WO2019124854A1 - Composition for preventing or treating dry eye syndrome, containing mixed extract or fraction thereof - Google Patents

Abstract

The present invention relates to a pharmaceutical composition for preventing or treating dry eye syndrome, containing, as an active ingredient, a mixed extract of Paeonia lactiflora and Glycyrrhiza uralensis or a fraction thereof, and a functional health food for preventing or alleviating dry eye syndrome, containing, as an active ingredient, the mixed extract or a fraction thereof. The mixed extract of Paeonia lactiflora and Glycyrrhiza uralensis or a fraction thereof, of the present invention, can significantly inhibit a reduction in tear secretion and topographic changes in the cornea, caused by dry eye syndrome, and thus can be provided as an active ingredient of a pharmaceutical composition and a functional health food for preventing or treating dry eye syndrome and in a treatment method.

Description

Composition for preventing or treating dry eye syndrome including mixed extracts or fractions thereof

The present invention relates to a pharmaceutical composition for preventing or treating dry eye syndrome comprising a mixed extract of peony root and licorice or a fraction thereof as an active ingredient, and a health functional food for preventing or ameliorating dry eye syndrome comprising the mixed extract or the fraction thereof as an active ingredient .

Dry eye syndrome is not simply a tear defect, but it causes eye discomfort, eye fatigue, decreased visual acuity, and instability of the tear layer due to inflammation of the tear and ocular surface (cornea and conjunctiva) , There is a great risk of pain, irregular corneal surface, blurred vision, increased corneal ulceration, and the like. However, the mechanisms of this pathogenesis have not yet been fully elucidated, but studies have shown that inflammation plays an important role in infiltration of inflammatory cells, increased expression of immune activation molecules and adhesion molecules, Th1 and Th17 responses, abnormalities of apoptotic markers and chemokines have.

In general, it is recommended to consume foods rich in potassium and anthocyanins for the treatment of dry eye syndrome. In addition, fruits such as kale, kiwi and apple are also highly recommended, and the amount of tears released by artificial tear drops and tear points They also use controlled treatments.

According to the Global Data Report, the world market for dry eye syndrome is expected to grow at a CAGR of 12.8% from US $ 1.6 billion in 2012 (US $ 1.88 trillion) to US $ 5.5 billion (US $ 6.4 trillion) in 2011. According to the Health Insurance Review and Assessment Service, total medical expenses used for the treatment of dry eye syndrome in Korea increased by 8.6% per year, reaching 52.1 billion won in 2009 and 72.6 billion won in 2013 (over 2 million won in 2016) .

However, dry eye syndrome is a common disease that occurs in about 20% of adults in Korea. Especially, global warming due to global climate change, especially El Niño phenomenon, and environmental pollution such as fine dust, There is no therapeutic or functional food.

Currently, there are large-scale imports of dry eye syndrome and eye fatigue-related functional foods overseas. When functional food products developed in Korea are prevented from being transferred to eye fatigue and dry eye syndrome, it is possible to prevent national health loss as well as national financial loss.

Paeonia lactiflora is a perennial plant belonging to the family Paeoniaceae and is native to parts of China, Siberia and Korea, and the herbal medicine and herbal medicines are defined as the roots of Paeonia lactiflora Pallas or other herbaceous plants . The pharmacological activities of peonies have been reported to inhibit platelet aggregation, to act on the circulatory system, to antitumor action, and to enhance immunity (Son Dong-Ju, Journal of the Korean Society of Food Science and Nutrition, 2002, 31, 511, 4, 445).

Licorice ( Glycyrrhiza uralensis ) is a perennial herbaceous plant belonging to the soybean family. The pharmacological activity of licorice was evaluated by the antitumor effect of chronic hepatitis improvement, antidiabetic effect (Mae, Tatsumasa, et al., The Journal of nutrition 133.11 (2003): 3369-3377) , Korean Journal of Plant Resources 27.5 (2014): 401-414.), Ulcerative Colitis Inhibitory Effect (Lee, Keyong-Ho, and Ki-Hyeong Rhee., The Korean Journal of Food and Nutrition 23.4 -439.), Antioxidant effects (Woo, Koan-Sik, et al., Journal of the Korean Society of Food Science and Nutrition 36.6 (2007): 689-695).

Accordingly, the present inventors have completed the present invention by confirming that a mixed extract of peony root and licorice, or a fraction thereof, can treat dry eye syndrome through an increase in tear secretion amount and inhibition of corneal morphological change.

It is an object of the present invention to provide a pharmaceutical composition for preventing or treating dry eye syndrome which comprises a mixed extract of peony root and licorice or a fraction thereof as an active ingredient.

Another object of the present invention is to provide a composition for preventing or treating dry eye syndrome comprising a mixture of peony root and licorice root extract or a fraction thereof as an active ingredient.

Another object of the present invention is to provide a health functional food for preventing or ameliorating dry eye syndrome comprising a mixed extract of peony root and licorice or a fraction thereof as an active ingredient.

It is another object of the present invention to provide a feed composition for preventing or improving dry eye syndrome comprising a mixed extract of peony root and licorice or a fraction thereof as an active ingredient.

Another object of the present invention is to provide a quasi-drug composition for the prevention or treatment of dry eye syndrome comprising a mixture of peony root and licorice root extract or a fraction thereof as an active ingredient.

Another object of the present invention is to provide an eye cosmetic additive composition for preventing or improving dry eye syndrome, which comprises a mixed extract of peony root and licorice or a fraction thereof as an active ingredient.

Another object of the present invention is to provide a method for preventing or treating dry eye syndrome comprising administering to a subject a mixed extract of licorice and licorice or a fraction thereof.

The peanut and licorice mixed extract of the present invention and the fractions thereof can be used for the development of a pharmaceutical composition for the prevention or treatment of dry eye syndrome since the amount of tear secretion due to dry eye syndrome and the change of corneal morphology can be significantly inhibited It will be possible.

FIG. 1 is a photograph showing a change in the amount of tear secretion according to the administration of the mixed extract through an eye volume test sheet.

FIG. 2 is a graph showing a quantitative change in the amount of tear secretion according to the mixed extract administration (*: p <0.05 vs. Normal; #: p <0.05 vs. dry eye).

FIG. 3 is a photograph showing changes in the corneal morphology of rats upon administration of mixed extracts.

FIG. 4 is a graph showing scores of corneal smoothness score in rats according to the mixed extract administration. The corneal smoothness score was evaluated by dividing the corneal morphology by 0 to 5 (zero point: no distortion, 1 point: distortion at 1/4 point, 2 points: 2/4 point , 3 points: Distortion at 3/4 point, 4 points: Distortion at all points, 5 points: Uncertainty of rounded shape due to severe distortion, #: p <0.05 vs. dry eye).

FIG. 5 is a graph showing a quantitative change in the amount of tear secretion according to administration of licorice extract (*: p <0.05 vs. Normal).

6 is a photograph showing changes in the corneal morphology of rats upon administration of licorice extract.

FIG. 7 is a graph showing the corneal smoothness score of rats according to administration of mixed extract (*: p <0.05 vs. Normal).

The inventors of the present invention have found that when a variety of studies are conducted to develop a therapeutic agent capable of effectively treating dry eye syndrome, a mixed extract of peony root and licorice or a fraction thereof shows an effect of treating dry eye syndrome. The above-mentioned mixed extracts or fractions of peanut and licorice not only significantly inhibited the decrease of tear secretion and changes in corneal morphology according to dry eye syndrome but also showed similar effects to the commercial drugs used for the treatment of dry eye syndrome there was. The technique for treating dry eye syndrome using the mixed extract or fraction has not been known at all and has been developed for the first time by the present inventors.

In one aspect of the present invention, the present invention provides a pharmaceutical composition for preventing or treating dry eye syndrome, which comprises a mixed extract of peony root and licorice or a fraction thereof as an active ingredient.

The present invention also provides a composition for preventing, ameliorating or treating dry eye syndrome, comprising a mixture of peony root and licorice, or a fraction thereof as an active ingredient.

The mixed extract of peanut and licorice having the preventive and therapeutic activity of dry eye syndrome can be extracted from various organs of natural, hybrid, and variant plants and can be extracted from various organs such as roots, stems, leaves, flowers, As well as extracts from plant tissue cultures.

As used herein, the term " Paeonia lactiflora "is a perennial herb that belongs to the family Paeoniaceae and is native to parts of China, Siberia and Korea. In the Chinese medicine standard book, peonies are defined as the roots of Paeonia lactiflora or other plants, and peeled, dried and dried together with peel and peel are called peptone. The pharmacological activities of peonies have been reported to inhibit platelet aggregation, to act on the circulatory system, to antitumor action, and to enhance immunity.

As used herein, the term " Glycyrrhiza uralensis "is a perennial herbaceous plant belonging to the soybean family and may be used as a medicinal or sweetener by drying the roots. The pharmacological activity of licorice has been reported to improve chronic hepatitis by detoxification, anti - diabetic effect, anti - ulcer effect, ulcerative colitis inhibitory effect, antioxidant effect.

In the present invention, the mixed extract may be extracted from roots, stems, leaves, flowers, or fruits of peony root and licorice, and is not particularly limited thereto.

In the present invention, the mixed extract of peony root and licorice includes, but is not limited to, extracts from a solvent selected from the group consisting of water, lower alcohols having 1 to 4 carbon atoms, and mixed solvents thereof. In addition, in the present invention, the above extract may contain any one of the extract obtained by the extraction treatment, the diluted solution or the concentrate of the extract, the dried product obtained by drying the extract, or the adjusted product or the purified product.

The alcohol may be butyl alcohol, ethyl alcohol, methyl alcohol or a water-soluble alcohol thereof. Specifically, the water-soluble alcohol may be an alcohol in an amount of 0.1 to 100% by weight.

The term "fraction " as used herein means a product obtained by performing fractionation to separate a specific component or a specific component group from a mixture containing various components.

The fractionation method for obtaining the fraction in the present invention is not particularly limited and may be carried out according to a method commonly used in the art. As a non-limiting example of the above-mentioned fractionation method, a method of obtaining a fraction from the extract by treating a predetermined solvent with an extract obtained by extracting a mixed extract of peony root and licorice root.

In the present invention, the fraction may be a hexane fraction, an ethyl acetate fraction, a butanol fraction or a water fraction of a mixture of peony root and licorice. The fractions may each comprise 0.01 to 100% by weight, more specifically 1 to 80% by weight, based on the total weight of the pharmaceutical composition.

The kind of the fraction solvent used for obtaining the fraction in the present invention is not particularly limited, and any solvent known in the art can be used. Non-limiting examples of the fraction solvent include polar solvents such as water and alcohol; And non-polar solvents such as hexane, ethyl acetate, chloroform, and dichloromethane. These may be used alone or in combination of two or more. When an alcohol is used in the fraction solvent, C1 to C4 alcohols can be specifically used.

As used herein, the term "dry eye syndrome" refers to dry eye syndrome, which is caused by inflammation of the lacrimal gland and decongestion of the cornea, inhibiting tear secretion, And abnormal conjunctival epithelial disorder caused by excessive dryness of the tears due to the dry eye syndrome and resulting in wounds of the cornea.

As used herein, the term "prevention" refers to any act that inhibits or delays the symptoms of dry eye syndrome by administration of a composition comprising the peony root extract of licorice and licorice, or fractions thereof, according to the present invention.

As used herein, the term "treatment" refers to any action that improves or alleviates the symptoms of dry eye syndrome by administration of a composition comprising the peony root extract and licorice root extract or fractions thereof according to the present invention.

In the present invention, the composition may increase the secretion amount of tears or inhibit the morphological change of the cornea. The morphological change of the cornea may be due to excessive irritation of the tears, which may cause the surface of the cornea to become rugged and the rounded circle to warp and distort. The composition of the present invention may improve smoothness and flatness.

In one embodiment of the present invention, it was confirmed that the tear secretion amount was significantly increased in all the concentration groups when the mixed extract of peony root and Licorice was administered, and it was confirmed that the effect was increased depending on the concentration (FIGS. 1 and 2 ).

In another embodiment of the present invention, it was confirmed that administration of a mixture of peony and licorice extract significantly inhibited the change in corneal morphology in the dry eye syndrome group at high concentrations (100 mg / kg and 250 mg / kg) 3 and 4).

Therefore, it can be seen from the above results that the mixed extract of peony root and licorice has a therapeutic effect on dry eye syndrome.

As used herein, the term "pharmaceutical composition" means a preparation intended for the prevention or treatment of disease, and may be formulated into various forms according to each ordinary method. For example, it can be formulated into a form such as powders, granules, tablets, capsules, suspensions, emulsions, syrups and the like, and can be formulated in the form of external preparations, suppositories and sterilized injection solutions. Specifically, it can be formulated into an external preparation for eye, a form suitable for topical administration, for example, an eye drop, a cream, an ointment, a gel or a lotion.

The composition of the present invention may be prepared in the form of a pharmaceutical composition for preventing or treating dry eye syndrome, which further comprises an appropriate carrier, excipient or diluent conventionally used in the production of a pharmaceutical composition, (non-naturally occuring carrier).

In the present invention, the carrier, excipient and diluent which may be contained in the pharmaceutical composition include lactose, dextrose, sucrose, sorbitol, mannitol, xylitol, erythritol, maltitol, starch, acacia rubber, alginate, gelatin, calcium phosphate, Calcium silicate, cellulose, methylcellulose, microcrystalline cellulose, polyvinylpyrrolidone, water, methylhydroxybenzoate, propylhydroxybenzoate, talc, magnesium stearate and mineral oil.

In the case of formulation, a diluent or excipient such as a filler, an extender, a binder, a wetting agent, a disintegrant, or a surfactant is usually used. Solid formulations for oral administration include tablets, pills, powders, granules, capsules and the like, which may contain at least one excipient such as starch, calcium carbonate, Sucrose, lactose, gelatin and the like. In addition to simple excipients, lubricants such as magnesium stearate and talc are also used. Liquid preparations for oral use may include various excipients such as wetting agents, sweetening agents, fragrances, preservatives, etc. in addition to water and liquid paraffin, which are simple diluents commonly used in suspension, liquid solutions, emulsions and syrups have. Formulations for parenteral administration include sterilized aqueous solutions, non-aqueous solutions, suspensions, emulsions, freeze-dried preparations, and suppositories. Examples of the suspending agent include propylene glycol, polyethylene glycol, vegetable oil such as olive oil, injectable ester such as ethyl oleate, and the like. Examples of the suppository base include witepsol, macrogol, tween 61, cacao butter, laurin, glycerogelatin and the like.

The dosage of the pharmaceutical composition of the present invention can be determined by those skilled in the art in consideration of the purpose of use, the degree of addiction to the disease, the age, body weight, sex, history, or kind of the substance used as the active ingredient. For example, the pharmaceutical composition of the present invention may be administered at a dose of from about 0.1 ng to about 1,000 mg / kg, in particular from 1 ng to 1,000 mg / kg, per adult, and the frequency of administration of the composition of the present invention is specifically limited However, it may be administered once a day or divided into several doses. The dose is not intended to limit the scope of the invention in any way.

In another aspect, the present invention provides a method for treating dry eye syndrome comprising administering the pharmaceutical composition to a subject suffering from dry eye syndrome in a pharmaceutically effective amount.

The term "individual" as used herein may include, without limitation, mammals including rats, livestock, and the like with dry eye syndrome.

More specifically, the "individual" may include companion animals. The companion animal refers to an animal living together with a human, and specific examples include, but are not limited to, mammals such as dogs, cats, hamsters, and guinea pigs, and birds such as parrots and canaries.

The composition may be administered in single or multiple doses in a pharmaceutically effective amount.

The administration route of the pharmaceutical composition for preventing or treating dry eye syndrome of the present invention can be administered through any ordinary route as long as it can reach the target tissue.

The pharmaceutical composition of the present invention may be administered orally, intraperitoneally, intramuscularly, subcutaneously, intradermally, transdermal patch, oral, intranasal, intrapulmonary, Intramuscular administration, intrathecal administration, intrarectal administration, and the like, and specifically administered orally.

In another aspect, the present invention provides a health functional food for preventing or ameliorating dry eye syndrome comprising a mixed extract of peony root and licorice or a fraction thereof as an active ingredient.

The definition of peanut, licorice, fraction, and dry eye syndrome in the health functional food of the present invention is as defined above.

As used herein, the term "improvement" means any action that alters or modifies dryness of the eye by orally administering the composition.

The term "functional" as used in the present invention means that the structure and function of the human body have a beneficial effect for health use such as controlling nutrients or physiological action.

The health functional food of the present invention can be prepared by a method commonly used in the art and can be prepared by adding raw materials and ingredients that are conventionally added in the art. In addition, the formulation of the health functional food may also be produced without limitation as long as the formulation is recognized as a health functional food. The health functional food of the present invention can be manufactured in various forms, and unlike general pharmaceuticals, it has advantages of being free from side effects that may occur when a food is used as a raw material for a long period of time, and is excellent in portability, Can be ingested as an adjuvant to improve the effect of preventing or improving dry eye syndrome.

Specifically, the health functional food is a food prepared by adding the mixed extract or fraction of the present invention to a food material such as beverage, tea, spice, gum, confectionery, or the like, or encapsulating, powdering, or suspending, But it has the advantage that there is no side effect that can occur when a drug is taken for a long time using a food as a raw material, unlike a general medicine.

As another embodiment of the present invention, there is provided an eye cosmetic additive composition for preventing or improving dry eye syndrome comprising extracts of Euphorbiaceae or fractions thereof as an active ingredient.

The definition of the extract of Eisenhower extract, fraction, dry eye syndrome, prevention and improvement in the eye cosmetic additive composition is as defined above.

The additive may be included in eye make-up products and may be effective in preventing or improving the disease. In the present invention, the composition may include eye make-up products. Examples of the eye make-up cosmetic products include any one selected from the group consisting of eye pencil, eye liner, eye shadow, mascara, and eye makeup remover. have.

In another aspect of the present invention, there is provided a quasi-drug composition for preventing or improving dry eye syndrome comprising extracts of Euphorbiaceae or fractions thereof as an active ingredient.

In the above-mentioned quasi-drug composition, the definitions of the extracts of Echinochloa sp., Fractions, dry eye syndrome, prevention and improvement are as defined above.

The term "quasi-drug product" in the present invention means products which are less active than drugs, for example, for the purpose of diagnosing, treating, improving, alleviating, treating or preventing a disease in a human or an animal. For example, Quasi-drugs are products that are not used for medicines, such as fibers and rubber products used for the treatment and prevention of diseases of humans and animals, and are not acting directly or indirectly on the human body, These include sterilization and insecticides to prevent infectious diseases. The type and formulations of the quasi-drug composition of the present invention are not particularly limited, but may be disinfectant cleaner, shower foam, gagrin, wet tissue, detergent soap, hand wash, humidifier filler, mask, ointment or filter filler.

In another aspect of the present invention, there is provided a feed composition for preventing or ameliorating dry eye syndrome comprising extracts of Euphorbiaceae or fractions thereof as an active ingredient.

The definition of the extract of Echinochloa sp., Fractions, dry eye syndrome, prevention and improvement in the composition is as defined above.

As used herein, the term "feed" means any natural or artificial diet, single meal or the like or ingredients of the above formula for ingesting, ingesting, digesting or suitable for the individual.

The kind of the feed is not particularly limited, and feeds conventionally used in the art can be used. Non-limiting examples of such feeds include vegetable feeds such as cereals, muscle roots, food processing busines logistics, algae, fibers, pharmaceuticals, buses, oils, pastes, pulses or cereals; Animal feeds such as proteins, inorganic substances, fats, oils, fats, oils, monocellular proteins, animal plankton or foods. These may be used alone or in combination of two or more.

In one embodiment of the present invention, it was confirmed that the tear secretion amount was significantly increased in all the concentration groups when the mixed extract of peony root and Licorice was administered, and it was confirmed that the effect was increased depending on the concentration (FIGS. 1 and 2 ).

In another embodiment of the present invention, it was confirmed that administration of a mixture of peony and licorice extract significantly inhibited the change in corneal morphology in the dry eye syndrome group at high concentrations (100 mg / kg and 250 mg / kg) 3 and 4).

Accordingly, the above-mentioned results indicate that the mixed extract of peony root and licorice or its fractions can be used as a pharmaceutical composition for preventing dry eye disease or eye fatigue, for improving or ameliorating eye fatigue, a health functional food, an eye cosmetic additive, And it can be used effectively.

Hereinafter, the present invention will be described in more detail with reference to examples. However, these examples are for illustrative purposes only, and the scope of the present invention is not limited to these examples.

Example 1. Preparation of mixed extract of peony and licorice

The extracts were filtered, and the filtrate was concentrated under reduced pressure at about 50 ° C and dried to prepare a mixed extract.

Example 2. Drug test using an experimental animal

Example 2.1: Dry eye syndrome Production of experimental animals

Six weeks old female SD rats (Orient Bio, Korea) were purchased and anesthetized with pentobarbital sodium (30 mg / kg body weight, Hanlim Pharm, Korea) for lacrimal clearance after one week purification. After removing the exorbital lacrimal gland from the incision site, the skin was sutured.After 1 week, the skin was sutured to the skin, Phenol-red thread volume test (FCI Opthalmics Zone Quick, Japan) was applied to the eyeball surface at the lateral end of the eyelid. After 30 seconds, the change in color of the test piece was measured by the tear test. The drug efficacy test was conducted using only these reduced preparations.

Example 2.2: Tear secretion measurement

In order to confirm the effect of the mixed extract on the dry eye syndrome, the change of the tear secretion amount according to the mixed extract administration was confirmed using the experimental animal of Example 2.1.

Five individuals were randomly assigned to each experimental group. The experimental group consisted of the following: non-invasive normal group (NOR) with no abnormality, the disease caused by dry eye lacrimal gland by the method of Example 2.1 (JGT-50) administered with 50 mg / kg of the mixed extract of the present invention (JGT), a drug administration group (JGT-50) administered with 100 mg / kg of the mixed extract of the present invention (JGT- 100), the drug-administered group (JGT-250) in which 250 mg / kg of the mixed extract of the present invention (JGT) was administered. The drug containing the mixed extract of the present invention was prepared by dissolving the above dose in sterilized physiological saline containing 0.5% DMSO. After the oral administration for 4 days, the dry eye was additionally administered on the 5th day for 3 days. On the 7th day after total administration, the animals were anesthetized and the change in color of the test strip was measured by tearing after 30 seconds of contact with the phenol-red thread volume test (FCI Opthalmics Zone Quick, Japan) And the efficacy of the drug was evaluated.

As a result, as shown in Fig. 1 and Fig. 2, it was confirmed that the length of the color change in the normal group was very long, while that of the dry eye disease group was short. Compared with dry eye disease group, drug - treated group showed significant increase in length at all experimental concentrations and increased dose - dependently.

Thus, through the above results, it was confirmed that the tear secretion amount was improved by administering the mixed extract of peony and licorice, so that the mixed extract was found to be effective in treating dry eye syndrome.

Example 2.3: Measurement of morphological change of cornea

In order to confirm the effect of the mixed extract on the dry eye syndrome, the morphological changes of the cornea according to administration of the mixed extract were confirmed using the experimental animal of Example 2.1.

The composition of the test group and administration of the drug were carried out in the same manner as in Example 2.2.

The animals were anesthetized and photographed using a stereoscopic microsope (Olympus, Japan) equipped with a fiberoptic ring illuminator. Changes in corneal morphology were assessed by grading the degree of distortion of the rounded circle shape of the circular light reflected on the corneal epithelium from 0 to 5. 0 point: No distortion, 1 point: Distortion at 1/4 point, 2 points: Distortion at 2/4 point, 3 points: Distortion at 3/4 point, 4 points: Distortion at all points, 5 point: Distortion at severe point Can not recognize the shape of the round circle.

The morphological changes of the cornea were evaluated. In the normal group, the tears secreted from the external lacrimal gland formed a tear film, and the smooth and flat surface state was maintained. As a result, Respectively. However, in the dry eye syndrome group, abnormalities in the tear film covering the cornea resulted in degeneration of the epithelium of the corneal epithelium and smooth surface of the cornea, so that the rounded shape was distorted and distorted. On the other hand, (JGT-100 and JGT-250) significantly inhibited corneal morphological changes such as the disease group (FIGS. 3 and 4).

Accordingly, it was confirmed through the above results that the combined extract of peony root and licorice inhibited the change of corneal morphology caused by dry eye syndrome. Thus, it was found that the mixed extract was effective in treating dry eye syndrome.

Comparative Example 1: Drug test for licorice root extract

Comparative Example 1.1 Measurement of tear secretion of licorice extract-treated group

The tear secretion amount was measured using the method of Example 2.2 in order to confirm the therapeutic effect of the licorice extract extracted by the method of Example 1 with dry liquorice alone. The dose of licorice extract was 84 mg / kg, the dose of Licorice based on JGT-250 (250 mg / kg dose).

As a result, as shown in FIG. 5, the tear secretion amount of the licorice extract-treated group was not significantly different from that of the dry eye syndrome group, confirming that the licorice extract did not increase the tear secretion amount.

Comparative Example 1.2 Measurement of corneal morphological change in licorice extract-treated group

In order to confirm the therapeutic effect of dry eye extract of licorice root extract, the change of corneal morphology was confirmed by the method of Example 2.3. The dose of licorice extract was 84 mg / kg, the dose of Licorice based on JGT-250 (250 mg / kg dose).

As a result, as shown in FIG. 6, it was confirmed that the corneal morphology of the licorice extract-treated group was not clear compared to the normal group, and the corneal morphology of the licorice extract-treated group No significant decrease in the score was observed, indicating that the licorice extract did not inhibit corneal morphological changes.

Thus, it was confirmed that the licorice extract alone did not affect the amount of tear secretion, and had no effect of inhibiting the corneal morphological change. Thus, it was confirmed that it was not suitable as a composition for treating dry eye syndrome.

It is to be understood that both the foregoing general description and the following detailed description of the present invention are exemplary and explanatory and are intended to provide further explanation of the invention as claimed. More variations are possible within a range that does not. Accordingly, the present invention may be embodied in other ways than those specifically described and illustrated herein, and it may be understood by those skilled in the art.

Claims (12)

1. A pharmaceutical composition for preventing or treating dry eye syndrome, which comprises a mixed extract of peony root and licorice or a fraction thereof as an active ingredient.
2. The method according to claim 1,

   Wherein the extract is an extract extracted with a solvent selected from the group consisting of water, a lower alcohol having 1 to 4 carbon atoms, and a mixed solvent thereof.
3. The method according to claim 1,

   Wherein said fraction is an n-hexane fraction, an ethyl acetate fraction, a butanol fraction or a water fraction of said mixed extract.
4. The method according to claim 1,

   The pharmaceutical composition for preventing and treating dry eye syndrome according to claim 1, wherein the extract is extracted by a method selected from the group consisting of vacuum, high temperature extraction, hot water extraction, reflux extraction, hot water extraction, room temperature extraction, ultrasonic extraction or steam extraction.
5. The method according to claim 1,

   Wherein said composition increases tear secretion, inhibits corneal morphological changes, or improves eye fatigue.
6. The method according to claim 1,

   Wherein said composition is a mixture of peony root and licorice root in a weight ratio of 10: 1 to 1:10.
7. The pharmaceutical composition according to claim 1, wherein the pharmaceutical composition is an external preparation for eyeball.
8. A health functional food for preventing or ameliorating dry eye syndrome, which comprises a mixed extract of peony root and licorice or a fraction thereof as an active ingredient.
9. A health functional food for enhancing tear secretion content comprising a mixture of peony and licorice or a fraction thereof as an active ingredient.
10. A method for preventing or treating dry eye syndrome comprising administering to a subject a mixed extract of peony root and licorice or a fraction thereof.
11. A cosmetic additive composition for preventing or ameliorating dry eye syndrome comprising a mixed extract of peony root and licorice or a fraction thereof as an active ingredient.
12. A quasi-drug composition for the prevention or treatment of dry eye syndrome comprising a mixture of peony root and licorice as an active ingredient or a fraction thereof.

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