Composition for regulating emotion and preparation method, medicine and application thereof

Abstract

The invention provides a composition for regulating emotion as well as a preparation method, a medicine and application thereof, and relates to the technical field of medicines. The composition provided by the invention comprises cannabidiol and 2 '-fucosyllactose, and the weight ratio of the cannabidiol to the 2'-fucosyllactose is 1: (16-24). The preparation method comprises the following steps: crushing industrial cannabis sativa, carrying out alcohol extraction, concentrating, drying to obtain cannabidiol, mixing the cannabidiol and 2 '-fucosyllactose in proportion, and sieving. The invention also provides application of the composition and the medicine in preparation of medicines for preventing or treating depression and anxiety disorder. Animal experiments prove that the combination of the cannabidiol and the 2 '-fucosyllactose has a curative effect in the aspect of treating depression and anxiety disorder, and particularly, the medicine effect is better under a specific ratio.

Description

Technical Field

[0001] The present invention relates to the field of pharmaceutical technology, and in particular to a composition for regulating emotions, a preparation method thereof, a medicine and an application thereof. Background Art

[0002] Depression, also known as depressive disorder, is a major type of mood disorder with significant and persistent low mood as its main clinical feature. In particular, long-term moderate or severe depression may become a serious illness. Patients may be greatly affected and perform poorly at work, in school, and in family life. In the most serious cases, depression can lead to suicide. Currently, there are a variety of active substances available for the treatment of depression, such as serotonin reuptake inhibitors (SRI), norepinephrine reuptake inhibitors (NERI), serotonin norepinephrine reuptake dual inhibitors (SNRI), monoamine oxidase inhibitors (MAQI), phosphodiesterase 4 (PDE4) inhibitors, etc. However, existing drugs still have no therapeutic effect or poor therapeutic effect on many patients.

[0003] Cannabidiol (CBD) is a pure natural ingredient extracted from industrial hemp plants that is beneficial to human health. In vivo experiments have found that CBD can not only antagonize the psychoactive effects caused by THC stimulating cannabinoid type I receptors (CB1R), but also has anticonvulsant, antianxiety, antipsychotic, sedative, hypnotic, anti-inflammatory and neuroprotective effects. Preclinical and clinical studies have shown that CBD has good pharmacokinetic properties, can quickly pass through the blood-brain barrier after injection, and has a significant protective effect on brain nerves. CBD can exert neuroprotective effects through multiple pathways, and its toxicity is weak and its side effects are few.

[0004] For example, Chinese patent CN 113116869 B discloses a composition for preventing and / or treating depression, which comprises cannabidiol and at least one other cannabinoid compound, wherein the other cannabinoid compound is selected from: cannabidiol, cannabigerol, and tetrahydrocannabinol. The above composition, especially a composition comprising cannabidiol, cannabidiol, cannabigerol, and tetrahydrocannabinol in a specific ratio, has an antidepressant effect.

[0005] Chinese patent CN 108079305 A discloses a composition, and provides a method for preventing and / or treating depression using the composition, and the use of the composition in preparing a drug for preventing and / or treating depression. The composition comprises cannabidiol and a tricyclic antidepressant, and may include one or more pharmaceutically acceptable carriers or excipients, wherein the amount of cannabidiol and the amount of tricyclic antidepressant are such that the effect of the composition is superior to the effect of each amount of drug when used alone.

[0006] However, many drug combinations have insignificant effects and some toxic side effects. Therefore, it is an important issue to continue to solve the problem of identifying new antidepressants with clear efficacy and few side effects, or new combination treatment plans.

[0007] Based on this, the present invention provides a mood regulating composition, whose active components are composed of CBD and 2'-FL (2'-FL, full name 2-fucosyllactose, is a non-reducing trisaccharide composed of lactose and L-fucose). The researchers of the present invention found in experiments that CBD and 2'-FL have a synergistic effect in the treatment of anxiety or depression, and the composition composed of the two in a specific ratio is significantly better than the single use of each component in the treatment of depression. Summary of the invention

[0008] In view of the above problems, the present invention provides a mood regulating composition, wherein the active components are composed of CBD and 2'-FL. By screening the specific ratio and optimizing the preparation process, a mood regulating composition with good effect is obtained.

[0009] To achieve the above purpose, the technical solution adopted by the present invention is as follows:

[0010] In one aspect, the present invention provides a mood regulating composition comprising cannabidiol and 2'-fucosyllactose, wherein the weight ratio of cannabidiol to 2'-fucosyllactose is 1:16-24.

[0011] Preferably, the weight ratio of cannabidiol to 2'-fucosyllactose can be 1:18-22.

[0012] Further preferably, the weight ratio of cannabidiol to 2'-fucosyllactose can be 1:20.

[0013] In another aspect, the present invention provides a medicine comprising the above-mentioned composition.

[0014] The pharmaceutical carrier used can be solid, liquid or gas. Examples of solid carriers include lactose, kaolin, sucrose, talc, gelatin, agar, pectin, gum arabic, magnesium stearate and stearic acid. Examples of liquid carriers include syrup, peanut oil, olive oil and water. Examples of gaseous carriers include carbon dioxide and nitrogen.

[0015] When preparing the composition for oral dosage form, any convenient pharmaceutical medium can be used. For example, water, ethanol, oil, alcohol, flavoring agent, preservative, coloring agent, etc. can be used to form oral liquid preparations, such as suspensions, elixirs and solutions; while carriers, such as starch, sugars, microcrystalline cellulose, diluents, granulating agents, emulsifiers, lubricants, binders, disintegrants can be used to form oral solid preparations, such as powders, capsules and tablets. Tablets and capsules are preferred oral dosage units using solid pharmaceutical carriers due to their ease of administration. Tablets can be coated using standard aqueous or non-aqueous techniques.

[0016] Tablets containing the Chinese medicine composition of the present invention can be prepared by tableting or molding, and one or more auxiliary ingredients or adjuvants can be used. The active ingredient can be tableted in a free-flowing form (such as powder or granules) in a suitable machine, and can be mixed with an adhesive, a lubricant, an inert diluent, a surfactant or a dispersant to prepare a tablet. Molded tablets can be molded in a suitable machine, i.e., a powdered compound mixture moistened with an inert liquid diluent. Each tablet preferably contains about 0.05 mg to about 5 g of active ingredient, and each sachet or capsule preferably contains about 0.05 mg to about 5 g of active ingredient. For example, a preparation intended for oral administration to humans may contain about 0.5 mg to about 5 g of active drug, mixed with an appropriate and convenient carrier material, which may account for about 5% to 95% of the total composition. The unit dosage form usually contains about 1 mg to about 2 g of active ingredient, usually 25 mg, 50 mg, 100 mg, 200 mg, 300 mg, 400 mg, 500 mg, 600 mg, 800 mg or 1000 mg.

[0017] The pharmaceutical composition suitable for parenteral administration of the present invention can be prepared as an aqueous solution or suspension of the active compound. Suitable surfactants such as hydroxypropylcellulose can be included. Dispersions can also be prepared in glycerol, liquid polyethylene glycol and oil mixtures thereof. In addition, preservatives can be added to prevent the harmful growth of microorganisms.

[0018] Medicine of the present invention can be in the form suitable for topical use, for example aerosol, cream, ointment, lotion, powder or the like. In addition, composition can be in the form suitable for transdermal administration device. Can use Chinese medicine composition of the present invention, prepare these prescriptions by conventional processing method. For example, by mixing hydrophilic material and water, and about 5wt% to about 10wt% of compound, prepare cream or ointment with required consistency.

[0019] The medicine of the present invention can be in a form suitable for rectal administration, wherein the carrier is a solid. Preferably, the mixture is made into a unit dose suppository. Suitable carriers include cocoa butter and other materials commonly used in the art. Suppositories can be prepared by first forming a composition containing a softened or melted carrier, followed by cooling and shaping in a mold.

[0020] In addition to the above-mentioned carrier components, the above-mentioned pharmaceutical preparations may include (if applicable) one or more additional carrier components, such as diluents, buffers, flavoring agents, adhesives, surfactants, thickeners, lubricants, preservatives (including antioxidants), etc. In addition, other excipients, such as lactose, starch, cellulose derivatives, magnesium stearate, stearic acid, etc., colorants and flavoring agents, etc., may be added. The preparation is made isotonic with the blood of the intended recipient. The components containing the Chinese medicine composition of the present invention can also be prepared in the form of powder or concentrate.

[0021] Preferably, the pharmaceutical preparation is an oral pharmaceutical preparation.

[0022] More preferably, the oral pharmaceutical preparation includes pills, capsules, granules, oral liquids, powders, tablets, lozenges, and lozenges. Further preferably, the dosage form is selected from capsules, tablets, or pills.

[0023] More preferably, the auxiliary material includes at least one of a disintegrant, a filler, a flavoring agent, a pH adjuster, a lubricant, and an antioxidant.

[0024] Preferably, the disintegrant can be selected from at least one of povidone, polyvinyl alcohol, low molecular weight HPC (hydroxypropyl cellulose), low molecular weight HPMC (hydroxypropyl methylcellulose), low molecular weight hydroxymethyl, cellulose acetate, gelatin, hydrolyzed gelatin, polyethylene oxide, gum arabic, and dextrin.

[0025] Preferably, the filler can be selected from at least one of microcrystalline cellulose, lactose, glucose, galactose, fructose, sucrose, calcium hydrogen phosphate, sorbitol, mannitol, lactitol, xylitol, isomalt, erythritol, and hydrogenated starch hydrolysate.

[0026] Preferably, the flavoring agent can be selected from at least one of sucrose, fructose, aspartame, apple flavor, sorbitol, glucose, isomalt, and erythritol.

[0027] Preferably, the pH adjuster can be selected from at least one of citric acid, potassium citrate, lactic acid, tartaric acid, fumaric acid and sodium citrate.

[0028] Preferably, the lubricant is selected from at least one of magnesium stearate, silicon dioxide, polyethylene glycol, talc, and micro-powdered silica gel.

[0029] Preferably, the antioxidant can be selected from at least one of L-cysteine ​​hydrochloride, L-cysteine ​​base, 4,4 (2,3-dimethyltetramethylene dicatechol), tocopherol-rich extract (natural vitamin E), α-tocopherol (synthetic vitamin E), B-tocopherol, 6-tocopherol, butylated hydroxyanisole (BHA), butylated hydroxytoluene (BHT), propyl gallate, octyl gallate, dodecyl gallate, tert-butylhydroquinone (TBHQ), fumaric acid, malic acid, ascorbic acid (vitamin C), sodium ascorbate, calcium ascorbate, potassium ascorbate, ascorbyl palmitate, and ascorbyl stearate.

[0030] In another aspect, the present invention provides a method for preparing the above-mentioned composition, comprising the following steps: crushing industrial hemp, extracting with alcohol, concentrating, and drying to obtain cannabidiol, and mixing cannabidiol and 2'-fucosyllactose in proportion and sieving.

[0031] In another aspect, the present invention provides the use of the above-mentioned composition or the above-mentioned drug in the preparation of a drug for preventing or treating anxiety and depression.

[0032] Preferably, the depression is selected from psychogenic depression, intrinsic depression, hypochondriacal depression, anxious depression, pseudodementia-type depression, and chronic depression.

[0033] Preferably, the depression includes the following symptoms: persistent sadness, anxiety or empty mood, feelings of hopelessness, pessimism, guilt, worthlessness or helplessness, loss of interest or pleasure in hobbies and activities that were once enjoyed, including sex, decreased energy, fatigue or slowness, difficulty concentrating, memory trouble or difficulty making decisions, insomnia, early morning awakening or excessive sleeping, loss of appetite and / or weight loss or excessive eating and weight gain, thoughts of death or suicide, suicide attempts, hyperactivity, irritability, persistent physical symptoms that are unresponsive to treatment, or any combination of the foregoing symptoms.

[0034] Terms and Claims of the Present Invention:

[0035] 1. As used herein, the articles “a”, “an” and “the” include plural referents unless expressly limited to one or more referents otherwise.

[0036] 2. As used herein, numerical range: Unless otherwise expressly indicated, all ranges or ratios disclosed herein will be understood to include any and all sub-ranges or sub-ratios contained therein. For example, a range or ratio of 1 to 30 stated should be considered to be included between a minimum value of 1 and a maximum value of 30, and any sub-range or sub-ratio, integer, decimal, or sub-range or sub-ratio consisting of integers or decimals including the end points.

[0037] 3. As used herein, the terms "comprises," "including," "have," "have," "may," "contain" and variations thereof mean open-ended conjunctions or terms that do not exclude the possibility of additional compositions or structures.

[0038] Compared with the prior art, the present invention has the following beneficial effects:

[0039] The present invention provides a composition for regulating mood, wherein the active components include cannabidiol and 2'-fucosyllactose. Animal experiments have shown that the combination of the two can treat depression and anxiety, and the efficacy is better in particular under a specific ratio. BRIEF DESCRIPTION OF THE DRAWINGS

[0040] Figure 1 A graph showing the time mice spent in the middle area of ​​the open field.

[0041] Figure 2 A graph showing the distance traveled by mice in the open field.

[0042] Figure 3 This is a graph showing the number of times mice entered the middle area of ​​the open field.

[0043] Figure 4 A graph showing the time mice spent in the open arms.

[0044] Figure 5 A graph showing the time mice spent immobile in the elevated maze.

[0045] Figure 6 This is a graph showing the time mice spend in the light box.

[0046] Figure 7 This is the time when the mouse first entered the dark chamber from the light chamber.

[0047] Figure 8 A graph showing the number of times the mouse crossed the light and dark boxes.

[0048] Fig. 9 Graph of the immobility time of mice during tail suspension. DETAILED DESCRIPTION

[0049] In order to make the technical means, creative features, purpose and effect of the present invention easy to understand, the present invention is further explained below in conjunction with specific embodiments, but the following embodiments are only preferred embodiments of the present invention, not all. Based on the embodiments in the implementation mode, other embodiments obtained by those skilled in the art without making creative work all belong to the protection scope of the present invention. It is worth noting that the raw materials used in the present invention are all common commercial products, and their sources are not specifically limited. The technology and scientific terms used in the embodiments have the meanings commonly understood by those of ordinary skill in the art to which the present invention belongs.

[0050] The prebiotics used in the present invention are cannabidiol (CBD) purchased from BOD Australia and 2'-fucosyllactose (2'-FL) (2'FL Glycom, GlyCareTM 2FL 9000, 20156002) purchased from DSM of the Netherlands.

[0051] Embodiment 1:

[0052] This experiment was reviewed and approved by the Institutional Animal Care and Use Committee (IACUC) of the Institute of Brain Cognition and Brain Diseases (BCBDI), Shenzhen Institutes of Advanced Technology, Chinese Academy of Sciences, with the ethics number SIAT-IACUC-20211222-NS-NTPZX-WLP-A2090-01. 7-week-old adult C57BL / 6J male mice (n=30) were purchased from Zhejiang Weitong Lihua.

[0053] After one week of environmental adaptation, 30 adult male C57BL / 6 mice in each batch were given samples of single components or different formulations by long-term oral gavage for 5 weeks. Then, in the fourth week of intervention, the mice were subjected to 1 week of stress induction. The blank control group was not intervened, and then their fecal samples were collected; finally, behavioral tests were performed, and the mice were continuously sampled during the above evaluation experiment. After the behavioral test, all animals will be handled and samples will be collected, including brain organs, blood samples, cecal colon tissues and bone samples. The collected samples will be further analyzed.

[0054] The stress response program is as follows:

[0055] a) Foot stimulation 10 times (current 0.5 mA, each time lasting 2 seconds, each time interval 10 seconds);

[0056] b) Tail suspension for 30 minutes;

[0057] c) Restrain for 1 hour.

[0058] The components or compositions involved in each group in the experiment are as follows:

[0059] a) Blank control group: intragastric administration of normal saline

[0060] b) Model group: intragastric administration of normal saline

[0061] c) Intervention 1 + Model group: intragastric administration of 25 mg / kg / d cannabidiol (CBD)

[0062] d) Intervention 2+ model group: intragastrically administered 500 mg / kg / d 2'-fucosyllactose (2'-FL)

[0063] e) Intervention 3+ model group: oral administration of 25 mg / kg / d CBD and 500 mg / kg / d 2'-fucosyllactose (2'-FL)

[0064] The mouse intervention dose was converted based on the human intervention dose using the body surface area method. Based on the principle that the intervention dose per kilogram of body weight per square meter of body surface area is equal, the mouse dose is 12.3 times that of an adult. The adult doses of 2'-FL and CBD are 3g / day and 150mg / day, respectively, while the average adult weight is about 70kg, so the mouse doses of 2'-FL and CBD are 500mg / kg / d and 25mg / kg / d, respectively.

[0065] Statistical analysis

[0066] Prism software was used for statistical analysis. In the behavioral experimental results, each group was first checked for outliers, and then a significance analysis was performed after elimination. The blank control group and the model group used an unpaired t-test, while the model group and the three intervention groups used a one-way anova.

[0067] 1. Anxiety-like behavior test

[0068] 1) Open field test

[0069] The open field consists of a square box (35cm*35cm*30cm), which is divided into 16 areas (8.75cm*8.75cm), and the 4 areas in the middle will be defined as the middle area (17.5cm*17.5cm). Mice will be randomly placed in the middle area of ​​the open field. After 10 minutes of exploration, the time the mice stay in the middle area will be recorded and used as an indicator of anxiety. The longer the mice stay in the middle area, the lower their anxiety level.

[0070] The results are as follows Figure 1 As shown: The open field experiment showed that compared with the blank group, the time that the mice after stress induction stayed in the middle area of ​​the open field was significantly shorter (p<0.05) ( Figure 1 ); After intervention with intervention 1 (CBD) and intervention 2 (2'-FL), the time mice stayed in the middle area of ​​the open field was significantly higher than that of the model group (p<0.05) ( Figure 1 ); The above results indicate that CBD or 2'-FL can significantly improve the anxiety-like behavior of mice in the open field ( Figure 1 ).

[0071] 2) Elevated maze

[0072] The elevated maze device is a cross-shaped maze with two open arms (35cm*5cm*15cm) and two closed arms (35cm*5cm). The middle area of ​​the cross maze is a fully open area (5cm*5cm). The entire cross maze is 50cm above the ground. At the beginning of the experiment, the mice were placed in the middle area of ​​the maze, facing the open arms. Then, the number of times the mice entered the open arms and closed arms within 7 minutes, the time they stayed in the open arms and closed arms, and the time they were still were automatically monitored. The time the mice stayed in the open arms was used as an anxiety indicator. The longer the mice stayed in the open arms, the lower their anxiety level.

[0073] The results are as follows Figure 4 As shown in the figure, the results of the elevated maze experiment showed that compared with the blank control group, the time mice stayed in the open arm after stress induction was significantly reduced (p<0.05), indicating that mice showed anxiety-like behavior in the elevated maze after stress induction; compared with the model group, the time mice in the intervention 1, intervention 2 and intervention 3 groups stayed in the open arm showed a certain increasing trend, and was close to the blank control group; the above results indicate that intervention 1, intervention 2 and intervention 3 have potential alleviating effects on the anxiety-like behavior of mice in the advanced maze.

[0074] 3) Light and dark box

[0075] The size of the light-dark box device is 50cm*25cm*25cm. It contains two spaces, a light box and a dark box. The partition wall between the two boxes has a 7.5cm*7.5cm door hole for mice to shuttle through. The test time for each mouse is 5 minutes. At the beginning of the test, the mouse is placed in the light box and allowed to explore freely in the device. Monitor the time the mouse stays in the light box, the number of times the light and dark boxes shuttle, and the time of the first entry into the dark room. The time spent in the light box is used as an anxiety indicator. The longer the mouse stays in the light box, the lower the anxiety level.

[0076] like Figure 8 As shown in the figure, in the light-dark box experiment, compared with the blank control group, the number of times the mice in the model group shuttled between the light and dark boxes was significantly reduced (p<0.05), indicating that the mice showed certain anxiety-like behaviors; compared with the model group, the time the mice stayed in the light box and the number of times they shuttled between the light and dark boxes in the intervention 1 (CBD), intervention 2 (2'-FL) and intervention 3 (CBD combined with 2'-FL) groups were significantly increased (p<0.05) (as shown in the figure). Figure 6 and 8 ); The above results showed that intervention 1, intervention 2 and intervention 3 significantly alleviated the anxiety-like behavior of mice in the light and dark box.

[0077] 2. Depression-like behavior test (tail suspension test)

[0078] The tail suspension test is widely used to assess despair behavior in rodents. Briefly, mice are suspended by tape about 1 cm from the tip of the tail 30 cm above the ground. The duration of the experiment is 6 min, and the immobility time (no struggling, little body movement) during the suspension process is automatically monitored during the last 5 min. The duration of immobility of mice will be used as an indicator of depression, and the longer the immobility time, the higher the degree of depression of the mice.

[0079] like Fig. 9 As shown in the figure, the results of the mouse tail suspension experiment showed that compared with the blank control group, the immobility time of mice in the stress-induced model group was significantly increased (p<0.05), indicating that the mice showed depressive-like behavior after stress induction; compared with the model group, intervention 1 (CBD), intervention 2 (2'-FL) and intervention 3 (CBD combined with 2'-FL) could significantly reduce the immobility time of mice, and were close to the blank control group; the above results indicate that intervention 1, intervention 2 and intervention 3 can significantly improve the depressive-like behavior of mice during tail suspension.

[0080] 3. Comparison of behavioral Z scores

[0081] In order to more accurately compare the significance between different experimental groups, the Z-score method was used to normalize the behavioral results and compare them, and finally rank the efficacy of each intervention group. Taking the open field experiment as an example, the Z-score calculation formula is as follows:

[0082]

[0083] in,

[0084] X: observed values ​​of behavioral indices of mice in the intervention group;

[0085] μ: mean values ​​of behavioral indicators of mice in the model group;

[0086] σ: standard deviation of behavioral indicators of mice in the model group;

[0087] TC: time mice stayed in the open area in the open field test;

[0088] DR: the ratio of the exploration distance of mice in the middle area to the total exploration distance in the open field test;

[0089] Then the elevated maze behavior Z EPM Scoring, light-dark box behavior Z LDB Scoring and tail suspension test Z TST Score, because the Z score of anxiety-like behavior (such as Z OF , Z EPM , Z LDB) indicates that the individual has a lower risk of anxiety; in addition, a higher Z score for depression-like behavior indicates that the individual has a higher risk of depression. A The score is the weighted average of the Z scores of each behavior, that is, Z A =(Z OF +Z EPM +Z LDB ) / 3. The overall anxiety and depression behavior is Z T The score is the mean of the sum of the anxiety behavior Z score minus the depression behavior Z score, that is, Z T =(Z OF +Z EPM +Z LDB -Z TST ) / 4.

[0090] As shown in Table 1, the scoring table shows that based on Z A The percentage of individuals with scores above the mean of this experiment was counted. The results showed that 62.5% (5 / 8) of the intervention group were in the intervention 1 group, 60% (6 / 10) were in the intervention 2 group, and 40% (4 / 10) were in the intervention 3 group. This indicates that intervention 1 performed best in the anxiety-like behavior Z score, followed by intervention 2, and finally intervention 3. T The scores were the mean of this experiment, and the percentage of individuals with scores above the mean was statistically analyzed. The results showed that intervention 1 had 50% (4 / 8), intervention 2 had 60% (6 / 10), and intervention 3 had 40% (4 / 10), indicating that intervention 2 and intervention 1 performed similarly in the overall behavioral Z score, and were better than intervention 3.

[0091] Table 1. Behavioral Z score table of each intervention group

[0092]

[0093]

[0094] Finally, it should be noted that the above content is only used to illustrate the technical solution of the present invention, rather than to limit the scope of protection of the present invention. Simple modifications or equivalent substitutions of the technical solution of the present invention by ordinary technicians in this field do not deviate from the essence and scope of the technical solution of the present invention.

Claims

1. A composition for regulating mood, characterized in that: It includes cannabidiol and 2'-fucosyllactose, and the weight ratio of cannabidiol to 2'-fucosyllactose is 1:16-24.

2. The composition according to claim 1, characterized in that The weight ratio of cannabidiol to 2'-fucosyllactose is 1:18-22.

3. A drug, characterized in that A composition comprising any one of claims 1 to 2.

4. The drug according to claim 3, characterized in that The dosage forms of the medicine include pills, capsules, granules, oral liquids, powders, tablets, lozenges, and sugar lozenges; the medicine also contains auxiliary materials.

5. The drug according to claim 4, characterized in that The auxiliary materials include at least one of a disintegrant, a binder, a flavoring agent, a suspending agent, a foaming agent, a pH adjuster, a lubricant, a glidant, an antioxidant, and a corrosion inhibitor.

6. The method for preparing the composition according to any one of claims 1 to 2, characterized in that: The method comprises the following steps: crushing industrial hemp, extracting with alcohol, concentrating and drying to obtain cannabidiol; mixing cannabidiol and 2'-fucosyllactose in proportion and sieving.

7. Use of the composition according to any one of claims 1 to 2, or the drug according to any one of claims 3 to 6 in the preparation of a drug for preventing or treating anxiety or depression.

8. The use according to claim 7, characterized in that: The depression is selected from psychogenic depression, endogenous depression, hypochondriacal depression, anxious depression, pseudodementia-type depression, and chronic depression.

9. The use according to claim 8, characterized in that: The depression symptoms include: Persistent sadness, anxiety or empty mood, feelings of hopelessness, pessimism, guilt, worthlessness or helplessness, loss of interest or pleasure in hobbies and activities that you once enjoyed, including sex, decreased energy, fatigue or slowness, difficulty concentrating, memory or making decisions, insomnia, early morning awakenings or excessive sleeping, loss of appetite and / or weight loss or excessive eating and weight gain, thoughts about death or suicide, suicide attempts, hyperactivity, irritability, persistent physical symptoms that do not respond to treatment, or any combination of the foregoing.

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