxiety model mice in the dark box (P<0.01). It is suggested that composition 1 has an anti-anxiety effect. Among them, the anti-anxiety effect of composition 1-3 has a significant advantage compared with composition 4-9, and the anti-anxiety effect of composition 1 is the best. It is suggested that the traditional Chinese medicines in composition 1-3 have a synergistic effect, and the compatibility ratio of composition 1 is the best, and its anti-anxiety effect is stronger than the individual application of any component in the composition.

[0151] Open field test (OFT) experiment:

[0152] After 1h of administration on the 3rd, 6th day, the mice were placed into the open field along the barrel wall, and the spontaneous activity of the animals was observed for 10 min using the computer real-time detection and analysis processing system. The total movement distance, movement time, etc. were automatically recorded by the system. The average value of two measurement results was taken for statistics. The decrease rate = (model group-experimental group) / model group x 100%. The results are shown in Table 9-10.

[0153] Table 9 Determination results of total movement distance of mice (X±SD)

[0154]

[0155] Note: # is compared with the blank control group, #p<0.05, ##p<0.01; * is compared with the model group, *p<0.05, **p<0.01

[0156] Table 10 Determination results of average movement speed of mice (X±SD)

[0157]

[0158]

[0159] Note: # is compared with the blank control group, #p<0.05, ##p<0.01; * is compared with the model group, *p<0.05, **p<0.01

[0160] According to the experimental results of Table 9, Table 10, it can be found that compared with the normal group, the model group has a significant increase in the total path length in the central field and a significant increase in the average activity speed (P<0.01), indicating that the anxiety model is successful; compared with the model group, the compositions 1-9 can significantly reduce the total path length and the activity speed of the anxiety model animals (P<0.01), indicating that the compositions 1-9 have an anti-anxiety effect. And the anti-anxiety effect of the compositions 1-3 is significantly stronger than that of the compositions 4-9, and the anti-anxiety effect of the composition 1 is the best, indicating that the compatibility ratio is the best, and the anti-anxiety effect is stronger than that of any single component in the composition.

[0161] Effect Example 3 Comparison and evaluation of anti-fatigue effects of different traditional Chinese medicine compositions

[0162] Experimental animals: ICR mice, male, SPF level, 22-24g, purchased from Changchun Yis Experimental Animal Technology Co., Ltd.

[0163] Test samples: The compositions 1-16 prepared in Example 1 are converted into mouse doses according to the human clinical dose by the body surface area method, and the corresponding doses of traditional Chinese medicine compositions are weighed, added with distilled water, and prepared into solutions for intragastrical administration.

[0164] Grouping and administration: After the mice are adapted to the environment for seven days, the mice are randomly divided into 18 groups, i.e., a model group, a tea polyphenol control group, and composition 1-16 groups, 12 mice in each group. The model group is given distilled water by intragastrical administration, the positive group is given tea polyphenol (30mg / (kg), and the composition 1-16 groups are given corresponding drugs at doses every day, continuously for 15 days.

[0165] Experimental method: 30min after the last administration, without affecting the swimming of the mice, a certain mass of tin wire is bound to the tail of the mice according to 5% of the body weight of the mice, and the mice are placed in a swimming tank [water temperature is (25±1)℃, and the depth is 30cm] to swim. The time from the start of swimming to the exhaustive swimming of the mice is recorded. After the head of the mouse is kept in the water for 10s, it cannot swim out of the water to breathe, which is the exhaustive swimming time of the mouse. The improvement rate = (experimental group-model group) / model group x 100%. The results are shown in Table 12.

[0166] Table 11 Results of anti-fatigue experiments of mice (X±SD)

[0167]

[0168]

[0169] Note: * is compared with the model group, *p<0.05, **p<0.01

[0170] According to the experimental results of Table 11, it can be found that compared with the fatigue model group, the load swimming time of mice in composition 1-10 group, composition 13 group and tea polyphenol control group is significantly prolonged (P<0.05 and P<0.01), which indicates that composition 1-10 group and composition 13 group can significantly improve the tolerance of mice to fatigue and relieve the fatigue of mice. The anti-fatigue effect of composition 1-3 is stronger than that of composition 4-10 and composition 13 group, and the anti-fatigue effect of composition 1 is the best, which indicates that the compatibility ratio is the best, and the anti-fatigue effect is stronger than that of any single component in the composition.

[0171] Effect Example 4 Comparison and evaluation of sedative and hypnotic effects of different traditional Chinese medicine compositions with acute administration

[0172] Experimental animals: ICR mice, male, SPF level, 18-20g, purchased from Changchun Yis Experimental Animal Technology Co., Ltd.

[0173] Tested samples: compositions 1-16 prepared in Example 1, according to the human clinical dose, the mouse dose was converted according to the body surface area method, the corresponding dose of traditional Chinese medicine composition was weighed, distilled water was added to prepare a solution for gavage.

[0174] Grouping and administration: after the mice were adapted to the environment for seven days, the mice were randomly divided into 18 groups, namely the blank control group, the diazepam group (3mg / kg), the composition 1-16 group, 12 mice in each group. The blank group was given distilled water by gavage, the positive group diazepam group was given diazepam 3mg / kg body weight by gavage, and the drug administration group was given the corresponding medicine according to the dose every day.

[0175] Experimental method: after the mice were adapted to the environment for seven days, the mice were randomly divided into normal control group, diazepam group and composition 1-16 group, and the gavage volume of mice in each group was 0.2mL / 10g. Among them, the normal control group was given distilled water by gavage, the diazepam group was given diazepam 3mg / kg body weight by gavage, and the drug administration group was given the corresponding medicine, 1h later, each group of mice was given intraperitoneal injection of sodium pentobarbital 30mg / kg body weight, 0.1mL / 10g, and the sleep latency, sleep time and number of sleeping animals (the disappearance of righting reflex was the beginning of sleep, and the recovery of righting reflex was the end of sleep, and the time between them was recorded as the sleep time of mice; the time from intraperitoneal injection of barbital sodium to the disappearance of righting reflex was the sleep latency of mice) of each group of mice were observed and recorded. The results are shown in Tables 12 and 13.

[0176] Table 12 Test results of sleep latency of mice (X±SD)

[0177]

[0178] Note: * is compared with the model group, *p<0.05, **p<0.01

[0179] Table 13 Results of sleep time test of mice (X±SD)

[0180]

[0181]

[0182] Note: * is compared with the model group, *p<0.05, **p<0.01

[0183] According to the experimental results of Table 12-Table 13, it can be found that compositions 1-16 have different degrees of sleep-aiding effect, wherein the sleep-aiding effect of compositions 1-3 is stronger than that of compositions 4-16, the sleep-aiding effect of composition 1 is the best, which indicates that the compatibility ratio is the best, and the sleep-aiding effect is stronger than the single application of any component in the composition.

[0184] Safety evaluation of effect example 5

[0185] Experiment 1, acute toxicity experiment

[0186] Select 40 healthy mice, half male and half female, the body weight of mice is 22±2g, after fasting for 12 hours, the traditional Chinese medicine composition 1 prepared by example 1 with a dose of 18.74g / kg is used for gavage, after administration, continue to fast for 4h, then give feed, continuously observe for 14 days, record the 14-day mouse physical signs, body weight, food intake, poisoning and death, the results are shown in Table 14, Table 15.

[0187] Experiment 2, subchronic toxicity experiment

[0188] Select 40 healthy mice, half male and half female, the body weight of mice is 22±2g, after fasting for 12 hours, the traditional Chinese medicine composition 1 prepared by example 1 with a dose of 18.74g / kg is used for gavage, after administration, continue to fast for 4h, then give feed, continuously give drug for 35 days, record the 35-day mouse physical signs, body weight, food intake, poisoning and death, the results are shown in Table 16.

[0189] Table 14 Results of body weight determination of mice in acute toxicity experiment

[0190]

[0191] Table 15 Results of food intake determination in acute toxicity experiment

[0192]

[0193] Table 16 Results of 35-day subchronic toxicity experiment

[0194]

[0195] According to the experimental results of Tables 14-16, it can be seen that during the experimental observation, the diet activities of the animals in each group were normal, and the growth was good, and no poisoning performance and death were observed. The oral toxicity LD50 of the traditional Chinese medicine composition in the present application for male and female rats was >18.74 g / kg, and according to the acute toxicity classification standard, it belonged to the non-toxic class.

[0196] Through the above description of the technical solutions of the present application, the beneficial effects of the present application are further illustrated. The formula of the present application deeply implements the concept of food and medicine homology, which means that it can be used as both a medicine and a food. The food and medicine homology traditional Chinese medicine composition of the present application can further reduce the safety hidden danger in long-term medication and improve the compliance of patients.

[0197] The above is only the preferred embodiment of the present application, and it should be noted that for ordinary skilled persons in the art, several improvements and refinements can be made without departing from the principles of the present application, and these improvements and refinements should also be considered within the protection scope of the present application.

Claims

1. A traditional Chinese medicine composition, characterized in that, It is made from the following components in parts by weight: 15-25 parts raw malt, 12-18 parts dried tangerine peel, 10-15 parts cassia seed, 8-13 parts chrysanthemum, 8-20 parts jujube seed, 10-20 parts lily bulb and 8-12 parts prepared licorice root.

2. The traditional Chinese medicine composition according to claim 1, characterized in that, It is made from the following components in parts by weight: 18 parts raw malt, 12-18 parts dried tangerine peel, 13 parts cassia seed, 10 parts chrysanthemum, 10-20 parts jujube seed, 10-20 parts lily bulb and 10 parts prepared licorice root.

3. The traditional Chinese medicine composition according to claim 1 or 2, characterized in that, It is made from the following components in parts by weight: 18 parts raw malt, 15 parts dried tangerine peel, 13 parts cassia seed, 10 parts chrysanthemum, 12 parts jujube seed, 15 parts lily bulb and 10 parts prepared licorice root; Alternatively, use 18 parts raw malt, 12 parts dried tangerine peel, 13 parts cassia seed, 10 parts chrysanthemum, 10 parts jujube seed, 10 parts lily bulb, and 10 parts prepared licorice root; Alternatively, use 18 parts raw malt, 18 parts dried tangerine peel, 13 parts cassia seed, 10 parts chrysanthemum, 20 parts jujube seed, 20 parts lily bulb, and 10 parts prepared licorice root.

4. The method for preparing the traditional Chinese medicine composition according to any one of claims 1 to 3, characterized in that, Includes the following steps: Step 1: Take raw malt, dried tangerine peel, cassia seed, chrysanthemum, jujube seed, lily bulb and roasted licorice root, soak them in a solution, heat and reflux to extract, and then obtain the extract and filter residue; Step 2: Take the filter residue from Step 1, soak it in a solution, and then heat it under reflux to extract the extract and filter residue. Step 3: Repeat step 2 to obtain the extract and filter residue, combine the extracts obtained in steps 1 to 3, and obtain the traditional Chinese medicine composition after depressurization, concentration and freeze-drying.

5. The preparation method according to claim 4, characterized in that, In steps 1 to 3, the solution is independently selected from ethanol or 0-95 vol% aqueous ethanol solution, and the volume of the solution is 5 to 20 times the total mass of the raw malt, dried tangerine peel, cassia seed, chrysanthemum, jujube seed, lily and roasted licorice.

6. The preparation method according to claim 4 or 5, characterized in that, The volume of the solution is 10 times the total mass of the raw malt, dried tangerine peel, cassia seed, chrysanthemum, jujube seed, lily bulb and roasted licorice.

7. The preparation method according to claim 4, characterized in that, In step 1 or 2, the soaking time is 12 hours and the heating and reflux extraction time is 2 hours.

8. The use of the traditional Chinese medicine composition according to any one of claims 1 to 3 or the traditional Chinese medicine composition prepared by the preparation method according to any one of claims 4 to 7 in the preparation of drugs for antidepressant, anti-anxiety, anti-fatigue and / or sleep aid.

9. A drug for treating depression, anxiety, fatigue, and / or sleep, characterized in that, It is made from the traditional Chinese medicine composition according to any one of claims 1 to 3 or the traditional Chinese medicine composition prepared by the preparation method according to any one of claims 4 to 7.

10. The medicament according to claim 9, characterized in that, The dosage form of the product is selected from any one of tablets, capsules, granules, pills, powders, elixirs, syrups, oral solutions, and oral suspensions.

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