KR20240055547A - Composition For Preventing Or Treating Eye Diseases Comprising Rehmanniae Radix Extract - Google Patents
Composition For Preventing Or Treating Eye Diseases Comprising Rehmanniae Radix Extract Download PDFInfo
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- KR20240055547A KR20240055547A KR1020220135980A KR20220135980A KR20240055547A KR 20240055547 A KR20240055547 A KR 20240055547A KR 1020220135980 A KR1020220135980 A KR 1020220135980A KR 20220135980 A KR20220135980 A KR 20220135980A KR 20240055547 A KR20240055547 A KR 20240055547A
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- KR
- South Korea
- Prior art keywords
- composition
- rehmannia glutinosa
- eye
- preventing
- dried rehmannia
- Prior art date
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Abstract
본 발명은 건지황 추출물을 유효성분으로 포함하는 안질환의 예방 또는 치료용 약학 조성물을 제공한다. 본 발명의 건지황 추출물을 포함하는 조성물은 망막색소상피세포에 축적 및 산화된 A2E에 의한 망막색소상피세포의 사멸을 억제하는 활성이 매우 우수하므로, 황반변성 등의 안질환을 예방하거나 치료하기 위한 용도로 사용될 수 있다. The present invention provides a pharmaceutical composition for preventing or treating eye diseases containing dried Rehmannia glutinosa extract as an active ingredient. The composition containing the dried Rehmannia glutinosa extract of the present invention has excellent activity in inhibiting the death of retinal pigment epithelial cells caused by A2E accumulated and oxidized in retinal pigment epithelial cells, and is therefore used for preventing or treating eye diseases such as macular degeneration. It can be used as
Description
본 발명은 건지황 추출물을 포함하는 안질환의 예방 또는 치료용 조성물에 관한 것이다. The present invention relates to a composition for preventing or treating eye diseases containing dried Rehmannia glutinosa extract.
눈은 가장 중요한 감각기관이므로 눈의 기능적 장애 또는 상실은 생활의 질을 떨어뜨리는 가장 큰 요인 중 하나이다. 현대인들은 대부분의 시간을 컴퓨터, 스마트폰 등의 다양한 디지털 스크린 앞에서 보내고 있는데 스마트 기기 화면에 LED가 자주 사용됨으로써 청색광으로 인해 눈 건강이 악화되고 있다.Since the eyes are the most important sense organ, functional disability or loss of the eyes is one of the biggest factors that reduces the quality of life. Modern people spend most of their time in front of various digital screens such as computers and smartphones, and as LEDs are frequently used in smart device screens, eye health is worsening due to blue light.
청색광은 가시광선 중에서 400-500nm 영역의 푸른색을 띄는 빛으로 청색광에 오랜 시간 노출될 경우 시신경을 자극하게 되어 눈의 피로를 유발하고 각종 안질환의 원인이 된다. 청색광은 에너지가 크고 투과력도 높기 때문에 눈에 그대로 들어오게 될 경우 망막에 초점을 불투명하게 맺히게 하여 선명도를 떨어뜨리고, 만성적으로 노출되는 경우에는 망막의 노화와 퇴화의 원인이 된다. 청색광이 인체에 미치는 영향으로는 안구 건조 및 눈 피로, 시력감퇴 및 각종 안질환, 망막 노화 촉진, 황반변성 및 멜라토닌 생성억제로 인한 불면증 등이 있다고 알려져 있다.Blue light is a blue light in the 400-500 nm range of visible light. If exposed to blue light for a long time, it stimulates the optic nerve, causing eye fatigue and causing various eye diseases. Blue light has high energy and high penetrating power, so when it enters the eye, it focuses opaquely on the retina, reducing clarity, and when exposed chronically, it causes aging and degeneration of the retina. It is known that the effects of blue light on the human body include dry eyes and eye fatigue, decreased vision and various eye diseases, acceleration of retinal aging, macular degeneration, and insomnia due to inhibition of melatonin production.
청색광의 작용으로 인해 평생 동안 대사성 폐기 부산물들이 망막세포 내에 누적되고, 특히, 간상세포 광수용체가 많이 밀집되어 있는 망막 중심부 아래의 망막색소상피세포에서 축적이 가장 활발하게 일어난다고 알려져 있다. 이러한 대사성 폐기 부산물 중에서 가장 중요한 것 중 하나는 리포푸신 성분인 N-레티닐리덴-N-레티닐-에탄올아민(N-retinylidene-N-retinyl-ethanolamine: A2E)으로서, 높은 농도의 A2E는 망막색소상피세포의 사멸에 관여하는 주요 원인이 된다. 또한, A2E는 낮은 농도에서도 청색광에 의해 광산화되고 에폭사이드(epoxide) 형태인 퍼옥시-A2E(peroxy-A2E)와 퓨라노-A2E(furano-A2E)로 변하게 된다. 반응성이 높은 에폭사이드 형태의 A2E는 산화적 스트레스와 염증 반응을 일으키고, 미토콘드리아의 단백질 활성을 변화시켜 세포사멸을 유도한다. 그 결과, 정상적인 망막색소상피세포의 기능이 소실되면 광수용체세포의 2차적 사멸로 이어진다. 특히, 광수용체세포가 많이 밀집되어 있는 황반의 경우 심각한 손상을 받아 황반변성이 일어나게 된다. 즉, 황반변성은 청색광으로 인한 망막의 세포 산화성 스트레스에 의해 A2E가 산화되고, 산화된 A2E의 축적에 의해 발병된다는 점에서 고혈당으로 인한 당화산물 및 VEGF 등과 같은 혈관형성인자들의 작용에 의해 발병하는 당뇨병성 망막병증과는 발병원인이 상이하다.Due to the action of blue light, metabolic waste by-products accumulate in retinal cells throughout life, and it is known that accumulation occurs most actively in retinal pigment epithelial cells under the central retina where rod cell photoreceptors are concentrated. One of the most important of these metabolic waste by-products is N-retinylidene-N-retinyl-ethanolamine (A2E), a lipofuscin component. At high concentrations, A2E can cause retinal pigmentation. It is a major cause of death of epithelial cells. In addition, even at low concentrations, A2E is photo-oxidized by blue light and changes into epoxide forms, such as peroxy-A2E and furano-A2E. A2E, a highly reactive epoxide form, causes oxidative stress and inflammatory responses, and induces cell death by changing mitochondrial protein activity. As a result, loss of normal retinal pigment epithelial cell function leads to secondary death of photoreceptor cells. In particular, the macula, where photoreceptor cells are densely packed, is severely damaged, causing macular degeneration. In other words, macular degeneration is caused by oxidation of A2E and accumulation of oxidized A2E due to cellular oxidative stress in the retina caused by blue light. In that, macular degeneration is caused by the action of glycation products caused by high blood sugar and angiogenic factors such as VEGF, etc. The cause is different from retinopathy.
황반변성은 크게 두 가지 타입으로 나뉠 수 있는데, 건성(비삼출성) 황반변성과 습성(삼출성) 황반변성이다. 건성 황반변성은 전체 황반변성 환자의 약 90%를 차지하며, 건성 황반변성은 망막색소상피(retinal pigment epithelium)와 브루크막(Bruch's membrane) 사이에 드루젠(drusen)이라는 노폐물이 쌓여 황반부 조직이 위축되거나 얇아진 것을 특징으로 한다. 한편, 습성 황반변성은 전체 환자의 약 10%을 차지하며, 황반부에 정상적인 혈액과 영양분이 공급되지 않아, 비정상적으로 신생혈관이 형성되고, 파열되어 황반으로 혈액이나 점액이 누수되어 심각한 시력 상실을 일으키는 것을 말한다. 건성 황반변성의 초기증상은 무증상이거나 증상이 있더라도 노안으로 여기기 때문에 방치하기 쉽다. 하지만, 건성 황반변성의 진행을 억제하거나 치료하지 않으면 지속적인 망막손상으로 인한 시력상실이 올 수 있고, 습성 황반변성으로 진행되어 실명까지 이르게 될 수 있기 때문에 초기에 건성 황반변성을 예방하는 것이 중요하다.Macular degeneration can be broadly divided into two types: dry (non-exudative) macular degeneration and wet (exudative) macular degeneration. Dry macular degeneration accounts for approximately 90% of all macular degeneration patients. Dry macular degeneration is a condition in which waste material called drusen accumulates between the retinal pigment epithelium and Bruch's membrane, causing atrophy or thinning of macular tissue. It is characterized by Meanwhile, wet macular degeneration accounts for about 10% of all patients, and occurs when normal blood and nutrients are not supplied to the macula, causing abnormal new blood vessels to form and rupture, causing blood or mucus to leak into the macula, causing serious vision loss. says It is easy to ignore the early symptoms of dry macular degeneration because they are asymptomatic or are considered presbyopia even if symptoms are present. However, if the progression of dry macular degeneration is not suppressed or treated, vision loss may occur due to persistent retinal damage, and it may progress to wet macular degeneration and lead to blindness, so it is important to prevent dry macular degeneration in the early stages.
기존에 출시된 눈 건강 관련 제품들은 대부분 합성된 치료제들이다(특허문헌 1). 그러나, 합성 화합물의 장기간 사용은 부작용을 발생시킬 수 있으므로, 인위적으로 합성된 특정 화합물이 대신 종래에 식품으로 섭취하고 있는 천연물 유래의 눈 건강 개선 물질의 개발이 필요한 실정이다.Most of the existing eye health products on the market are synthetic treatments (Patent Document 1). However, since long-term use of synthetic compounds can cause side effects, there is a need to develop eye health improvement substances derived from natural products that are conventionally consumed as food instead of artificially synthesized specific compounds.
본 발명의 일 목적은 안질환의 예방 또는 치료용 약학 조성물을 제공하는 것이다.One object of the present invention is to provide a pharmaceutical composition for preventing or treating eye diseases.
본 발명의 다른 일 목적은 안질환의 예방 또는 개선용 건강기능식품 조성물을 제공하는 것이다.Another object of the present invention is to provide a health functional food composition for preventing or improving eye diseases.
본 발명의 또 다른 일 목적은 눈 손상 방지용 건강기능식품 조성물을 제공하는 것이다.Another object of the present invention is to provide a health functional food composition for preventing eye damage.
상기 목적을 달성하기 위하여 본 발명의 일 측면은 건지황 추출물을 유효성분으로 포함하는 안질환의 예방 또는 치료용 약학 조성물을 제공한다.In order to achieve the above object, one aspect of the present invention provides a pharmaceutical composition for preventing or treating eye diseases containing dried Rehmannia glutinosa extract as an active ingredient.
본 발명의 다른 일 측면은 건지황 추출물을 유효성분으로 포함하는 안질환의 예방 또는 개선용 건강기능식품 조성물을 제공한다.Another aspect of the present invention provides a health functional food composition for preventing or improving eye diseases containing dried Rehmannia glutinosa extract as an active ingredient.
본 발명의 또 다른 일 측면은 건지황 추출물을 유효성분으로 포함하는 눈 손상 방지용 건강기능식품 조성물을 제공한다.Another aspect of the present invention provides a health functional food composition for preventing eye damage containing dried Rehmannia glutinosa extract as an active ingredient.
본 발명의 건지황 추출물을 포함하는 조성물은 망막색소상피세포에 축적 및 산화된 A2E에 의한 망막색소상피세포의 사멸을 억제하는 활성이 매우 우수하므로, 황반변성 등의 안질환을 예방하거나 치료하기 위한 용도로 사용될 수 있다. The composition containing the dried Rehmannia glutinosa extract of the present invention has excellent activity in inhibiting the death of retinal pigment epithelial cells caused by A2E accumulated and oxidized in retinal pigment epithelial cells, and is therefore used for preventing or treating eye diseases such as macular degeneration. It can be used as
본 발명의 효과는 상기에서 언급한 효과로 제한되지 아니하며, 언급되지 않은 또 다른 효과들은 하기의 기재로부터 당업자에게 명확히 이해될 수 있을 것이다.The effects of the present invention are not limited to the effects mentioned above, and other effects not mentioned will be clearly understood by those skilled in the art from the following description.
도 1은 인간 망막색소상피세포 ARPE-19에서 청색광 처리에 의해 감소된 세포 생존율이 제조예 1 내지 5의 건지황 추출물의 처리에 의해 증가함을 보여주는 그래프이다.Figure 1 is a graph showing that the cell survival rate decreased by blue light treatment in human retinal pigment epithelial cells ARPE-19 is increased by treatment with the dried Rehmannia glutinosa extract of Preparation Examples 1 to 5.
이하, 본 발명을 상세히 설명한다.Hereinafter, the present invention will be described in detail.
본 발명의 일 측면은 건지황 추출물을 유효성분으로 포함하는 안질환의 예방 또는 치료용 약학 조성물을 제공한다.One aspect of the present invention provides a pharmaceutical composition for preventing or treating eye diseases containing dried Rehmannia glutinosa extract as an active ingredient.
본 발명에서 지황(Rehmanniae glutinosa)은 현삼과(Scrophulariaceae)에 속하는 다년생 초본으로 채약한 후 모래에 저장한 신선한 지황을 생지황(生地黃), 그 뿌리를 건조한 것을 건지황(乾地黃, Rehmanniae Radix), 건지황을 9번 쪄서 말린 것을 숙지황(Rehmanniae Radix Preparata)이라 한다. 본 발명의 건지황은 본 기술분야에서 자명하고 본 발명의 예방, 개선 및 치료 목적과 동일 또는 유사한 용도로 사용할 수 있는 동속생약을 포함한다.In the present invention, Rehmanniae glutinosa is a perennial herb belonging to the Scrophulariaceae family. Fresh Rehmannia glutinosa harvested and stored in sand is called fresh Rehmannia glutinosa, and its dried roots are called dried Rehmanniae Radix. Dry Rehmanniae that has been steamed and dried nine times is called Rehmanniae Radix Preparata. The dried Rehmannia glutinosa of the present invention is known in the art and includes herbal medicines that can be used for the same or similar purposes as the prevention, improvement, and treatment purposes of the present invention.
상기 "추출물"은 상기 건지황의 추출처리에 의하여 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. 예를 들어, 본 발명의 상기 추출물은 추출 후 건조 분말 형태로 제조되어 사용될 수 있다.The "extract" refers to the extract itself and the extract, such as the extract obtained by the extraction treatment of the dried dried sulfur, a diluted or concentrated liquid of the extract, a dried product obtained by drying the extract, a crude product or purified product of the extract, or a mixture thereof. It includes extracts of all formulations that can be formed using. For example, the extract of the present invention can be prepared and used in the form of a dry powder after extraction.
상기 건지황 추출물을 추출하는 방법은 특별히 제한되지 아니하며, 본 기술분야에서 통상적으로 사용하는 방법에 따라 추출할 수 있다. 상기 추출 방법의 비제한적인 예로는, 열수 추출법, 초음파 추출법, 여과법, 환류 추출법 등일 수 있고, 이들은 단독으로 수행되거나 2종 이상의 방법을 병용하여 수행될 수 있다.The method for extracting the dried Rehmannia glutinosa extract is not particularly limited, and can be extracted according to a method commonly used in the art. Non-limiting examples of the extraction method may include hot water extraction, ultrasonic extraction, filtration, and reflux extraction, and these may be performed alone or by combining two or more methods.
상기 건지황 추출물을 추출하는 데 사용되는 추출 용매의 종류는 특별히 제한되지 아니하며, 본 기술분야에서 공지된 임의의 용매를 사용할 수 있다. 상기 추출 용매의 비제한적인 예로는 물, 메탄올, 에탄올, 프로필알코올, 부틸알코올 등의 C1~C4의 저급 알코올; 글리세린, 부틸렌글리콜, 프로필렌글리콜 등의 다가 알코올; 및 메틸아세테이트, 에틸아세테이트, 아세톤, 벤젠, 헥산, 디에틸에테르, 디클로로메탄 등의 탄화수소계 용매; 또는 이들의 혼합물을 사용할 수 있다. 예를 들어, 본 발명의 상기 건지황 추출물은 건지황의 뿌리를 물, C1~C4의 저급 알코올 또는 이들의 혼합용매로 추출할 수 있다.The type of extraction solvent used to extract the dried Rehmannia glutinosa extract is not particularly limited, and any solvent known in the art can be used. Non-limiting examples of the extraction solvent include lower C 1 to C 4 alcohols such as water, methanol, ethanol, propyl alcohol, and butyl alcohol; Polyhydric alcohols such as glycerin, butylene glycol, and propylene glycol; and hydrocarbon solvents such as methyl acetate, ethyl acetate, acetone, benzene, hexane, diethyl ether, and dichloromethane; Or a mixture thereof can be used. For example, the dried Rehmannia glutinosa extract of the present invention can be obtained by extracting the dried Rehmannia glutinosa roots with water, C 1 -C 4 lower alcohol, or a mixed solvent thereof.
본 발명에서 "안질환"은 미숙아 망막병증(retinopathy of prematurity), 망막 변성(retinal degeneration), 황반변성(macular degeneration), 고혈압성 망막 질환(hypertensive retinopathy), 망막색소변성(retinitis pigmentosa), 스타가트병(Stargardt disease), 맥락막 결손(choroideremia), 맥락망막 위축(gyrate-atrophy), 망막박리(retinal detachment), 안구건조증(dry eye syndrome), 녹내장(glaucoma) 및 시신경병증(optic neuropathy)으로 이루어진 군에서 선택되는 것일 수 있다. In the present invention, “eye disease” refers to retinopathy of prematurity, retinal degeneration, macular degeneration, hypertensive retinopathy, retinitis pigmentosa, Stargart, etc. A group consisting of Stargardt disease, choroideremia, gyrate-atrophy, retinal detachment, dry eye syndrome, glaucoma, and optic neuropathy. It may be selected from .
상기 안질환은 청색광(blue light)에 의해 유발되는 것일 수 있고, 구체적으로 청색광에 의한 A2E의 광산화 및 드루젠의 축적에 의한 것일 수 있다. The eye disease may be caused by blue light, and specifically may be caused by photo-oxidation of A2E and accumulation of drusen by blue light.
본 발명에서 황반변성(macular degeneration: MD)은 황반의 손상에 의해 중심 시력이 파괴되는 현상을 의미하며, 황반변성 질환은 건성 황반변성, 습성 황반변성, 연령관련 황반변성, 근시성 황반변성 및 특발성 황반변성 등을 포함할 수 있고, 구체적으로 노인성 황반변성(age related macular degeneration: AMD)일 수 있다.In the present invention, macular degeneration (MD) refers to a phenomenon in which central vision is destroyed due to damage to the macula, and macular degeneration diseases include dry macular degeneration, wet macular degeneration, age-related macular degeneration, myopic macular degeneration, and idiopathic macular degeneration. It may include macular degeneration, etc., and specifically may be age related macular degeneration (AMD).
노인성 황반변성에 대한 정확한 병인은 아직 확실하게 알 수 없지만, 일반적으로 노화에 따른 망막색소상피세포에 과도한 색소물질의 축적이 노인성 황반변성의 초기 진행 단계에 나타나는 것으로 알려져 있으며, 올 트랜스 레티날(all-trans-retinal)과 에탄올아민(ethanolamine)의 합성에 의해 생성되는 A2E는 대표적으로 망막상피세포에 축적되는 물질로 청색광에 의해 1중항산소(singlet oxygen)를 생성하고, 탄소간 이중결합부위가 산화되면서 망막색소상피세포에 손상을 일으킬 수 있다.Although the exact etiology of age-related macular degeneration is not yet known, it is generally known that excessive accumulation of pigments in retinal pigment epithelial cells due to aging occurs in the early stages of age-related macular degeneration, and all-trans retinal (all-trans retinal) A2E, produced by the synthesis of -retinal and ethanolamine, is a substance that typically accumulates in retinal epithelial cells. It generates singlet oxygen by blue light, and the double bond between carbons is oxidized, causing damage to the retina. It may cause damage to pigmented epithelial cells.
상기 안구건조증은 눈물막의 불안정성과 고삼투압, 안구표면의 염증과 손상, 신경학적 이상 등의 원인으로 눈물의 항상성이 유지되지 않아 다양한 증상을 보이는 다인성 질환을 의미한다. 본 발명에서 안구 건조증은 무루증, 각막건조증, 쇼그렌 증후군, 건조 각막결막염, 스티븐-존슨 증후군, 눈 유사물집증, 안과 수술 후 안구건조증, 알레르기성 결막염 수반 안구건조증, 영상 단말기(Visual Display Terminal, VDT) 노동자의 눈물 감소 및 건조한 환경 및 콘택트 렌즈 착용으로 이루어진 군으로부터 선택되는 하나 이상에 의해 야기된 것일 수 있다.The dry eye syndrome refers to a multifactorial disease that exhibits various symptoms due to tear film instability, hyperosmolarity, inflammation and damage to the ocular surface, neurological abnormalities, etc. due to tear homeostasis not being maintained. In the present invention, dry eye syndrome includes anuria, dry cornea, Sjögren's syndrome, keratoconjunctivitis sicca, Stevens-Johnson syndrome, eye pseudoblister, dry eye syndrome after ophthalmic surgery, dry eye syndrome with allergic conjunctivitis, and visual display terminal (VDT). ) may be caused by one or more factors selected from the group consisting of reduced tearing by workers and dry environments and wearing contact lenses.
상기 건지황 추출물은 상기 안질환의 예방 또는 치료용 약학 조성물의 총 중량에 대하여 0.005 내지 20.0 중량%, 또는 0.01 내지 10.0 중량%, 또는 0.01 내지 5 중량%, 또는 0.01 내지 3 중량%, 또는 0.1 내지 2 중량%, 또는 0.5 내지 1.5 중량%의 함량으로 함유될 수 있으나 이에 한정되지 않는다. 상기 건지황 추출물의 유효 함량이 0.005 중량% 미만일 경우에는 안질환의 예방 또는 치료 효과가 낮아지고, 20 중량%를 초과할 경우에는 함유량 증가에 따른 뚜렷한 효능 상승 효과가 떨어져 비경제적일 수 있다. The dried Rehmannia glutinosa extract is used in an amount of 0.005 to 20.0% by weight, or 0.01 to 10.0% by weight, or 0.01 to 5% by weight, or 0.01 to 3% by weight, or 0.1 to 2% by weight, based on the total weight of the pharmaceutical composition for preventing or treating eye diseases. It may be contained in weight%, or in an amount of 0.5 to 1.5 weight%, but is not limited thereto. If the effective content of the dried Rehmannia glutinosa extract is less than 0.005% by weight, the effectiveness of preventing or treating eye diseases is lowered, and if it exceeds 20% by weight, the effect of increasing the effective efficacy due to the increase in content decreases and may be uneconomical.
본 발명에서 안질환의 예방 또는 치료는 청색광에 의한 A2E의 산화를 억제하거나, 청색광에 의해 산화된 A2E에 의한 세포 사멸을 억제함으로써 달성할 수 있다. In the present invention, prevention or treatment of eye diseases can be achieved by inhibiting the oxidation of A2E by blue light or by inhibiting cell death caused by A2E oxidized by blue light.
본 발명의 구체적인 실시예에서는 상기 건지황 추출물이 산화된 A2E에 의한 세포 손상을 방지하는 효과를 확인하기 위하여, 망막색소상피세포에 청색광과 함께 건지황 추출물을 처리하여 세포 생존율을 확인한 결과, 청색광에 의해 감소된 세포 생존율이 건지황 추출물의 처리에 의해 뚜렷하게 증가하는 것을 확인하였다.In a specific embodiment of the present invention, in order to confirm the effect of the dried Rehmannia glutinosa extract on preventing cell damage caused by oxidized A2E, retinal pigment epithelial cells were treated with the dried Rehmannia glutinosa extract along with blue light and the cell survival rate was confirmed, which was found to be reduced by blue light. It was confirmed that the cell survival rate was significantly increased by treatment with dried Rehmannia glutinosa extract.
따라서, 상기 건지황 추출물은 A2E 산화에 의한 망막색소상피세포의 손상을 방지하는 활성을 가짐이 분명하므로, 상기 건지황 추출물을 황반변성을 비롯한 안질환의 예방 또는 치료용 조성물의 유효성분으로 유용하게 사용할 수 있다.Therefore, since it is clear that the dried Rehmannia glutinosa extract has the activity of preventing damage to retinal pigment epithelial cells due to A2E oxidation, the dried Rehmannia glutinosa extract can be usefully used as an active ingredient in a composition for preventing or treating eye diseases including macular degeneration. there is.
또한, 본 발명의 약학 조성물은 상기 건지황 추출물 외에 본 발명이 목적으로 하는 효과를 손상시키지 않는 범위 내에서, 바람직하게는 상기 건지황 추출물의 효과에 상승 효과를 줄 수 있는 다른 성분 등을 추가로 함유할 수 있다. 예를 들어 항산화제, 안정화제, 용해화제, 비타민, 안료 및 향료와 같은 통상적인 보조제, 또는 약학적으로 허용되는 담체를 포함할 수 있다.In addition, the pharmaceutical composition of the present invention may further contain, in addition to the dried Rehmannia glutinosa extract, other ingredients that can have a synergistic effect on the effect of the dried Rehmannia glutinosa extract within a range that does not impair the effect aimed at by the present invention. You can. For example, it may include conventional auxiliaries such as antioxidants, stabilizers, solubilizers, vitamins, pigments and flavors, or pharmaceutically acceptable carriers.
상기 약학적으로 허용되는 담체는 제제 시에 통상적으로 이용되는 것으로서, 락토스, 덱스트로스, 수크로스, 솔비톨, 만니톨, 전분, 아카시아 고무, 인산 칼슘, 알기네이트, 젤라틴, 규산 칼슘, 미세결정성 셀룰로스, 폴리비닐피롤리돈, 셀룰로스, 물, 시럽, 메틸 셀룰로스, 메틸히드록시벤조에이트, 프로필히드록시벤조에이트, 활석, 스테아르산 마그네슘 및 미네랄 오일 등을 포함하나, 이에 한정되는 것은 아니다. 적합한 약학적으로 허용되는 담체 및 제제는 Remington's Pharmaceutical Sciences (19th ed., 1995)에 상세히 기재되어 있다.The pharmaceutically acceptable carriers are commonly used in formulations and include lactose, dextrose, sucrose, sorbitol, mannitol, starch, gum acacia, calcium phosphate, alginate, gelatin, calcium silicate, microcrystalline cellulose, Includes, but is not limited to, polyvinylpyrrolidone, cellulose, water, syrup, methyl cellulose, methylhydroxybenzoate, propylhydroxybenzoate, talc, magnesium stearate, and mineral oil. Suitable pharmaceutically acceptable carriers and formulations are described in detail in Remington's Pharmaceutical Sciences (19th ed., 1995).
상기 약학 조성물의 투여 경로는 구강, 정맥내, 근육내, 동맥내, 경피, 피하, 복강내, 비강내, 장관, 국소, 설하 또는 직장이 포함되고, 예컨대 도포에 의한 국부투여(topical application) 방식으로 적용될 수 있다. 상기 비경구는 피하, 피내, 정맥내, 근육내, 병소내 주사 또는 주입기술을 포함한다. The route of administration of the pharmaceutical composition includes oral, intravenous, intramuscular, intraarterial, transdermal, subcutaneous, intraperitoneal, intranasal, enteral, topical, sublingual or rectal routes, such as topical application. It can be applied as. The parenteral includes subcutaneous, intradermal, intravenous, intramuscular, and intralesional injection or infusion techniques.
본 발명의 약학 조성물은 약학적으로 유효한 양으로 투여할 수 있다.The pharmaceutical composition of the present invention can be administered in a pharmaceutically effective amount.
본 발명에서 "약학적으로 유효한 양"은 의학적 치료에 적용 가능한 합리적인 수혜/위험 비율로 질환을 치료하기에 충분한 양을 의미하며, 유효 용량 수준은 개체 종류 및 중증도, 연령, 성별, 질병의 종류, 약물의 활성, 약물에 대한 민감도, 투여 시간, 투여 경로 및 배출 비율, 치료 기간, 동시 사용되는 약물을 포함한 요소 및 기타 의학 분야에 잘 알려진 요소에 따라 결정될 수 있다. 본 발명의 조성물은 개별 치료제로 투여하거나 다른 치료제와 병용하여 투여될 수 있고 종래의 치료제와는 순차적 또는 동시에 투여될 수 있다. 그리고 단일 또는 다중 투여될 수 있다. 상기 요소를 모두 고려하여 부작용없이 최소한의 양으로 최대 효과를 얻을 수 있는 양을 투여하는 것이 중요하며, 본 기술분야의 통상의 기술자에 의해 용이하게 결정될 수 있다.In the present invention, “pharmaceutically effective amount” means an amount sufficient to treat a disease with a reasonable benefit/risk ratio applicable to medical treatment, and the effective dose level is determined by the type and severity of the individual, age, gender, type of disease, It can be determined based on factors including the activity of the drug, sensitivity to the drug, time of administration, route of administration and excretion rate, duration of treatment, drugs used simultaneously, and other factors well known in the medical field. The composition of the present invention may be administered as an individual therapeutic agent or in combination with other therapeutic agents, and may be administered sequentially or simultaneously with conventional therapeutic agents. And it can be administered single or multiple times. Considering all of the above factors, it is important to administer an amount that can achieve the maximum effect with the minimum amount without side effects, and can be easily determined by a person skilled in the art.
본 발명의 약학 조성물은 안질환의 예방 또는 치료를 목적으로 하는 개체이면 특별히 한정되지 않고, 어떠한 것이든 적용가능하다. 예를 들면, 본 발명의 약학 조성물은 인간뿐만 아니라 원숭이, 개, 고양이, 토끼, 모르모트, 랫트, 마우스, 소, 양, 돼지, 염소 등과 같은 인간이 아닌 동물, 조류 및 어류 등 어느 것에 사용가능하다.The pharmaceutical composition of the present invention is not particularly limited and can be applied to any subject as long as it is intended for the prevention or treatment of eye disease. For example, the pharmaceutical composition of the present invention can be used not only on humans, but also on non-human animals such as monkeys, dogs, cats, rabbits, guinea pigs, rats, mice, cows, sheep, pigs, goats, birds, and fish. .
상기 약학 조성물은 상기 건지황 추출물에 추가로 동일 또는 유사한 기능을 나타내는 유효성분을 1종 이상 함유할 수 있다. 상기 조성물은 각각 통상의 방법에 따라 산제, 과립제, 정제, 캡슐제, 현탁액, 에멀젼, 시럽 등의 경구형 제형, 외용제, 좌제 및 멸균 주사용액의 형태로 제형화하여 사용될 수 있다.The pharmaceutical composition may contain one or more active ingredients that exhibit the same or similar functions in addition to the dried Rehmannia glutinosa extract. The composition can be formulated and used in the form of oral dosage forms such as powders, granules, tablets, capsules, suspensions, emulsions, syrups, external preparations, suppositories, and sterile injection solutions according to conventional methods.
경구 투여를 위한 고형 제제에는 산제, 과립제, 정제, 캡슐제, 연질 캅셀제, 환 등이 포함된다. 경구투여를 위한 액상 제제로는 현탁제, 내용액제, 유제, 시럽제 등이 해당되는데 흔히 사용되는 단순 희석제인 물, 리퀴드 파라핀 이외에 여러 가지 부형제, 예를 들면 습윤제, 감미제, 방향제, 보존제 등이 포함될 수 있다. Solid preparations for oral administration include powders, granules, tablets, capsules, soft capsules, pills, etc. Liquid preparations for oral administration include suspensions, oral solutions, emulsions, and syrups. In addition to the commonly used simple diluents such as water and liquid paraffin, various excipients such as wetting agents, sweeteners, fragrances, and preservatives may be included. there is.
비경구 투여를 위한 제제로는 각각 통상의 방법에 따라 산제, 과립제, 정제, 캡슐제, 멸균된 수용액, 액제, 비수성용제, 현탁제, 에멀젼, 시럽, 좌제, 에어로졸 등의 외용제 및 멸균 주사제제의 형태로 제형화하여 사용될 수 있으며, 바람직하게는 크림, 젤, 패취, 분무제, 연고제, 경고제, 로션제, 리니멘트제, 파스타제 또는 카타플라스마제의 피부 외용 약학 조성물을 제조하여 사용할 수 있으나, 이에 한정하는 것은 아니다. 비수성용제, 현탁제로는 프로필렌글리콜, 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.Preparations for parenteral administration include external preparations such as powders, granules, tablets, capsules, sterilized aqueous solutions, solutions, non-aqueous solvents, suspensions, emulsions, syrups, suppositories, and aerosols, and sterilized injection preparations according to conventional methods. It can be formulated and used in the form of a cream, gel, patch, spray, ointment, warning agent, lotion, liniment agent, pasta agent or cataplasma agent. It can be prepared and used as a pharmaceutical composition for external use on the skin. It is not limited to this. Non-aqueous solvents and suspensions include propylene glycol, polyethylene glycol, vegetable oil such as olive oil, and injectable ester such as ethyl oleate. As a base for suppositories, witepsol, macrogol, tween 61, cacao, laurin, glycerogenatin, etc. can be used.
상기 약학 조성물은 또한, 점안액 및 안 연고와 같은 안과용 조성물로서 제형화될 수 있다. 상기 형태는 안과 분야에서 사용되는 안구 국소 투여용의 모든 안과용 제제를 포함할 수 있다. 점안액은 활성 성분을 식염수 및 완충액과 같은 멸균 수용액에 용해시킴으로써 제조된다. 점안액은 사용 전에 용해되도록 분말 조성물로서 제공될 수 있거나, 또는 사용 전에 용해되도록 분말 조성물과 배합함으로써 제공될 수 있다. 안 연고는 활성 성분을 연고 기제에 혼합함으로써 제조될 수 있다.The pharmaceutical compositions can also be formulated as ophthalmic compositions such as eye drops and eye ointments. This form may include all ophthalmic preparations for topical ocular administration used in the field of ophthalmology. Eye drops are prepared by dissolving the active ingredients in sterile aqueous solutions such as saline and buffer solutions. Eye drops may be provided as a powder composition to be dissolved prior to use, or may be provided by combining them with a powder composition to be dissolved prior to use. Ophthalmic ointments can be prepared by mixing the active ingredients into an ointment base.
상기 약학 조성물의 투여량은 개체의 연령, 체중, 일반적인 건강, 성별, 투여시간, 투여 경로, 배출률, 약물 배합 및 특정 질환의 중증을 포함한 여러 요인에 따라 다양하게 변할 수 있다.The dosage of the pharmaceutical composition may vary depending on various factors, including the subject's age, weight, general health, gender, administration time, administration route, excretion rate, drug combination, and severity of a specific disease.
또한, 본 발명의 약학 조성물은 단독으로, 또는 수술, 방사선 치료, 호르몬 치료, 화학 치료 및 생물학적 반응 조절제를 사용하는 방법들과 병용하여 사용할 수 있다. 또한 상기 약학 조성물은 성인 기준으로 0.001 내지 200 ㎎/㎏ 범위 내의 투여량으로 투여될 수 있고, 상기 약학 조성물이 외용제인 경우에는 성인기준으로 1.0 내지 3.0㎖의 양으로 1일 1회 내지 5회 도포하여 1개월 이상 계속하는 것이 좋으나, 상기 투여량은 본 발명의 범위를 한정하는 것이 아니다.Additionally, the pharmaceutical composition of the present invention can be used alone or in combination with surgery, radiation therapy, hormone therapy, chemical therapy, and methods using biological response regulators. In addition, the pharmaceutical composition can be administered in a dosage range of 0.001 to 200 mg/kg for adults, and when the pharmaceutical composition is an external preparation, it is applied 1 to 5 times a day in an amount of 1.0 to 3.0 ml for adults. Therefore, it is recommended to continue for more than 1 month, but the above dosage does not limit the scope of the present invention.
상기 약학 조성물을 단위 용량 형태로 제형화하는 경우, 유효성분으로서 본 발명의 건지황 추출물은 약 0.01 내지 1,500㎎의 단위 용량으로 함유되는 것이 바람직하고, 성인 치료에 필요한 투여량은 투여의 빈도와 강도에 따라 하루에 약 1 내지 500㎎ 범위가 보통이나 이에 한정되는 것은 아니며, 일부 환자의 경우 더 높은 1일 투여량이 바람직할 수 있다.When formulating the pharmaceutical composition in unit dosage form, the dried Rehmannia glutinosa extract of the present invention as an active ingredient is preferably contained in a unit dose of about 0.01 to 1,500 mg, and the dosage required for adult treatment depends on the frequency and intensity of administration. Accordingly, the range is usually about 1 to 500 mg per day, but it is not limited to this, and for some patients, a higher daily dose may be desirable.
상기 약학 조성물은 단독으로, 또는 수술, 방사선 치료, 호르몬 치료, 화학 치료 및 생물학적 반응 조절제를 사용하는 방법들과 병용하여 사용할 수 있다.The pharmaceutical composition can be used alone or in combination with surgery, radiation therapy, hormone therapy, chemotherapy, and methods using biological response regulators.
본 발명의 다른 일 측면은 건지황 추출물을 유효성분으로 포함하는 안질환의 예방 또는 개선용 건강기능식품을 제공한다.Another aspect of the present invention provides a health functional food for preventing or improving eye disease containing dried Rehmannia glutinosa extract as an active ingredient.
본 발명의 또 다른 일 측면은, 건지황 추출물을 유효성분으로 포함하는 눈 손상 방지용 건강기능식품 조성물을 제공한다.Another aspect of the present invention provides a health functional food composition for preventing eye damage containing dried Rehmannia glutinosa extract as an active ingredient.
상기 건지황, 추출물, 안질환은 전술한 바와 같다.The dried rehmannia glutinosa, extract, and eye disease are as described above.
상기 건지황은 천연 물질로서 오랫동안 사용되어 인체에 안전한 물질임이 입증되었으므로, 상식할 수 있으면서도 안질환 또는 눈 손상의 예방 또는 개선을 도모할 수 있는 식품의 형태로 제조되어 섭취할 수 있다.Since the dried rehmannia glutinosa has been used as a natural substance for a long time and has been proven to be safe for the human body, it can be manufactured and consumed in the form of a food that is common sense and can prevent or improve eye disease or eye damage.
본 발명에서 "눈 손상"은 청색광에 의해 유발되는 것일 수 있고, 구체적으로 청색광에 의한 A2E의 광산화 및 드루젠의 축적에 의한 눈 손상을 의미할 수 있다. 더 구체적으로, 눈 손상은 눈의 산화적 손상, 눈의 노화, 눈의 피로, 눈의 기능 저하 또는 안질환에 의해 발생되는 눈 손상을 의미할 수 있으나, 이에 제한되지 않는다.In the present invention, “eye damage” may be caused by blue light, and may specifically mean eye damage caused by photo-oxidation of A2E and accumulation of drusen by blue light. More specifically, eye damage may mean, but is not limited to, eye damage caused by oxidative damage to the eye, eye aging, eye fatigue, decreased eye function, or eye disease.
상기 "예방"은 상기 건강기능식품의 섭취에 의해 안질환 또는 눈 손상을 억제 또는 지연시키는 모든 행위를 의미한다.The “prevention” refers to all actions that suppress or delay eye disease or eye damage by consuming the health functional food.
상기 "개선"은 상기 건강기능식품의 섭취로 치료되는 상태와 관련된 파라미터, 예를 들면 증상의 정도를 감소시키는 모든 행위를 의미한다.The “improvement” refers to any action that reduces parameters, such as the severity of symptoms, related to the condition being treated by ingestion of the health functional food.
상기 건지황 추출물은 상기 건강기능식품 조성물의 총 중량에 대하여 0.005 내지 20.0 중량%, 또는 0.01 내지 10.0 중량%, 또는 0.01 내지 5 중량%, 또는 0.01 내지 3 중량%, 또는 0.1 내지 2 중량%, 또는 0.5 내지 1.5 중량%의 함량으로 함유될 수 있으나 이에 한정되지 않는다. 상기 건지황 추출물의 유효 함량이 0.005 중량% 미만일 경우에는 안질환이나 눈 손상의 예방 또는 개선 효과가 낮아지고, 20 중량%를 초과할 경우에는 함유량 증가에 따른 뚜렷한 효능 상승 효과가 떨어져 비경제적일 수 있다. The dried Rehmannia glutinosa extract is used in an amount of 0.005 to 20.0% by weight, or 0.01 to 10.0% by weight, or 0.01 to 5% by weight, or 0.01 to 3% by weight, or 0.1 to 2% by weight, or 0.5% by weight, based on the total weight of the health functional food composition. It may be contained in an amount of from 1.5% by weight, but is not limited thereto. If the effective content of the dried rehmannia extract is less than 0.005% by weight, the effect of preventing or improving eye disease or eye damage is lowered, and if it exceeds 20% by weight, the effect of increasing the effective efficacy due to the increase in content decreases, making it uneconomical. .
건강기능식품이란 인체에 유용한 기능성을 가진 원료나 성분을 사용하여 정제, 캅셀, 분말, 과립, 액상 및 환 등의 형태로 제조 및 가공한 식품을 의미한다. 여기서 기능성이라 함은 인체의 구조 및 기능에 대하여 영양소를 조절하거나 생리학적 작용 등과 같은 보건용도에 유용한 효과를 얻는 것을 의미한다. Health functional foods refer to foods manufactured and processed in the form of tablets, capsules, powders, granules, liquids, and pills using raw materials or ingredients with functional properties useful to the human body. Here, functionality means obtaining useful effects for health purposes, such as controlling nutrients or physiological effects on the structure and function of the human body.
본 발명의 건강기능식품 조성물은 본 발명의 건지황 추출물 외에 본 발명이 목적으로 하는 효과를 손상시키지 않는 범위 내에서, 바람직하게는 상기 건지황 추출물의 효과에 상승 효과를 줄 수 있는 다른 성분 등을 추가로 함유할 수 있다. 예를 들어 안정화제, 용해화제, 비타민, 안료 및 향료와 같은 통상적인 보조제, 또는 담체를 포함할 수 있다.The health functional food composition of the present invention, in addition to the dried Rehmannia glutinosa extract of the present invention, preferably contains other ingredients that can have a synergistic effect on the effect of the dried Rehmannia glutinosa extract within a range that does not impair the effect aimed at by the present invention. It may contain. For example, it may include conventional auxiliaries such as stabilizers, solubilizers, vitamins, pigments and flavors, or carriers.
또한 건강기능식품 조성물 제조시 통상적으로 첨가되는 성분을 포함할 수 있으며, 예를 들어, 단백질, 탄수화물, 지방, 영양소, 조미제 및 향미제를 포함한다. 상기 탄수화물의 예는 모노사카라이드, 예를 들어, 포도당, 과당 등; 디사카라이드, 예를 들어 말토스, 슈크로스, 올리고당 등; 및 폴리사카라이드, 예를 들어 덱스트린, 사이클로덱스트린 등과 같은 통상적인 당 및 자일리톨, 소르비톨, 에리트리톨 등의 당알콜이다. 상기 향미제로는 천연 향미제 타우마틴, 스테비아 추출물 및 합성 향미제를 사용할 수 있다. 예컨대, 본 발명의 건강기능식품 조성물이 드링크제로 제조되는 경우에는 본 발명의 건지황 추출물 이외에 구연산, 액상과당, 설탕, 포도당, 초산, 사과산, 과즙, 천연 추출액 등이 추가로 포함될 수 있다.It may also contain ingredients commonly added when manufacturing a health functional food composition, including, for example, proteins, carbohydrates, fats, nutrients, seasonings, and flavoring agents. Examples of such carbohydrates include monosaccharides such as glucose, fructose, etc.; Disaccharides such as maltose, sucrose, oligosaccharides, etc.; and polysaccharides, such as common sugars such as dextrin and cyclodextrin, and sugar alcohols such as xylitol, sorbitol, and erythritol. As the flavoring agent, natural flavoring agent thaumatin, stevia extract, and synthetic flavoring agent may be used. For example, when the health functional food composition of the present invention is manufactured as a drink, citric acid, high fructose corn syrup, sugar, glucose, acetic acid, malic acid, fruit juice, natural extract, etc. may be additionally included in addition to the dried rehmannia glutinosa extract of the present invention.
본 발명의 건지황 추출물을 첨가할 수 있는 건강기능식품은 특별히 제한되지 않으나, 예를 들어 육류, 소세지, 빵, 쵸코렛, 캔디류, 스넥류, 과자류, 피자, 라면, 기타 면류, 껌류, 아이스크림류를 포함한 낙농제품, 각종 스프, 음료수, 차, 드링크제, 알콜 음료 및 비타민 복합제 등이 있으며, 통상적인 의미에서의 식품을 모두 포함한다.Health functional foods to which the dried Rehmannia glutinosa extract of the present invention can be added are not particularly limited, but for example, dairy products including meat, sausages, bread, chocolate, candy, snacks, confectionery, pizza, ramen, other noodles, gum, and ice cream. It includes products, various soups, beverages, tea, drinks, alcoholic beverages, and vitamin complexes, and includes all foods in the conventional sense.
상기 건강기능식품 조성물은 안질환이나 눈 손상의 예방 또는 개선을 목적으로, 정제, 캅셀, 분말, 과립, 액상, 환 등의 형태로 제조 및 가공할 수 있다.The health functional food composition can be manufactured and processed in the form of tablets, capsules, powders, granules, liquids, pills, etc. for the purpose of preventing or improving eye diseases or eye damage.
예를 들어, 정제 형태의 건강기능식품은 상기 건강기능식품 조성물을 부형제, 결합제, 붕해제 및 다른 첨가제와 혼합한 혼합물을 통상의 방법으로 과립화한 다음, 활택제 등을 넣어 압축성형하거나, 상기 혼합물을 직접 압축 성형할 수 있다. 또한 상기 정제 형태의 건강기능식품은 필요에 따라 교미제 등을 함유할 수도 있다.For example, health functional food in the form of tablets is made by granulating a mixture of the health functional food composition with excipients, binders, disintegrants, and other additives in a conventional manner, adding a lubricant, etc., and compression molding, or The mixture can be directly compression molded. In addition, the health functional food in the form of tablets may contain flavoring agents, etc., if necessary.
캅셀 형태의 건강기능식품 중 경질 캅셀제는 통상의 경질 캅셀에 상기 건강기능식품 조성물을 부형제 등의 첨가제와 혼합한 혼합물을 충진하여 제조할 수 있으며, 연질 캅셀제는 상기 건강기능식품 조성물을 부형제 등의 첨가제와 혼합한 혼합물을 젤라틴과 같은 캅셀기제에 충진하여 제조할 수 있다. 상기 연질 캅셀제는 필요에 따라 글리세린 또는 소르비톨 등의 가소제, 착색제, 보존제 등을 함유할 수 있다.Among capsule-type health functional foods, hard capsules can be manufactured by filling a regular hard capsule with a mixture of the health functional food composition mixed with additives such as excipients, and soft capsules can be manufactured by mixing the health functional food composition with additives such as excipients. It can be manufactured by filling the mixture with a capsule base such as gelatin. The soft capsule may contain plasticizers such as glycerin or sorbitol, colorants, preservatives, etc., if necessary.
환 형태의 건강기능식품은 상기 건강기능식품 조성물과 부형제, 결합제, 붕해제 등을 혼합한 혼합물을 기존에 공지된 방법으로 성형하여 조제할 수 있으며, 필요에 따라 백당이나 다른 제피제로 제피할 수 있으며, 또는 전분, 탈크와 같은 물질로 표면을 코팅할 수도 있다.The health functional food in the form of a pill can be prepared by molding a mixture of the health functional food composition and excipients, binders, disintegrants, etc. using a known method. If necessary, it can be coated with white sugar or other coating agents. , or the surface can be coated with substances such as starch or talc.
과립 형태의 건강기능식품은 상기 건강기능식품 조성물과 부형제, 결합제, 붕해제 등을 혼합한 혼합물을 기존에 공지된 방법으로 입상으로 제조할 수 있으며, 필요에 따라 착향제, 교미제 등을 함유할 수 있다. Health functional food in the form of granules can be manufactured into granules by mixing the above-mentioned health functional food composition with excipients, binders, disintegrants, etc., using a known method. If necessary, it may contain flavoring agents, flavoring agents, etc. You can.
이하, 본 발명을 제조예 및 실시예에 의해 상세히 설명한다.Hereinafter, the present invention will be described in detail through preparation examples and examples.
단, 하기 제조예, 실험예, 실시예는 본 발명을 예시하기 위한 것일 뿐, 본 발명의 내용이 하기 제조예 및 실시예에 의해 한정되는 것은 아니다.However, the following preparation examples, experimental examples, and examples are only for illustrating the present invention, and the content of the present invention is not limited by the following preparation examples and examples.
실시예Example
제조예 1 - 건지황 추출물의 제조Preparation Example 1 - Preparation of dried Rehmannia glutinosa extract
건지황 1㎏에 중량 대비 10배수의 증류수를 가하고, 60℃에서 4시간 1-3회 추출하고, 각 추출에서 얻어진 추출물들을 혼합한 추출액을 5㎛ 필터를 이용하여 여과하였다. 여액은 회전감압농축기(BUCHI, R-220)를 이용하여 55℃에서 감압농축였다. 농축액에 멸균된 증류수를 가해 20 brix가 되도록 희석한 후 동결건조하여 분말화된 건지황 추출물 620g을 수득하였다.10 times the weight of distilled water was added to 1 kg of dried rehmannia glutinosa, extracted 1-3 times at 60°C for 4 hours, and the extract mixed with the extracts obtained from each extraction was filtered using a 5㎛ filter. The filtrate was concentrated under reduced pressure at 55°C using a rotary vacuum concentrator (BUCHI, R-220). The concentrate was diluted to 20 brix by adding sterilized distilled water and then freeze-dried to obtain 620 g of powdered dried Rehmannia glutinosa extract.
제조예 2 내지 5Preparation Examples 2 to 5
추출용매로서 증류수 대신에 각각 30%(v/v) 에탄올 수용액, 50%(v/v) 에탄올 수용액, 70%(v/v) 에탄올 수용액, 100% 에탄올을 사용한 것을 제외하고는 제조예 1과 동일한 방법에 의해 건지황 추출물을 제조하였다. Preparation Example 1, except that 30% (v/v) ethanol aqueous solution, 50% (v/v) ethanol aqueous solution, 70% (v/v) ethanol aqueous solution, and 100% ethanol were used as extraction solvents instead of distilled water, respectively. Dried Rehmannia glutinosa extract was prepared by the same method.
실험예 1 - 건지황 추출물의 청색광 유도 광산화에 대한 망막색소상피세포 보호 효과Experimental Example 1 - Protective effect of dried Rehmannia glutinosa extract on retinal pigment epithelial cells against blue light-induced photo-oxidation
망막색소상피세포에 축적된 A2E는 황반변성의 원인물질로 망막색소상피세포에 침착하며 청색광 조사 시 광산화가 일어나 세포독성을 유발하는 것으로 알려져 있다. 건지황 추출물이 청색광에 의해 유도되는 세포독성 및 세포사멸을 억제할 수 있는지 확인하였다.A2E accumulated in retinal pigment epithelial cells is a causative agent of macular degeneration and is known to deposit in retinal pigment epithelial cells and cause cytotoxicity due to photo-oxidation when irradiated with blue light. It was confirmed whether dried Rehmannia glutinosa extract can inhibit cytotoxicity and cell death induced by blue light.
구체적으로, ARPE-19 세포에 상기 제조예 1 내지 5에서 수득한 건지황 추출물 50 ㎍/㎖를 각각 24시간 동안 처리한 다음, A2E 20μM을 24시간 동안 처리하고, 청색광을 10분 동안 조사하였다. 이후, ARPE-19 세포의 세포 생존율을 셀 카운팅 키트(cell counting kit, Dojindo Labs, 일본)로 측정하였으며, A2E를 축적시키고, 청색광을 조사하지 않은 대조군에 대한 각 처리군의 세포 생존율을 백분율(%)로 나타냈다(도 1).Specifically, ARPE-19 cells were treated with 50 μg/ml of the dried Rehmannia glutinosa extract obtained in Preparation Examples 1 to 5 for 24 hours each, then treated with 20 μM A2E for 24 hours, and irradiated with blue light for 10 minutes. Afterwards, the cell survival rate of ARPE-19 cells was measured using a cell counting kit (Dojindo Labs, Japan), and the cell survival rate of each treatment group was calculated as a percentage (%) relative to the control group that accumulated A2E and did not irradiate blue light. ) (Figure 1).
그 결과, A2E를 축적시키고, 청색광을 조사한 음성대조군의 세포 생존율이 대조군 대비 유의하게 감소하여 세포 사멸이 유도되었다. 반면, 건지황 추출물 처리군에서는 A2E만 처리한 음성대조군에 비해 세포 생존율이 증가한 것으로 확인되었다. 이로부터, 건지황 추출물은 망막색소상피세포에 축적 및 산화된 A2E에 의한 세포 사멸을 억제함으로써 황반변성을 예방 또는 치료하는 것을 알 수 있다.As a result, the cell survival rate of the negative control group that accumulated A2E and was irradiated with blue light was significantly reduced compared to the control group, leading to cell death. On the other hand, the cell survival rate was confirmed to be increased in the group treated with dried Rehmannia glutinosa extract compared to the negative control group treated only with A2E. From this, it can be seen that dried Rehmannia glutinosa extract prevents or treats macular degeneration by inhibiting cell death caused by A2E accumulated and oxidized in retinal pigment epithelial cells.
특히, 추출용매로서 증류수를 사용한 제조예 1의 건지황 추출물의 경우 현저히 높은 세포 생존율을 나타냈다. 이와 같은 결과는 건지황의 대표적인 유효성분인 카타폴(catapol) 또는 아우쿠빈(aucubin)보다도 높은 세포 생존율을 나타냈다(도 1). 따라서, 추출용매로서 증류수를 활용할 경우 망막색소상피세포에 축적 및 산화된 A2E에 의한 세포 사멸을 억제함으로써 황반변성을 예방 또는 치료하는 효과가 더욱 우수할 것임을 예상할 수 있다.In particular, the dried Rehmannia glutinosa extract of Preparation Example 1 using distilled water as an extraction solvent showed a significantly high cell survival rate. These results showed a higher cell survival rate than catapol or aucubin, which are representative active ingredients of dried rehmannia glutinosa (Figure 1). Therefore, it can be expected that when distilled water is used as an extraction solvent, the effect of preventing or treating macular degeneration will be greater by suppressing cell death caused by A2E accumulated and oxidized in retinal pigment epithelial cells.
Claims (7)
상기 건지황 추출물은 추출용매로 물을 가하여 추출된 것인 조성물.In claim 1,
A composition in which the dried Rehmannia glutinosa extract is extracted by adding water as an extraction solvent.
상기 안질환은 미숙아 망막병증(retinopathy of prematurity), 망막 변성(retinal degeneration), 황반변성(macular degeneration), 고혈압성 망막 질환(hypertensive retinopathy), 망막색소변성(retinitis pigmentosa), 스타가트병(Stargardt disease), 맥락막 결손(choroideremia), 맥락망막 위축(gyrate-atrophy), 망막박리(retinal detachment), 안구건조증(dry eye syndrome), 녹내장(glaucoma) 및 시신경병증(optic neuropathy)으로 이루어진 군에서 선택되는 하나 이상인 조성물.In claim 1,
The eye diseases include retinopathy of prematurity, retinal degeneration, macular degeneration, hypertensive retinopathy, retinitis pigmentosa, and Stargardt disease. ), one selected from the group consisting of choroideremia, chorioretinal atrophy, retinal detachment, dry eye syndrome, glaucoma, and optic neuropathy. The above composition.
상기 안질환은 청색광의 조사에 의해 유발되는 황반변성인 조성물.In claim 1,
A composition wherein the eye disease is macular degeneration caused by irradiation of blue light.
상기 조성물은 i) 청색광에 의한 N-레티닐리덴-N-레티닐-에탄올아민(N-retinylidene-Nretinyl-ethanolamine: A2E)의 산화를 억제하거나, 또는 ⅱ) 산화된 A2E에 의한 세포 사멸을 억제하는 것인 조성물.In claim 1,
The composition i) inhibits the oxidation of N-retinylidene-Nretinyl-ethanolamine (A2E) by blue light, or ii) inhibits cell death caused by oxidized A2E. A composition that does.
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