KR20190136543A - Compostion for preventing or treating the Developmental Disability comprising Humulus japonicus extract as active ingredient - Google Patents

Abstract

The present invention relates to a pharmaceutical composition for preventing or treating developmental disability containing a Humulus japonicus extract or a fraction thereof as an active component. In addition, the present invention relates to a food composition, a feed composition or quasi-drug composition for preventing or alleviating developmental disability containing the Humulus japonicus extract or the fraction thereof as the active component.

Description

Compensation for preventing or treating the Developmental Disability comprising Humulus japonicus extract as active ingredient}

The present invention is Humulus japonicus ) relates to a pharmaceutical composition for the prevention or treatment of developmental disorders comprising an extract or a fraction thereof as an active ingredient. In another aspect, the present invention relates to a food composition, feed composition or quasi-drug composition for the prevention or improvement of developmental disorders comprising hwansam vine extract or fractions thereof as an active ingredient.

Developmental disorders (neural developmental disorders) are characterized by retardation and abnormalities in attention, memory, cognition, language, problem solving, or social interaction, and do not develop at an age-appropriate level, leading to 25% higher than normal expectations on developmental tests. If you fall behind.

Developmental disorder is one of the most common health problems in children, and it is not easy to detect such a developmental disorder early in the disease with high prevalence occurring in about 5-10% of all children. Unless very severe developmental disorders, it does not occur well in infancy or infancy, especially language disorders, hyperactivity disorders, emotional disorders are difficult to detect before the age of 3-4, it is difficult to diagnose early. Despite the difficulty in early diagnosis of developmental disorders, efforts to detect children with these disorders early can reduce the long-term disability that may result from them by appropriate early intervention, such as early education or rehabilitation services. Because it can.

Developmental disorders include abnormalities in the four main domains of development: movement (large muscles, microscopic), language (acceptance, expression), cognition, emotion, and sociality. It includes a wide range of diseases, including language development disorder due to ability developmental disorder, cognitive development disorder due to problem solving ability developmental disorder, emotional and sociality due to adaptive ability developmental disorder, and self-help developmental disorder.

In general, as a method for treating developmental disorders, such as Korean Patent Nos. 10-1008541 and 10-1276097, methods for improving cognitive ability by stimulating visually and aurally, and providing a treatment through a display device for treatment In addition, methods of treating visual stimuli and physical vestibular stimuli to the brain and treating them by inhalation of drugs have been applied.

However, the conventional apparatus for changing brain waves using audiovisual stimulation does not provide a real kinematic environment using only a predetermined stimulus signal, and thus, there is a shortage in actual operation even in a real environment.

Under these circumstances, the present inventors are working to develop a natural-derived extract that can directly obtain a prophylactic and therapeutic effect on the main symptoms of developmental disorders, while the extract of BTBR T ⁺ Itpr3 ^tf / J is a mouse model of developmental disorders. (BTBR) improves the degree of social action and social curiosity, and improves repetitive or restrictive behavior and new object cognitive memory, which can be used for the prevention and treatment of developmental disorders. The present invention was completed.

One object of the present invention is Humulus japonicus ) to provide a pharmaceutical composition for the prevention or treatment of developmental disorders comprising the extract or fractions thereof as an active ingredient.

Another object of the present invention is to provide a health functional food for the prevention or improvement of developmental disorders comprising hwansam vine extract or fractions thereof as an active ingredient.

Yet another object of the present invention is to provide a feed composition for the prevention or improvement of developmental disorders comprising hwansam vine extract or fractions thereof as an active ingredient.

Yet another object of the present invention is to provide a quasi-drug composition for the prevention or improvement of developmental disorders comprising hwansam vine extract or fractions thereof as an active ingredient.

Yet another object of the present invention is to provide a method for preventing or treating a developmental disorder, comprising administering to a subject a pharmaceutical composition comprising the extract or fraction as an active ingredient.

In order to achieve the above object, one embodiment of the present invention provides a pharmaceutical composition for preventing or treating developmental disorders comprising Humulus japonicus extract or a fraction thereof as an active ingredient.

The term in the invention, "Humulus japonicus (Humulus japonicus ) "belongs to the Cannabaceae and is a vine-like annual plant distributed mainly throughout Korea and in East Asia. However, there is no disclosure of the use of the treatment or prevention of diseases related to developmental disorders, and for the first time, the present inventors have developed developmental disorders including intellectual disorders, cerebral palsy, genetic disorders, chromosomal disorders, general developmental disorders, and the like. It has been found that there is a use for the treatment or prevention of related diseases, etc. In the present invention, hwansam vine may be purchased commercially, or may be used that is collected or cultivated in nature.

As used herein, the term "extract" refers to a liquid component obtained by immersing a desired substance in various solvents and then extracting the mixture for a predetermined time at room temperature, low temperature, or warm state, and removing the solvent from the liquid component. The resulting solid content is meant. In addition, in addition to the result, it can be comprehensively interpreted to include all of the dilution of the resultant, their concentrates, their modifiers, purified products and the like.

In the present invention, the extract means hwansam vine extract. The ginseng vine extract may be extracted from various organs of natural, hybrid, and mutant plants, for example, from roots, ground, stems, leaves, flowers, trunks of fruits, bark of fruit, as well as plant tissue cultures. . The hwansam vine extract may be obtained by extracting with water or various organic solvents. At this time, the organic solvent used is not particularly limited as long as it can obtain an extract having a prophylactic or therapeutic effect of developmental disorders, specifically, may be water, a polar solvent or a non-polar solvent, more specifically water , Lower alcohols having 1 to 6 carbon atoms (methanol, ethanol, propanol or butanol, etc.), mixed solvents thereof, and most specifically methanol or a mixed solvent thereof. In addition, the method for obtaining the extract is not particularly limited as long as it can obtain an extract having a prophylactic or therapeutic effect of developmental disorders, specifically, the roots, stems, leaves, fruits, flowers, Methods such as cold extraction method for immersing these dried products and processed products in the solvent, extraction at room temperature, heating extraction method for extraction by heating to 40 to 100 ° C, ultrasonic extraction method for applying ultrasonic wave, reflux extraction method using reflux condenser, etc. Can be used.

The term "fraction" in the present invention means the result obtained by the fractionation method of separating a specific component or a specific group from a mixture containing various components.

In the present invention, the fraction may be interpreted as a fraction obtained by applying the hwansam vine extract to various fractionation methods. Fractions of the extract can be obtained by applying the extract to a variety of fractionation method, the fractionation method is not particularly limited to this, solvent fractionation method performed by treating a variety of solvents, ultrafiltration membrane having a constant molecular weight cut-off value Ultrafiltration fractionation method performed by passing through, chromatographic fractionation method for performing a variety of chromatography (manufactured for separation according to size, charge, hydrophobicity or affinity) and the like. In particular, the solvent used in the solvent fractionation method is not particularly limited, but a polar solvent or a nonpolar solvent may be used, and specifically, a nonpolar solvent may be used. The solvent fractionation method may be performed by sequentially fractionating the extract using a low solvent from a solvent having a high nonpolar level. For example, a method of sequentially fractionating the extract using nucleic acid or ethyl acetate may be used. Can be.

In the present invention, the fraction may be obtained by fractionation with a solvent selected from the group consisting of water, alcohol, hexane, ethyl acetate, acetone, chloroform and a mixed solvent thereof.

"Developmental Disability" in the present invention refers to a case in which mental and physical development is not as advanced as age and is about 25% behind the normal expectation of the age in the development screening test. In general, developmental disorders may be classified as intellectual disorders, general developmental disorders, specific developmental disorders, etc., but the classification may vary because of various classification criteria. Common symptoms of developmental disorders are difficulties in understanding and using language, difficulty in understanding the overall social situation and forming relationships, showing particular patterns of particular objects, and repeating patterns of behavior. The causes of developmental disorders are not limited to any one but are complex.

Specifically, aspects of developmental disorder include abnormalities in four major areas of development: motor (large muscle, fine), language (acceptance, expression), cognition, emotion, and sociality. The diseases commonly included in the category of developmental disorders include mental retardation, cerebral palsy, autism disorder, developmental language disorder, special sensory dysfunction including visual or hearing, learning disorder, attention deficit hyperactivity disorder, etc. Among them, cerebral palsy, mental retardation, and special sensory dysfunction, which have relatively low incidence, are mainly detected early (average age of cerebral palsy: 10 months), while the incidence is high but the degree of disability is relatively high. Less severe learning disabilities and attention deficit disorders are found in much later periods of schooling (average 69 and 59 months, respectively).

For the purposes of the present invention, developmental disorders may be caused by biological factors such as chromosomal abnormalities, premature babies, drinking during pregnancy, environment separated from parents, drug addiction of parents, and the like. It's not clear.

Developmental disorders in the present invention include intellectual disorders, cerebral palsy, general developmental disorders, developmental language disorders, functional disorders of special senses including vision or hearing, learning disorders, attention deficit hyperactivity disorder, epilepsy and combinations thereof It may be selected from the group consisting of, but is not limited thereto.

In addition, the general developmental disorder may be selected from the group consisting of autism category disorder, Asperger syndrome, Childhood Disintegrative Disorder, Rett Syndrome, atypical autism category disorder, and a combination thereof, It is not limited to this. In addition, developmental disorders may include all disorders that occur in developmental areas such as perception, cognition, movement, and language, and include learning disorders, communication disorders, motor dysfunctions, cerebral palsy, genetic disorders, and chromosomal disorders. (Down Syndrome; Down Syndrome, Fragile X Syndrome), including all developmental disorders with a delay in development or function.

As used herein, the term "prevention" means any action that inhibits or delays the development of a developmental disorder by administration of a pharmaceutical composition according to the invention, and "treatment" means suspicion of a developmental disorder by administration of the pharmaceutical composition. And any action in which the symptoms of the affected individual improve or beneficially change.

Prevention or treatment of a developmental disorder in the present invention can be achieved by significantly increasing social behavior, reducing repetitive behavior, and exhibiting cognitive and memory enhancing effects by the extract or fractions thereof.

According to one embodiment of the present invention, it was confirmed that the social behavior of mice orally administered with hwansamvine extract in the BTBR mouse animal model, which is a developmental disorder model, significantly increased (FIG. 1). In addition, it was confirmed that the repetitive behavioral phenotype of BTBR mice was effectively reduced by the administration of hwansamvine extract (Fig. 2). In addition, it was confirmed that in the case of BTBR mice administered with the Korean Peninsula vine extract, the new object cognitive memory was significantly improved (FIG. 3). In addition, it was confirmed that the moving distance of BTBR mice significantly reduced by the administration of hwansamvine extract (Fig. 4).

Through this, the ring ginseng extract or fractions thereof may be used to treat intellectual impairment, cerebral palsy, autism, developmental speech impairment, special sensory dysfunction including visual or hearing, learning disability, attention deficit hyperactivity disorder, and epilepsy. It was found to have an effect on the prevention or treatment of developmental disorders.

The pharmaceutical compositions of the present invention may further comprise suitable carriers, excipients or diluents commonly used in the manufacture of pharmaceutical compositions. Specifically, the pharmaceutical compositions may be used in the form of oral dosage forms, external preparations, suppositories, and sterile injectable solutions, such as powders, granules, tablets, capsules, suspensions, emulsions, syrups, aerosols, etc., according to conventional methods, respectively. Can be.

In the present invention, carriers, excipients and diluents that may be included in the pharmaceutical composition include lactose, dextrose, sucrose, sorbitol, mannitol, xylitol, erythritol, maltitol, starch, acacia rubber, alginate, gelatin, calcium phosphate, Calcium silicate, cellulose, methyl cellulose, microcrystalline cellulose, polyvinyl pyrrolidone, water, methylhydroxybenzoate, propylhydroxybenzoate, talc, magnesium stearate and mineral oil. When formulated, diluents or excipients such as fillers, extenders, binders, wetting agents, disintegrating agents and surfactants are usually used. Solid preparations for oral administration include tablets, pills, powders, granules, capsules and the like, and such solid preparations include at least one excipient such as starch, calcium carbonate, It is prepared by mixing sucrose or lactose, gelatin and the like. In addition to simple excipients, lubricants such as magnesium styrate and talc are also used. Liquid preparations for oral use may include various excipients such as wetting agents, sweeteners, fragrances, preservatives, etc., in addition to water and liquid paraffin, which are simple diluents commonly used in suspensions, solvents, emulsions, and syrups. have. Formulations for parenteral administration include sterile aqueous solutions, non-aqueous solvents, suspensions, emulsions, lyophilized preparations, suppositories. As the non-aqueous solvent and suspending agent, propylene glycol, polyethylene glycol, vegetable oil such as olive oil, injectable ester such as ethyl oleate and the like can be used. As the base of the suppository, witepsol, macrogol, tween 61, cacao butter, laurin butter, glycerogelatin and the like can be used.

The content of the extract or fractions thereof of the round ginseng vine in the pharmaceutical composition of the present invention is not limited as long as the pharmaceutical composition has a prophylactic or therapeutic effect on a developmental disorder, but is 0.0001 to 99.9% by weight based on the total weight of the final composition, More specifically, it may be included in an amount of 0.01 to 80% by weight.

The pharmaceutical composition of the present invention may be administered in a pharmaceutically effective amount, wherein the term "pharmaceutically effective amount" of the present invention is sufficient to treat or prevent a disease at a reasonable benefit / risk ratio applicable to medical treatment or prevention. The effective dose level refers to the severity of the disease, the activity of the drug, the age, body weight, health, sex, sensitivity of the patient to the drug, the time of administration of the composition of the invention used, the route of administration and the rate of release used. And factors well known in the art and other ingredients, including drugs used in combination or coincidental with the compositions of the invention used. The pharmaceutical compositions of the present invention may be administered as individual therapeutic agents or in combination with other therapeutic agents and may be administered sequentially or simultaneously with conventional therapeutic agents. And single or multiple administrations. In consideration of all the above factors, it is important to administer an amount that can obtain the maximum effect in a minimum amount without side effects.

The dosage of the pharmaceutical composition of the present invention may be administered, for example, at 0.1 to 500 mg / kg body weight per day, for example, to an animal including a human, but is not limited thereto. The frequency of administration of the composition of the present invention is not particularly limited, but may be administered once a day or several times in divided doses. The dosage does not limit the scope of the invention in any aspect.

Another aspect of the present invention provides a method for preventing or treating a developmental disorder, comprising administering the pharmaceutical composition to a subject having or possibly developing a developmental disorder in a pharmaceutically effective amount.

The developmental disorders, prevention and treatment are as described above.

As described above, the extract or fractions thereof of hwansam vine provided by the present invention has a prophylactic or therapeutic effect of developmental disorders, and a pharmaceutical composition comprising the same may be used to prevent or treat a developmental disorder.

The term "individual" of the present invention means all animals, such as rats, livestock, humans, or the like, which may or may not develop a developmental disorder.

In the method for treating a developmental disorder of the present invention, the route of administration of the pharmaceutical composition may be administered via any general route as long as it can reach the target tissue. The pharmaceutical composition of the present invention is not particularly limited to this, but as desired, routes of intraperitoneal administration, intravenous administration, intramuscular administration, subcutaneous administration, intradermal administration, oral administration, intranasal administration, pulmonary administration, rectal administration, etc. It can be administered through. However, the oral composition should be formulated to coat the active agent or to protect it from degradation in the stomach because oral administration may denature the extract or fractions thereof by gastric acid. In addition, the composition may be administered by any device in which the active substance may migrate to the target cell.

Another aspect of the present invention is to provide a food composition for the prevention or improvement of developmental disorders comprising a hwansam vine extract or a fraction thereof as an active ingredient. Ring vine extract, fractions, developmental disorders, prevention is as described above.

Since the food composition of the present invention can be consumed on a daily basis, it can be expected to be effective in preventing or improving a developmental disorder.

As used herein, the term "improvement" means any action that at least reduces the parameters associated with a condition, e.g., the degree of symptoms, treated with the administration of a composition comprising the gingival vine extract of the present invention or a fraction thereof.

The food composition of the present invention includes the form of pills, powders, granules, acupuncture, tablets, capsules or liquids, and the like to which the composition of the present invention can be added, for example, various foods, for example, Drinks, gums, teas, vitamin complexes, and dietary supplements.

There is no particular restriction on the other ingredients except for containing the hwansam vine extract or fractions thereof as essential components that may be included in the food composition of the present invention, and various herbal extracts, food supplement additives, or natural carbohydrates are added as in general foods. It may contain as a component. In addition, the food supplement additives include food supplement additives conventional in the art, such as flavoring agents, flavoring agents, coloring agents, fillers, stabilizers and the like.

Examples of such natural carbohydrates include monosaccharides such as glucose, fructose, and the like; Disaccharides such as maltose, sucrose and the like; And conventional sugars such as polysaccharides such as dextrin, cyclodextrin, and sugar alcohols such as xylitol, sorbitol, and erythritol. In addition to those mentioned above, natural flavoring agents (for example, rebaudioside A, glycyrrhizin, etc.) and synthetic flavoring agents (saccharin, aspartame, etc.) can be advantageously used as flavoring agents.

In addition to the above, the food composition of the present invention includes various nutrients, vitamins, minerals (electrolytes), flavors such as synthetic flavors and natural flavors, colorants and fillers (such as cheese and chocolate), pectic acid and salts thereof, alginic acid and its Salts, organic acids, protective colloidal thickeners, pH adjusting agents, stabilizers, preservatives, glycerin, alcohols, carbonation agents used in carbonated beverages, and the like. Others may contain pulp for the production of natural fruit juices and fruit juice drinks and vegetable drinks. These components can be used independently or in combination.

The health supplement food in the present invention includes a health functional food and health food.

The functional food (functional food) is the same term as a food for special health use (Food for special health use, FoSHU), in addition to the nutritional supply, the processed food, medical effect is highly effective to appear bioregulatory function Means food. Here, the term "functionality" means obtaining useful effects on health use such as nutrient control or physiological action on the structure and function of the human body. The food of the present invention can be prepared by a method commonly used in the art, and the preparation can be prepared by adding the raw materials and ingredients commonly added in the art. In addition, the formulation of the food may also be prepared without limitation as long as the formulation is recognized as a food. Food composition of the present invention can be prepared in various forms of formulation, unlike the general medicine has the advantage that there is no side effect that can occur when taking a long-term use of the drug as a food raw material, excellent portability, Food can be taken as an adjuvant to enhance the effect of preventing or ameliorating developmental disorders.

Another aspect of the present invention, to provide a feed composition for the prevention or improvement of developmental disorders comprising a hwansam vine extract or a fraction thereof as an active ingredient.

Ring vine extract, fractions, developmental disorders, prevention and improvement are as described above.

The feed composition may include a feed additive . The feed additive of the present invention corresponds to a feed supplement in the Feed Control Act.

As used herein, the term "feed" means any natural or artificial diet, one meal, or the like or any ingredient of the one meal for the animal to eat, ingest, and digest.

The kind of the feed is not particularly limited, and may be used a feed commonly used in the art. Non-limiting examples of the feed include, but are not limited to, vegetable feeds such as cereals, fruits, food processing by-products, algae, fibres, pharmaceutical by-products, oils, starches, gourds or grain by-products; And animal feeds such as proteins, minerals, fats and oils, minerals, fats and oils, single cell proteins, zooplankton or foods. These may be used alone or in combination of two or more thereof.

As another aspect for achieving the above object, it is to provide a quasi-drug composition for the prevention or improvement of developmental disorders comprising hwansam vine extract or fractions thereof as an active ingredient.

In the present invention, the quasi-drug composition may have an effect of preventing or improving a developmental disorder, but is not limited thereto.

As used herein, the term hwansam vine extract, fractions, developmental disorders, prevention and improvement are as described above.

The quasi-drug composition of the present invention may further include a pharmaceutically acceptable carrier, excipient or diluent as necessary in addition to the above components. The pharmaceutically acceptable carriers, excipients or diluents are not limited so long as they do not impair the effect of the present invention. It may include.

The "pharmaceutically acceptable carrier" may refer to a carrier, excipient or diluent that does not impair the biological activity and properties of the compound to be injected, without stimulating the organism, specifically, non-naturally occuring carrier). The kind of the carrier usable in the present invention is not particularly limited, and any carrier can be used as long as it is a conventionally used and pharmaceutically acceptable carrier in the art. Non-limiting examples of the carrier include saline, sterile water, Ringer's solution, buffered saline, albumin injection solution, dextrose solution, maltodextrin solution, glycerol, ethanol and the like. These may be used alone or in combination of two or more thereof.

The composition comprising a pharmaceutically acceptable carrier may be in various oral or parenteral formulations. When formulated, diluents or excipients such as fillers, extenders, binders, wetting agents, disintegrating agents, and surfactants are usually used. Specifically, solid preparations for oral administration include tablets, pills, powders, granules, capsules, and the like, and the solid preparations may include at least one excipient such as starch, calcium carbonate, sucrose, lactose, It can be prepared by mixing gelatin and the like. In addition to simple excipients, lubricants such as magnesium stearate, talc can also be used. Oral liquid preparations include suspensions, solvents, emulsions, and syrups.In addition to commonly used simple diluents such as water and liquid paraffin, various excipients such as wetting agents, sweeteners, fragrances, and preservatives may be included. have. Formulations for parenteral administration include sterile aqueous solutions, non-aqueous solvents, suspensions, emulsions, lyophilized preparations and suppositories. As the non-aqueous solvent and suspending agent, propylene glycol, polyethylene glycol, vegetable oils such as olive oil, injectable esters such as ethyl oleate and the like can be used. As the base of the suppository, utopsol, macrogol, tween 61, cacao butter, laurin butter, glycerogelatin and the like can be used.

The quasi-drug composition of the present invention may be exemplified by disinfecting detergents, shower foams, ointments, wet tissues, coatings, etc., but is not limited thereto. Formulation methods, dosages, methods of use, components, etc. of the quasi-drugs are well known in the art Can be appropriately selected from the description of.

In addition, the quasi-drug composition for the prevention or improvement of developmental disorders comprising the hwansam vine extract or fractions thereof of the present invention as an active ingredient may be used in a method for improving developmental disorders, including applying to the skin of an individual. The subject includes, without limitation, mammals including rats, livestock, humans and the like.

The composition containing the hwansam vine extract of the present invention or a fraction thereof as an active ingredient significantly increases the social behavior of the mouse, decreases the repetitive behavioral phenotype in the BTBR mouse animal model, which is a developmental disorder model, and also recognizes a new object cognitive memory. This significantly improved, etc. bar, it can be applied to pharmaceutical compositions, dietary supplements, feed compositions and quasi-drug compositions for the prevention, improvement or treatment of developmental disorders.

1 is a diagram illustrating the behavior of social development and social curiosity between two mice by the administration of Hwansam vine extract to BTBR T ⁺ Itpr3 ^tf / J (BTBR) mice. This is the result of analyzing the number of times A. Vehicle refers to a control group administered orally with 0.5% carboxymethylcellulose (CMC) daily, and hwansam vine refers to a group administered orally daily with 400 mg / kg of hwansam vine extract.
Figure 2 is a result of analyzing the time of grooming behavior (grooming behavior) to determine the degree of repetitive behavior of autism model mouse by administration of hwansamvine extract in BTBR mice. Vehicle refers to a control group administered orally 0.5% CMC daily, and hwansam vine refers to a group orally administered daily with 400 mg / kg hwansam vine extract.
3 is a test result of the effect of improving the cognitive function of the autism model mouse by the administration of hwansam vine extract in BTBR mice (A, the number of discrimination for the new object search time; B, the number of discrimination for the number of new object search). Vehicle refers to a control group administered orally 0.5% CMC daily, and hwansam vine refers to a group orally administered daily with 400 mg / kg hwansam vine extract.
Figure 4 is the result of testing the hyperactivity behavioral improvement effect by the administration of hwansamvine extract in BTBR mice. Vehicle refers to a control group administered orally 0.5% CMC daily, and hwansam vine refers to a group orally administered daily with 400 mg / kg hwansam vine extract.

Hereinafter, the present invention will be described in more detail with reference to Examples. These examples are only intended to illustrate the invention and are not to be construed as limiting the scope of the invention by these examples.

Example 1 Preparation of Ring Ginseng Extract

For hwansam vine extract, 20% ethanol is added to the crushed or cut hwansam vine dried sample, sonicated for 15 minutes, and the extraction solution obtained by repeating the procedure for 10 hours at room temperature for 10 hours is filtered and filtered. After concentration, the sample frozen in a deep freezer was obtained by drying in a freeze dryer. Ring ginseng vine extract obtained as described above was used by dissolving in 0.5% CMC (carboxy methylcellulose) solution, respectively, for use in animal experiments.

Example 2 Verification of Efficacy of Ring Ginseng Extract against Autism Category Disorders

In order to verify the efficacy of Hwansam vine extract on developmental disorders, BTBR mice, a model of developmental disorders, were used as experimental animals. Vehicles were orally administered daily at 3 weeks of age for male BTBR mice at 400 mg / kg of 0.5% CMC and fern extract. From 4 weeks after the administration, the mice were observed for repetitive and social behaviors and behavioral evaluations such as cognitive memory tests were performed. The mice were allowed to freely consume sterilized feed and water in a breeding facility in a specific pathogen free environment in which the temperature was maintained at 22 to 24 ° C., and were maintained while maintaining a 12 hour day and night cycle.

Example 2-1 Preparation of Mouse Model of Developmental Disorders and Administration of Ginseng Extract

In order to analyze the social behavior of mice, the interaction behavior with other mice (sniffing behavior) was observed for 3 minutes to measure the time (A) and the number (B) of sniffing. Compared to the group administered with vehicle to the BTBR mice, the social behavior of the mice orally administered with the gingival vine extract was significantly increased (* p <0.05, one-tailed t-test) (FIG. 1).

Through the above results, it can be seen that the administration of hwansam vine extract has a prophylactic and therapeutic effect against the social behavioral disorder represented by the developmental disorder.

Example 2-2: Repetitive Behavior Analysis in a Developmental Disorder Mouse Model

In order to analyze the repetitive behavior of the mice, grooming behavior of BTBR mice was measured for 30 minutes. Compared to the vehicle administration group, the grooming behavior was significantly reduced in the statistically significant level (* p <0.05, two-tailed t-test). In other words, it was confirmed that the repetitive behavioral phenotype of BTBR mice was effectively reduced by administration of hwansamvine extract (FIG. 2).

Through the above results, it was confirmed that the annular vine extract has an effect of reducing the repetitive behavior, hwansam vine extract and its fractions are effective in the prevention and treatment of developmental disorders.

Example 2-3: Cognitive Memory Test in Developmental Disorder Mouse Model

A novel object recognition test was used to test the cognitive memory of a new object when a new object was provided with a previously viewed object to identify the effect of cognitive improvement of the mouse.

Specifically, on the first training day, the mice were placed in a white box of 41.5 cm × 20 cm × 21.5 cm and allowed to move freely for 10 minutes. After 10 minutes of adaptation as described above, they were returned to the original cage. On the second day, two identical cylindrical wooden blocks were placed on both sides of the box and exposed for 10 minutes to allow the mouse to explore them. After 24 hours, the box was placed with a new cylindrical block (new object) together with the cylindrical block (used object) that was originally seen, and the mouse movement was observed. At this time, the time (sniffing time) and the number (sniffing number) of touching each block, snoring, or moving toward the block were measured.

Discrimination index = new object sniffing time (number)-calculated as familiar object sniffing time (number) / new object sniffing time (number) + familiar object sniffing time (number).

As a result of the experiment, in the case of vehicle-administered BTBR mice, the recognition time of the new object and the cylindrical block, which is a familiar object, is not well recognized, and the search time for the new object is significantly reduced, and the distinction between the familiar object and the new object is well distinguished. In the case of BTBR mice treated with hwansam vine extract, it was confirmed that the new object cognitive memory was significantly improved (A, the number of distinctions for the new object search time; B, the degree of discrimination for the number of new object searches). Numerical values, ^* p <0.05, two-tailed t-test) (FIG. 3).

Through the above results, it was confirmed that the annular vine extract has a cognitive ability and memory enhancement effect, the hwansam vine extract and its fractions are effective in the prevention and treatment of developmental disorders.

Example 2-4. Hyperactivity Behavior Analysis in Mice

In order to analyze the activity of the mouse, the moving distance of the mouse was measured for 5 minutes in an open field test (45 cm × 45 cm × 40 cm). Vehicle refers to a control group administered orally 0.5% CMC daily, hwansam vine refers to a group of BTBR mice orally administered daily with 400 mg / kg hwansam vine extract.

As a result, it was confirmed that the moving distance of the mouse significantly decreased by the administration of hwansamvine extract ( ^* p <0.05, one-tailed t-test) (Fig. 4).

Through the above results, it was confirmed that the annular vine extract has an effect of improving the active behavior, the hwansam vine extract and its fractions are effective in the prevention and treatment of developmental disorders.

From the above description, those skilled in the art will appreciate that the present invention can be implemented in other specific forms without changing the technical spirit or essential features. In this regard, the embodiments described above are to be understood in all respects as illustrative and not restrictive. The scope of the present invention should be construed that all changes or modifications derived from the meaning and scope of the following claims and equivalent concepts rather than the detailed description are included in the scope of the present invention.

Claims (9)

Humulus japonicus ) pharmaceutical composition for the prevention or treatment of developmental disorders comprising the extract or fractions thereof as an active ingredient.
The method of claim 1,
The extract is a pharmaceutical composition that is extracted with a solvent selected from the group consisting of water, C1 ~ C6 alcohol and mixed solvents thereof.
The method of claim 1,
The pharmaceutical composition will further comprise a pharmaceutically acceptable carrier.
The method of claim 1,
The developmental disorders include a group consisting of intellectual disorders, cerebral palsy, general developmental disorders, developmental language disorders, special sensory dysfunctions including vision or hearing, learning disorders, attention deficit hyperactivity disorder, epilepsy, and combinations thereof It is a disease selected from, pharmaceutical composition.
The method of claim 4, wherein
Wherein said general developmental disorder is a disease selected from the group consisting of autism category disorder, asperger syndrome, childhood disruptive disorder, let's syndrome, atypical autism category disorder and combinations thereof.
Health functional foods for the prevention or improvement of developmental disorders comprising hwansam vine extract or fractions thereof as an active ingredient.
Feed composition for the prevention or improvement of developmental disorders comprising hwansam vine extract or fractions thereof as an active ingredient.
A quasi-drug composition for the prevention or improvement of developmental disorders comprising hwansam vine extract or fractions thereof as an active ingredient.
A method for preventing or treating a developmental disorder, comprising administering the pharmaceutical composition of claim 1 to an individual except a human.

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