WO2020013582A1 - Composition pour la prévention, le soulagement ou le traitement du syndrome de l'œil sec comprenant un extrait de racine d'achyranthes ou une fraction de celui-ci en tant que principe actif - Google Patents

Composition pour la prévention, le soulagement ou le traitement du syndrome de l'œil sec comprenant un extrait de racine d'achyranthes ou une fraction de celui-ci en tant que principe actif Download PDF

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WO2020013582A1
WO2020013582A1 PCT/KR2019/008440 KR2019008440W WO2020013582A1 WO 2020013582 A1 WO2020013582 A1 WO 2020013582A1 KR 2019008440 W KR2019008440 W KR 2019008440W WO 2020013582 A1 WO2020013582 A1 WO 2020013582A1
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Prior art keywords
dry eye
extract
eye syndrome
composition
prevention
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PCT/KR2019/008440
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English (en)
Korean (ko)
Inventor
김찬식
현수왕
조규형
김진숙
이익수
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한국 한의학 연구원
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Publication of WO2020013582A1 publication Critical patent/WO2020013582A1/fr

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/21—Amaranthaceae (Amaranth family), e.g. pigweed, rockwort or globe amaranth
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A23L33/105—Plant extracts, their artificial duplicates or their derivatives
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0048—Eye, e.g. artificial tears
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P27/00—Drugs for disorders of the senses
    • A61P27/02—Ophthalmic agents
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23V—INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
    • A23V2002/00—Food compositions, function of food ingredients or processes for food or foodstuffs
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23V—INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
    • A23V2200/00—Function of food ingredients
    • A23V2200/30—Foods, ingredients or supplements having a functional effect on health

Definitions

  • the present invention relates to a composition for the prevention, amelioration or treatment of dry eye syndrome comprising the extract of Emulsion or fractions thereof as an active ingredient.
  • Dry eye syndrome is an eye disorder in which the surface of the eye is damaged, the eye gets cold and there are irritating symptoms such as irritation, foreign body and dryness due to lack of tears, excessive tears of evaporation, or poor balance of tear components. It is not simply a lack of tears, it causes eye discomfort, decreased vision, and instability of the tear layer due to inflammation of the tears and the ocular surface (cornea and conjunctiva), causing damage to the ocular surface, resulting in pain, irregular corneal surface, clouding and fluctuation. Greater risk of developing vision and corneal ulcers.
  • inflammation plays an important role, such as invasion of inflammatory cells, increased immune activating molecule and adhesion molecule expression, Th1 and Th17 responses, apoptosis markers and abnormal changes in chemokines. have.
  • dry eye syndrome is a common disease that occurs in about 20% of Korean adults. Especially, due to the rising temperature due to global climate change, especially El Ni ⁇ o, and environmental pollution, patients with dry eye syndrome continue to increase. There is no food.
  • the dew is a perennial plant belonging to the Amaranthaceae, distributed in Korea, China, Japan, etc., and is known to be effective in arthritis in the folklore, called iron knee. Originated plants vary from country to country.
  • Achyranthes japonica is used and in China, Achyranthes bidentata ), Cyathula officinalis and Musus ( Cythulacapitata Moq ) are used.
  • the Korean Pharmacopoeia of Korea defines two types of domestic native tousle and sashimi of Korean origin as wooseul, which are used in Korea without any special use.
  • Woosel is a herbal medicinal material and can be used as a raw material for food, and it has been reported that there is no cytotoxicity and genotoxicity. It is known for its mild temper, bitterness and sour taste, which act on the kidneys and liver to remove fish blood, promote blood circulation, and reduce blood and heat.
  • the main pharmacological components of wort are oleanolic acid, inosterone, ecdysterone, beta-sitosterol, stigmasterol and feruloyl tyramine glycoside tyramine glycoside).
  • incubation has been carried out mainly for in-flight cultures for large-scale proliferation, but in recent years, it has been converted to useful bioactivity for efficient use of dew.
  • Anti-inflammatory activity, heavy metal removal and detoxification effect, arthritis alleviation and hard tissue regeneration effect, osteoclast differentiation inhibitory effect, blood flow improvement effect and the like have been reported.
  • Korean Unexamined Patent Publication No. 2018-0065933 discloses a composition for preventing or treating inflammatory eye disease, including a maple leaf extract or a fraction thereof, and a Chinese herbal medicine for dry eye syndrome in Chinese Patent Publication No. 105362799. And the preparation method is disclosed, but has not yet been disclosed for the composition for the prevention, improvement or treatment of dry eye syndrome comprising the dew extract or fractions thereof of the present invention as an active ingredient.
  • the present invention is derived from the above requirements, the present invention provides a composition for the prevention, amelioration or treatment of dry eye syndrome comprising the extract of the dew drops or fractions thereof as an active ingredient, the extract of the dew drop according to the invention is dry eye
  • the extract of the dew drop according to the invention is dry eye
  • the present invention was completed by confirming that the amount of tear secretion was increased, and that the change in the shape of the cornea, which was rounded and warped, was suppressed.
  • the present invention provides a pharmaceutical composition for the prevention or treatment of dry eye syndrome comprising the extract of Emulsion or fractions thereof as an active ingredient.
  • the present invention provides a health functional food composition for preventing or improving dry eye syndrome comprising the extract of Emulsion or fractions thereof as an active ingredient.
  • the present invention relates to a composition for the prevention, improvement or treatment of dry eye syndrome
  • the extract of the extract of the present invention is IL-8 gene expression increased by fine dust Dry eye disease, as well as increased expression of reduced mucin-1 protein, as well as increased tear secretion decreased by dry eye syndrome, and inhibiting changes in corneal morphologies that are rounded and distorted. It can be usefully used as a medicine or health functional food for the prevention, improvement or treatment of the.
  • Figure 2 shows the results of confirming the change in the expression level of Mucin-1 protein according to the treatment of fine dust and the extract of the present invention.
  • Figure 4 is a result of calculating the corneal smoothness (corneal smoothness score) (B) from the corneal morphology change (A) of the rat according to the administration of the extract of the present invention.
  • the corneal smoothness score is an evaluation of corneal morphology with a round circle distortion at a score of 0-5, with 0 points: no distortion, 1 point: dent at 1/4 area, 2 points: 2/4 Distortion at site, 3 points: Distortion at 3/4 area, 4 points: Distortion at all areas, 5 points: Severe distortion indicates round shape is unrecognizable
  • ### is more likely to cause dry eye than normal group
  • the smoothness score according to the change of corneal morphology of p ⁇ 0.001 was statistically significant, and ** indicates that the smoothness score of the drop extract administration group of the present invention was significantly decreased compared to the dry eye induction group. ⁇ 0.01.
  • the present invention relates to a pharmaceutical composition for the prevention or treatment of dry eye syndrome comprising the extract of Emulsion or fractions thereof as an active ingredient.
  • the hyssop of the present invention is Achyranthes japonica , Achyranthes bidentata , Cyathula officinalis and Maussl Cyathulacapitata Moq ) is preferably any one selected from, but is not limited thereto, and more preferably may be Achyranthes japonica .
  • the dew extract may be prepared by a method comprising the following steps, but is not limited thereto:
  • step (3) concentrating and drying the filtered extract of step (2) to produce an extract.
  • the extraction solvent in step (1) is preferably selected from water, C 1 ⁇ C 4 lower alcohol or a mixture thereof, more preferably water, but is not limited thereto.
  • the extraction method may use all conventional methods known in the art, such as filtration, hot water extraction, immersion extraction, reflux cooling extraction and ultrasonic extraction.
  • the extraction solvent is preferably extracted by adding 1 to 20 times the weight of the dew, more preferably 5 to 15 times, and even more preferably 10 times.
  • Extraction temperature is preferably 60 ⁇ 100 °C but not limited thereto.
  • the extraction time is preferably 1 to 48 hours, more preferably 1 to 24 hours, most preferably 3 hours is not limited thereto.
  • the concentration in step (3) is preferably, but not limited to, using a vacuum rotary concentrator or a vacuum rotary evaporator.
  • drying is preferably carried out under reduced pressure drying, vacuum drying, boiling drying, spray drying or lyophilization, more preferably freeze drying but not limited thereto.
  • the term 'fraction' refers to a result obtained by performing a fractionation to separate a specific component or a specific component group from a mixture comprising various various components.
  • the fractionation method for obtaining the fraction is not particularly limited, and may be performed according to a method commonly used in the art.
  • Non-limiting examples of the fractionation method include a method of obtaining a fraction from the extract by treating the extract obtained by extracting the dew with a predetermined solvent.
  • the fraction may be a hexane fraction, ethyl acetate fraction, butanol fraction or water fraction of the dew extract.
  • the fractions may each comprise 0.01 to 100% by weight, more specifically 1 to 80% by weight relative to the total weight of the pharmaceutical composition.
  • the solvent fraction of the dew drop extract is polarized by distilling the dew drop extract with water and then fractionating using a nonpolar solvent such as n-hexane, ethyl acetate (EtOAc) or n-butanol (n-BuOH). Solvent fractions and nonpolar solvent fractions can be obtained respectively.
  • the solvent fraction is provided with water fraction, n-hexane fraction, ethyl acetate fraction or n-butanol fraction.
  • the kind of the fractionation solvent used to obtain the fraction in the present invention is not particularly limited, and any solvent known in the art may be used.
  • Non-limiting examples of the fractionation solvents include polar solvents such as water and alcohols; And nonpolar solvents such as hexane, ethyl acetate, chloroform, dichloromethane, and the like. These may be used alone or in combination of two or more thereof.
  • the term 'dry eye syndrome' refers to abnormal tears caused by tear secretion or meibomian gland dysfunction or eyelid dysfunction due to inflammation of the tear glands and denervation of the cornea. It may be a disease caused by evaporation or the like, and may be a corneal conjunctival epithelial disorder that appears as a wound of the cornea due to excessive dryness of the tear due to dry eye.
  • the term 'prevention' refers to any action that inhibits or delays the symptoms of dry eye with the administration of a composition comprising the extract of sesame powder or fractions thereof according to the present invention.
  • the term 'improvement' or 'treatment' refers to any action in which the symptoms of dry eye symptoms are improved or beneficially changed by administration of a composition comprising a dew extract or a fraction thereof according to the present invention.
  • the dry eye may be due to fine dust, but is not limited thereto, and the composition is preferably for eye drop administration, but is not limited thereto.
  • the dew extract or fractions thereof may increase tear secretion or inhibit corneal morphology, and may further include a pharmaceutically acceptable carrier, excipient or diluent in addition to the dew extract or fractions thereof.
  • Pharmaceutically acceptable carriers included in the pharmaceutical composition of the present invention are conventionally used in the preparation, and include saline, sterile water, Ringer's solution, buffered saline, dextrose solution, maltodextrin solution, glycerol, ethanol, lactose, dex Straw, sucrose, sorbitol, mannitol, starch, acacia rubber, calcium phosphate, alginate, gelatin, calcium silicate, microcrystalline cellulose, polyvinylpyrrolidone, cellulose, syrup, methyl cellulose, methyl hydroxybenzoate, propyl Hydroxybenzoate, talc, magnesium stearate and mineral oil, and the like.
  • Suitable dosages of the pharmaceutical compositions of the present invention may be prescribed in various ways depending on factors such as the formulation method, mode of administration, age, weight, sex, morbidity, condition of food, time of administration, route of administration, rate of excretion and response to response of the patient. Can be.
  • the route of administration of the pharmaceutical composition for preventing or treating dry eye syndrome of the present invention may be administered through any general route as long as it can reach the target tissue.
  • the pharmaceutical composition of the present invention is not particularly limited, but as desired, eye drops, intraperitoneal administration, intravenous administration, intramuscular administration, subcutaneous administration, intradermal administration, transdermal patch administration, oral administration, intranasal administration, pulmonary administration, It may be administered via a route such as rectal administration, and specifically, may be administered through a route of eye drop administration.
  • the present invention relates to a health functional food composition for preventing or improving dry eye syndrome comprising the extract of Emulsion or its fraction as an active ingredient.
  • composition is preferably, but not limited to, prepared in any one formulation selected from powders, granules, pills, tablets, capsules, candy, syrups and beverages.
  • the nutraceutical composition of the present invention may be prepared by adding the extract of sesame as it is or mixing with other food or food ingredients, and may be appropriately prepared according to a conventional method.
  • foods to which the dew extract may be added include dairy products including caramel, meat, sausage, bread, chocolate, candy, snacks, confectionery, pizza, ramen, other noodles, gum, ice cream, various soups, beverages, tea , Drink, alcoholic beverages and vitamin complexes may be in any one form selected, and includes all of the health functional food in the conventional sense. That is, the kind of food is not particularly limited.
  • the dietary supplement composition includes various nutrients, vitamins, minerals (electrolytes), synthetic and natural flavors, colorants and enhancers (such as cheese and chocolate), pectic acid and salts thereof, alginic acid and salts thereof, organic acids, protective colloidal thickeners. , pH adjusting agents, stabilizers, preservatives, glycerin, alcohols, carbonation agents used in carbonated drinks, and the like. It may also contain pulp for the production of natural fruit juices and vegetable drinks. The above components can be used independently or in combination.
  • the health functional food composition of the present invention may contain various flavors or natural carbohydrates, etc.
  • the natural carbohydrates are monosaccharides such as glucose, fructose, maltose, sucrose, disaccharides, dextrin, cyclo Polysaccharides such as dextrin, sugar alcohols such as xylitol, sorbitol, and erythritol.
  • the ratio of the said natural carbohydrate is not important, it is preferable that it is 0.01-0.04g with respect to 100g of the composition of this invention, More preferably, it contains 0.02-0.03g, but it is not limited to this.
  • natural sweeteners such as taumartin, stevia extract, synthetic sweeteners such as saccharin, aspartame, and the like can be used.
  • the amount of IL-8 gene expression in the group treated with fine dust was significantly increased compared to the control group (Control), and compared with the group of fine dust treated (Veh).
  • the expression level of IL-8 gene in the drop extract treatment group was significantly decreased.
  • Example 3 Fine dust and the present invention Dew According to the treatment of the extract Mucin Analysis of Changes in the Expression Level of -1 Protein
  • Human conjunctival cells were lysed using a cell lysis solution containing proteolytic enzymes, and then centrifuged to obtain supernatant. The obtained supernatant was diluted and placed in an ELISA well. After reacting at 37 ° C. for 2 hours, a detection antibody was added and reacted at 37 ° C. for 1 hour. Then, a secondary antibody fused with HRP (horseradish-peroxidase) was added and reacted at 37 ° C. for about 30 minutes. Then, TMB (tetramethylbenzidine) substrate was added and reacted at 37 ° C. for 10 minutes. Finally, the absorbance was measured at 450 nm within 30 minutes after adding the STOP solution.
  • HRP horseradish-peroxidase
  • Example 4 in order to cause dry eye, 20 mg of fine dust was dissolved in 1 ml of saline solution and applied directly to the eye 3 times / day. On the other hand, from the second day of fine dust administration, the dew extract was administered, 20 minutes after the administration of the fine dust, 1, 5 or 10 mg / ml of the dew extract to the eye for 8 days, and once in the morning after 10 days The tear amount was measured by the tear amount measurement method.
  • the dew extract of the present invention was prepared by dissolving in sterile physiological saline containing 0.5% DMSO at concentrations of 1, 5 and 10 mg / ml, and dropping 1 drop (drop) on both eyes twice daily and afternoon. The tear amount was measured by the tear amount measurement method after drug administration.
  • the control group significantly reduced tear secretion compared to the normal group
  • the contrast extract administration group in contrast with the normal group confirmed that the tear secretion increased.
  • the dew drop extract was administered to the animal model (rat) which caused dry eye syndrome and the change of the cornea was confirmed.
  • Example 5 The configuration of Example 5 was carried out in the same manner as in Example 4 composed of a normal group, a control group and an experimental group.
  • the cornea was anesthetized and photographed using a stereoscopic microsope (Olympus, Japan) with a fiberoptic ring illuminator.
  • the morphological changes of the corneas were evaluated by scoring the circular illuminators reflected from the corneal epithelial cells from 0 to 5 for the degree of distortion of round circles. 0 points: no distortion, 1 point: dent at 1/4 area, 2 points: dent at 2/4 area, 3 points: dent at 3/4 area, 4 points: dent at all parts, 5 points: severe dent
  • the round shape was not recognized.
  • tears secreted from the external tear gland form a tear film to maintain a smooth and flat surface state, and the circular shape is reflected as the light is reflected as a round circle.
  • the tear film covering the cornea had an abnormality, and the corneal epithelial cell degeneration and the smooth corneal surface dried out to become rugged, resulting in a rounded and curved round shape.
  • the change in corneal morphology was suppressed compared to the control group.
  • corneal smoothness score corneal smoothness score
  • the control group was significantly increased compared to the normal group (zero point), and the level of crushed at the 2/4 site in the group administered with the extract of dew drops of the present invention ( 2 points), indicating a statistically significant decrease (FIG. 4).

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Abstract

La présente invention concerne une composition pour la prévention, le soulagement ou le traitement du syndrome de l'œil sec, ladite composition contenant un extrait de racine d'Achyranthes ou une fraction de celui-ci en tant que principe actif. L'extrait de racine d'Achyranthes ou la fraction de celui-ci selon la présente invention peut non seulement minimiser l'expression du gène IL-8 qui est renforcée par la poussière fine et renforcer l'expression de la protéine mucine-1 qui est minimisée par la poussière fine, mais peut également renforcer la sécrétion de larmes qui est réduite par le syndrome de l'œil sec et inhiber les modifications de la forme de la cornée dont la forme circulaire est incurvée et déformée, et peut ainsi être utilement utilisé en tant que médicament ou aliment fonctionnel de santé pour la prévention, le soulagement ou le traitement du syndrome de l'œil sec.
PCT/KR2019/008440 2018-07-10 2019-07-09 Composition pour la prévention, le soulagement ou le traitement du syndrome de l'œil sec comprenant un extrait de racine d'achyranthes ou une fraction de celui-ci en tant que principe actif WO2020013582A1 (fr)

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KR1020180080046A KR102041549B1 (ko) 2018-07-10 2018-07-10 우슬 추출물 또는 이의 분획물을 유효성분으로 포함하는 안구건조증의 예방, 개선 또는 치료용 조성물
KR10-2018-0080046 2018-07-10

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KR20230040067A (ko) 2021-09-15 2023-03-22 동의대학교 산학협력단 오미자 추출물을 포함하는 눈 질환 개선 또는 예방용 조성물
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CN104771664A (zh) * 2015-03-21 2015-07-15 济南鸿飞生物技术有限公司 一种治疗肺阴不足型干眼症的汤剂及制备方法
KR20170006795A (ko) * 2015-07-09 2017-01-18 김용원 안구건조증 및 골다공증에 효과가 있는 석결명 식초 및 이의 제조방법 및 그 복용방법
CN105362799A (zh) * 2015-12-29 2016-03-02 青岛市市立医院 一种治疗干眼症的中药制剂及其制备方法
KR101740028B1 (ko) * 2016-07-25 2017-05-25 (주)휴럼 우슬, 황금의 혼합 추출물 또는 우슬, 황금, 오가피의 혼합 추출물을 포함하는 관절염 예방, 개선 또는 치료용 조성물

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