KR20050094079A - Pharmaceutical composition comprising the crude drug extract for improving eye symptoms of vdt syndrome - Google Patents

Abstract

The present invention relates to a pharmaceutical composition for improving ocular symptoms containing herbal extracts, and more specifically, for improving ocular symptoms, which essentially include C. vulgaris, Astragalus, Tosa, Bokbunja, Crustacea, Yellow Jung, Gugija and Licorice. It relates to a composition. The composition of the present invention can be usefully used in medicines and health functional foods for improving ocular symptoms because it is stable to the human body while reducing eye fatigue, reducing ocular sensation and ocular pain.

Description

Pharmaceutical composition comprising the crude drug extract for improving eye symptoms of VDT syndrome}

The present invention relates to a composition for improving the ocular symptom and health functional food of VDT syndrome, which essentially contains a deficiency, Astragalus, earth and sand, bokbunja, crustacean, citrine, goji and licorice extract.

Recently, with the rapid expansion of computerization of business due to industrialization and division of labor and the increase of the use of computer display terminals (VDT), VDT syndrome, a new occupational disease occurring in office workers, is emerging as a new social problem worldwide. (Lee Seung-duk, Kap-sung Kim, The Journal of Korean Acupuncture and Moxibustion Society, 2001, 18, 70-83). In general, VDT syndrome refers to a combination of health disorders such as eye disorders, low back pain, and mental stress that occur in workers who handle VDT for a long time.

The most common and frequently occurring symptom of subjective symptoms of VDT syndrome is eye fatigue (Dainoff MJ, et al., Human factors, 1981, 23, 421-437; Smith MJ, et al., Human factors , 1981). , 23, 387-400). Specifically, a comparison of 395 VDT groups and 141 non-VDT groups of insurers, airlines, post offices, and newspaper workers showed that the VDT group was `` sick '', `` itchy '', or `` sandy eyes ''. Has been reported to be significantly higher in the five items, which are likely to enter the eyes', 'the eyes are dazzling' and 'the eyes are red.' (Knave, BG, et al., J. Work Environ. Health, 1985, 11 , 457-466). Other symptoms of VDT syndrome include reduction of tear film break up time due to dry eye syndrome and myopia due to the action of electromagnetic waves (Armaly MF, et al., Ophthal. Vis. Sci). , 1982, 1, 480-483; Tsubota K., Retina Eye Res. , 1998, 4, 565-596).

Therefore, various drugs, natural foods, and the like are favored for the improvement of eye symptoms as described above. Among these drugs, vision enhancers mainly composed of anthocyanides extracted from wild blueberries are widely used at home and abroad. As a tea has been drinking.

Cassia tora (決明子, Cassiae SEMEN) is the annual chobun of Mesquite (Leguminosae), gyeolmyeong using drying the seeds (Cassia tora L.), and Cri sofa play (chrysophanol), the emodine (emodin), rehin (rhein) Etc. are contained as an active ingredient. The deficiency mainly has nominal effect, hepatic nourishment effect, blood pressure lowering effect, anti-inflammatory effect and palliative effect (Bo Bo-seop and Shin Min-kyo; Hyangje-sa Dictionary, Yeonglimsa, pp672-673, 1998).

Astragalus membranaceus (FISCH.) BGE is a perennial herb, used to dry roots, and contains glucuron acid, saccharin, several amino acids, and folic acid as active ingredients. Astragalus has a cardiovascular effect, dilates coronary or systemic peripheral blood vessels, lowers blood pressure and diuretic. In addition, it protects the liver and has the effect of preventing hepatic glycogen reduction, sedation, uterine contraction, and blood sugar reduction (Jung Bo-seop and Shin, Min-Kyo; Hyang-Jung-Dae, Yeonglimsa, pp662-664, 1998).

Seedlings of Cuscuta japonica Choisy, C. australis R. and C. chinensis Lam are known as potting and tonic, and have a resin glycoside, vitamin A. It is also known to contain β-carotene-5, 6-epoxide, taraxanthin, and lutein. Younglimsa, 1998, p. 882-883).

Bokbunja ( Rubus coreanus MIQ) is an immature fruit of the deciduous shrub of the Rosaceae family, Bokbunja Strawberry, and the related plant, which contains carbolic acid, sugars and vitamin C of the small intestine. It is known to protect the liver and kidneys, and to be effective in treating symptoms such as urination, nocturnal urination, frequent urination, and oil well due to the effects of insertion, urination, and urine (Jung Ji-seop, Shin Min-kyo, Ph.D. , Yeonglimsa, 1998, p.652-653).

Crust is an immature fruit just before the maturation of Tangerine and Tangerine trees belonging to the Rutaceae. It is dried and used.

Yellow goose ( Polygonatum sibiricum ) is used to dry the root of the yellow belonging to the genus Liliaceae. Azetidine-2-carboxylic acid, aspartic acid, digitalis glycosides It is contained as an active ingredient. As a nourishing tonic, it has the effect of Bojungikgi (골 中 심장) and strengthening the heart and musculature (Jung Ji-sup, Shin Min-kyo, Yeong-myeon Daejeon, Yeonglimsa, 1998, p.181-182).

Gojija is a mature fruit of Lycium chinese and Lycium barbarum L. belonging to the family Solanaceae. Carotene, vitamin B, C, nicotinic acid, etc. It contains. It has the effect of protecting the liver and kidneys, producing blood, and clearing the eyes (Information Seop, Shin Min Kyo, Hyang Yak Dictionary, Young Lim, 1998, p. 826-827).

Licorice ( Glycyrrhiza uralensis FISCH.) Is a perennial herb, which is a herbaceous perennial herb. It is used as a drug, and itself has a weakness such as neutralization of poison. For example, licorice has the effect of protecting the liver and smoothing the liver and regulating fatigue, and taking licorice reduces the burden on the liver by its detoxification. Triterpene-based saponins and glycyrrhizin are contained in the roots and roots of plants, which have all the detoxifying effects on bacterial toxins as well as drug addiction, food poisoning, and metabolism in the body. And thyroid sebum hormone amount is regulating action. Licorice has anti-inflammatory and anti-allergic reactions, antagonistic action against acetylcholine, and a potent effect of adrenaline stimulation. 1998).

As mentioned above, many researches on the efficacy and toxicity of scientifically related to the defector, Astragalus, earthenware, bokbunja, crust, yellow, wolfberry, licorice have been used for a long time without special toxicity or side effects in oriental medicine and folk medicine. Has been made. However, there is no research literature or other data regarding the ocular symptoms improving composition containing the herbal extract as well as the study itself.

Therefore, the present inventors focused on the study of foods for improving the ocular symptom of VDT syndrome derived from natural products. The present invention has been found to have an effect of improving ocular symptoms such as reducing ocular sensation and ocular pain.

It is an object of the present invention to provide a pharmaceutical composition and health functional food for improving the ocular symptoms of VDT syndrome, which essentially contains a deficiency, Astragalus, earthenware, bokbunja, crust, yellow, goji and licorice extract.

In order to achieve the above object, the present invention comprises a compound herbal extract containing as an active ingredient to the deficiency, Astragalus, earthenware, bokbunja, crust, yellow flower, wolfberry and licorice extract and includes a pharmaceutically acceptable carrier, excipient or diluent It provides a pharmaceutical composition for improving the ocular symptoms of the VDT (Visual Display Terminal) syndrome.

Hereinafter, the present invention will be described in detail.

The extract is characterized in that it is included in the form of a pulverized product, extract or powder extract thereof. At this time, the composition according to the present invention includes a single extract of each herbal medicine, a mixed extract containing two or more of these single extracts, or a complex extract prepared by extracting a plant containing two or more of each herbal medicine.

The extract according to the present invention may be a crude extract prepared by applying a solvent extraction method using a conventional water extract, alcohol, etc. as a solvent, and may also be a fraction extract purified using column chromatography. Extraction method according to the invention can be applied to all extraction methods known to those of ordinary skill in the art, for example, extraction with water, alcohol or mixed solvents, extraction method using a bath or room temperature, etc. Including but not limited to.

In a preferred embodiment of the present invention, dried herbal medicines may be washed to remove foreign substances, etc. present on the surface of the material, and then dried in a dryer, mixed in an appropriate blending ratio, and ground to obtain the herbal powders.

In addition, 5 to 20 times, preferably 10 to 15 times the volume / weight of distilled water, lower alcohol having 1 to 4 carbon atoms or a mixed solvent thereof, preferably distilled water alone or 10 to 50% of the powdered complex herbal medicines. A mixed solvent of water and ethanol is added and cold-pressed at a temperature of 0 ° C to room temperature, preferably 4 to 6 ° C for 12 hours to 48 hours, preferably 20 to 24 hours, or 80 to 100 ° C, preferably Extract the extract of the complex herbal extract soluble in polar solvent by extracting 2 to 5 times with water of 20 to 50 times the total amount of extraction by hot water extraction for 1 to 24 hours, preferably 3 to 5 hours at an extraction temperature of 90 ° C. or higher. Can be.

Further, after filtering the extract obtained from the extraction step, it was concentrated under reduced pressure at 40 to 80 ℃ concentrated X 1 to 5 times azeotropically with water of 10 to 60 times the total amount of X, then lyophilization or vacuum drying Preferably, it can be lyophilized to obtain a powder extract.

The present invention provides a composition for improving ocular symptoms of VDT syndrome, including a complex herbal extract containing as an essential ingredient an extract, Astragalus, earthenware, bokbunja, crust, citrine, goji and licorice extract.

In addition, the herbal extracts have been used as food for a long time as the extract of the present invention extracted therefrom also does not have problems such as toxicity and side effects.

The ocular fatigue, the eyelid fatigue, the ocular symptoms, the ocular sensation, the ocular pain, the refractive index, and the tear film destruction time of the composition obtained by the above-described method were examined. The effect was confirmed.

The composition for improving ocular symptoms of the present invention is 5 to 10% by weight of the extract of the Clarifier extract, 18 to 27% by weight of Astragalus extract, 5 to 15% by weight of Tosa extract, 3 to 8% by weight of Bokbunja extract, crust extract 7 ~ 15% by weight, 5-10% by weight of the yellow extract, wolfberry extract 20-30% by weight and licorice extract 5-10% by weight.

Pharmaceutical compositions comprising the extract of the present invention may further comprise suitable carriers, excipients and diluents commonly used in the manufacture of pharmaceutical compositions.

The pharmaceutical dosage forms of the extracts of the present invention may be used in the form of their pharmaceutically acceptable salts, and may be used alone or in combination with other pharmaceutically active compounds as well as in a suitable collection.

Pharmaceutical compositions comprising extracts according to the invention, in the form of powders, granules, tablets, capsules, suspensions, emulsions, syrups, aerosols and the like, oral preparations, suppositories and sterile injectable solutions, respectively, according to conventional methods. Can be formulated and used. Carriers, excipients and diluents that may be included in the composition comprising the extract 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 may include at least one excipient such as starch, calcium carbonate and sucrose in the extract. ) Or lactose, gelatin and the like are mixed. In addition to simple excipients, lubricants such as magnesium stearate and talc are also used. Oral liquid preparations include suspensions, solvents, emulsions, and syrups, and may include various excipients, such as wetting agents, sweeteners, fragrances, and preservatives, in addition to commonly used simple diluents such as water and liquid paraffin. . 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.

Preferred dosages of the extracts of the present invention vary depending on the condition and weight of the patient, the extent of the disease, the form of the drug, the route of administration and the duration, and may be appropriately selected by those skilled in the art. However, for the desired effect, the extract of the present invention is preferably administered at 0.0001 to 100 mg / kg, preferably 0.001 to 100 mg / kg per day. Administration may be administered once a day or may be divided several times. The dosage does not limit the scope of the invention in any aspect.

The extract of the present invention can be administered to mammals such as mice, mice, livestock, humans, etc. by various routes. All modes of administration can be expected, for example by oral, rectal or intravenous, intramuscular, subcutaneous, intrauterine dural or intracerebroventricular injection.

Complex herbal extract of the present invention is a drug that can be used with confidence even when taken for a long time for the purpose of prevention because there is little toxicity and side effects.

In addition, the present invention provides a health functional food for improving liver function, including the complex herbal extract and food supplements acceptable food supplement.

In detail, the present invention is a health function for improving liver function, including complex herbal extracts containing food extracts, coriander, earthenware, bokbunja, crust, citrine, goji berry and licorice extract as an active ingredient, and food supplements. Provide food. The health functional food of the present invention includes the complex herbal extract in the form of a ground powder, extract or powder extract.

The composition containing the multi-drug extract of the present invention can be used in various ways, such as drugs, foods and beverages for improving eye symptoms or eye diseases. Foods to which the complex herbal extract of the present invention may be added include various foods, for example, beverages, gums, teas, vitamin complexes, health supplements, and the like, pills, powders, granules, acupuncture tablets, capsules, or the like. It can be used in the form of a drink. At this time, the amount of the extract in the food or beverage may be added in 0.01 to 60% by weight of the total food weight, the health beverage composition may be added in a ratio of 0.02 to 5 g, preferably 0.3 to 1g based on 100 ml. have.

The health functional beverage composition of the present invention is not particularly limited to other ingredients except for having the extract as an essential ingredient in the indicated ratio, and may contain various flavors or natural carbohydrates, etc. as additional ingredients, as in general beverages. Examples of the above-mentioned 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. As flavoring agents other than those mentioned above, natural flavoring agents (tauumatin, stevia extract (for example, rebaudioside A, glycyrrhizin, etc.) and synthetic flavoring agents (saccharin, aspartame, etc.) can be advantageously used. The proportion of said natural carbohydrates is generally about 1-20 g, preferably about 5-12 g per 100 ml of the composition of the present invention.

In addition to the above, the extract of the present invention includes various nutrients, vitamins, minerals (electrolytes), flavors such as synthetic flavors and natural flavors, coloring and neutralizing agents (such as cheese and chocolate), pectic acid and salts thereof, alginic acid and its Salts, organic acids, protective colloidal thickeners, pH adjusters, stabilizers, preservatives, glycerin, alcohols, carbonation agents used in carbonated beverages, and the like. In addition, the extracts of the present invention may contain flesh for the production of natural fruit juices and fruit juice beverages and vegetable beverages. These components can be used independently or in combination. The proportion of such additives is not so critical but is usually selected in the range of 0 to about 50 parts by weight per 100 parts by weight of the extract of the present invention.

Hereinafter, the present invention will be described in detail by the following Examples and Experimental Examples.

However, the following Examples and Experimental Examples are merely illustrative of the present invention, and the content of the present invention is not limited by the following Examples and Experimental Examples.

Example 1 Preparation of Extract

1-1. Preparation of Cassia Extract

1 kg of dried Clamella (Gyeongdong Market) was crushed with a grinder, placed in 20 liters of purified water, and extracted by heating twice at 90 to 100 ° C. for 6 hours. The extract was filtered, concentrated under reduced pressure and lyophilized to give 264 g of Cassia extract.

1-2. Preparation of Astragalus Extract

1 kg of dried Astragalus (Gyeongdong Market) was crushed by a pulverizer, placed in 20 liters of purified water, and extracted by heating twice at 90 to 100 ° C. for 6 hours. The extract was filtered and then concentrated under reduced pressure to obtain 160 g of Astragalus extract.

1-3. Preparation of Tosa Extract

1 kg of dried earthenware (Gyeongdong Market) was crushed by a pulverizer, placed in 20 liters of purified water, and extracted by heating twice at 90 to 100 ° C. for 6 hours. The extract was filtered, concentrated under reduced pressure and lyophilized to obtain 304 g of Tosa extract.

1-4. Preparation of Bokbunja Extract

1 kg of dried bokbunja (Gyeongdong market) was pulverized with a grinder, placed in 20 liters of purified water, and extracted by heating twice at 90 to 100 ° C. for 6 hours. The extract was filtered, concentrated under reduced pressure and lyophilized to obtain 340 g of Bokbunja extract.

1-5. Preparation of Crust Extracts

1 kg of dried crust (Gyeongdong Market) was crushed with a grinder, placed in 20 liters of purified water, and heated and extracted twice at 90 to 100 ° C. for 6 hours. The extract was filtered, concentrated under reduced pressure and lyophilized to yield 104 g of crust extract powder.

1-6. Preparation of Citrine Extract

1 kg of dried yellow ginseng (Gyeongdong Market) was crushed with a grinder, placed in 20 liters of purified water, and extracted by heating twice at 90 to 100 ° C. for 6 hours. The extract was filtered, concentrated under reduced pressure and lyophilized to give 226 g of yellow extract powder.

1-7. Preparation of wolfberry extract

1 kg of dried wolfberry (Gyeongdong Market) was pulverized with a grinder, placed in 20 liters of purified water, and extracted by heating twice at 90 to 100 ° C. for 6 hours. The extract was filtered, concentrated under reduced pressure and lyophilized to give 294 g of Goji extract.

1-8. Preparation of Licorice Extract

1 kg of dried licorice (Gyeongdong Market) was crushed with a grinder, placed in 20 liters of purified water, and extracted by heating twice at 90 to 100 ° C. for 6 hours. The extract was filtered, concentrated under reduced pressure and lyophilized to give 198 g of licorice extract.

Example 2. Preparation of Compositions and Preparation of Products

2-1. Preparation of the composition

To prepare a composition for improving ocular symptoms consisting of the extract obtained in Example 1 ( Table 1 ).

Ingredient Name Compounding ratio (% by weight) Cassava Extract 7.77 Astragalus Extract 22.23 Tosa Extract 11.12 Bokbunja Extract 5.55 Crust extract 11.12 Yellow extract 7.77 Wolfberry extract 26.67 Licorice extract 7.77 system 100.0

2-2. Manufacture of products

The health food for ocular symptoms improvement comprising the composition of Example 2-1 was prepared according to a conventional method for preparing a capsule using a composition ratio as shown in Table 2 below.

Ingredient Name Compounding ratio (% by weight) Composition of Example 2-1 55.556 Bilberry Extract Powder 0.444 Grape seed extract powder 0.444 Vitamin A Acetate 0.778 Millet powder 0.222 Beta Carotene (10%) Powder 0.667 beestings 2.222 Seaweed calcium 2.222 Vitamin c 1.111 Vitamin B1 Hydrochloride 0.133 Vitamin B2 Hydrochloride 0.178 Vitamin E powder 2.222 Mannitol 11.222 Sorbitol 8.889 Magnesium stearate 0.911 Stevioside 0.222 Carboxymethyl Cellulose Calcium 1.222 White sugar 10.222 Grape 1.111 gun 100.00

Reference Example 1 Preparation of a Placebo and a formulation containing a composition for improving eye function

55.56% by weight of the composition of Example 2-1, 10.22% by weight sucrose, 8.89% by weight sorbitol, 11.22% by weight mannitol and 14.11% by weight sweetener based on the total weight Was prepared and used as an experimental material. Meanwhile, placebo was prepared by adding 60% by weight of pine fiber, 10% by weight of cellulose, 15% by weight of lactose and 15% by weight of other sweeteners to the total weight so that the taste and aroma were similar. . The preparations prepared as above were filled in 450 mg of the same capsules so that they could not be identified and were taken one capsule per day.

Reference Example 2. Subject Selection and Survey Method

Subjects were recruited for men and women in their 20s and 50s. Initial tests were performed to exclude patients with a history of hypertension, angina pectoris, and other cerebrovascular diseases. Most of the subjects consisted of male and female office workers in their 20s and 40s working on VDT work, and some of them (4) were in their 50s with advanced eye aging. Finally, 40 subjects were selected and conducted for 2 months (10 weeks).

In randomly assigning the above-selected subjects to the placebo group and the experimental group, the stratified randomization method was used so that the characteristics of the subjects located in each group were similar. That is, subjects were divided into several layers having similar characteristics by combining age, sex, and initial test results, and then randomized to placebo and experimental groups in each layer.

In addition, in the present invention, a double-blind method is applied to eliminate bias. That is, the subjects, as well as the researchers measuring and determining the response variables, did not know where the subject belonged to the placebo and experimental groups.

Reference Example 3. Statistics Processing

All results were evaluated for statistical significance by the Mann-Whitney test, a nonparametric test using SPSS 9.0. In addition, the statistical analysis set the significance level to x = 0.2, thereby analyzing the experimental results of a small number of samples, was applied to the test of the therapeutic effect of the drug on eye fatigue reduction and vision protection.

Experimental Example 1. Effect on eye fatigue and eyelid fatigue

The effects on the eye fatigue and the eyelid (eyelid) fatigue of the composition prepared in Example 2-1 were examined. Specifically, the evaluation was performed using a VAS (Visual Analogous Scale) consisting of 10 steps once a week.

As a result, the experimental group taking the composition of the present invention decreased 2.74 from 5.16 ± 0.53 before taking to 2.42 ± 0.56 after taking, whereas the placebo group took 1.86 ± 0.52 from 3.86 ± 0.52 before taking. It only decreased ( Figure 1 ). In addition, in eyelid fatigue, the experimental group taking the composition of the present invention decreased 1.95 from 2.79 ± 0.59 before taking to 0.84 ± 0.37 on average, whereas the placebo group decreased from 2.43 ± 0.68 before taking to 2.43 ± 0.04 after taking. Not ( FIG. 2 ).

Therefore, it was confirmed that the composition of the present invention showed a statistically significant effect of reducing eye fatigue (p = 0.05) and also reducing eyelid fatigue (p = 0.006) as compared to the placebo group.

Experimental Example 2. Effect on the eye syndrome

The effect on the ocular symptoms of tears in the composition prepared in Example 2-1 was examined. Specifically, the evaluation was performed using a VAS (Visual Analogous Scale) consisting of 10 steps once a week.

As a result, the experimental group taking the composition of the present invention decreased by 2.32 from 3.37 ± 0.75 before taking to 1.05 ± 0.37 after taking, whereas the placebo group decreased by 0.76 from 4.14 ± 0.71 before taking to 3.38 ± 0.69 after taking ( Fig. 3 ). Therefore, it was confirmed that the composition of the present invention significantly reduced the ocular symptoms (p = 0.057) compared to the placebo group.

Experimental Example 3. Effect on the ocular sensation

The intensity and frequency patterns of ocular sensation (itching of the eyes) of the composition prepared in Example 2-1 were examined. Specifically, the evaluation was performed using a VAS (Visual Analogous Scale) consisting of 10 steps once a week.

As a result, in the intensity of ocular sensation, the experimental group taking the composition of the present invention decreased by 1.89 from the average of 2.68 ± 0.59 before taking to 1.05 ± 0.37 after taking, whereas the placebo group was 2.57 ± 0.04 before taking at 3.00 ± 0.73. It only decreased by 0.43 ( Fig. 4 ). In addition, in the frequency of feeling ophthalmopathy, the experimental group taking the composition of the present invention decreased from 1.84 ± 0.41 times per week before taking the average of 0.47 ± 0.27 times, while the placebo group was taken at 2.24 ± 0.58 times before taking It was then reduced to 0.14 times after 2.10 ± 0.01 cycles ( FIG. 5 ). Therefore, it was confirmed that the composition of the present invention showed a statistically significant intensity decrease (p = 0.047) and a decrease in frequency (p = 0.025) of the ocular feelings compared to the placebo group.

Experimental Example 4. Effect on eye pain

The strength and frequency of eye pain (eye pain) of the composition prepared in Example 2-1 were examined. Specifically, the evaluation was performed using a VAS (Visual Analogous Scale) consisting of 10 steps once a week.

As a result, in the intensity of eye pain, the experimental group taking the composition of the present invention decreased 2.58 from 3.47 ± 0.70 before taking to 0.89 ± 0.37 after taking, whereas the placebo group increased from 3.43 ± 0.62 to 2.90 ± 0.63 after taking. It only decreased by 0.52 ( FIG. 6 ). In addition, in the frequency of ocular pain, the experimental group taking the composition of the present invention decreased from 2.32 ± 0.53 times per week to 1.35 times on average 0.95 ± 0.42 times after taking, whereas the placebo group was taken 2.43 ± 0.50 before taking 2.19. It was only 0.24 decreases of ± 0.43 cycles ( FIG. 7 ). Therefore, it was confirmed that the composition of the present invention showed a statistically significant decrease in the intensity of ocular pain (p = 0.014) and a decrease in the frequency (p = 0.039) compared to the placebo group.

Experimental Example 5. Effects on Glare and Refractive Index

The effect on the refractive index showing the glare and myopia tendency of the composition prepared in Example 2-1 was examined. Specifically, the evaluation was performed using a Visual Analogous Scale (VAS) consisting of 10 steps once a week, and the refractive index test was performed using an automatic refraction tester.

As a result, in the glare symptoms, the experimental group taking the composition of the present invention decreased by an average of 2.53 from 3.11 ± 0.66 before taking to 0.58 ± 0.21 after taking, whereas the placebo group increased from 3.33 ± 0.68 to 2.71 ± 0.68 after taking. It only decreased by 0.62 ( FIG. 8 ). In addition, in the refractive index, the experimental group taking the composition of the present invention decreased the refractive index by an average of 0.089 diopters (dopter) before taking, whereas the placebo group reduced the refractive index by an average of 0.250 diopters.

Therefore, it was confirmed that the composition of the present invention statistically significantly reduced the symptoms of glare (p = 0.029) and also suppressed the tendency of myopia compared to the placebo group.

Experimental Example 6. Effect on tear film break time

The effect on the tear film break time of the composition prepared in Example 2-1 was examined. Specifically, the tear film break-up time (BUT) test uses a 1% fluorescein strip soaked in distilled water to apply a drop of fluorescein to the subject's conjunctival sac and then blinks the eye several times. Then, Cobalt blue filter (Cobalt blue filter) was used to measure the time in seconds the first appearance of dry spots in the tear layer from the blink of the eye stops.

As a result, the placebo group BUT decreased by an average of 0.56 seconds during the test period of 2 months, but the experimental group taking the composition of the present invention was found to reduce the average BUT decrease compared to the placebo group by 1.17 seconds.

Experimental Example 7. Toxicity Test

7-1. Single dose toxicity test

1 g / kg, 2 g / kg and 5 g / kg in male and female rats of SD system, respectively, in order to investigate the presence or absence of toxicity by oral administration to rats of the composition of Example 2-1 except for food additives. Five oral single doses of three doses were administered and 14 deaths, general symptoms, body weight changes, and autopsy findings were observed. The result of this test is as follows.

(1) There were no deaths observed during the entire test period in all administration groups of the composition of the present invention during the test period, and there was no change in general symptoms specifically observed compared to the control group.

(2) Body weight change showed significant weight loss on day 3 after administration in 5 g / kg dose group, but was not different from control group in all other administration groups.

As a result, no clinical symptoms were observed in all the test substance-treated groups compared to the death and control groups, and there were almost no specific symptoms in the anatomical changes at the time of body weight and autopsy. In addition, since the composition did not show a clear toxicity at the dose of 5 g / kg or less, LD ₅₀ (lethal dose) in rats by oral administration is determined to be more than 5 g / kg.

Extract of the present invention can be administered in the following formulations, the formulation examples below are merely to illustrate the invention, whereby the content of the invention is not limited.

Formulation Example 1 Preparation of Powder

20 mg of the composition of Example 2

Lactose 100 mg

Talc 10 mg

The above ingredients are mixed and filled in an airtight cloth to prepare a powder.

Formulation Example 2 Preparation of Tablet

10 mg of the composition of Example 2

Corn starch 100 mg

Lactose 100 mg

2 mg magnesium stearate

After mixing the above components, tablets are prepared by tableting according to a conventional method for preparing tablets.

Formulation Example 3 Preparation of Capsule

10 mg of the composition of Example 2

3 mg of crystalline cellulose

Lactose 14.8 mg

Magnesium Stearate 0.2 mg

According to a conventional capsule preparation method, the above ingredients are mixed and filled into gelatin capsules to prepare capsules.

Formulation Example 4 Preparation of Injection

10 mg of the composition of Example 2

Mannitol 180 mg

Sterile distilled water for injection 2974 mg

Na ₂ HPO _4, 12H ₂ O 26 mg

According to the conventional method for preparing an injection, the amount of the above ingredient is prepared per ampoule (2 ml).

Formulation Example 5 Preparation of Liquid

20 mg of the composition of Example 2

10 g of isomerized sugar

5 g of mannitol

Purified water

According to the conventional method of preparing a liquid solution, each component is added to the purified water to dissolve it, the lemon flavor is added appropriately, the above components are mixed, purified water is added, the whole is adjusted to 100 ml by the addition of purified water, and then filled in a brown bottle. The solution is prepared by sterilization.

Formulation Example 6 Preparation of Healthy Food

1000 mg of the composition of Example 2

Bilberry Extract Powder 8.8 mg

Grape Seed Extract Powder 8.8 mg

Vitamin A Acetate 14.0 mg

4 mg of millet powder

Beta-carotene (10%) powder 12.2 mg

Colostrum 40.2 mg

Seaweed Calcium 40.2 mg

Vitamin C 20 mg

Vitamin B1 Hydrochloride 2.8 mg

Vitamin B2 Hydrochloride 3.5mg

Vitamin E Powder 40.2mg

Mannitol 200 mg

Sorbitol 150 mg

Magnesium Stearate 18 mg

Stevioside 4 mg

Carboxymethyl cellulose calcium 20 mg

180 mg per white

Grape flavour 20 mg

The vitamin and mineral mixtures are prepared by mixing the relatively suitable ingredients for health foods in a preferred embodiment, but the mixing ratio may be arbitrarily modified, and the above ingredients are mixed according to a general health food manufacturing method, and then granulated. It can be prepared and used in the manufacture of health food compositions according to conventional methods.

Formulation Example 7 Preparation of Healthy Drink

1000 mg of extract of Example 2

Citric acid 1000 mg

100 g oligosaccharides

Plum concentrate 2 g

1 g of taurine

Add 900 ml of purified water

After mixing the above components in accordance with the conventional healthy beverage manufacturing method, and stirred and heated at 85 ℃ for about 1 hour, the resulting solution is filtered and obtained in a sterilized 2 L container, sealed sterilization and refrigerated Used to prepare the healthy beverage composition of the invention.

 Although the composition ratio is a composition suitable for a preferred beverage in a preferred embodiment, the composition ratio may be arbitrarily modified according to regional and ethnic preferences such as demand hierarchy, demand country, use purpose.

As mentioned above, the composition of the present invention exhibits excellent ocular symptoms improvement effect on the ocular symptoms caused by VDT syndrome and is stable to the human body, and thus, drugs and health foods for preventing or treating ocular symptoms and eye diseases. It can be usefully used.

1 is a VAS (Visual Analogous Scale) graph comparing the effect of the composition of the present invention and placebo (Anti-Pyro diagram of Placebo),

Figure 2 is a VAS (Visual Analogous Scale) graph comparing the effect on the eyelid fatigue of the composition and placebo (Placebo) of the present invention,

3 is a VAS graph comparing the effect of the composition of the present invention on the strength of the ocular symptoms of the placebo group,

4 is a VAS graph comparing the effect on the ocular relief strength of the composition of the present invention and placebo group,

5 is a VAS graph comparing the effect of the composition of the present invention and placebo group ocular sensation frequency,

Figure 6 is a VAS graph comparing the effect on the strength of the eye pain in the composition and placebo group of the present invention,

Figure 7 is a VAS graph comparing the effect on the frequency of eye pain in the composition of the present invention and placebo group,

Figure 8 is a VAS graph comparing the effect on the glare symptoms of the composition of the present invention and a placebo group.

Claims (4)

A pharmaceutical composition for improving ocular symptoms, comprising a complex herbal extract comprising as an active ingredient an extract, astragalus, earth and sand, bokbunja, perception, yellow, goji and licorice extract, and comprising a pharmaceutically acceptable carrier, excipient or diluent. According to claim 1, wherein the extract is 5 to 10% by weight of the extract of the Cultivator, 18 to 27% by weight of Astragalus extract, 5 to 15% by weight of Tosa extract, 3 to 8% by weight of Bokbunja extract, 7 to 15% by weight of crust extract, A pharmaceutical composition comprising 5 to 10% by weight of extract, 20 to 30% by weight of Goji berry extract and 5 to 10% by weight of licorice extract. A health functional food comprising the clarifier, Astragalus, earthenware, bokbunja, crust, spermatozoon, wolfberry and licorice extract of claim 1, which exhibit an ocular symptom-improving effect, and a food acceptable additive. The health functional food of claim 3, wherein the food is a dietary supplement.