JP7664217B2 - Composition for preventing or improving eye diseases containing medicinal plant extract as an active ingredient and method for producing the same - Google Patents

Description

The present invention relates to a composition for preventing or treating eye diseases (retinal and corneal diseases) that contains fenugreek extract, clove extract, or a mixture thereof as an active ingredient.

As the average lifespan of humans increases worldwide, people are becoming more interested in living a long and healthy lifespan. The eyes are the most important sensory organ, as we obtain more than 80% of the information we need in our daily lives. However, the eyes are also the organ in the body that ages the fastest. In addition to aging, eye diseases are increasing in all age groups due to factors such as menopausal symptoms, autoimmune diseases, thyroid diseases, and decreased sensitivity of the cornea. In recent years, visual impairment and various eye diseases have become more prevalent due to Westernized eating habits, excessive exposure to media devices such as computers and smartphones, and polluted environments. Therefore, as functional disorders and loss of the eyes are the biggest factor in reducing the quality of life, interest in eye health is increasing and management of eye health is required. Representative eye diseases include xerophthalmia, macular degeneration, cataracts, glaucoma, and diabetic retinopathy.

Xerophthalmia is a common disease that affects about 20% of Korean adults, and is caused by a decrease in the quantity and quality of tears, or inflammation of the tears and the surface of the eye. Xerophthalmia causes damage to the ocular surface due to oxidative damage to the cornea and instability of the tear film, which leads to a decrease in visual function and a marked decrease in contrast sensitivity compared to normal subjects, significantly reducing quality of life. The overall prevalence in Korea is estimated at 16%, and the prevalence rate in the elderly population aged 65 and over is reported to be about 33%. If xerophthalmia is not treated at the appropriate time, there is a risk of losing vision due to corneal ulcers and scars. In general, the intake of foods rich in potassium and anthocyanin is recommended to improve xerophthalmia, and treatments such as instilling artificial tears or blocking the lacrimal puncta to regulate the amount of tears discharged are used. However, temporary replenishment of tears with artificial tears only improves symptoms temporarily, and long-term use of anti-inflammatory eye medications containing steroids or vasoconstrictors can cause side effects such as increased intraocular pressure, glaucoma, and cataracts due to the ingredients. As a result, there has been active development of treatments for xerophthalmia that utilize apoptosis or cell viability of corneal epithelial cells as biomarkers, and many research cases of treatments using natural materials have been revealed. A treatment for xerophthalmia that contains maqui berry extract as an active ingredient (Patent Document 1), and a composition for treating xerophthalmia that contains fish eye extract (Patent Document 2) have been developed.

Macular degeneration occurs mainly in people over the age of 50, and is already the number one cause of blindness in adults in developed countries. In Korea, the disease is also showing an increasing trend as the elderly population increases. The exact cause of macular degeneration is still unknown, but risk factors include aging, family history, race, and smoking. In the early stages of the disease, vision becomes blurred and nearby objects appear distorted, but it eventually leads to blindness.

The macula is the central part of the retina where photoreceptor cells and optic nerve cells are densely packed, and is responsible for central vision. To maintain central vision, photoreceptor cells must be protected and there must be no limitations in transmitting visual signals. Retinal pigment epithelial cells are essential cells for maintaining the function of photoreceptor cells, and they also form a blood-retinal barrier like the blood-brain barrier (BBB) in the brain. As the function of retinal pigment epithelial cells gradually declines with age, a molecule called "A2E," which is a metabolic by-product within the cells, accumulates without being excreted from within the retinal pigment epithelial cells. There have been previous reports that A2E molecules, one of the main chromophores of lipofuscin, are converted to oxidized A2E when exposed to light stimulation or various oxidative stresses, and that oxidized A2E molecules are associated with the death of retinal pigment epithelial cells. Therefore, blocking the accumulation of A2E molecules in retinal pigment epithelial cells in advance and increasing cell viability by reducing the risk of oxidation itself may help maintain eye health.

Most of the choroid is made up of a vascular layer, which supplies nutrients to the retinal layer and removes metabolic substances released from retinal cells. However, due to aging and other factors, blood vessels in the choroid penetrate to the retinal cell area and are abnormally generated in the optic nerve cell area, creating abnormal blood vessels (choroidal neovascularization). Neovascularization occurs when vascular endothelial growth factors (VEGF, FGF, etc.) are expressed in cancer cells and tissues, and microvessels grow from existing blood vessels. The generation of neovascularization in the retina leads to the generation of abnormal blood vessels, which cause blood exudation and induce macular degeneration.

Currently, the demand for functional health foods for improving eye health is increasing, with eye health-related ingredients being included in the top five individually certified ingredients with sales exceeding 30 billion won based on 2020 production performance. Therefore, it is important to not only develop therapeutic drugs to treat eye diseases, but also to develop food ingredients that can be taken long-term for the purpose of prevention to protect eyesight and keep the health of the eyes. Various natural ingredients such as carrots, spinach, cassia seeds, goji berries, and blueberries have long been known to be beneficial for eye health. In fact, a vision improvement agent has been developed that contains anthocyanosides extracted from wild blueberries as its main ingredient, and herbal ingredients such as cassia seeds and goji berries have long been drunk as tea to maintain and improve eyesight.

However, the effects of the compositions currently on the market for improving eye diseases are insufficient, and research into materials that show better effects is needed.

Korean Patent Publication No. 10-2015-0109354 Korean Patent No. 10-1211969 Korean Patent No. 10-1932862 Korean Patent Publication No. 10-2020-0022930

In this invention, the antioxidant capacity to prevent oxidative damage to the eye, A2E activity evaluation, and retinal and corneal cell viability were measured for the herbal materials (more than 60 species) that were the subject of the search, through in vitro testing, a preliminary step for evaluating the in vivo eye health efficacy of natural materials. Therefore, it is necessary to prevent and improve such eye-related diseases by utilizing the beneficial components of natural products to provide a composition with excellent functionality and few side effects.

In order to solve the above problems, the present invention provides the following solutions:

One aspect of the present invention provides a health functional food composition for preventing or improving corneal and retinal diseases, which contains one or more of fenugreek and clove extracts as active ingredients.

In one aspect of the present invention, a functional health food composition for preventing or improving corneal and retinal diseases is provided, in which the fenugreek and clove extracts are extracted, either independently or in combination, using water, an alcohol having 1 to 5 carbon atoms, or an aqueous alcohol solution having 1 to 5 carbon atoms as an extraction solvent.

In one aspect of the present invention, the fenugreek and clove extracts are water extracts extracted at 60°C to 150°C for 1 hour to 8 hours, providing a health functional food composition for preventing or improving corneal and retinal diseases.

In one aspect of the present invention, a functional health food composition for preventing or improving corneal and retinal diseases is provided, in which the fenugreek extract and the clove extract are contained in a weight ratio of 9:1 to 1:9.

In one aspect of the present invention, the composition provides a functional health food composition for preventing or improving corneal and retinal diseases, which reduces oxidative stress and osmotic shock caused by internal and external stimuli in the human body.

In another aspect of the present invention, the present invention provides a composition for preventing, alleviating, or treating an eye-related disease selected from dry eye, glaucoma, uveitis, and macular degeneration.

In another aspect of the present invention, a composition is provided, the composition being a pharmaceutical composition.

In another aspect of the present invention, a composition is provided, the composition being a food composition.

The composition according to one aspect of the present invention is highly effective in preventing, improving or treating corneal and retinal diseases caused by oxidative stress in the body and external environmental stress.

These are the results of Example 3.

Unless otherwise noted, all numbers, values and/or expressions expressing ingredients, reaction conditions, and amounts of ingredients used herein should be understood to be modified in all cases by the term "about" in that these numbers are approximations that inherently reflect various uncertainties of measurement that arise in deriving such values from one another. Also, when numerical ranges are disclosed in this description, such ranges are continuous and include all values from the minimum value to the maximum value, inclusive, unless otherwise stated. Furthermore, when such ranges refer to integers, all integers from the minimum value to the maximum value, inclusive, unless otherwise stated.

When a range is recited herein for a variable, the variable will be understood to include all values within the recited range, including the recited endpoints of the range. For example, the range "5 to 10" will be understood to include values of 5, 6, 7, 8, 9, and 10, as well as any subranges such as 6 to 10, 7 to 10, 6 to 9, 7 to 9, and any value between the integers that fall within the recited range, such as 5.5, 6.5, 7.5, 5.5 to 8.5, and 6.5 to 9. Also, for example, the range "10% to 30%" will be understood to include values such as 10%, 11%, 12%, 13%, and all integers up to and including 30%, as well as any subranges such as 10% to 15%, 12% to 18%, 20% to 30%, and any value between reasonable integers within the stated range, such as 10.5%, 15.5%, 25.5%, etc.

The present invention will be described in detail below.

The present invention provides a mixture containing one or more of fenugreek extract and clove extract, or a composition for preventing and improving retinal and corneal diseases containing one medicinal plant selected from fenugreek extract and clove extract, and a method for producing the same.

In one embodiment, the medicinal plant is extracted at a temperature of 80 to 100°C for 1 to 8 hours, and a composition for preventing and improving retinal and corneal diseases containing the medicinal plant extract and a method for producing the same are provided.

The present invention relates to a composition for preventing and improving retinal and corneal diseases, which is manufactured by containing a mixture containing fenugreek extract and clove extract, and one medicinal plant selected from fenugreek extract and clove extract, and has the ability to inhibit oxidative stress in the body, which is believed to be the cause of retinal aging and damage, and efficiently prevents cell damage caused by hyperosmotic pressure, which is believed to be the cause of corneal damage, and has no side effects on the human body, and a method for manufacturing the same.

The extract may be a substance extracted with one selected from water, alcohol, and carbon dioxide. Preferably, 2,000 parts by weight of water based on 100 parts by weight of the fenugreek or clove is heated at 80°C for 2 hours in a reflux extraction device, followed by filtration, concentration, and drying steps, but is not limited thereto. Alternatively, a process of heating at a temperature of 60 to 100°C for 0.5 to 8 hours, filtration, concentration, and drying steps may be performed. In addition, each extract may be mixed and extracted, or each may be extracted and the extracts may be mixed.

The aforementioned fenugreek (Trigonella foenum-graecum) is a legume plant that is mainly used as a spice. It is written as fenugreek in English and methi in Hindi/Urdu. As the word means Greek hay, it can be used either as dried grass or in the form of seeds. In traditional Chinese medicine, it is said to have the effect of relieving abdominal pain and colic (not the pain of childbirth, but a sharp pain in the abdomen caused by prostatitis, etc.), and the seeds are sometimes roasted for medicinal purposes.

The aforementioned clove (Syzygium aromaticum) is an evergreen grass belonging to the Myrtaceae family. Native to Indonesia, it was named clove because its dried buds resemble nails. Not only does it have a pleasant fragrance, but it also has excellent anti-corrosion and antibacterial properties among fragrances. Clove is also a valuable medicine in Korea and has been used in various forms such as pills, powders, and decoctions since ancient times, and its prescription is also listed in the Donguibogam. It is used for weak spleen and stomach, cold or painful stomach, nausea or diarrhea, loss of appetite, hiccups, digestive disorders, knee and back pain, roundworms, etc.

The mixture containing fenugreek extract and clove extract, and the health functional food containing one medicinal plant selected from fenugreek extract and clove extract for preventing or improving retinal or corneal diseases may be manufactured in any one of the following dosage forms: beverage, pill, tablet, capsule, or powder, or may be manufactured by adding it to other foods or food ingredients, and may be appropriately manufactured by conventional methods.

Examples of foods included in the health food of the present invention may be any one of meat, sausage, bread, chocolate, candy, snacks, confectionery, pizza, ramen, other noodles, gums, dairy products including ice cream, various soups, drinking water, tea, energy drinks, alcoholic beverages and vitamin complexes, and include any health food in the usual sense.

The health functional foods may contain various nutrients, vitamins, minerals (electrolytes), synthetic and natural flavors, colorants and enhancers (cheese, chocolate, etc.), pectinic acid and its salts, alkynic acid and its salts, organic acids, protective colloid thickeners, pH adjusters, stabilizers, preservatives, glycerin, alcohol, carbonation agents used in carbonated drinks, etc. In addition, fruit pulp may be included for the production of natural fruit juices and vegetable drinks. These ingredients may be used independently or in combination.

The health functional food of the present invention may contain various flavoring agents or natural carbohydrates as additional ingredients. The natural carbohydrates are monosaccharides such as glucose and fructose, disaccharides such as maltose and sucrose, polysaccharides such as dextrin and cyclodextrin, and sugar alcohols such as xylitol, sorbitol, and erythritol. As sweeteners, natural sweeteners such as thaumatin and stevia extract, and synthetic sweeteners such as saccharin and aspartame can be used.

The present invention also relates to a mixture containing fenugreek extract and clove extract, and a pharmaceutical composition for preventing or improving retinal or corneal diseases, containing one medicinal plant selected from fenugreek extract and clove extract. The pharmaceutical composition of the present invention may further contain a carrier, excipient or diluent in addition to the fenugreek or clove extract. Preferably, the carrier, excipient or diluent that may be contained in the composition of the present invention includes, but is not limited to, lactose, dextrose, sucrose, sorbitol, mannitol, xylitol, erythritol, maltitol, starch, acacia gum, alginate, gelatin, calcium phosphate, calcium silicate, cellulose, methylcellulose, microcrystalline cellulose, polyvinylpyrrolidone, water, methyl hydroxybenzoate, propyl hydroxybenzoate, talc, and magnesium stearate.

It may also be administered orally or parenterally by a conventional method, and when formulated, it is prepared by including diluents or excipients such as fillers, extenders, binders, wetting agents, disintegrants, and surfactants that are commonly used. Solid preparations for oral administration include tablets, pills, powders, granules, capsules, and the like, and such solid preparations are prepared by mixing the composition with 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 administration include suspensions, solution-resistant agents, emulsions, syrups, and the like, and may include various excipients such as wetting agents, sweeteners, flavoring agents, preservatives, and the like in addition to the commonly used simple diluents such as water and liquid paraffin. Preparations for parenteral administration include sterile aqueous solutions, non-aqueous solvents, suspensions, emulsions, freeze-dried preparations, and suppositories. In addition, non-aqueous solvents and suspending agents may include propylene glycol, polyethylene glycol, vegetable oils such as olive oil, and injectable esters such as ethyl oleate. As base materials for suppositories, witepsol, macrogol, tween 61, cacao butter, laurin butter, glycerogelatin, and the like may be used.

Various aspects of the invention are described in more detail below.

One aspect of the present invention provides a pharmaceutical composition for preventing, alleviating or treating eye diseases, comprising at least one of fenugreek extract and clove extract as an active ingredient.

In this specification, the term "extract" refers to any substance obtained by extracting a component from a natural product, regardless of the extraction method or type of component. For example, it is a broad concept including any substance obtained by extracting a component dissolved in a solvent from a natural product using water or an organic solvent, or any substance obtained by extracting only a specific component from a natural product. In one embodiment of the present invention, the organic solvent is not particularly limited and may be a C1-C5 lower alcohol such as methanol, ethanol, isopropyl alcohol, n-propyl alcohol, n-butanol, and isobutanol, a polyhydric alcohol such as glycerol, ethylene glycol, propylene glycol, and 1,3-butylene glycol, a hydrocarbon solvent such as methyl acetate, ethyl acetate, benzene, n-hexane, diethyl ether, dichloromethane, and chloroform, and a non-polar organic solvent such as petroleum ether, methyl acetate, benzene, hexane, chloroform, methylene chloride, dimethyl ether, and ethyl acetate.

In one aspect of the present invention, a composition is provided, wherein the extract is an extract of the above-ground or below-ground parts of a medicinal plant.

In one aspect of the present invention, a composition is provided in which the extract is extracted using water, a C1-C5 alcohol, acetone, an acetone aqueous solution, or a C1-C5 alcohol aqueous solution.

In one aspect of the present invention, a composition is provided in which the C1-C5 alcohol is at least one selected from the group consisting of methanol, ethanol, isopropyl alcohol, n-propyl alcohol, n-butanol, and isobutanol.

In one aspect of the present invention, a composition is provided in which the concentrations of the C1-C5 alcohol aqueous solution and the acetone aqueous solution are each independently 10% to 90% (v/v).

In one aspect of the present invention, a pharmaceutical composition is provided, in which the active ingredient further comprises one or more of extracts of Uyakku extract, Acanthus arbutus extract, Chickpea extract, and White-necked oak extract.

In one aspect of the present invention, a pharmaceutical composition is provided in which the extract is extracted with water, a C1-6 lower alcohol, or a mixed solvent thereof.

In one aspect of the present invention, a pharmaceutical composition is provided in which the active ingredient is administered at a dose of 0.01 mg/kg/day to 10 g/kg/day.

In one aspect of the present invention, a pharmaceutical composition is provided, in which the eye disease is any one of xerophthalmia, macular degeneration, cataracts, glaucoma, and diabetic retinopathy.

Another aspect of the present invention provides a health functional food composition for improving eye diseases, comprising at least one of fenugreek extract and clove extract as an active ingredient.

In another aspect of the present invention, a food composition is provided, in which the active ingredient further comprises one or more of extracts of Uyaku extract, Acanthus arbutus extract, Chickpea extract, and White-necked oak extract.

In another aspect of the present invention, a food composition is provided in which the extract is extracted with water, a C1-6 lower alcohol, or a mixed solvent thereof.

In another aspect of the present invention, a food composition is provided, wherein the eye disease is any one of xerophthalmia, macular degeneration, cataracts, glaucoma, and diabetic retinopathy.

The pharmaceutical composition according to one aspect of the present invention may be in various oral or parenteral dosage forms. When formulated, it is prepared using a diluent or excipient such as a filler, extender, binder, wetting agent, disintegrant, or surfactant that is commonly used. Solid preparations for oral administration include tablets, pills, powders, granules, soft or hard capsules, etc., and such solid preparations are prepared by mixing one or more compounds with at least one or more excipients, such as starch, calcium carbonate, sucrose or lactose, gelatin, etc. In addition to simple excipients, lubricants such as magnesium stearate, talc, etc. are also used. Liquid preparations for oral administration include suspensions, solution-resistant agents, emulsions, syrups, etc., and may include various excipients such as wetting agents, sweeteners, flavorings, preservatives, etc. in addition to water and liquid paraffin, which are commonly used simple diluents. Preparations for parenteral administration include sterile aqueous solutions, non-aqueous solvents, suspensions, emulsions, freeze-dried preparations, and suppositories. Non-aqueous solvents and suspension solvents may include propylene glycol, polyethylene glycol, vegetable oils such as olive oil, and injectable esters such as ethyl oleate. Suppository bases may include witepsol, macrogol, tween 61, cacao butter, laurin butter, and glycerogelatin.

The pharmaceutical composition according to one aspect of the present invention may be administered parenterally or orally depending on the purpose, and may be administered once or several times in an amount of 0.1 to 500 mg, specifically 1 to 100 mg, per kg of body weight per day. The dosage for a particular patient may vary depending on the patient's body weight, age, sex, health condition, diet, administration time, administration method, excretion rate, severity of disease, etc.

The pharmaceutical composition according to one aspect of the present invention can be formulated by a conventional method into any form suitable for pharmaceutical preparations, including oral dosage forms such as powders, granules, tablets, soft or hard capsules, suspensions, emulsions, syrups, drinks, and aerosols, topical skin preparations such as ointments and creams, suppositories, injections, and sterile injection solutions, and can be used. Specifically, it can be formulated into injections or topical skin preparations for use.

The pharmaceutical composition according to one aspect of the present invention may be administered to mammals such as rats, mice, livestock, and humans by various routes, such as parenteral and oral, and all modes of administration are contemplated, for example, by oral, transdermal, rectal, or intravenous, intramuscular, subcutaneous, intrauterine, intradural, or intracerebroventricular injection.

The pharmaceutical composition according to one aspect of the present invention may be administered by various routes that can be easily applied by a person skilled in the art. In particular, the pharmaceutical composition according to the present specification may be an external preparation for the skin, and may be administered by being applied to the skin surface.

In another aspect of the present invention, the dosage form of the food composition is not particularly limited, and may be, for example, a tablet, granule, powder, liquid such as a drink, caramel, gel, bar, etc. In addition to the active ingredient, a food composition in each dosage form can be easily formulated by a person skilled in the art with ingredients commonly used in the field according to the dosage form or purpose of use, and when applied simultaneously with other ingredients, an enhancing effect can be obtained.

In the food composition according to another aspect of the present invention, the dosage of the active ingredient can be determined by those skilled in the art, and the daily dosage may be, for example, 0.1 mg/kg/day to 5000 mg/kg/day, more specifically, 50 mg/kg/day to 500 mg/kg/day, but is not limited thereto, and may vary depending on various factors such as the age, health condition, and complications of the subject to be administered.

The food composition according to another aspect of the present invention may be, for example, various foods such as chewing gum, caramel products, candies, ice creams, confectionery, etc., beverage products such as soft drinks, mineral water, alcoholic drinks, etc., foods containing vitamins and minerals, etc. In addition, the food composition according to another aspect of the present invention may contain various nutrients, vitamins, minerals (electrolytes), flavorings such as synthetic flavors and natural flavors, coloring agents and enhancers (cheese, chocolate, etc.), pectinic acid and its salts, alginic acid and its salts, organic acids, protective colloid thickeners, pH adjusters, stabilizers, preservatives, glycerin, alcohol, carbonation agents used in carbonated drinks, etc. In addition, the functional food composition according to another aspect of the present invention may contain natural fruit juices and fruit pulps for the production of fruit juice drinks and vegetable drinks. Such ingredients may be used independently or in combination. The ratio of such additives is not particularly important, but is generally in the range of 0 to about 20 parts by weight per 100 parts by weight of the composition herein.

The present invention will be described in detail below with reference to manufacturing examples, examples, and experimental examples. However, the manufacturing examples, examples, and experimental examples below are merely intended to illustrate the present invention, and the content of the present invention is not limited to the following examples.

Example 1. Preparation of medicinal plant extracts Dried medicinal plants were crushed to a particle size ranging from 20 to 100 mesh, preferably 40 to 80 mesh. 1 L of purified water was added to 50 g of the crushed medicinal plants, and the mixture was extracted at 80°C for 2 hours. The filtered liquid was concentrated under reduced pressure at 55°C and freeze-dried to obtain medicinal plant extracts.

Table 1 below shows the types of medicinal plants extracted and the extraction yields.

Example 2. Improvement of oxidative stress in retinal cells induced by hydrogen peroxide To confirm the effect of the 60 natural product extracts prepared in Example 1 on improving oxidative stress in retinal cells, human retinal cell line ARPE-19 cells were used in the experiment.

Various substances are used to induce oxidative stress in retinal cells, but hydrogen peroxide (H ₂ O ₂ ) was used in this experiment. The optimal treatment concentration of hydrogen peroxide was set to 600 uM based on the results of previous studies. ARPE-19 cells cultured for 24 hours were pretreated with the 60 kinds of natural product extracts prepared in Example 1, and then treated with 600 uM H ₂ O ₂ and cultured for 24 hours. To examine the inhibitory effect on oxidative stress induced by _{H 2} O ₂ treatment, cell viability was confirmed using MTT, and the results are shown in Table 2 below.

Retinal protection (%)=(experimental _substance absorbance (O.D.)/ _H2O2 treatment group absorbance (O.D.))×100

Example 3. Improvement of osmotic stress in corneal cells induced by NaCl In order to confirm the effect of the six natural product extracts (fenugreek, scutellaria root, rhizome, chickpea, white-necked oak, and clove) having a retinal protective effect against oxidative stress in Example 2 on improving the osmotic stress in corneal cells, human corneal epithelial primary cells (HCEC) were used in the experiment.

Various substances are used to induce osmotic stress in corneal cells, but NaCl was used in this experiment. The optimum concentration of NaCl treatment was set to 120 mM based on the results of previous studies. HCEC cells cultured for 24 hours were pretreated with fenugreek, scutellaria root, Chinese quince, chickpea, Chinese quince, and cloves, and then treated with 120 mM NaCl and cultured for 24 hours. To examine the inhibitory effect on osmotic stress induced by NaCl treatment, cell viability was confirmed using MTT.
Cell viability (%)=(experimental substance absorbance (O.D.)/NaCl-treated group absorbance (O.D.))×100

The results are shown in Figure 1.

The experimental results showed that fenugreek and clove extracts showed the best efficacy in improving osmotic pressure in corneal cells.

Exemplary Dosage Forms Exemplary dosage forms of the compositions according to one aspect of the present invention are described below, but are applicable to a variety of other dosage forms and are not intended to limit the scope of the present invention but are merely for illustrative purposes.

[Formulation Example 1] Soft Capsules 8 mg of the mixed extract of the embodiment, 9 mg of vitamin E, 9 mg of vitamin C, 2 mg of palm oil, 8 mg of hardened vegetable oil, 4 mg of yellow lead, and 9 mg of lecithin are mixed by a conventional method to prepare a soft capsule filling liquid. 400 mg is filled into each capsule to prepare a soft capsule. Separately from the above, a soft capsule sheet is prepared with 66 parts by weight of gelatin, 24 parts by weight of glycerin, and 10 parts by weight of sorbitol liquid, and the filling liquid is filled to prepare a soft capsule containing 400 mg of the composition according to the present specification.

[Formulation Example 2] Tablets 8 mg of the mixed extract of the embodiment, 9 mg of vitamin E, 9 mg of vitamin C, 200 mg of galactooligosaccharide, 60 mg of lactose, and 140 mg of maltose are mixed and granulated using a fluidized bed dryer, and then 6 mg of sugar ester is added. 500 mg of the composition is compressed into tablets by a conventional method.

[Formulation Example 3] Drink preparation Mix 8 mg of the mixed extract of the embodiment, 9 mg of vitamin E, 9 mg of vitamin C, 10 g of glucose, 0.6 g of citric acid, and 25 g of liquid oligosaccharides, add 300 ml of purified water, and fill each bottle to a total volume of 200 ml. After filling into the bottles, sterilize at 130°C for 4 to 5 seconds to produce a drink preparation.

[Formulation Example 4] Granules 8 mg of the mixed extract of the embodiment, 9 mg of vitamin E, 9 mg of vitamin C, 250 mg of anhydrous crystalline glucose and 550 mg of starch are mixed and formed into granules using a fluidized bed granulator, and then filled into a cloth to produce granules.

[Formulation Example 5] Injection Injections were prepared according to the composition shown in Table 3 below in a conventional manner.

Formulation Example 6: Health Drink A health drink was produced in a conventional manner according to the composition shown in Table 4 below.

After mixing the above ingredients using normal health drink manufacturing methods, stir and heat at 85°C for about 1 hour, then filter and sterilize the resulting solution.

The present invention has been described above using examples, experimental examples, and manufacturing examples, but a person having ordinary knowledge in the technical field to which the present invention pertains can understand that the present invention may be embodied in other specific forms without changing its technical concept or essential characteristics. Therefore, it should be understood that the examples described above are illustrative in all respects and not limiting.

Claims (5)

A pharmaceutical composition for preventing, alleviating or treating dry eye, comprising fenugreek extract and clove extract as active ingredients. The pharmaceutical composition according to claim 1, wherein the active ingredient further comprises one or more of the following extracts: Uyaku extract, Acanthus arbutus extract, Chickpea extract, and White-sleeved oak extract. The pharmaceutical composition according to claim 1, wherein the active ingredient is administered at a dose of 0.01 mg/kg/day to 10 g/kg/day. A health functional food composition for improving xerophthalmia, comprising fenugreek extract and clove extract as active ingredients. The food composition according to claim 4, wherein the active ingredient further comprises one or more of extracts of Uyaku extract, Aomori extract, Chickpea extract, and White-necked Crab extract.