KR20210056013A - Pharmaceutical composition for preventing or treating retinal disease comprising extract of black rice - Google Patents
Pharmaceutical composition for preventing or treating retinal disease comprising extract of black rice Download PDFInfo
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- KR20210056013A KR20210056013A KR1020190142547A KR20190142547A KR20210056013A KR 20210056013 A KR20210056013 A KR 20210056013A KR 1020190142547 A KR1020190142547 A KR 1020190142547A KR 20190142547 A KR20190142547 A KR 20190142547A KR 20210056013 A KR20210056013 A KR 20210056013A
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Abstract
Description
본 발명은 흑미벼 추출물을 포함하는 망막질환 예방 또는 치료용 약학 조성물에 관한 것으로, 보다 구체적으로 본 발명은 흑미벼의 추출물 또는 그의 분획물을 포함하는 망막질환 예방 또는 치료용 약학 조성물, 상기 추출물 또는 그의 분획물을 포함하는 망막질환 예방 또는 개선용 식품 조성물, 상기 추출물 또는 그의 분획물을 포함하는 망막질환 예방 또는 개선용 사료첨가용 조성물 및 상기 약학 조성물을 이용하여 망막질환을 예방 또는 치료하는 방법에 관한 것이다.The present invention relates to a pharmaceutical composition for preventing or treating retinal diseases comprising a black rice extract, and more specifically, the present invention, a pharmaceutical composition for preventing or treating retinal diseases comprising an extract of black rice or a fraction thereof, the extract or its It relates to a food composition for preventing or improving retinal disease comprising a fraction, a composition for preventing or improving retinal disease including the extract or a fraction thereof, and a method for preventing or treating retinal disease using the pharmaceutical composition.
인간을 포함한 동물의 눈은 주변 정보의 인식을 통한 정보 전달에 중요한 역할을 한다. 즉, 눈을 통해 주변 환경에 대해 정확한 이미지를 끊임없이 받아들이고 이를 뇌에서 받아들인 정보들을 처리하여 상황에 맞는 행동을 유도하는 다양한 기능들을 수행한다. 신체의 다른 장기들과 마찬가지로 눈에도 다양한 안과질환들이 발생한다. The eyes of animals, including humans, play an important role in transmitting information through recognition of surrounding information. In other words, it performs various functions to induce actions appropriate to the situation by constantly receiving accurate images of the surrounding environment through the eyes and processing the information received from the brain. Like other organs in the body, various eye diseases occur in the eye.
이러한 안과질환은 주로 각막 또는 망막의 기능이 손상되어 발생하는데, 각막의 경우 외부환경에 의해 쉽게 손상될 수 있어, 안과질환 환자의 대다수가 각막의 손상에 의한 것으로 알려져 있다. 이러한 각막의 손상은 약물 또는 외과수술적인 치료에 의해 회복될 수 있는데, 이러한 외과수술적인 치료의 대표적인 예로서 엑시머레이저를 이용한 굴절교정 각막수술법을 들 수 있다.These ophthalmic diseases are mainly caused by impaired functions of the cornea or retina. Since the cornea can be easily damaged by the external environment, it is known that the majority of patients with ophthalmic diseases are due to corneal damage. Such corneal damage can be recovered by drug or surgical treatment, and a representative example of such surgical treatment is refractive corneal surgery using an excimer laser.
이에 반하여, 망막은 외부환경에 의해 거의 영향을 받지 않고, 신체적 요인 또는 유전적 요인에 의한 망막질환이 발생되는 것으로 알려져 있다. 이러한 신체적 요인의 대표적인 예로서 노화를 들 수 있는데, 노화가 진행될 경우 망막에 존재하는 황반의 기능이 저하되어 발생되는 황반손상이 발병될 가능성이 증가되는 것으로 알려져 있다. 상기 망막질환은 각막질환과는 달리 외좌수술적인 치료에 의해 치료하기가 어렵기 때문에, 대체로 약물치료법, 유전자 치료법 또는 최근들어 활발히 개발되고 있는 줄기세포 치료법 등이 사용되고 있다.In contrast, the retina is hardly affected by the external environment, and it is known that retinal diseases are caused by physical or genetic factors. A typical example of such a physical factor is aging, and it is known that when aging progresses, the likelihood of developing macular damage caused by a decrease in the function of the macula present in the retina increases. Unlike corneal diseases, since the retinal disease is difficult to treat by an ectopic surgical treatment, drug therapy, gene therapy, or stem cell therapy, which has been actively developed in recent years, are generally used.
예를 들어, 한국공개특허 제2017-0028132호에는 군소 유래 추출물을 포함하는 망막질환 예방 및 치료용 약학적 조성물이 개시되어 있고, 한국공개특허 제2017-0049775호에는 miR-410 억제제를 포함하는 망막색소상피 분화 유도용 조성물이 개시되어 있으며, 한국공개특허 제2017-0055012호에는 자기조립되어 응축된 고분자량의 siRNA 코어입자와 외부를 양이온성 고분자와 히알루론산으로 순착적으로 코팅하여 망막내부로 다량의 siRNA를 효율적으로 전달하는 입자 및 이의 제조방법이 개시되어 있다. 그러나, 이들 치료제는 망막질환이 발병되어 망막조직이 손상된 후에, 손상된 망막조직을 재생 또는 회복시키는 효과를 나타낼 뿐, 망막조직의 손상을 억제하는 효과는 나타내지 못하는 것으로 알려져 있다.For example, Korean Patent Laid-Open No. 2017-0028132 discloses a pharmaceutical composition for preventing and treating retinal diseases including extracts derived from small groups, and Korean Patent Publication No. 2017-0049775 discloses a retinal containing miR-410 inhibitor. A composition for inducing pigment epithelial differentiation is disclosed, and Korean Patent Publication No. 2017-0055012 discloses self-assembled and condensed high molecular weight siRNA core particles and a large amount inside the retina by sequentially coating the outside with cationic polymer and hyaluronic acid. Particles that efficiently deliver siRNA of and a method for preparing the same are disclosed. However, these therapeutic agents are known to have an effect of regenerating or restoring damaged retinal tissue after the retinal tissue is damaged due to the onset of retinal disease, but not having an effect of suppressing damage to the retinal tissue.
이러한 배경하에서, 본 발명자들은 망막질환을 효과적으로 예방 또는 치료할 수 있는 제제를 개발하기 위하여 예의 연구노력한 결과, 최근 개발된 흑미벼의 추출물이 망막색소상피세포의 손상을 억제하는 효과를 나타냄을 확인하고, 본 발명을 완성하였다.Under this background, the present inventors have made diligent research efforts to develop a formulation capable of effectively preventing or treating retinal diseases, and as a result, it has been confirmed that the recently developed extract of black rice has an effect of suppressing damage to retinal pigment epithelial cells, The present invention has been completed.
본 발명의 하나의 목적은 흑미벼의 추출물 또는 그의 분획물을 포함하는 망막질환 예방 또는 치료용 약학 조성물을 제공하는 것이다.One object of the present invention is to provide a pharmaceutical composition for preventing or treating retinal diseases comprising an extract of black rice or a fraction thereof.
본 발명의 다른 목적은 상기 약학 조성물을 이용하여 망막질환을 예방 또는 치료하는 방법을 제공하는 것이다.Another object of the present invention is to provide a method for preventing or treating retinal diseases by using the pharmaceutical composition.
본 발명의 또 다른 목적은 흑미벼의 추출물 또는 그의 분획물을 포함하는 망막질환 예방 또는 개선용 식품 조성물을 제공하는 것이다.Another object of the present invention is to provide a food composition for preventing or improving retinal diseases comprising an extract of black rice or a fraction thereof.
본 발명의 또 다른 목적은 흑미벼의 추출물 또는 그의 분획물을 포함하는 망막질환 예방 또는 개선용 사료첨가용 조성물을 제공하는 것이다.Another object of the present invention is to provide a composition for adding feed for preventing or improving retinal diseases comprising an extract of black rice or a fraction thereof.
상기의 목적을 달성하기 일 실시양태로서, 본 발명은 흑미벼(KACC 98047P)의 추출물 또는 그의 분획물을 포함하는 망막질환 예방 또는 치료용 약학 조성물을 제공한다.As an embodiment of achieving the above object, the present invention provides a pharmaceutical composition for preventing or treating retinal diseases comprising an extract of black rice (KACC 98047P) or a fraction thereof.
본 발명의 용어 "흑미벼(KACC 98047P)"란, 한아름벼와 조생흑찰을 인공교배하여 선발한 신품종의 흑미벼로서, 8월 20일 내지 9월 5일의 출수기; 70 내지 85cm의 간장; 15 내지 20cm의 수장; 15 내지 20개의 수수; 75 내지 95개의 수당수립수; 450 내지 550 kg/10a의 현미수량; 4 내지 6 %의 단백질 함량; 및 15 내지 25 %의 아밀로스 함량을 가지는 특징을 나타내고, 경기도 수원시 권선구 서둔동 소재 국립농업과학원 농업유전자원센터에 2016년 4월 18일자로 기탁번호 KACC 98047P로 특허 기탁을 하였는바, 상기 신품종 벼는 상기 기관 등을 통해 용이하게 입수할 수 있다.The term "heukmi rice (KACC 98047P)" of the present invention is a new variety of heukmi rice selected by artificial crossing Hana-reum rice and early heuk-chal, and the watering period from August 20 to September 5; Soy sauce of 70 to 85 cm; A head of 15 to 20 cm; 15 to 20 sorghum; 75 to 95 allowances; Brown rice quantity of 450 to 550 kg/10a; Protein content of 4 to 6%; And 15 to 25% amylose content, and a patent was deposited at the Agricultural Genetic Resource Center of the National Academy of Agricultural Sciences located in Seodun-dong, Gwonseon-gu, Suwon-si, Gyeonggi-do on April 18, 2016 under the deposit number KACC 98047P. It can be easily obtained through an institution or the like.
본 발명의 용어 "추출물"이란, 상기 흑미벼의 열매, 줄기, 잎, 뿌리 또는 그들의 분쇄물을 추출 처리하여 얻어지는 추출액, 상기 추출액의 희석액이나 농축액, 상기 추출액을 건조하여 얻어지는 건조물, 상기 추출액의 조정제물이나 정제물, 또는 이들의 혼합물 등, 추출액 자체 및 추출액을 이용하여 형성 가능한 모든 제형의 추출물을 포함한다. The term "extract" of the present invention is an extract obtained by extracting the fruits, stems, leaves, roots or pulverized products of the black rice, the dilution or concentrate of the extract, the dried product obtained by drying the extract, and the adjustment of the extract. It includes extracts of all formulations that can be formed using the extract itself and the extract, such as preparations, purified products, or mixtures thereof.
본 발명에 있어서, 상기 흑미벼를 추출하는 방법은 망막질환을 예방 또는 치료하는 효과를 나타내는 추출물을 수득할 수 있는 한 특별히 이에 제한되지 않으며, 당해 기술 분야에서 통상적으로 사용하는 방법에 따라 추출할 수 있다. 상기 추출 방법의 비제한적인 예로는, 열수 추출법, 초음파 추출법, 여과법, 환류 추출법 등을 들 수 있으며, 이들은 단독으로 수행되거나 2종 이상의 방법을 병용하여 수행될 수 있다.In the present invention, the method of extracting the black rice is not particularly limited as long as an extract exhibiting an effect of preventing or treating retinal diseases can be obtained, and can be extracted according to a method commonly used in the art. have. Non-limiting examples of the extraction method include a hot water extraction method, an ultrasonic extraction method, a filtration method, a reflux extraction method, and the like, which may be performed alone or in combination of two or more methods.
본 발명에서 상기 흑미벼를 추출하는데 사용되는 추출 용매의 종류는 망막질환을 예방 또는 치료하는 효과를 나타내는 추출물을 수득할 수 있는 한 특별히 이에 제한되지 않고, 당해 기술 분야에서 공지된 임의의 용매를 사용할 수 있다. 일 예로서, 상기 추출 용매로는 물, 알코올 등을 단독으로 또는 1종 이상 혼합하여 사용할 수 있고, 다른 예로서, 상기 추출 용매로는 물 또는 탄소수 1 내지 4의 알코올을 단독으로 또는 1종 이상 혼합하여 사용할 수 있으며, 또 다른 예로서, 상기 추출 용매는 물을 사용할 수 있다.In the present invention, the type of extraction solvent used to extract the black rice is not particularly limited as long as an extract exhibiting an effect of preventing or treating retinal diseases can be obtained, and any solvent known in the art may be used. I can. As an example, as the extraction solvent, water or alcohol may be used alone or in combination of one or more, and as another example, water or an alcohol having 1 to 4 carbon atoms may be used alone or as the extraction solvent. It may be mixed and used, and as another example, water may be used as the extraction solvent.
본 발명의 용어 "분획물"이란, 여러 다양한 구성 성분들을 포함하는 혼합물로부터 특정 성분 또는 특정 성분 그룹을 분리하기 위하여 분획을 수행하여 얻어진 결과물을 의미한다.The term "fraction" in the present invention means a result obtained by performing fractionation in order to separate a specific component or a specific group of components from a mixture containing several different constituents.
본 발명에서 상기 분획물은 상기 흑미벼 추출물을 용매 분획법, 한외여과 분획법, 크로마토그래피 분획법 등의 다양한 방법으로 분획한 결과물이 될 수 있다.In the present invention, the fraction may be a result of fractionation of the black rice extract by various methods such as a solvent fractionation method, an ultrafiltration fractionation method, and a chromatography fractionation method.
상기 분획물을 수득하는 방법 역시 망막질환을 예방 또는 치료하는 효과를 나타내는 분획물을 수득할 수 있는 한 특별히 이에 제한되지 않으며, 당해 기술 분야에서 통상적으로 사용하는 방법에 따라 수행될 수 있다. 일 예로서, 용매 분획법을 이용하여 흑미벼 열수 추출물로부터 분획물을 수득하는 방법을 사용할 수 있다.The method of obtaining the fraction is also not particularly limited as long as it can obtain a fraction exhibiting an effect of preventing or treating retinal diseases, and may be performed according to a method commonly used in the art. As an example, a method of obtaining a fraction from a hot water extract of black rice using a solvent fractionation method may be used.
본 발명에서 상기 분획물을 얻는 데 사용되는 분획 용매의 종류 역시 망막질환을 예방 또는 치료하는 효과를 나타내는 분획물을 수득할 수 있는 한 특별히 이에 제한되지 않으며, 당해 기술 분야에서 통상적으로 사용하는 방법에 따라 수행될 수 있다. 일 예로서, 상기 분획 용매로는 물, 알코올 등의 극성 용매; 헥산(Hexan), 에틸 아세테이트(Ethyl acetate), 클로로포름(Chloroform), 디클로로메탄(Dichloromethane) 등의 비극성 용매 등을 단독으로 또는 1종 이상 혼합한 것을 사용할 수 있다.The type of solvent fraction used to obtain the fraction in the present invention is not particularly limited as long as a fraction exhibiting an effect of preventing or treating retinal diseases can be obtained, and it is performed according to a method commonly used in the art. Can be. As an example, the fractionation solvent may include a polar solvent such as water and alcohol; Non-polar solvents such as hexane, ethyl acetate, chloroform, and dichloromethane may be used alone or in combination of one or more.
본 발명의 용어 "망막질환"이란, 신체적 요인 또는 유전적 요인에 의하여 망막이 손상되어 발병되는 질환을 의미한다.The term "retinal disease" of the present invention refers to a disease caused by damage to the retina due to physical or genetic factors.
본 발명에 있어서, 상기 망막질환은 흑미벼의 추출물 또는 그의 분획물에 의하여 예방 또는 치료될 수 있는 한 특별히 이에 제한되지 않으나, 일 예로서 망막색소상피세포 손상에 의한 망막질환이 될 수 있고, 다른 예로서, 망막색소상피세포 손상에 의하여 발병되는 망막색소변성증, 노인성 황반변성, NCMD(North Carolina Macular) 등이 될 수 있다.In the present invention, the retinal disease is not particularly limited as long as it can be prevented or treated by an extract of black rice or a fraction thereof, but as an example, it may be a retinal disease caused by damage to retinal pigment epithelial cells, and other examples As an example, it may be retinal pigment epithelial cell damage caused by retinal pigment epithelial cell damage, senile macular degeneration, NCMD (North Carolina Macular), and the like.
본 발명의 용어 "예방"이란, 본 발명의 흑미벼 추출물 또는 그의 분획물을 포함하는 약학 조성물의 투여에 의해 망막질환의 발병을 억제시키거나 또는 지연시키는 모든 행위를 의미한다.The term "prevention" of the present invention refers to any action of inhibiting or delaying the onset of retinal disease by administration of a pharmaceutical composition comprising the extract of black rice or a fraction thereof of the present invention.
본 발명의 용어 "치료"란, 상기 약학 조성물의 투여에 의해 망막질환의 증상이 호전되거나 이롭게 변경되는 모든 행위를 의미한다.The term "treatment" of the present invention refers to any action in which symptoms of retinal disease are improved or beneficially changed by administration of the pharmaceutical composition.
본 발명의 약학 조성물은 총 조성물의 중량 대비 흑미벼 추출물 또는 그의 분획물을 0.0001 내지 50 중량%로 포함할 수 있으며, 구체적으로 0.01 중량% 내지 10 중량%로 포함할 수 있으나, 이에 제한되지 않는다.The pharmaceutical composition of the present invention may contain 0.0001 to 50% by weight of a black rice extract or a fraction thereof based on the weight of the total composition, and specifically 0.01% to 10% by weight, but is not limited thereto.
상기 본 발명의 약학 조성물은 약학 조성물의 제조에 통상적으로 사용하는 약학적으로 허용가능한 담체, 부형제 또는 희석제를 추가로 포함할 수 있고, 상기 담체는 비자연적 담체(non-naturally occuring carrier)를 포함할 수 있다. The pharmaceutical composition of the present invention may further include a pharmaceutically acceptable carrier, excipient, or diluent commonly used in the manufacture of pharmaceutical compositions, and the carrier may include a non-naturally occurring carrier. I can.
본 발명의 용어 "약학적으로 허용가능한"이란, 상기 조성물에 노출되는 세포나 인간에게 독성이 없는 특성을 나타내는 것을 의미한다.The term "pharmaceutically acceptable" of the present invention means exhibiting properties that are not toxic to cells or humans exposed to the composition.
구체적으로, 상기 약학 조성물은, 각각 통상의 방법에 따라 산제, 과립제, 정제, 캡슐제, 현탁액, 에멀젼, 시럽, 에어로졸 등의 경구형 제형, 외용제, 좌제 및 멸균 주사용액의 형태로 제형화하여 사용될 수 있다. Specifically, the pharmaceutical composition is formulated in the form of oral dosage forms such as powders, granules, tablets, capsules, suspensions, emulsions, syrups, aerosols, etc., external preparations, suppositories, and sterile injectable solutions according to a conventional method. I can.
본 발명에서, 상기 약학 조성물에 포함될 수 있는 담체, 부형제 및 희석제로는 락토즈, 덱스트로즈, 수크로스, 솔비톨, 만니톨, 자일리톨, 에리스리톨, 말티톨, 전분, 아카시아 고무, 알지네이트, 젤라틴, 칼슘 포스페이트, 칼슘 실리케이트, 셀룰로즈, 메틸 셀룰로즈, 미정질 셀룰로스, 폴리비닐 피롤리돈, 물, 메틸히드록시벤조에이트, 프로필히드록시벤조에이트, 탈크, 마그네슘 스테아레이트 및 광물유를 들 수 있다. 제제화할 경우에는 보통 사용하는 충진제, 증량제, 결합제, 습윤제, 붕해제, 계면활성제 등의 희석제 또는 부형제를 사용하여 조제된다. 경구투여를 위한 고형제제에는 정제, 환제, 산제, 과립제, 캡슐제 등이 포함되며, 이러한 고형제제는 적어도 하나 이상의 부형제 예를 들면, 전분, 칼슘카보네이트(calcium carbonate), 수크로스(sucrose) 또는 락토오스(lactose), 젤라틴 등을 섞어 조제된다. 또한 단순한 부형제 이외에 마그네슘 스티레이트, 탈크 같은 윤활제들도 사용된다. 경구를 위한 액상 제제로는 현탁제, 내용액제, 유제, 시럽제 등이 해당되는 데 흔히 사용되는 단순희석제인 물, 리퀴드 파라핀 이외에 여러 가지 부형제, 예를 들면 습윤제, 감미제, 방향제, 보존제 등이 포함될 수 있다. 비경구 투여를 위한 제제에는 멸균된 수용액, 비수성용제, 현탁제, 유제, 동결건조 제제, 좌제가 포함된다. 비수성용제, 현탁제로는 프로필렌글리콜(propylene glycol), 폴리에틸렌 글리콜, 올리브 오일과 같은 식물성 기름, 에틸올레이트와 같은 주사 가능한 에스테르 등이 사용될 수 있다. 좌제의 기제로는 위텝솔(witepsol), 마크로골, 트윈(tween) 61, 카카오지, 라우린지, 글리세로제라틴 등이 사용될 수 있다. In the present invention, the carriers, excipients and diluents that may be included in the pharmaceutical composition include lactose, dextrose, sucrose, sorbitol, mannitol, xylitol, erythritol, maltitol, starch, gum acacia, alginate, gelatin, calcium phosphate, Calcium silicate, cellulose, methyl cellulose, microcrystalline cellulose, polyvinyl pyrrolidone, water, methylhydroxybenzoate, propylhydroxybenzoate, talc, magnesium stearate, and mineral oil. In the case of formulation, it is prepared using diluents or excipients such as fillers, extenders, binders, wetting agents, disintegrants, and surfactants that are usually used. Solid preparations for oral administration include tablets, pills, powders, granules, capsules, and the like, and these solid preparations include at least one excipient, such as starch, calcium carbonate, sucrose, or lactose. It is prepared by mixing (lactose) and gelatin. In addition to simple excipients, lubricants such as magnesium stearate and talc are also used. Liquid preparations for oral use include water and liquid paraffin, which are simple diluents commonly used for suspensions, liquid solutions, emulsions, syrups, etc., and various excipients such as wetting agents, sweetening agents, fragrances, and preservatives. have. Formulations for parenteral administration include sterilized aqueous solutions, non-aqueous solutions, suspensions, emulsions, lyophilized formulations, and suppositories. As the non-aqueous solvent and suspending agent, propylene glycol, polyethylene glycol, vegetable oil such as olive oil, and injectable ester such as ethyl oleate may be used. As a base for suppositories, witepsol, macrogol, tween 61, cacao butter, laurin paper, glycerogelatin, and the like may be used.
다른 양태로서, 본 발명은 상기 약학 조성물을 망막질환이 발병되거나 또는 발병될 가능성이 있는 인간을 제외한 개체에 투여하는 단계를 포함하는 망막질환의 예방 또는 치료 방법을 제공한다. In another aspect, the present invention provides a method for preventing or treating retinal diseases comprising administering the pharmaceutical composition to an individual other than a human who has or is likely to develop retinal disease.
본 발명의 용어 "투여"란, 적절한 방법으로 개체에게 소정의 물질을 도입하는 것을 의미한다. The term "administration" of the present invention means introducing a given substance to a subject in an appropriate manner.
본 발명의 용어 "개체"란, 망막질환이 발병하였거나 발병할 수 있는 인간을 포함한 쥐, 생쥐, 가축 등의 모든 동물을 의미한다. 구체적인 예로, 인간을 포함한 포유동물일 수 있다.The term "individual" of the present invention means all animals such as rats, mice, livestock, including humans who have or may develop retinal disease. As a specific example, it may be a mammal including a human.
본 발명의 망막질환의 예방 또는 치료 방법은 구체적으로, 인간을 제외한 개체에 흑미벼의 추출물 또는 그의 분획물을 포함하는 망막질환 예방 또는 치료용 약학 조성물을 약학적으로 유효한 양으로 투여하는 단계를 포함할 수 있다. The method for preventing or treating retinal diseases of the present invention specifically includes the step of administering a pharmaceutical composition for preventing or treating retinal diseases including an extract of black rice or a fraction thereof to an individual other than humans in a pharmaceutically effective amount. I can.
본 발명의 용어, "약학적으로 유효한 양"이란, 의학적 치료에 적용 가능한 합리적인 수혜/위험 비율로 질환을 치료하기에 충분하며 부작용을 일으키지 않을 정도의 양을 의미하며, 유효 용량 수준은 환자의 성별, 연령, 체중, 건강상태, 질병의 종류, 중증도, 약물의 활성, 약물에 대한 민감도, 투여 방법, 투여 시간, 투여 경로, 및 배출 비율, 치료 기간, 배합 또는 동시에 사용되는 약물을 포함한 요소 및 기타 의학 분야에 잘 알려진 요소에 따라 당업자에 의해 용이하게 결정될 수 있다.As used herein, the term "pharmaceutically effective amount" refers to an amount sufficient to treat a disease at a reasonable benefit/risk ratio applicable to medical treatment and does not cause side effects, and the effective dose level is the gender of the patient. , Age, weight, health condition, type of disease, severity, activity of the drug, sensitivity to the drug, method of administration, time of administration, route of administration, and rate of excretion, duration of treatment, factors including drugs used in combination or simultaneously, and others It can be readily determined by a person skilled in the art according to factors well known in the medical field.
구체적으로 본 발명의 조성물은 고형분을 기준으로 1일 0.0001 내지 100 mg/체중 kg으로, 더욱 구체적으로 0.001 내지 100 mg/체중 kg으로 투여할 수 있다. 투여는 상기 권장 투여량을 하루에 한 번 투여할 수도 있고, 수회 나누어 투여할 수도 있다.Specifically, the composition of the present invention may be administered in an amount of 0.0001 to 100 mg/kg body weight per day based on solid content, and more specifically at 0.001 to 100 mg/kg body weight per day. Administration may be administered once a day at the above recommended dosage, or may be divided several times.
본 발명의 망막질환의 예방 또는 치료 방법에서, 상기 조성물을 투여하는 투여 경로 및 투여 방식은 특별히 제한되지 않으며, 목적하는 해당 부위에 상기 조성물을 포함하는 조성물이 도달할 수 있는 한 임의의 투여 경로 및 투여 방식에 따를 수 있다. 구체적으로, 상기 조성물은 경구 또는 비경구의 다양한 경로를 통하여 투여될 수 있으며, 그 투여 경로의 비제한적인 예로는, 구강, 직장, 국소, 정맥내, 복강내, 근육내, 동맥내, 경피, 비측내 또는 흡입 등을 통하여 투여되는 것을 들 수 있다.In the method for preventing or treating retinal diseases of the present invention, the route of administration and the method of administration for administering the composition are not particularly limited, and any route of administration and administration as long as the composition containing the composition can reach the target site. It can be according to the mode of administration. Specifically, the composition may be administered through various routes, either oral or parenteral, and non-limiting examples of the route of administration include oral, rectal, topical, intravenous, intraperitoneal, intramuscular, intraarterial, transdermal, non- And those administered through intralateral or inhalation.
또 다른 양태로서, 본 발명은 흑미벼의 추출물 또는 그의 분획물을 포함하는 망막질환 예방 또는 개선용 식품 조성물을 제공한다.In another aspect, the present invention provides a food composition for preventing or improving retinal diseases comprising an extract of black rice or a fraction thereof.
상기 흑미벼는 식용으로 섭취할 수 있기 때문에 그의 추출물 또는 분획물 역시 상식할 수 있으면서도 면역조직 또는 기관 손상 예방 또는 개선을 도모할 수 있는 식품의 형태로 제조되어 섭취할 수 있다.Since the black rice can be consumed for food, its extracts or fractions can also be prepared and consumed in the form of foods capable of preventing or improving immune tissue or organ damage while having common sense.
본 발명의 용어 "개선"이란, 본 발명의 흑미벼의 추출물 또는 그의 분획물을 포함하는 조성물의 투여로 치료되는 상태와 관련된 파라미터, 예를 들면 증상의 정도를 적어도 감소시키는 모든 행위를 의미한다.The term "improvement" of the present invention refers to all actions of at least reducing the severity of a parameter related to the condition to be treated, for example, symptoms, by administration of a composition comprising an extract of black rice or a fraction thereof of the present invention.
본 발명의 용어 "식품"이란, 육류, 소시지, 빵, 초콜릿, 캔디류, 스낵류, 과자류, 피자, 라면, 기타 면류, 껌류, 아이스크림류를 포함한 낙농제품, 각종 스프, 음료수, 차, 드링크제, 알코올음료, 비타민 복합제, 건강 기능 식품 및 건강 식품 등이 있으며, 통상적인 의미에서의 식품을 모두 포함한다.The term "food" in the present invention means meat, sausage, bread, chocolate, candy, snacks, confectionery, pizza, ramen, other noodles, gum, dairy products including ice cream, various soups, beverages, tea, drinks, alcoholic beverages , Vitamin complexes, health functional foods, and health foods, and all foods in the usual sense are included.
본 발명의 식품 조성물은, 일상적으로 섭취하는 것이 가능하기 때문에 높은 망막질환 개선 효과를 기대할 수 있으므로, 건강 증진 목적으로 매우 유용하게 사용될 수 있다.Since the food composition of the present invention can be consumed on a daily basis, a high retinal disease improvement effect can be expected, and thus it can be very usefully used for health promotion purposes.
상기 건강 기능(성) 식품(functional food)이란, 특정보건용 식품(food for special health use, FoSHU)과 동일한 용어로, 영양 공급 외에도 생체조절기능이 효율적으로 나타나도록 가공된 의학, 의료효과가 높은 식품을 의미한다. 여기서 '기능(성)'이라 함은 인체의 구조 및 기능에 대하여 영양소를 조절하거나 생리학적 작용 등과 같은 보건용도에 유용한 효과를 얻는 것을 의미한다. 본 발명의 식품은 당 업계에서 통상적으로 사용되는 방법에 의하여 제조가능하며, 상기 제조시에는 당 업계에서 통상적으로 첨가하는 원료 및 성분을 첨가하여 제조할 수 있다. 또한 상기 식품의 제형 또한 식품으로 인정되는 제형이면 제한 없이 제조될 수 있다. 본 발명의 식품용 조성물은 다양한 형태의 제형으로 제조될 수 있으며, 일반 약품과는 달리 식품을 원료로 하여 약품의 장기 복용 시 발생할 수 있는 부작용 등이 없는 장점이 있고, 휴대성이 뛰어나므로, 본 발명의 식품은 망막질환 개선 효과를 증진시키기 위한 보조제로 섭취가 가능하다.The health function (functional food) is the same term as food for special health use (FoSHU). In addition to supplying nutrition, functional food is a medicine that is processed so that the bioregulatory function is effectively displayed, and has high medical effects. Means food. Here, the term'function (sex)' means to control nutrients for the structure and function of the human body or to obtain useful effects for health purposes such as physiological actions. The food product of the present invention can be prepared by a method commonly used in the art, and during the production, raw materials and ingredients commonly added in the art may be added to prepare the food product. In addition, the formulation of the food may be prepared without limitation as long as it is a formulation recognized as a food. The food composition of the present invention can be prepared in various forms of formulation, and unlike general drugs, it has the advantage of not having side effects that may occur when taking drugs for a long time using food as a raw material, and is excellent in portability. The food of the present invention can be ingested as an adjuvant for enhancing the effect of improving retinal diseases.
상기 건강 식품(health food)은 일반식품에 비해 적극적인 건강유지나 증진 효과를 가지는 식품을 의미하고, 건강보조식품(health supplement food)은 건강보조 목적의 식품을 의미한다. 경우에 따라, 건강 기능 식품, 건강식품, 건강보조식품의 용어는 호용된다.The health food refers to a food having an active health maintenance or promotion effect compared to a general food, and a health supplement food refers to a food for the purpose of health supplementation. In some cases, the terms health functional food, health food, and health supplement are used interchangeably.
구체적으로, 상기 건강 기능 식품은 본 발명의 화합물을 음료, 차류, 향신료, 껌, 과자류 등의 식품 소재에 첨가하거나, 캡슐화, 분말화, 현탁액 등으로 제조한 식품으로, 이를 섭취할 경우 건강상 특정한 효과를 가져오는 것을 의미하나, 일반 약품과는 달리 식품을 원료로 하여 약품의 장기 복용 시 발생할 수 있는 부작용이 없는 장점이 있다.Specifically, the health functional food is a food prepared by adding the compound of the present invention to food materials such as beverages, teas, spices, chewing gum, confectionery, or encapsulating, powdering, suspension, etc. It means bringing about an effect, but unlike general drugs, it has the advantage of having no side effects that may occur when taking the drug for a long time by using food as a raw material.
상기 식품 조성물은 생리학적으로 허용 가능한 담체를 추가로 포함할 수 있는데, 담체의 종류는 특별히 제한되지 않으며 당해 기술 분야에서 통상적으로 사용되는 담체라면 어느 것이든 사용할 수 있다.The food composition may further include a physiologically acceptable carrier, and the kind of the carrier is not particularly limited, and any carrier commonly used in the art may be used.
또한, 상기 식품 조성물은 식품 조성물에 통상 사용되어 냄새, 맛, 시각 등을 향상시킬 수 있는 추가 성분을 포함할 수 있다. 예들 들어, 비타민 A, C, D, E, B1, B2, B6, B12, 니아신(niacin), 비오틴(biotin), 폴레이트(folate), 판토텐산(panthotenic acid) 등을 포함할 수 있다. 또한, 아연(Zn), 철(Fe), 칼슘(Ca), 크롬(Cr), 마그네슘(Mg), 망간(Mn), 구리(Cu), 크륨(Cr) 등의 미네랄; 및 라이신, 트립토판, 시스테인, 발린 등의 아미노산을 포함할 수 있다. In addition, the food composition may include additional ingredients that are commonly used in food compositions to improve smell, taste, vision, and the like. For example, vitamins A, C, D, E, B1, B2, B6, B12, niacin, biotin, folate, panthotenic acid, and the like may be included. In addition, minerals such as zinc (Zn), iron (Fe), calcium (Ca), chromium (Cr), magnesium (Mg), manganese (Mn), copper (Cu), and chromium (Cr); And amino acids such as lysine, tryptophan, cysteine, and valine.
또한, 상기 식품 조성물은 방부제(소르빈산 칼륨, 벤조산나트륨, 살리실산, 데히드로초산나트륨 등), 살균제(표백분과 고도 표백분, 차아염소산나트륨 등), 산화방지제(부틸히드록시아니졸(BHA), 부틸히드록시톨류엔(BHT) 등), 착색제(타르색소 등), 발색제(아질산 나트륨, 아초산 나트륨 등), 표백제(아황산나트륨), 조미료(MSG 글루타민산나트륨 등), 감미료(둘신, 사이클레메이트, 사카린, 나트륨 등), 향료(바닐린, 락톤류 등), 팽창제(명반, D-주석산수소칼륨 등), 강화제, 유화제, 증점제(호료), 피막제, 검기초제, 거품억제제, 용제, 개량제 등의 식품 첨가물(food additives)을 포함할 수 있다. 상기 첨가물은 식품의 종류에 따라 선별되고 적절한 양으로 사용될 수 있다.In addition, the food composition includes preservatives (potassium sorbate, sodium benzoate, salicylic acid, sodium dehydroacetate, etc.), disinfectants (bleaching and highly bleaching, sodium hypochlorite, etc.), antioxidants (butylhydroxyanisol (BHA), butylhydride, etc.) Oxytoleuene (BHT), etc.), coloring agent (tar color, etc.), coloring agent (sodium nitrite, sodium nitrite, etc.), bleach (sodium sulfite), seasoning (MSG sodium glutamate, etc.), sweetener (dulsin, cyclamate, saccharin, etc.) , Sodium, etc.), flavoring (vanillin, lactones, etc.), expanding agents (alum, D-potassium hydrogen stannate, etc.), reinforcing agents, emulsifying agents, thickening agents (smelting agents), coating agents, gum base agents, foam inhibitors, solvents, improving agents, etc. It may contain food additives. The additive may be selected according to the type of food and used in an appropriate amount.
본 발명의 식품 조성물의 일 예로 건강음료 조성물로 사용될 수 있으며, 이 경우 통상의 음료와 같이 여러 가지 향미제 또는 천연 탄수화물 등을 추가 성분으로 함유할 수 있다. 상술한 천연 탄수화물은 포도당, 과당과 같은 모노사카라이드; 말토스, 슈크로스와 같은 디사카라이드; 덱스트린, 사이클로덱스트린과 같은 폴리사카라이드; 자일리톨, 소르비톨, 에리트리톨 등의 당알콜일 수 있다. 감미제는 타우마틴, 스테비아 추출물과 같은 천연 감미제; 사카린, 아스파르탐과 같은 합성 감미제 등을 사용할 수 있다. 상기 천연 탄수화물의 비율은 본 발명의 건강음료 조성물 100 mL 당 일반적으로 약 0.01 ~ 0.04 g, 구체적으로 약 0.02 ~ 0.03 g이 될 수 있다.As an example of the food composition of the present invention, it may be used as a health drink composition, and in this case, it may contain various flavoring agents or natural carbohydrates, etc. as an additional component, such as a conventional beverage. The natural carbohydrates described above include monosaccharides such as glucose and fructose; Disaccharides such as maltose and sucrose; Polysaccharides such as dextrin and cyclodextrin; It may be a sugar alcohol such as xylitol, sorbitol, and erythritol. Sweeteners include natural sweeteners such as taumatin and stevia extract; Synthetic sweeteners such as saccharin and aspartame can be used. The ratio of the natural carbohydrate may be generally about 0.01 to 0.04 g, specifically about 0.02 to 0.03 g per 100 mL of the health beverage composition of the present invention.
상기 외에 건강음료 조성물은 여러 가지 영양제, 비타민, 전해질, 풍미제, 착색제, 펙트산, 펙트산의 염, 알긴산, 알긴산의 염, 유기산, 보호성 콜로이드 증점제, pH 조절제, 안정화제, 방부제, 글리세린, 알코올 또는 탄산화제 등을 함유할 수 있다. 그 밖에 천연 과일주스, 과일주스 음료, 또는 야채 음료의 제조를 위한 과육을 함유할 수 있다. 이러한 성분은 독립적으로 또는 혼합하여 사용할 수 있다. 이러한 첨가제의 비율은 크게 중요하진 않지만 본 발명의 건강음료 조성물 100 중량부당 0.01 ~ 0.1 중량부의 범위에서 선택되는 것이 일반적이다.In addition to the above, health drink compositions include various nutrients, vitamins, electrolytes, flavoring agents, colorants, pectic acid, salts of pectic acid, alginic acid, salts of alginic acid, organic acids, protective colloid thickeners, pH adjusters, stabilizers, preservatives, glycerin, It may contain alcohol or a carbonation agent. In addition, it may contain flesh for the manufacture of natural fruit juice, fruit juice beverage, or vegetable beverage. These ingredients may be used independently or in combination. Although the ratio of these additives is not very important, it is generally selected from 0.01 to 0.1 parts by weight per 100 parts by weight of the health beverage composition of the present invention.
또 다른 양태로서, 본 발명은 흑미벼의 추출물 또는 그의 분획물을 포함하는 망막질환 예방 또는 개선용 사료첨가용 조성물을 제공한다.In another aspect, the present invention provides a composition for adding feed for preventing or improving retinal diseases, including an extract of black rice or a fraction thereof.
상기 흑미벼의 추출물 또는 그의 분획물은 망막색소상피세포의 손상을 억제할 수 있으므로, 가축 등에서 발병되는 망막질환의 예방 또는 개선을 도모할 수 있는 동물 사육용 사료에 첨가할 수 있는 사료첨가용 조성물의 형태로 제조되고, 상기 사료첨가용 조성물을 포함하는 동물 사육용 사료를 제조하여 동물에 섭식시킬 수 있다. Since the extract of black rice or its fractions can suppress damage to retinal pigment epithelial cells, the composition of a feed additive composition that can be added to animal breeding feeds that can prevent or improve retinal diseases caused in livestock, etc. It is manufactured in a form, and can be fed to animals by preparing a feed for animal breeding comprising the composition for feed addition.
본 발명의 사료첨가용 조성물은 사료의 제조에 사용될 수 있는 부형제, 희석제를 추가로 포함할 수 있다. 상기 부형제 및 희석제로는 락토즈, 덱스트로즈, 수크로스, 솔비톨, 만니톨, 자일리톨, 에리스리톨, 말티톨, 전분, 아카시아 고무, 알지네이트, 젤라틴, 칼슘 포스페이트, 칼슘 실리케이트, 셀룰로즈, 메틸 셀룰로즈, 미정질 셀룰로스, 폴리비닐 피롤리돈, 물, 메틸히드록시벤조에이트, 프로필히드록시벤조에이트, 탈크, 마그네슘 스테아레이트, 광물유, 스테비아 추출물 및 천연소재 추출물을 들 수 있다. The composition for feed addition of the present invention may further include excipients and diluents that can be used in the manufacture of feed. The excipients and diluents include lactose, dextrose, sucrose, sorbitol, mannitol, xylitol, erythritol, maltitol, starch, gum acacia, alginate, gelatin, calcium phosphate, calcium silicate, cellulose, methyl cellulose, microcrystalline cellulose, Polyvinyl pyrrolidone, water, methylhydroxybenzoate, propylhydroxybenzoate, talc, magnesium stearate, mineral oil, stevia extract and natural material extract.
아울러, 본 발명의 사료첨가용 조성물은 상기 흑미벼의 추출물 또는 그의 분획물 뿐만 아니라, 가축의 생산성 또는 건강 증진에 필요한 필수 영양소를 완전공급하는 데 필요한 뉴클레오티드류, 효소류, 미량성분 뿐만 아니라 가축의 생육을 보조하는 미생물을 추가로 포함할 수 있다. 예를 들어, 뉴클레오티드류로는 5'-아데닐산, 크산틴산, 리보핵산, 디옥시리보핵산 등을 단독으로 또는 조합하여 사용할 수 있고; 효소류로는 아라비나제(arabinase), 아라비노퓨라노시타제(arabinofuranosidase), 갈락타나제(galactanase), 펙티나제(pectinase), 말타제(maltase), 인버타제(invertase), 리파제(lipase) 등을 단독으로 또는 조합하여 사용할 수 있으며; 미량성분으로는 아미노산, 칼슘, 인산, 유기산 등을 단독으로 또는 조합하여 사용할 수 있고; 미생물로는 류코노스톡 속(Leuconostoc sp.) 균주, 웨이셀라 속(Weisella sp.) 균주, 엔테로코커스 속(Enterococcus sp.) 균주, 스트렙토마이세스 속(Streptomyces sp.) 균주, 노카르디아 속(Nocardia sp.) 균주 등을 단독으로 또는 조합하여 사용할 수 있다.In addition, the composition for feed addition of the present invention includes not only the extract of the black rice or its fractions, but also nucleotides, enzymes, and trace components necessary to completely supply essential nutrients necessary for improving the productivity or health of livestock, as well as the growth of livestock. It may further include a microorganism that assists. For example, as nucleotides, 5'-adenylic acid, xanthic acid, ribonucleic acid, deoxyribonucleic acid, and the like can be used alone or in combination; Enzymes include arabinase, arabinofuranosidase, galactanase, pectinase, maltase, invertase, and lipase. ) And the like may be used alone or in combination; As trace components, amino acids, calcium, phosphoric acid, organic acids, etc. may be used alone or in combination; Microorganisms include Leukonostoc sp. strain, Weisella sp. strain, Enterococcus sp. strain, Streptomyces sp. strain, and Nocardia sp. Nocardia sp.) strains and the like may be used alone or in combination.
또 다른 양태로서, 본 발명은 상기 사료첨가용 조성물을 포함하고, 망막질환 예방 또는 개선 효과를 나타내는 가축용 사료를 제공한다.In another aspect, the present invention provides a feed for livestock comprising the composition for adding feed and exhibiting a preventive or improving effect of retinal diseases.
상술한 바와 같이, 본 발명에서 제공하는 흑미벼의 추출물 또는 그의 분획물은 동물에 섭식시킬 경우, 특별한 독성없이 망막질환을 예방 또는 개선시킬 수 있으므로, 이를 원료사로에 혼합하여 제조된 가축용 사료는 가축의 건강을 증진시키는 효과를 나타낼 수 있다.As described above, when the extract of black rice or a fraction thereof provided in the present invention is fed to animals, it can prevent or improve retinal disease without special toxicity. It can have the effect of improving the health of the body.
본 발명에서 제공하는 가축용 사료를 섭식시킬 수 있는 가축은 흑미벼의 추출물 또는 그의 분획물에 의하여 망막질환을 예방 또는 개선시키는 효과를 나타내는 한 특별히 이에 제한되지 않으나, 일 례로서, 닭, 오리, 거위, 소, 염소, 양, 말, 개, 돼지 등이 될 수 있다.Livestock capable of feeding the feed for livestock provided by the present invention is not particularly limited as long as it exhibits an effect of preventing or improving retinal diseases by an extract of black rice or a fraction thereof, but as an example, chicken, duck, goose , Cows, goats, sheep, horses, dogs, pigs, etc.
본 발명의 용어 "원료사료"란, 상기 사료첨가용 조성물이 첨가되는 사료를 의미한다.The term "raw material feed" of the present invention means a feed to which the feed additive composition is added.
본 발명에 있어서, 상기 원료사료는 상기 사료첨가용 조성물이 부가되어 가축의 망막질환을 예방 또는 개선시키는 효과를 나타내는 한 특별히 이에 제한되지 않으나, 일 예로서 쌀, 발효대두분, 대두, 이탈리안그라스, 수단그라스, 호밀, 볏짚, 옥수수, 소맥피, 쌀겨, 당맥피 등을 단독으로 또는 조합하여 주성분으로 포함하는 배합사료가 될 수 있고, 이들 주성분은 가축용 원료사료에 일반적으로 사용되는 적절한 범위로 포함될 수 있다.In the present invention, the raw material feed is not particularly limited as long as the feed additive composition is added to show an effect of preventing or improving retinal diseases of livestock, but as an example, rice, fermented soybean meal, soybean, Italian grass, Sudangrass, rye, rice straw, corn, wheat bark, rice bran, sugar bark, etc. may be used alone or in combination to be a compounded feed containing as main ingredients, and these main ingredients are included in the appropriate range generally used in raw material feed for livestock. I can.
본 발명의 용어 "배합사료"란, 가축의 사육목적에 맞는 영양소를 고르게 공급할 수 있도록 배합하여 만든 사료를 의미하며, 상기 배합사료는 가축이 필요로 하는 에너지, 단백질, 지질, 비타민, 광물질 등 영양소를 포함한다. 배합사료를 만들 때는, 영양적인 면에서 볼 때, 가축의 식욕을 증진시키고 소화기관의 정상적인 작용을 촉진시키기 위하여 적정량의 고형물(固型物)이 반드시 필요하며, 가축의 생산활동을 충분히 발휘시키기 위해 적당한 양의 단백질을 넣어 주어야 하며, 가축의 체온유지와 생산활동을 정상적으로 유지하기 위한 열량이 들어가야 하며, 기타 칼슘 또는 인과 같은 무기물과 비타민도 충분히 함유되어야 한다. The term "mixed feed" of the present invention refers to a feed made by blending so that nutrients suitable for the purpose of raising livestock are evenly supplied, and the blended feed is nutrients such as energy, protein, lipid, vitamins, minerals, etc. required by livestock. Includes. When making mixed feed, from a nutritional point of view, an appropriate amount of solids is indispensable in order to enhance the appetite of livestock and to promote the normal functioning of the digestive system, and to fully demonstrate the production activities of livestock. Proper amount of protein must be added, calories must be included to maintain the body temperature and production activities of livestock normally, and other minerals such as calcium or phosphorus and vitamins must be sufficiently contained.
한편, 상기 사료에 포함되는 사료첨가용 조성물의 함량은 특별히 이에 제한되지 않으나, 일 례로서 사료의 최종 중량을 기준으로 0.01 내지 10%(w/w)가 될 수 있고, 다른 예로서 0.1 내지 5%(w/w)가 될 수 있으며, 또 다른 예로서 1%(w/w)가 될 수 있다.Meanwhile, the content of the feed additive composition included in the feed is not particularly limited thereto, but as an example, it may be 0.01 to 10% (w/w) based on the final weight of the feed, and as another example, 0.1 to 5 It can be% (w/w), and as another example, it can be 1% (w/w).
또한, 상기 사료는 상술한 주성분 이외에 통상적인 가축용 배합사료에 포함될 수 있는 혈장 단백질, 어분, 유장, 복합유제품, 대두유, 아미노산 프리믹스, 산미제 프리믹스, 홍삼박, 소금, 비타민-미네랄 혼합물 등을 단독으로 또는 혼합하여 추가로 포함할 수 있다.In addition, the feed contains plasma proteins, fish meal, whey, complex dairy products, soybean oil, amino acid premix, acidulant premix, red ginseng meal, salt, vitamin-mineral mixture, etc. It may be further included as or mixed.
본 발명에서 제공하는 흑미벼의 추출물 또는 그의 분획물을 포함하는 조성물은 부작용이 없으면서도 망막질환을 예방 또는 개선시킬 수 있으므로, 망막질환을 포함하는 다양한 형태의 안과질환 예방 또는 치료용 제제의 개발에 널리 활용될 수 있을 것이다.Since the composition containing the extract of black rice or its fraction provided by the present invention can prevent or improve retinal diseases without side effects, it is widely used in the development of preparations for preventing or treating various types of ophthalmic diseases including retinal diseases. It will be able to be utilized.
도 1은 망막색소상피세포(ARPE-19 세포)를 배양한 후, 시간의 경과에 따른 증식결과를 나타내는 현미경사진이다.
도 2a는 일반 흑미벼 추출물의 처리에 따른, 망막색소상피세포(ARPE-19 세포)의 손상수준의 변화를 나타내는 그래프이다.
도 2b는 본 발명의 흑미벼의 추출물의 처리에 따른, 망막색소상피세포(ARPE-19 세포)의 손상수준의 변화를 나타내는 그래프이다.1 is a photomicrograph showing a proliferation result over time after culturing retinal pigment epithelial cells (ARPE-19 cells).
Figure 2a is a graph showing the change in the damage level of the retinal pigment epithelial cells (ARPE-19 cells) according to the treatment of the general black rice extract.
Figure 2b is a graph showing the change in the damage level of the retinal pigment epithelial cells (ARPE-19 cells) according to the treatment of the extract of the black rice of the present invention.
이하 본 발명을 실시예를 통하여 보다 상세하게 설명한다. 그러나 이들 실시예는 본 발명을 예시적으로 설명하기 위한 것으로 본 발명의 범위가 이들 실시예에 한정되는 것은 아니다.Hereinafter, the present invention will be described in more detail through examples. However, these examples are for illustrative purposes only, and the scope of the present invention is not limited to these examples.
실시예Example 1: One: 흑미벼Black rice 추출물의 제조 Preparation of extract
먼저, 20 내지 80% 주정에 0.1% 초산을 첨가한 추출용매를 수득하였다.First, an extraction solvent in which 0.1% acetic acid was added to 20 to 80% alcohol was obtained.
상기 추출용매를 흑미벼(KACC 98047P)의 현미에 가하고, 24 또는 48시간동안 실온에서 교반하면서 추출하여, 각각의 추출물을 수득하였다.The extraction solvent was added to brown rice of black rice (KACC 98047P), followed by extraction with stirring at room temperature for 24 or 48 hours to obtain respective extracts.
상기 수득한 각 추출물을 여과하여 액상성분을 수득하고, 상기 수득한 액상성분을 농축시킨 후, 동결건조하여 분말상의 추출물을 수득하고, 수득한 분말상 추출물의 함량을 정량분석하였다(표 1).Each of the obtained extracts was filtered to obtain a liquid component, the obtained liquid component was concentrated, and then freeze-dried to obtain a powdery extract, and the content of the obtained powdery extract was quantitatively analyzed (Table 1).
상기 표 1에서 보듯이, 80% 주정에 0.1% 초산을 첨가한 추출용매를 사용하여, 48시간 동안 실온에서 추출한 경우에 가장 우수한 함량의 추출물을 수득할 수 있음을 확인하였다.As shown in Table 1, it was confirmed that the extract having the best content can be obtained when extracted at room temperature for 48 hours using an extraction solvent in which 0.1% acetic acid was added to 80% alcohol.
실시예Example 2: 2: 망막색소상피세포의Retinal pigment epithelial cells 손상에 미치는 Damaging 흑미벼Black rice (( KACCKACC 98047P) 추출물의 효과분석 98047P) Effect analysis of extract
실시예Example 2-1: 2-1: 망막색소상피세포의Retinal pigment epithelial cells 배양 culture
상기 실시예 1에서 수득한 흑미벼 추출물의 안전성을 확인하기 위하여, 망막색소상피세포(ARPE-19)를 배양하였다. In order to confirm the safety of the black rice extract obtained in Example 1, retinal pigment epithelial cells (ARPE-19) were cultured.
구체적으로, 96 웰 플레이트에 망악색소상피세포를 2×102 세포/웰로 계수하여 분주하였고, 10, 50 및 100 ㎍/mL 농도의 흑미벼 추출물을 상기 세포에 처리하여 48시간 동안 배양하였다(도 1). Specifically, maniac pigment epithelial cells were counted and dispensed into a 96-well plate at 2×10 2 cells/well, and black rice extract at concentrations of 10, 50 and 100 μg/mL were treated with the cells and cultured for 48 hours (Fig. One).
도 1은 망막색소상피세포(ARPE-19 세포)를 배양한 후, 시간의 경과에 따른 증식결과를 나타내는 현미경사진이다.1 is a photomicrograph showing the results of proliferation over time after culturing retinal pigment epithelial cells (ARPE-19 cells).
실시예Example 2-2: 2-2: 흑미벼Black rice (( KACCKACC 98047P) 추출물의 효과 98047P) Effect of extract
먼저, 상기 실시예 1의 결과에 따라, 80% 주정에 0.1% 초산을 첨가한 추출용매를 사용하여, 흑미벼(KACC 98047P) 현미와 일반 흑미벼 현미(대조군)의 추출물을 각각 수득하였다. First, according to the results of Example 1, extracts of black rice (KACC 98047P) brown rice and general black rice brown rice (control) were obtained, respectively, using an extraction solvent in which 0.1% acetic acid was added to 80% alcohol.
(상기 대조군으로 사용된 일반 (General used as the control 흑미벼의Black rice 품종을 알려주시기 바랍니다) Please tell me the breed)
다음으로, 상기 실시예 2-1에서 배양된 ARPE-19 세포에 A2E(Pyridinum Bisretinoid)과 청색광(BL)을 가하여 상기 ARPE-19 세포를 손상시키고, 상기 손상된 ARPE-19 세포에 상기 수득한 각 추출물을 다양한 농도(10 내지 100 ㎍/㎖)로 가하여 배양한 다음, 배양된 ARPE-19 세포의 세포생존율을 비교하였다(도 2a 및 2b).Next, the ARPE-19 cells were damaged by adding A2E (Pyridinum Bisretinoid) and blue light (BL) to the ARPE-19 cells cultured in Example 2-1, and each of the obtained extracts was applied to the damaged ARPE-19 cells. Was added at various concentrations (10 to 100 μg/ml) and cultured, and then the cell viability of the cultured ARPE-19 cells was compared (FIGS. 2A and 2B ).
도 2a는 일반 흑미벼 추출물의 처리에 따른, 망막색소상피세포(ARPE-19 세포)의 손상수준의 변화를 나타내는 그래프이고, 도 3b는 본 발명의 흑미벼의 추출물의 처리에 따른, 망막색소상피세포(ARPE-19 세포)의 손상수준의 변화를 나타내는 그래프이다.Figure 2a is a graph showing the change in the damage level of the retinal pigment epithelial cells (ARPE-19 cells) according to the treatment of the general black rice extract, Figure 3b is the retinal pigment epithelium according to the treatment of the extract of the black rice of the present invention It is a graph showing the change in the damage level of cells (ARPE-19 cells).
도 2a에서 보듯이, 일반 흑미벼 추출물을 처리한 경우에는, 높은 농도(100 ㎍/㎖)로 처리한 경우에도, 손상된 ARPE-19 세포의 생존율이 변화되지 않음을 확인하였다.As shown in Fig. 2a, when the general black rice extract was treated, it was confirmed that the survival rate of damaged ARPE-19 cells did not change even when treated at a high concentration (100 µg/ml).
이에 반하여, 도 2b에서 보듯이, 흑미벼(KACC 98047P) 추출물을 처리한 경우에는, 낮은 농도(25 ㎍/㎖)로 처리한 경우에도, 손상된 ARPE-19 세포의 생존율이 증가되었고, 상기 추출물의 처리농도가 증가할 수록 이에 비례하여 손상된 ARPE-19 세포의 생존율이 증가됨을 확인하였다.On the other hand, as shown in FIG. 2B, when the extract of black rice (KACC 98047P) was treated, the survival rate of damaged ARPE-19 cells was increased even when the extract was treated with a low concentration (25 μg/ml). It was confirmed that as the treatment concentration increased, the survival rate of damaged ARPE-19 cells increased proportionally.
따라서, 흑미벼(KACC 98047P) 추출물은 외부 요인에 의한 망막색소상피세포의 손상을 농도의존적으로 억제하는 효과를 나타냄을 알 수 있었다.Therefore, it was found that the extract of Black Rice (KACC 98047P) showed an effect of suppressing the damage of retinal pigment epithelial cells caused by external factors in a concentration-dependent manner.
이상의 설명으로부터, 본 발명이 속하는 기술분야의 당업자는 본 발명이 그 기술적 사상이나 필수적 특징을 변경하지 않고서 다른 구체적인 형태로 실시될 수 있다는 것을 이해할 수 있을 것이다. 이와 관련하여, 이상에서 기술한 실시 예들은 모든 면에서 예시적인 것이며 한정적인 것이 아닌 것으로서 이해해야만 한다. 본 발명의 범위는 상기 상세한 설명보다는 후술하는 특허 청구범위의 의미 및 범위 그리고 그 등가 개념으로부터 도출되는 모든 변경 또는 변형된 형태가 본 발명의 범위에 포함되는 것으로 해석되어야 한다.From the above description, those skilled in the art to which the present invention pertains will understand that the present invention can be implemented in other specific forms without changing the technical spirit or essential features thereof. In this regard, the embodiments described above are illustrative in all respects and should be understood as non-limiting. The scope of the present invention should be construed as including the meaning and scope of the claims to be described later rather than the above detailed description, and all changes or modifications derived from the equivalent concepts within the scope of the present invention.
Claims (11)
A pharmaceutical composition for preventing or treating retinal diseases comprising an extract of black rice (KACC 98047P) or a fraction thereof.
상기 추출물은 흑미벼(KACC 98047P)를 물, 탄소수 1 내지 4의 알코올 및 이들의 혼합 용매로 이루어진 군에서 선택된 1종 이상의 용매로 추출하여 수득한 것인, 약학 조성물.
The method of claim 1,
The extract is obtained by extracting black rice (KACC 98047P) with at least one solvent selected from the group consisting of water, an alcohol having 1 to 4 carbon atoms, and a mixed solvent thereof.
상기 분획물은 상기 추출물을 극성 용매, 비극성 용매 및 이들의 혼합 용매로 이루어진 군에서 선택된 1종 이상의 용매로 분획하여 수득한 것인, 약학 조성물.
The method of claim 1,
The fraction is obtained by fractionating the extract with at least one solvent selected from the group consisting of a polar solvent, a non-polar solvent, and a mixed solvent thereof.
상기 극성 용매는 물 또는 알코올인 것인, 약학 조성물.
The method of claim 3,
The polar solvent is water or alcohol.
상기 비극성 용매는 헥산(Hexan), 에틸 아세테이트(Ethyl acetate), 클로로포름(Chloroform), 디클로로메탄(Dichloromethane) 및 이들의 혼합 용매로 이루어진 군에서 선택된 1종 이상의 용매인 것인, 약학 조성물.
The method of claim 3,
The non-polar solvent is one or more solvents selected from the group consisting of hexane, ethyl acetate, chloroform, dichloromethane, and mixed solvents thereof.
상기 망막질환은 망막색소상피세포 손상에 의해 유발되는 질환인 것인, 약학 조성물.
The method of claim 1,
The retinal disease is a disease caused by damage to retinal pigment epithelial cells, pharmaceutical composition.
상기 망막색소상피세포 손상에 의해 유발되는 질환은 망막색소변성증, 노인성 황반변성, NCMD(North Carolina Macular) 및 이들의 조합으로 이루어진 군에서 선택된 1종 이상의 질환인 것인, 약학 조성물.
The method of claim 6,
The disease caused by the retinal pigment epithelial cell damage is one or more diseases selected from the group consisting of retinal pigmentation, senile macular degeneration, NCMD (North Carolina Macular), and combinations thereof.
상기 조성물은 약학적으로 허용되는 담체, 부형제 또는 희석제를 추가로 포함하는 것인, 조성물.
The method of claim 1,
The composition further comprises a pharmaceutically acceptable carrier, excipient, or diluent.
A method for preventing or treating retinal diseases, comprising administering the composition of any one of claims 1 to 8 to an individual other than a human having or likely to develop retinal disease.
Black rice (KACC 98047P) extract or a food composition for improving retinal diseases comprising a fraction thereof.
Black rice (KACC 98047P) extract or a feed additive composition for improving retinal diseases comprising a fraction thereof.
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