CN113397171A - Composition and application thereof - Google Patents
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- CN113397171A CN113397171A CN202110585553.8A CN202110585553A CN113397171A CN 113397171 A CN113397171 A CN 113397171A CN 202110585553 A CN202110585553 A CN 202110585553A CN 113397171 A CN113397171 A CN 113397171A
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Classifications
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- A—HUMAN NECESSITIES
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- A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
- A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
- A23L33/17—Amino acids, peptides or proteins
- A23L33/175—Amino acids
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- A—HUMAN NECESSITIES
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Abstract
The application discloses a composition and application thereof. The composition comprises the following components: 5-16 parts of S-adenosylmethionine; 5-16 parts of gamma-aminobutyric acid; 5-25 parts of alpha-lactalbumin. The components of the composition are reasonably selected, have a synergistic interaction effect among the components, are scientific in proportion among the components, are compatible for use, and have a remarkable effect of treating and/or preventing depression.
Description
Technical Field
The application relates to a composition and application thereof, belonging to the technical field of health-care food.
Background
Depression is a common affective disorder, characterized primarily by a marked and persistent depression, which is manifested primarily by: the symptoms of low mood, delayed thought response, hypovolemia, anxiety, anorexia, insomnia, hypodynamia and other physical discomfort symptoms, and even extreme behaviors such as suicide. With the increasing social competition in recent years, the pace of life is increasing, and many emergency factors are increasing, so that the depression is in a high-rise situation year by year. Depression is currently ranked fourth in the world's disabling disease and has been second only to heart disease by the year 2020. In china alone, over 2600 million people suffer from depression, which brings the total economic burden to china up to 622 billion yuan.
The pathogenesis of depression is not clear so far, and the most studied monoamine neurotransmitters and their receptor hypothesis, inflammatory response hypothesis, hypothalamus-pituitary-adrenal (HPA axis) dysfunction hypothesis, neurotrophic factor hypothesis, and multifactorial combined action hypothesis are the main drugs for treating depression: tricyclic antidepressants, monoamine oxidase inhibitors and reversible selective monoamine oxidase inhibitors, 5-hydroxytryptamine (5-HT) and Norepinephrine (NE) reuptake inhibitors, NE and Dopamine (DA) reuptake inhibitors, and the like. Although these drugs can improve the depressed state to various degrees, the side effects of these drugs are large, mainly apathy, fatigue, sleep disorders, cognitive dysfunction, sexual dysfunction, stroke, and the like.
Therefore, it is imperative to use ingredients without any toxic side effects and products for treating and preventing depression with significant effects.
Disclosure of Invention
According to one aspect of the application, the composition is provided, the components of the composition are reasonably selected, the components have a synergistic interaction effect, the mixture ratio of the components is scientific, and the composition is compatible with the components and has a remarkable effect of treating and/or preventing depression.
A composition comprising the following components:
5-16 parts of S-adenosylmethionine;
5-16 parts of gamma-aminobutyric acid;
5-25 parts of alpha-lactalbumin.
S-adenosylmethionine is an important physiological active substance, and is involved in more than 40 biochemical reactions in organisms, such as gene expression, cell membrane flow to polypeptide synthesis and the like, and SAMe is involved in more important biochemical reactions in such a complex way, so that the S-adenosylmethionine has wide and various therapeutic effects and has good curative effects on depression, arthritis, liver dysfunction and the like. SAMe is the most important methyl donor in the body, methyl is provided through methionine circulation to participate in synthesis and metabolism of various important physiological active substances in the body, such as 5-hydroxytryptamine, acetylcholine, epinephrine, creatine, carnitine, dopamine and the like, and normal emotional activity is maintained; methylation of phospholipids helps to enhance receptor function, increase receptor density, and improve receptor coupling. Therefore, SAMe content and dysfunction must affect synthesis or methylation of the mediators involved in the 1-carbon metabolic pathway to cause neuropsychiatric disorders. For example, in 1966, it was suggested that "pathological methyl transfer" is a schizophrenia pathogenesis, and when monoamine transmitter anabolism is affected, neurological disorders such as depression and anxiety are inevitably caused. And SAMe is a natural substance existing in human bodies, and has no side effect.
Gamma-aminobutyric acid (GABA), also known as aminobutyric acid, is a non-protein natural amino acid, is widely distributed, and has GABA presence in animals, plants, and microorganisms. GABA is a main inhibitory neurotransmitter in the central nervous system of mammals, mediates over 40% of inhibitory nerve conduction, has a postsynaptic inhibition effect, can enable postsynaptic neurons to be in a protective inhibition state through mechanisms of postsynaptic membrane super-activation, ion influx reduction, cell metabolism reduction, oxygen consumption reduction and the like, and can reduce release of glutamic acid through presynaptic inhibition, so that death of neurons in a perfusion region is reduced, and the vitality of the neurons is improved.
Alpha-lactalbumin, a tightly structured calcium-binding globulin, is one of whey proteins, and is mainly present in breast milk. The alpha-lactalbumin is rich in various amino acids necessary for human bodies, particularly has high relative content of tryptophan, lysine and cysteine, wherein the tryptophan participates in the synthesis of regulatory protein and has the function of promoting the differentiation of bone marrow T lymphocyte precursors into mature T lymphocytes; lysine not only participates in the synthesis of body protein, but also is a precursor substance of carnitine synthesis, and participates in the beta-oxidation process of fat in vivo; cysteine is a component of glutathione and has anti-inflammatory effect.
The innovation of the application is as follows:
1. the components are reasonably selected, and particularly, the addition of S-adenosylmethionine, gamma-aminobutyric acid and alpha-lactalbumin obviously improves the treatment effect of the traditional Chinese medicine composition on depression;
2. the invention has scientific mixture ratio among the components, and particularly controls the proportion of S-adenosylmethionine, gamma-aminobutyric acid and alpha-lactalbumin to be 1: 1: 1-2: 2: 5, the efficacy of the product can be greatly improved;
3. the compatibility of medicines reduces the cost of single raw material and obviously increases the effect.
Optionally, the composition comprises the following components:
5-10 parts by weight of S-adenosylmethionine;
5-10 parts of gamma-aminobutyric acid;
5-25 parts of alpha-lactalbumin.
Optionally, the composition comprises the following components:
5-12 parts by weight of S-adenosylmethionine;
5-12 parts of gamma-aminobutyric acid;
5-15 parts of alpha-lactalbumin.
Optionally, the composition comprises the following components:
5-8 parts of S-adenosylmethionine;
5-10 parts of gamma-aminobutyric acid;
5-12 parts of alpha-lactalbumin.
Optionally, the composition comprises the following components:
8-16 parts of S-adenosylmethionine;
5-10 parts of gamma-aminobutyric acid;
12-20 parts of alpha-lactalbumin.
Optionally, the composition comprises the following components:
10-16 parts of S-adenosylmethionine;
8-10 parts of gamma-aminobutyric acid;
15-20 parts of alpha-lactalbumin.
Optionally, the composition consists of:
5-16 parts of S-adenosylmethionine;
5-16 parts of gamma-aminobutyric acid;
5-25 parts of alpha-lactalbumin.
Optionally, the composition consists of:
5-10 parts by weight of S-adenosylmethionine;
5-10 parts of gamma-aminobutyric acid;
5-25 parts of alpha-lactalbumin.
Optionally, the composition consists of:
5-12 parts by weight of S-adenosylmethionine;
5-12 parts of gamma-aminobutyric acid;
5-15 parts of alpha-lactalbumin.
Optionally, the composition consists of:
5-8 parts of S-adenosylmethionine;
5-10 parts of gamma-aminobutyric acid;
5-12 parts of alpha-lactalbumin.
Optionally, the composition consists of:
8-16 parts of S-adenosylmethionine;
5-10 parts of gamma-aminobutyric acid;
12-20 parts of alpha-lactalbumin.
Optionally, the composition consists of:
10-16 parts of S-adenosylmethionine;
8-10 parts of gamma-aminobutyric acid;
15-20 parts of alpha-lactalbumin.
According to one aspect of the application, the use of the composition of any one of the above in the preparation of a product for the treatment and/or prevention of depression is provided.
Optionally, the depression is liver disease-induced depression or postpartum depression.
Optionally, the product for treating and/or preventing depression is a health food or a pharmaceutical preparation.
According to one aspect of the present application, there is provided a health food comprising the composition of any one of the above and an adjuvant.
According to one aspect of the present application, there is provided a pharmaceutical formulation comprising the composition of any one of the above and an adjuvant.
Optionally, the health food or the pharmaceutical preparation comprises the following components:
15-51 parts by weight of the composition;
20-60 parts of a flavoring agent;
1-20 parts by weight of a binder;
0.1-1 part by weight of a flow aid.
Optionally, the flavoring agent is selected from at least one of isomalt, erythritol, sorbitol, citric acid, malic acid, stevioside, food essence and fruit and vegetable powder;
the filler is at least one selected from microcrystalline cellulose and lactose;
the glidant is selected from at least one of magnesium stearate and silicon dioxide.
According to one aspect of the present application, there is provided a method for preparing the health food or the pharmaceutical preparation according to any one of the above, the method comprising the steps of:
mixing the composition with adjuvants to obtain the health food or the pharmaceutical preparation.
As an embodiment, the present application provides a composition comprising the following components:
5-16 parts of S-adenosylmethionine;
5-16 parts of gamma-aminobutyric acid;
5-20 parts of alpha-lactalbumin.
Optionally, the composition comprises the following components:
8 parts by weight of S-adenosylmethionine
10 parts by weight of gamma-aminobutyric acid
12 parts by weight of alpha-lactalbumin
The composition provided by the application is reasonable in compatibility and synergistic, and the health food for treating depression provided by the invention has obvious effects on depression, depression caused by liver diseases, postpartum depression and the like.
The composition provided by the application has obvious effect of treating depression: it can be used for preventing and treating emotion, anxiety, insomnia, asthenia, and pain.
The composition provided by the application has the effect of treating depression, is beneficial to the health of organisms, is suitable for healthy people, endangered depressed people and depression people, is matched with S-adenosylmethionine, gamma-aminobutyric acid and alpha-lactalbumin in raw materials, is reasonably compatible in the whole formula, is mild in medicine property, and is suitable for being used by more people for a long time.
The beneficial effects that this application can produce include:
(1) the composition provided by the application has the advantages that the component selection is reasonable, the components have a synergistic interaction effect, the proportion among the components is scientific, the components are compatible for use, and the effect is remarkably improved.
(2) The composition provided by the application is matched with S-adenosylmethionine, gamma-aminobutyric acid and alpha-lactalbumin in raw materials, is reasonably compatible in the whole formula, is mild in drug property, and is suitable for long-term use by more crowds.
(3) The composition and the health food provided by the application have good application prospects in being used as products for treating and/or preventing depression.
Detailed Description
The present application will be described in detail with reference to examples, but the present application is not limited to these examples.
The raw materials in the examples of the present application were all purchased commercially, unless otherwise specified.
Examples 1 to 5,Comparative examples 1 to 5A Single component or composition
The formulations of the individual components or compositions of examples 1 to 5 and comparative examples 1 to 5 are shown in Table 1.
TABLE 1 formulation of the individual Components or compositions of examples 1-5 and comparative examples 1-5
Preparation of the composition
The powder in the embodiment 1-5 and the powder in the comparative example 1-5 are weighed according to the weight parts and uniformly mixed to obtain the corresponding single component or composition.
The preparation method of the health food or the medicine comprises the following steps:
respectively adding 54 parts by weight of sorbitol, 15 parts by weight of microcrystalline cellulose and 1 part by weight of magnesium stearate into corresponding compositions, independently granulating the sorbitol according to the formula, wherein the wetting agent is 95% edible alcohol, the amount of the wetting agent is 10 wt% of the sorbitol, adding the sorbitol into a high-efficiency wet granulator, spraying the wetting agent, starting the stirring rotating speed at 80r/min, the shearing rotating speed at 1500r/min, taking the wetting agent out of the granulator after the wetting agent is added, carrying out 20-mesh wet granulation, adding the prepared wet granules into a fluidized drying machine for drying, setting the air inlet temperature to be less than 50 ℃, and obtaining dry granules when the moisture content of the materials is less than 3%; premixing S-adenosylmethionine, gamma-aminobutyric acid, alpha-lactalbumin and half of the dry granules, adding into a total mixing tank after uniformly premixing, simultaneously adding microcrystalline cellulose and the other half of the dry granules for mixing for 30min, adding magnesium stearate, and mixing for 4min to obtain total mixed granules; and tabletting the total mixed granules to obtain a finished product.
The advantageous effects of the present application are specifically described below by way of test examples.
1. Experimental Material
(ii) animals
The Beijing-breed mice are half male and half female, and the body mass is 18-22 g. Provided by Beijing research center for laboratory animals.
② medicine and main reagent
A. Experimental drugs:
the single components or compositions (without adjuvants) prepared in examples 1-5 and comparative examples 1-5.
B. Experimental reagent:
imipramine hydrochloride (3B Scientific, usa); physiological saline (national drug group); reserpine injection (national drug group); 5-hydroxytryptamine standard (Fluka, Switzerland); norepinephrine standard (Sigma, usa).
2. Experiment method and result of forced swimming experiment, open field experiment and tail suspension experiment
120 healthy Beijing-breed mice, half of male and female, were taken, and after 1 week acclimatization, were randomly divided into 12 groups, namely, 10 mice per group, namely, a blank control group, an imipramine hydrochloride group (dose 15 mg/kg. d), and test groups (examples 1 to 5 groups and comparative examples 1 to 5 groups) (dose 15 mg/kg. d). The medicine with the corresponding dose is dissolved in distilled water every day, the medicine is administered for 1 time by intragastric administration, the administration volume is 10ml/kg, the medicine is continuously administered for 14 days, a forced swimming experiment is carried out on the 14 th day, a mouse open field experiment is carried out on the 15 th day, a mouse tail suspension experiment is carried out on the 16 th day, wherein the blank group is intragastric administered with physiological saline with the same volume.
2.1 forced swimming test of mice
The forced swimming experiment is one of behavior despair models, is a classic method of an antidepressant drug evaluation model, is also one of models commonly used for antidepressant evaluation and screening, and is widely used for basic research of psychopharmacology.
The mice were moved to a quiet test room 60min before the experiment to reduce the stress on the animals. During the experiment, the mouse is placed in a cylindrical glass container with a water depth of 10cm, a diameter of 14cm and a water temperature of 23 +/-2 ℃, the upper opening is opened, the time lasts for 6min, the whole process is recorded by a high-definition digital camera, and the total time of the mouse moving within 4min is counted by using a timer in a double-blind mode. Immobility time is defined as the time the mouse stopped struggling in the water, floated on the water surface, and moved slightly to keep the head floating on the water surface.
The results are shown in Table 2.
Group of | The total time/s of mouse immobility was counted within 4min |
Blank control group | 128.66±3.15 |
Imipramine hydrochloride group | 90.34±1.08* |
Example 1 | 62.77±3.03* |
Example 2 | 38.46±2.36* |
Example 3 | 45.89±3.01* |
Example 4 | 54.13±2.24* |
Example 5 | 59.64±1.78* |
Comparative example 1 | 79.35±2.02* |
Comparative example 2 | 70.29±1.07* |
Comparative example 3 | 73.11±1.11* |
Comparative example 4 | 76.32±0.58* |
Comparative example 5 | 83.97±2.27* |
Note: p < 0.05 compared to the blank control group.
As can be seen from the data, compared with a blank control group, the immobile time of the swimming of the mice can be obviously shortened by the example group and the comparative group, wherein the shortened time of the example group is longer than that of the comparative group, and is simultaneously longer than that of the positive control group, which shows that the example group has a remarkable improvement effect on the shortening of the immobile time of the mice in a swimming despair model, and the composition has a certain antidepressant effect in a behavior despair model and generates a synergistic effect among the components.
2.2 mice open field experiment
The mice were moved to the open field experimental test room 60min before the experiment and adapted to the environment in advance. During the experiment, the mouse is taken out of the cage and placed in the center of an open field experimental device (500mm multiplied by 415mm) in an ethological test station, a shading cover curtain is rapidly pulled, and the central area is a bright room area. And (3) recording the serial number, date and state of the mouse in the operation software, then opening a recording system, recording the activity condition of the mouse within 10min through a camera above the starting equipment and a monitor connected with the camera, and recording the sum of the residence time of the central area of the mouse.
The results are shown in Table 3.
Group of | Residence time/s in the central zone |
Blank control group | 105.67±2.05 |
Imipramine hydrochloride group | 206.34±1.77* |
Example 1 | 400.88±2.63* |
Example 2 | 456.06±2.42* |
Example 3 | 439.19±3.09* |
Example 4 | 421.35±2.87* |
Example 5 | 408.52±3.11* |
Comparative example 1 | 234.01±2.55* |
Comparative example 2 | 264.25±3.63* |
Comparative example 3 | 251.54±2.99* |
Comparative example 4 | 247.66±2.81* |
Comparative example 5 | 222.49±3.27* |
Note: p < 0.05 compared to the blank control group.
Compared with a blank control group, the residence time of the example group, the comparative group and the positive control group in the central area is prolonged, and the data show that the prolonged time of the example group is longer than that of the positive control group, so that the pharmaceutical composition can prolong the residence time of the mouse in the bright room, the effect is obviously better than that of the comparative sample administration group, and the composition has a synergistic effect among the components and can obviously improve the anti-depression effect.
2.3 Tail suspension experiment
Mice were moved to the test room 60min prior to the experiment. The tail-hanging experimental frame is about 1m long, and is horizontally placed and fixed at a position which is about 30cm away from the table top. During the experiment, the tail of the mouse is fixed by an adhesive tape and hung on the tail hanging device, the head of the mouse is 8cm away from the desktop, the experiment lasts for 6min, the mouse is recorded by a high-definition digital camera, and the total motionless time of the mouse in 4min is counted by using a timer in a double-blind mode.
The results are shown in Table 4.
Group of | Suspension tail motionless time/s |
Blank control group | 96.63±3.99 |
Imipramine hydrochloride group | 80.15±0.76* |
Example 1 | 55.98±1.07* |
Example 2 | 40.33±1.13* |
Example 3 | 43.04±1.22* |
Example 4 | 47.61±1.34* |
Example 5 | 50.27±1.55* |
Comparative example 1 | 76.02±2.01* |
Comparative example 2 | 63.19±1.95* |
Comparative example 3 | 67.42±1.14* |
Comparative example 4 | 71.55±1.50* |
Comparative example 5 | 79.08±1.68* |
Note: p < 0.05 compared to the blank control group.
Compared with a blank control group, the tail suspension immobility time of the example group, the comparative example group and the positive control group can be reduced, and the data show that the tail suspension immobility time of the example group is more obvious than that of the positive control group, so that the composition can obviously reduce the tail suspension immobility time of mice through the synergistic effect of the components, and the effect is obviously better than that of the comparative example sample administration group and the positive control group, so that the composition has a remarkable effect on resisting depression.
3. Detection of 5-hydroxytryptamine and norepinephrine levels in brain tissue
The monoamine neurotransmitter hypothesis is the most studied and most profound hypothesis, and the 5-hydroxytryptamine and norepinephrine systems, which are the basis for most of the current clinical antidepressants, are still important systems for evaluating antidepressant components. When 5-hydroxytryptamine and norepinephrine in the brain are below normal, there is insufficient excitability and mood is in a state of negative depression, which over time causes depression.
Reserpine can exhaust monoamine transmitter in mouse brain, produce depression symptom, and be used as monoamine evacuator to establish depression animal model.
130 healthy Beijing-breed mice are selected, male and female are half of the healthy Beijing-breed mice, and after 1 week of adaptation to the environment, the healthy Beijing-breed mice are randomly divided into 13 groups, namely a blank control group, a imipramine hydrochloride group (the dose is 15 mg/kg. d), a model group and a test group (the dose is 15 mg/kg. d) (examples 1-5 groups and comparative examples 1-5 groups), and 10 mice are selected in each group. The model group, the imipramine hydrochloride group and the tested group are all injected subcutaneously for 6 days by 0.25mg/kg reserpine, the gastric perfusion of 10ml/kg of physiological saline is started on the 3 rd day of the model group, the gastric perfusion of the composition aqueous solution with the same volume is started on the 3 rd day of the tested group, the gastric perfusion of the imipramine hydrochloride aqueous solution with the same volume is continuously performed for 10 days, after the administration for 0.5h on the 10 th day, cervical vertebra dislocation is performed, the brain is rapidly cut off, the weight is measured, the cerebellum is removed in ice bath, a glass homogenizer for ice bath is used for preparing brain tissue homogenate, and the content of 5-hydroxytryptamine and norepinephrine is measured. The blank group was gavaged daily with an equal volume of saline, and the same model group and test group were treated 0.5h after the administration on day 10.
The results of the mouse 5-hydroxytryptamine and norepinephrine levels are shown in Table 5.
Note: compared with the blank control group, the composition of the composition,#p < 0.05, p < 0.05 compared to model group.
Compared with a blank control group, the water average of 5-hydroxytryptamine and norepinephrine in the brain tissue of the mouse in the model group is obviously reduced, which indicates that the molding is successful. Compared with the model group, the administration group of the embodiment can obviously improve the levels of 5-hydroxytryptamine and norepinephrine of the model mouse, and the effect is obviously better than that of the comparative example. The administration group of the illustrated example has a significant improvement effect on depression symptoms caused by reserpine.
The above experimental results show that the antidepressant effect of the composition is obviously better than that of the administration group of the comparative sample and better than that of the imipramine hydrochloride group.
Although the present application has been described with reference to a few embodiments, it should be understood that various changes, substitutions and alterations can be made herein without departing from the spirit and scope of the application as defined by the appended claims.
Claims (10)
1. A composition, comprising the following components:
5-16 parts of S-adenosylmethionine;
5-16 parts of gamma-aminobutyric acid;
5-25 parts of alpha-lactalbumin.
2. The composition according to claim 1, characterized in that it comprises the following components:
5-8 parts of S-adenosylmethionine;
5-10 parts of gamma-aminobutyric acid;
5-12 parts of alpha-lactalbumin.
3. The composition according to claim 1, characterized in that it consists of:
5-16 parts of S-adenosylmethionine;
5-16 parts of gamma-aminobutyric acid;
5-25 parts of alpha-lactalbumin.
4. Use of a composition according to any one of claims 1 to 3 in the manufacture of a product for the treatment and/or prevention of depression.
5. The use according to claim 4, wherein the depression is liver disease-induced depression or postpartum depression.
6. The use according to claim 5, wherein the product for the treatment and/or prevention of depression is a health food or a pharmaceutical preparation.
7. A health food comprising the composition of any one of claims 1 to 3 and an adjuvant.
8. A pharmaceutical formulation comprising the composition of any one of claims 1 to 3 and an adjuvant.
9. The nutraceutical or pharmaceutical preparation according to claim 7 or 8, wherein the nutraceutical or pharmaceutical preparation comprises the following components:
15-51 parts by weight of the composition;
20-60 parts of a flavoring agent;
1-20 parts by weight of a binder;
0.1-1 part by weight of a flow aid;
preferably, the flavoring agent is selected from at least one of isomalt, erythritol, sorbitol, citric acid, malic acid, stevioside, edible essence and fruit and vegetable powder;
the filler is at least one selected from microcrystalline cellulose and lactose;
the glidant is selected from at least one of magnesium stearate and silicon dioxide.
10. A process for preparing a nutraceutical or pharmaceutical formulation according to any of claims 7 to 9, comprising the steps of:
mixing the composition and the auxiliary materials to obtain the health-care food or the pharmaceutical preparation.
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CN101677543A (en) * | 2007-01-31 | 2010-03-24 | 甲基化物科学国际有限公司 | The time-delay release pharmaceutical formulations of S-adenosylmethionine |
CN110959824A (en) * | 2018-09-30 | 2020-04-07 | 石家庄以岭药业股份有限公司 | Tranquilizing composition and preparation method thereof |
CN109620863A (en) * | 2018-12-19 | 2019-04-16 | 泓博元生命科技(深圳)有限公司 | A kind of composition and the preparation method and application thereof for alleviating depression |
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