KR102381856B1 - HEALTH FUNCTIONAL FOOD COMPOSITION COMPRISING Hovenia dulcis PEDICEL EXTRACT AS AN EFFECTIVE INGREDIENT AND METHOD FOR VERIFING FUNCTION OF THE SAME - Google Patents
HEALTH FUNCTIONAL FOOD COMPOSITION COMPRISING Hovenia dulcis PEDICEL EXTRACT AS AN EFFECTIVE INGREDIENT AND METHOD FOR VERIFING FUNCTION OF THE SAME Download PDFInfo
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Abstract
본 발명은 헛개나무 과병 추출물을 유효성분으로 포함하는 액상 제형의 건강기능식품 조성물의 지표성분으로 암페롭신 또는 탁시폴린 함량을 측정하는 단계;를 포함하는 헛개나무 과병 추출물을 유효성분으로 포함하는 액상 제형 건강기능식품 조성물의 기능성 확인방법에 관한 것이다. 이에 의하여, 액상 제형의 건강기능식품 조성물에서 장기간 보관시에도 함량 변화가 매우 적은 암페롭신 또는 탁시폴린을 지표성분으로 이용할 수 있다.The present invention relates to a liquid formulation comprising an extract from the genus cypress as an active ingredient, comprising the step of measuring the content of ampheropsin or taxifolin as an indicator component of a health functional food composition of a liquid dosage form containing the extract It relates to a method for confirming the functionality of a health functional food composition. Accordingly, ampheropsin or taxifolin, which has a very small content change even when stored for a long period of time in a liquid health functional food composition, can be used as an indicator component.
Description
본 발명은 헛개나무 과병 추출물을 유효성분으로 포함하는 액상 제형 건강기능식품 조성물 및 이의 기능성 확인방법에 관한 것으로, 지표성분 활성에 따른 알코올성 간질환 개선 또는 예방, 숙취해소, 스트레스성 피로회복 및 운동능력향상 효과를 갖는 액상 제형의 건강기능식품과 지표성분을 이용한 조성물의 액상 제형 건강기능식품 조성물의 기능성 확인방법에 관한 것이다.The present invention relates to a health functional food composition in a liquid formulation comprising an extract of the genus oleifera extract as an active ingredient and a method for verifying its functionality, and to improve or prevent alcoholic liver disease according to the activity of an indicator component, relieve a hangover, recover from stress fatigue, and exercise ability It relates to a health functional food in a liquid dosage form having an improving effect and a method for confirming the functionality of a health functional food composition in a liquid dosage form of a composition using an indicator component.
생체 내로 들어온 생체 외 물질은 일단 간을 통해 대사되므로 간은 영양소 이외에도 많은 독성물질에 노출될 위험이 다른 장기보다 많아 그 만큼 손상될 확률도 매우 높다. 또한, 우리의 몸은 산업화에 따른 공해물질, 독성물질에 항상 노출되어 있어 우리의 간은 끊임없이 해독작용에 시달리고 있는데 간독성을 유발하는 물질 외에도 알코올, 흡연 등은 간 손상을 가중시켜 인체가 방어 해독 작용을 하지 못해 면역 체계에 이상을 가져와 다른 질병의 원인이 되기도 한다.Since ex vivo substances that enter the body are metabolized through the liver once, the liver has a higher risk of being exposed to many toxic substances in addition to nutrients than other organs, so the probability of damage is very high. In addition, our body is always exposed to pollutants and toxic substances according to industrialization, so our liver is constantly suffering from detoxification. Failure to do so may cause abnormalities in the immune system and cause other diseases.
간독성 질환은 병이 생기는 원인에 따라 약물독성 간질환, 알코올성 간질환등으로 구분할 수 있고, 간독성 질환을 비롯한 간질환은 초기에 자각증상이 없어 상당히 진행되어서야 발견되기 때문에, 우리나라뿐만 아니라 세계적으로도 사망원인의 수위를 차지하고 있으나, 효과적인 치료제 및 진단방법이 없는 실정이다. Hepatotoxic disease can be classified into drug-toxic liver disease and alcoholic liver disease depending on the cause of the disease. Although it occupies the level of the cause, there is no effective treatment or diagnostic method.
현재까지 천연식물에서 추출되어 실제 임상에서 응용되고 있는 간 기능 보호제로서는 실리범 마리아넘(Silybum marianum)이라는 식물에서 추출된 실리빈(silybin), 실리디아민(silydiamine), 실리크리스틴(silycristine) 등의 이성체로 구성된 실리마린(silymarin) 제제가 있다. 이와 같이, 천연물로부터 간질환 치료제를 개발하려는 수많은 노력에도 불구하고 실제로 치료제로 현재 사용 중이거나 임상시험 중인 예는 소수에 불과하다.As a liver function protective agent extracted from natural plants and applied in clinical practice, isomers such as silybin, silydiamine, and silycristine extracted from a plant called Silybum marianum . There is a formulation of silymarin consisting of As such, despite numerous efforts to develop liver disease therapeutics from natural products, there are only a few examples currently being used as therapeutic agents or undergoing clinical trials.
한편, 건강기능식품에 관한 법률 14조에 의해 건강기능식품은 기준과 규격을 정하게 되어 있고, 동법 14조 2항과 15조 2항에 의하여 건강기능식품 기능성 원료 및 기준·규격 인정에 관한 규정에는 기능성분이나 지표성분을 설정하게 되어 있으며(제 2조 정의, 제 5조 인정 신청), 제14조 제출자료 내용 및 요건 2항의 5 기능성분(또는 지표성분)에 대한 규격 및 시험방법에 관한 자료 및 시험성적서 (가)목 기능성분(또는 지표성분)의 규격에 의해 기능성분 또는 지표성분의 함량은 분석오차를 고려하여 표시하고자 하는 값에 대한 하한치와 상한치는 표시량의 80～120%를 규정하도록 되어있다.On the other hand, according to Article 14 of the Health Functional Food Act, standards and specifications are set for health functional food, and in accordance with Article 14 (2) and 15 (2) of the Act, the regulations on the recognition of functional ingredients and standards and standards for functional health functional food Ingredients or indicator ingredients are to be established (
또한, 동법 7조 1항에 해 건강기능식품을 제조하기 위해서는 품목제조보고를 하여야 하며, 건강기능식품에 관한 법률 시행규칙 제8조 품목제조시에는 식품, 식품첨가물, 축산물 및 건강기능식품의 유통기한 설정기준에 의해 유통기한을 설정해야 하며, 유통기한은 포장재질, 보존조건, 제조방법, 원료배합비율 등 제품의 특성과 냉장 또는 냉동보존 등 기타 유통실정을 고려하여 위해 방지와 품질을 보장할 수 있도록 유통기간 설정을 위한 실험을 실시하고, 설정된 "유통기간" 내에서 실제 유통조건을 고려하여 제품의 유통 중 안전성과 품질을 보장할 수 있도록 유통기한을 설정하도록 되어있어 유통기한 안에 기능성분 또는 지표성분이 하한치를 넘지 않아야 한다(유통기한 설정기준 제4조 유통기한 설정방법 등).In addition, in order to manufacture health functional food in accordance with
그러나, 지금까지 헛개나무 과병 추출분말의 종래 지표성분으로 사용되었던 퀘르세틴의 함량이 음료, 요거트, 푸딩, 젤 등의 액상 제형으로 만들 경우 제조시에 비하여 그 함량이 현저히 떨어져 지표성분으로서 역할이 불충분하여 유통기한을 설정하기 어려운 문제점이 있었다. 따라서 헛개나무 과병 추출분말을 음료나 젤리 등의 액상형으로 개발할 수 있도록 퀘르세틴이 아닌 지표성분이 요구된다.However, when the content of quercetin, which has been used as a conventional indicator component of the extract powder of genus oleifera, is made into a liquid formulation such as beverage, yogurt, pudding, gel, etc., the content is significantly lower than that during manufacture, and its role as an indicator component is insufficient. There was a problem in that it was difficult to set the expiration date. Therefore, an indicator component, not quercetin, is required so that the extract powder of the sagebrush tree can be developed in a liquid form such as beverages or jelly.
본 발명의 목적은 헛개나무 과병 추출물을 유효성분으로 포함하는 알코올성 간질환 예방 또는 개선용 액상 제형의 건강기능식품 조성물의 알코올성 간질환 개선 효과를 지표성분으로 암페롭신 또는 탁시폴린 함량을 측정함으로써 음료, 요거트, 푸딩, 젤 등의 액상 제형의 건강기능식품에서 장기간 보관시 종래 지표성분으로 사용되었던 퀘르세틴의 함량이 제조시에 비하여 현저히 떨어져 지표성분으로서 역할이 불충분한 문제점을 해결하기 위하여 지표성분으로 암페롭신 또는 탁시폴린 함량을 측정하는 단계;를 포함하는 헛개나무 과병 추출물을 유효성분으로 포함하는 액상 제형 건강기능식품 조성물의 기능성 확인방법에 관한 것이다.It is an object of the present invention to measure the content of ampheropsin or taxifolin as an indicator component for the improvement effect of alcoholic liver disease of a health functional food composition of a liquid formulation for preventing or improving alcoholic liver disease, which includes an extract from the genus oleracea as an active ingredient. In liquid health functional foods such as yogurt, pudding, gel, etc., when stored for a long period of time, the content of quercetin, which has been used as an indicator in the past, is significantly lower than in manufacturing. Or measuring the taxifolin content; relates to a method for confirming the functionality of a liquid health functional food composition comprising an extract of a genus oleifera fruit as an active ingredient.
본 발명의 다른 목적은 지표성분으로 암페롭신 또는 탁시폴린을 소정의 함량으로 포함하고, 장기간 보관시에도 지표성분의 함량이 최초 제조시와 유사한 수준으로 유지할 수 있는 간질환 개선 또는 예방, 숙취해소, 스트레스성 피로회복 및 운동능력향상 효능이 있는 액상 제형의 건강기능식품 조성물을 제공하는 데 있다.Another object of the present invention is to improve or prevent liver disease, relieve a hangover, including ampheropsin or taxifolin as an indicator component in a predetermined content, and maintaining the content of the indicator component at a level similar to that at the time of initial production even when stored for a long period of time; An object of the present invention is to provide a health functional food composition in a liquid formulation having the effect of recovering from stress fatigue and improving exercise capacity.
본 발명의 일 측면에 따르면,According to one aspect of the present invention,
헛개나무 과병 추출물을 유효성분으로 포함하는 액상 제형의 건강기능식품 조성물의 지표성분으로 암페롭신 또는 탁시폴린 함량을 측정하는 단계;를 포함하는 헛개나무 과병 추출물을 유효성분으로 포함하는 액상 제형 건강기능식품 조성물의 기능성 확인방법이 제공된다.Measuring the content of ampheropsin or taxifolin as an indicator component of a health functional food composition in a liquid formulation comprising a genus oleifera extract as an active ingredient; A liquid health functional food containing an extract of fenugreek as an active ingredient A method for determining the functionality of a composition is provided.
상기 기능성은 알코올성 간질환 개선 또는 예방, 숙취해소, 스트레스성 피로회복 및 운동능력향상 중에서 선택된 어느 하나일 수 있다.The functionality may be any one selected from improvement or prevention of alcoholic liver disease, hangover relieving, stress-related fatigue recovery, and exercise ability improvement.
상기 액상 제형의 건강기능식품은 헛개나무 과병 추출물 함량은 5 내지 2460 mg/100㎖ 일 수 있다.The health functional food of the liquid formulation may have an extract content of Heotgae
상기 액상 제형의 건강기능식품 조성물에서 상기 암페롭신 함량이 60 내지 1000 ng/㎖이거나, 또는 상기 탁시폴린 함량은 20 내지 90 ng/㎖ 일 수 있다.In the health functional food composition of the liquid formulation, the amperopsin content may be 60 to 1000 ng/ml, or the taxifolin content may be 20 to 90 ng/ml.
본 발명의 다른 하나의 측면에 따르면,According to another aspect of the present invention,
지표성분으로 암페롭신 60 내지 1000 ng/㎖, 또는 탁시폴린 20 내지 90 ng/㎖을 포함할 수 있다.As an indicator component, 60 to 1000 ng/ml of ampheropsin, or 20 to 90 ng/ml of taxifolin may be included.
본 발명의 헛개나무 과병 추출물을 유효성분으로 포함하는 액상 제형 건강기능식품 조성물의 기능성 확인방법은 헛개나무 과병 추출물을 유효성분으로 포함하는 알코올성 간질환 예방 또는 개선용 액상 제형의 건강기능식품 조성물의 알코올성 간질환 개선 효과를 지표성분으로 암페롭신 또는 탁시폴린 함량을 측정함으로써 음료, 요거트, 푸딩, 젤 등의 액상 제형의 건강기능식품에서 장기간 보관시 종래 지표성분으로 사용되었던 퀘르세틴의 함량이 제조시에 비하여 현저히 떨어져 지표성분으로서 역할이 불충분한 문제점을 해결할 수 있다.The method for confirming the functionality of a liquid health functional food composition comprising an extract of a genus oleifera fruit disease as an active ingredient of the present invention is the alcoholicity of a health functional food composition of a liquid dosage form for preventing or improving alcoholic liver disease, which includes an extract of a nutmeg tree fruit disease as an active ingredient. By measuring the content of ampheropsin or taxifolin as an indicator component for the improvement of liver disease, the content of quercetin, which was used as an indicator in the past, is lower than that during long-term storage in liquid health functional foods such as beverages, yogurt, puddings, and gels. It is possible to solve the problem of insufficient role as an indicator component by falling significantly.
본 발명의 헛개나무 과병 추출물을 유효성분으로 포함하는 액상 제형 건강기능식품 조성물은 지표성분으로 암페롭신 또는 탁시폴린을 소정의 함량으로 포함하고, 장기간 보관시에도 지표성분의 함량이 최초 제조시와 유사한 수준으로 유지할 수 있고 간질환 개선 또는 예방, 숙취해소, 스트레스성 피로회복 및 운동능력향상에 효과가 있다.The liquid health functional food composition comprising the extract of the genus oleracea of the present invention as an active ingredient contains ampheropsin or taxifolin in a predetermined amount as an indicator ingredient, and even when stored for a long period of time, the content of the indicator ingredient is similar to that at the time of initial manufacture. It is effective in improving or preventing liver disease, relieving hangover, recovering from stress-related fatigue, and improving exercise capacity.
도 1은 실시예 1에 따른 암페롭신의 함량 변화 측정결과이다.
도 2는 실시예 2에 따른 탁시폴린의 함량 변화 측정결과이다.
도 3은 실시예 3에 따른 미리세틴의 함량 변화 측정결과이다.
도 4는 비교예 1에 따른 퀘르세틴의 함량 변화 측정결과이다.
도 5는 실험예 1에 따른 ALT 혈중 농도의 측정 결과이다.
도 6은 실험예 1에 따른 AST 혈중 농도의 측정 결과이다.
도 7은 실험예 2에 따른 피로회복 효과 분석 결과이다.
도 8 및 도 9는 실험예 3의 유산소성 운동수행 능력 분석 결과이다.1 is a measurement result of the content change of amperopsin according to Example 1.
2 is a measurement result of the content change of taxifolin according to Example 2.
3 is a measurement result of the content change of paroxetine according to Example 3.
4 is a measurement result of the content change of quercetin according to Comparative Example 1.
5 is a measurement result of ALT blood concentration according to Experimental Example 1.
6 is a measurement result of AST blood concentration according to Experimental Example 1.
7 is an analysis result of fatigue recovery effect according to Experimental Example 2.
8 and 9 are aerobic exercise performance analysis results of Experimental Example 3.
본 발명은 다양한 변환을 가할 수 있고 여러 가지 실시예를 가질 수 있는 바, 특정 실시예들을 도면에 예시하고 상세한 설명에 상세하게 설명하고자 한다. 그러나, 이는 본 발명을 특정한 실시 형태에 대해 한정하려는 것이 아니며, 본 발명의 사상 및 기술 범위에 포함되는 모든 변환, 균등물 내지 대체물을 포함하는 것으로 이해되어야 한다. 본 발명을 설명함에 있어서 관련된 공지 기술에 대한 구체적인 설명이 본 발명의 요지를 흐릴 수 있다고 판단되는 경우 그 상세한 설명을 생략한다.Since the present invention can apply various transformations and can have various embodiments, specific embodiments are illustrated in the drawings and described in detail in the detailed description. However, this is not intended to limit the present invention to specific embodiments, and should be understood to include all modifications, equivalents, and substitutes included in the spirit and scope of the present invention. In describing the present invention, if it is determined that a detailed description of a related known technology may obscure the gist of the present invention, the detailed description thereof will be omitted.
제1, 제2 등의 용어는 다양한 구성요소들을 설명하는데 사용될 수 있지만, 상기 구성요소들은 상기 용어들에 의해 한정되어서는 안 된다. 상기 용어들은 하나의 구성요소를 다른 구성요소로부터 구별하는 목적으로만 사용된다. Terms such as first, second, etc. may be used to describe various elements, but the elements should not be limited by the terms. The above terms are used only for the purpose of distinguishing one component from another.
본 출원에서 사용한 용어는 단지 특정한 실시예를 설명하기 위해 사용된 것으로, 본 발명을 한정하려는 의도가 아니다. 단수의 표현은 문맥상 명백하게 다르게 뜻하지 않는 한, 복수의 표현을 포함한다. 본 출원에서, "포함하다" 또는 "가지다" 등의 용어는 명세서상에 기재된 특징, 숫자, 단계, 동작, 구성요소, 부품 또는 이들을 조합한 것이 존재함을 지정하려는 것이지, 하나 또는 그 이상의 다른 특징들이나 숫자, 단계, 동작, 구성요소, 부품 또는 이들을 조합한 것들의 존재 또는 부가 가능성을 미리 배제하지 않는 것으로 이해되어야 한다.
The terms used in the present application are only used to describe specific embodiments, and are not intended to limit the present invention. The singular expression includes the plural expression unless the context clearly dictates otherwise. In the present application, terms such as “comprise” or “have” are intended to designate that a feature, number, step, operation, component, part, or combination thereof described in the specification exists, but one or more other features It should be understood that this does not preclude the existence or addition of numbers, steps, operations, components, parts, or combinations thereof.
이하, 본 발명의 헛개나무 과병 추출물을 유효성분으로 포함하는 액상 제형 건강기능식품 조성물의 기능성 확인방법 에 대해 설명하도록 한다.Hereinafter, a method for verifying the functionality of a liquid formulation health functional food composition comprising the extract of the present invention as an active ingredient will be described.
헛개나무(Hovenia dulcis Thunb)는 갈매나무과 낙엽활엽교목으로 경기, 강원 이남의 표고 50-800m에 분포하고 있으며, 일본, 중국에도 분포하고 있다. 또한 한국과 일본에는 Hovenia dulcis Thunb(한국, 일본, 중국; 꽃은 연녹색, 잎에는 털이 없다)라는 기본종외에 그 변종들인 Hovenia dulcis var. latifolia Nakai.(일본특산 동북지방; Hovenia dulcis 에 비해 잎이 대단히 크다), Hovenia dulcis var. koreana Nakai(한국특산; 꽃은 백색이다) 그리고, Hovenia dulcis var. tomentella Makino(일본특산 본주, 사국; 잎에 털이 있다)가 분포하고 있다. 수고 10-15m, 흉고직경 30-40cm에 달하며 대경목으로는 수고 20m, 직경 80cm까지 자란다. 또한 내한성과 내음성, 맹아력이 강하다.Hovenia dulcis Thunb ( Hovenia dulcis Thunb) is a deciduous broad-leaved tree in the buckthorn family, distributed at an altitude of 50-800m south of Gyeonggi-do and Gangwon-do, and is also distributed in Japan and China. Also, in Korea and Japan, Hovenia dulcis Thunb (Korea, Japan, China; flowers are light green, leaves are hairless), in addition to the basic species, Hovenia dulcis var. latifolia Nakai. (Special to the Tohoku region of Japan; leaves are very large compared to Hovenia dulcis), Hovenia dulcis var. koreana Nakai (special to Korea; flowers are white) and Hovenia dulcis var. tomentella Makino (Japanese main wine, Saguk; leaves are hairy) is distributed. It reaches a height of 10-15m and a diameter of 30-40cm at breast height. In addition, it has strong cold resistance, sound resistance, and sprouting power.
상기 액상 제형의 건강기능식품 조성물은 헛개나무 과병 추출물을 유효성분으로 포함한다.The health functional food composition of the liquid formulation includes an extract of Heotgae tree fruit disease as an active ingredient.
헛개나무 과병 추출물은 헛개나무 과병(pedicel)의 추출물을 의미하다.Heotgae pedigree extract refers to an extract of pedicel.
헛개나무 과병은 헛개열매를 포함하는 꼭지 부분을 의미한다.The saplings of the sagebrush mean the part of the stalk that contains the nutmeg fruit.
상기 헛개나무 과병 추출물은 헛개나무 과병을 분쇄한 후, 건조 중량의 1 내지 30배, 바람직하게는 5 내지 15배 부피의 용매에 투입하고, 80 내지 120℃의 온도에서 1 내지 5시간 동안 추출한 추출물일 수 있다.The hutgae tree fruit bottle extract is after pulverizing the hutgae tree fruit bottle, 1 to 30 times the dry weight, preferably 5 to 15 times the volume of the solvent, and the extract extracted at a temperature of 80 to 120 ° C. for 1 to 5 hours. can be
상기 헛개나무 과병을 추출하는데 사용되는 용매는 물, 탄소수 1 내지 4의 저급알코올, 에틸렌글리콜, 에틸에테르 또는 이들의 혼합용매일 수 있다.The solvent used for extracting the fruit disease of Heotgae tree may be water, a lower alcohol having 1 to 4 carbon atoms, ethylene glycol, ethyl ether, or a mixed solvent thereof.
추출 공정을 수행한 후에는 여과지로 여과하고 여액을 감압 진공농축기를 이용하여 20 내지 65℃의 온도에서 1 내지 10시간 동안 농축시키는 것이 바람직하다. 더욱 바람직하게는 감압 농축한 다음에 농축물을 진공동결 건조 또는 열풍건조 또는 분사 방식에 의한 건조 등을 통하여 추출물을 분말화하는 것이나, 본 발명의 범위가 여기에 한정되는 것은 아니다.After performing the extraction process, it is preferable to filter it with a filter paper and to concentrate the filtrate at a temperature of 20 to 65° C. for 1 to 10 hours using a vacuum concentrator under reduced pressure. More preferably, after concentration under reduced pressure, the extract is powdered through vacuum freeze-drying or hot-air drying or drying by spraying the concentrate, but the scope of the present invention is not limited thereto.
본 명세서에서 사용되는 용어인 '추출물'은 추출용매를 처리하여 얻은 조추출물 뿐만 아니라 추출물의 가공물도 포함할 수 있다. 예를 들어, 헛개나무 과병 추출물은 감압 증류 및 동결 건조 또는 분무 건조 등과 같은 추가적인 과정에 의해 분말 상태로 제조될 수 있다.As used herein, the term 'extract' may include not only the crude extract obtained by treating the extraction solvent, but also the processed product of the extract. For example, the genus oleifera extract may be prepared in a powder state by an additional process such as distillation under reduced pressure and freeze-drying or spray-drying.
본 발명의 헛개나무 과병 추출물을 유효성분으로 포함하는 액상 제형의 건강기능식품 조성물의 기능성 확인방법은 지표성분으로 암페롭신 또는 탁시폴린 함량을 측정하는 단계를 포함하는 것을 특징으로 한다.The method for confirming the functionality of a health functional food composition in a liquid dosage form comprising the extract of the genus oleifera fruit disease as an active ingredient of the present invention is characterized in that it comprises the step of measuring the content of ampheropsin or taxifolin as an indicator component.
상기 기능성은 알코올성 간질환 개선 또는 예방, 숙취해소, 스트레스성 피로회복 및 운동능력향상 중에서 선택된 어느 하나인 것을 특징으로 한다.The function is characterized in that any one selected from the improvement or prevention of alcoholic liver disease, hangover relieving, stress-related fatigue recovery and exercise ability improvement.
상기 액상 제형의 건강기능식품은 헛개나무 과병 추출물 함량은 5 내지 2460 mg/100㎖ 일 수 있다.The health functional food of the liquid formulation may have an extract content of Heotgae
상기 액상 제형의 건강기능식품 조성물에서 상기 암페롭신 함량은 60 내지 1000 ng/㎖ 일 수 있다.In the health functional food composition of the liquid formulation, the amperopsin content may be 60 to 1000 ng/ml.
상기 액상 제형의 건강기능식품 조성물에서 상기 탁시폴린 함량은 20 내지 90 ng/㎖ 일 수 있다.In the health functional food composition of the liquid formulation, the taxifolin content may be 20 to 90 ng/ml.
암페롭신과 탁시폴린은 안정성이 높아 장기간 보관시에도 성분의 변화가 크지 않는다. 따라서 헛개나무 과병 추출물을 유효성분으로 알코올성 간질환 개선, 또는 숙취해소용 식품 또는 음료의 간질환 개선 효능을 측정하는 지표성분으로 사용될 수 있다.Amperopsin and Taxifolin have high stability, so their composition does not change much even when stored for a long period of time. Therefore, it can be used as an index component to measure the improvement of alcoholic liver disease or the improvement of liver disease of food or beverage for relieving hangover as an active ingredient.
암페롭신은 숙취의 원인인 아세트알데히드 성분을 빠르게 분해해 숙취해소에 도움을 주고, 몸속에 있는 독소를 배출 시켜주는 효능이 있고 알코올성 간질환을 예방하고 개선하는 효능을 갖고 있다.Ampheropsin helps to relieve hangover by rapidly decomposing acetaldehyde, the cause of hangover, and has the effect of discharging toxins from the body and preventing and improving alcoholic liver disease.
또한, 탁시폴린은 간독성 유발물질인 사염화탄소로부터 유도된 간세포 손상을 보호하는 활성을 나타내므로, 간질환 개선 또는 예방, 숙취해소, 스트레스성 피로회복 및 운동능력향상에 효과적일 수 있다.
In addition, because taxifolin exhibits an activity of protecting hepatocellular damage induced from carbon tetrachloride, a hepatotoxic substance, it can be effective in improving or preventing liver disease, relieving hangover, recovering from stress fatigue, and improving exercise ability.
본 발명은 지표성분으로 암페롭신 60 내지 1000 ng/㎖, 또는 탁시폴린 20 내지 90 ng/㎖을 포함하는 것을 특징으로 하는 헛개나무 과병 추출물을 유효성분으로 포함하는 액상 제형 건강기능식품 조성물을 제공한다.The present invention provides a liquid health functional food composition comprising, as an active ingredient, an extract from the genus oleifera, characterized in that it contains 60 to 1000 ng/ml of ampheropsin, or 20 to 90 ng/ml of taxifolin as an indicator component. .
상기 액상 제형의 건강기능식품 조성물은 음료, 요거트, 푸딩, 젤리, 죽 등의 형태를 포함할 수 있다.The health functional food composition of the liquid formulation may include beverages, yogurt, pudding, jelly, porridge, and the like.
본 발명의 식품 조성물은 당해 발명이 속하는 기술분야에서 통상의 지식을 가진 자가 용이하게 실시할 수 있는 방법에 따라, 담체 및/또는 부형제를 이용하여 제제화 함으로써 단위 용량 형태로 제조되거나 또는 다용량 용기 내에 내입시켜 제조될 수 있다. 이때 제형은 오일 또는 수성 매질중의 용액, 현탁액 또는 유화액 형태이거나 엑스제, 분말제, 과립제, 정제 또는 캅셀제 형태일 수도 있으며, 분산제 또는 안정화제를 추가적으로 포함할 수 있다.The food composition of the present invention is prepared in a unit dose form by formulating using a carrier and/or excipient according to a method that can be easily performed by a person skilled in the art to which the present invention pertains, or in a multi-dose container. It can be prepared by incorporation. At this time, the formulation may be in the form of a solution, suspension, or emulsion in oil or aqueous medium, or may be in the form of an extract, powder, granule, tablet or capsule, and may additionally include a dispersant or stabilizer.
본 발명의 식품 조성물은 유효성분으로서 헛개나무 과병 추출물뿐만 아니라, 식품 제조 시에 통상적으로 첨가되는 성분을 포함할 수 있으며, 예를 들어, 단백질, 탄수화물, 지방, 영양소, 조미제 및 향미제를 포함한다. 상술한 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. 향미제로서 천연 향미제 [타우마틴, 스테비아 추출물 (예를 들어 레바우디오시드 A, 글리시르히진 등]) 및 합성 향미제(사카린, 아스파르탐 등)를 사용할 수 있다. 예컨대, 본 발명의 식품 조성물이 드링크제와 음료류로 제조되는 경우에는 본 발명의 탁시폴린 이외에 구연산, 액상과당, 설탕, 포도당, 초산, 사과산, 과즙, 및 각종 식물 추출액 등을 추가로 포함시킬 수 있다.
The food composition of the present invention may include ingredients commonly added during food production, as well as extracts from sagebrush as an active ingredient, for example, proteins, carbohydrates, fats, nutrients, seasonings and flavoring agents. do. Examples of the above-mentioned carbohydrates include monosaccharides such as glucose, fructose and the like; disaccharides such as maltose, sucrose, oligosaccharides and the like; and polysaccharides, for example, conventional sugars such as dextrin, cyclodextrin, and the like, and sugar alcohols such as xylitol, sorbitol, and erythritol. As flavoring agents, natural flavoring agents [taumatine, stevia extract (eg, rebaudioside A, glycyrrhizin, etc.)) and synthetic flavoring agents (saccharin, aspartame, etc.) can be used. For example, when the food composition of the present invention is prepared as a drink or beverage, citric acid, high fructose, sugar, glucose, acetic acid, malic acid, fruit juice, and various plant extracts may be additionally included in addition to the taxifolin of the present invention.
본 발명은 헛개나무 과병 추출물을 유효성분으로 포함하는 알코올성 간질환 예방 또는 개선용 액상 제형의 건강기능식품 조성물을 포함하는 액상 제형의 건강기능식품을 제공한다. 액상 제형의 건강기능식품이란, 헛개나무 과병 추출물을 포함하는 음료, 차류, 요거트, 젤, 푸딩, 죽 식품에 첨가하는 것으로, 이를 섭취할 경우 건강상 특정한 효과를 가져오는 것을 의미하나, 일반 약품과는 달리 식품을 원료로 하여 약품의 장기 복용시 발생할 수 있는 부작용 등이 없는 장점이 있다. 이와 같이 하여 얻어지는 본 발명의 액상 제형의 건강기능식품은, 일상적으로 섭취하는 것이 가능하기 때문에 매우 유용하다.
The present invention provides a health functional food in a liquid dosage form, comprising a health functional food composition in a liquid dosage form for the prevention or improvement of alcoholic liver disease, which includes an extract from the genus oleifera fruit as an active ingredient. Health functional food in liquid form is added to beverages, teas, yogurt, gel, pudding, and porridge containing extracts from the genus oleracea, and it means that it has a specific health effect when consumed, but In contrast to this, it has the advantage that there are no side effects that may occur when taking the drug for a long time by using food as a raw material. The health functional food in the liquid dosage form of the present invention obtained in this way is very useful because it can be ingested on a daily basis.
이하, 본 발명의 이해를 돕기 위하여 바람직한 실시예를 제시하나, 하기 실시예는 본 발명을 예시하는 것일 뿐 본 발명의 범주 및 기술사상 범위 내에서 다양한 변경 및 수정이 가능함은 당업자에게 있어서 명백한 것이다.
Hereinafter, preferred examples are presented to help the understanding of the present invention, but it will be apparent to those skilled in the art that various changes and modifications are possible within the scope and spirit of the present invention.
[[ 실시예Example ]]
제조예production example 1: One: 헛개나무hawthorn tree 과병peduncle 추출물 분말 제조 Extract Powder Preparation
헛개나무과병을 물과 1:10(W/V)의 비율로 95℃에서 4시간 동안 추출하고 추출물을 고형분의 함량이 40%(w/v)가 되게 농축하였다. 고형분 40%의 추출물과 부형제를 4:6의 중량비로 혼합하여 분무건조(spray-dry)하여 헛개나무 과병 추출물 분말을 얻었다. 헛개나무 과병 추출물 분말은 실온에서 보관하고 본 실험의 재료로 사용하였다. 상기 부형제는 말토덱스트린 또는 β-사이클로덱스트린을 사용하고 첨가제로는 비타민 C를 사용하였다.
H. saprum was extracted with water at a ratio of 1:10 (W/V) at 95° C. for 4 hours, and the extract was concentrated to a solid content of 40% (w/v). The extract and excipients having a solid content of 40% were mixed in a weight ratio of 4:6 and spray-dried to obtain a powdery mildew extract. The extract powder of H. saplings was stored at room temperature and used as a material for this experiment. As the excipient, maltodextrin or β-cyclodextrin was used, and as an additive, vitamin C was used.
실시예Example 1: One: 암페롭신ampheropsin (( ampelopsinampelopsin ) 함량 측정) content measurement
제조예 1에 따라 수득한 헛개나무 과병 추출물 분말을 물과 혼합하여 5mg/㎖의 헛개나무 과병 추출물 수용액을 제조하였다. 아래와 같은 3종의 조합으로 샘플을 제조하여 9주에 걸쳐 암페롭신 성분의 함량 변화를 측정하였다. By mixing the extract powder obtained from the genus oleracea fruit according to Preparation Example 1 with water, a 5 mg/ml aqueous solution of the genus hulliferae extract was prepared. Samples were prepared with the following three combinations, and changes in the content of ampheropsin components were measured over 9 weeks.
(1) (One) 실시예Example 1-1: 1-1: 헛개나무hawthorn tree 과병peduncle 추출물 + extract + 말토덱스트린의of maltodextrin 암페롭신ampheropsin 함량 측정 content measurement
헛개나무 과병 추출물:말토덱스트린=4:6의 중량비로 혼합한 분말에 대하여 암페롭신 함량 변화를 9주간 측정한 결과를 아래의 표 1에 나타내었다.Table 1 below shows the results of measuring changes in ampheropsin content for 9 weeks for the powder mixed in a weight ratio of H. nutmeg extract: maltodextrin = 4:6.
(2) (2) 실시예Example 1-2: 1-2: 헛개나무hawthorn tree 과병peduncle 추출물 + extract + 말토덱스트린maltodextrin + 비타민 C의 + Vitamin C 암페롭신ampheropsin 함량 측정 content measurement
헛개나무 과병 추출물:말토덱스트린=4:6의 중량비로 혼합한 분말에 1mg/㎖의 농도로 비타민 C를 첨가한 혼합물에 대하여 암페롭신 함량 변화를 9주간 측정하고, 그 결과를 아래의 표 2에 나타내었다.The change in the content of ampheropsin was measured for 9 weeks for a mixture containing vitamin C at a concentration of 1 mg/ml to a powder mixed in a weight ratio of H. nutmeg extract: maltodextrin = 4:6, and the results are shown in Table 2 below. indicated.
(3) (3) 실시예Example 1-3: 1-3: 헛개나무hawthorn tree 과병peduncle 추출물 + β- extract + β- 사이클로덱스트린의of cyclodextrins 암페롭신ampheropsin 함량 측정 content measurement
헛개나무 과병 추출물: β-사이클로덱스트린 =4:6의 중량비로 혼합한 분말에 대하여 암페롭신 함량 변화를 9주간 측정하고, 그 결과를 아래의 표 3에 나타내었다.Honeysuckle fruit bottle extract: The change in the content of amperopsin was measured for 9 weeks with respect to the powder mixed in a weight ratio of β-cyclodextrin = 4:6, and the results are shown in Table 3 below.
실시예 1-1 내지 1-3에 따른 결과를 도 1에 나타냈다. 이에 따르면, 암페롭신은 상온인 25℃에서 9주간 성분 변화가 거의 없었으며, 45℃에서도 비타민 C와 혼합된 상태에서는 성분의 변화가 서서히 나타나는 것으로 나타나 헛개나무 과병 추출물의 지표성분으로 매우 적절할 뿐 아니라, 헛개나무 과병 추출물을 포함하는 음료나 건강기능식품을 장기간 보관하여도 암페롭신과 관련된 활성을 높게 유지할 수 있음을 알 수 있었다.
The results according to Examples 1-1 to 1-3 are shown in FIG. 1 . According to this, the composition of ampheropsin hardly changed for 9 weeks at room temperature of 25℃, and even at 45℃, when it was mixed with vitamin C, the change in ingredient appeared gradually, so it is very suitable as an indicator ingredient for the extract , it was found that the activity related to ampheropsin can be maintained high even when beverages or health functional foods containing the extract of the genus oleracea are stored for a long period of time.
실시예Example 2: 2: 탁시폴린Taxifolin (( taxifolintaxifolin ) 함량 측정) content measurement
실시예 1과 동일 조건에서 탁시폴린 함량을 측정하였다.Taxifolin content was measured under the same conditions as in Example 1.
(1) (One) 실시예Example 2-1: 2-1: 헛개나무hawthorn tree 과병peduncle 추출물 + extract + 말토덱스트린의of maltodextrin 탁시폴린Taxifolin 함량 측정 content measurement
헛개나무 과병 추출물:말토덱스트린=4:6의 중량비로 혼합한 분말에 대하여 탁시폴린 함량 변화를 9주간 측정한 결과를 아래의 표 4에 나타내었다.Table 4 below shows the results of measuring the change in taxifolin content for 9 weeks for the powder mixed in a weight ratio of H. basil fruit extract:maltodextrin=4:6.
(2) (2) 실시예Example 2-2: 2-2: 헛개나무hawthorn tree 과병peduncle 추출물 + extract + 말토덱스트린maltodextrin + 비타민 C의 + Vitamin C 탁시폴린Taxifolin 함량 측정 content measurement
헛개나무 과병 추출물: 말토덱스트린=4:6의 중량비로 혼합한 분말에 1mg/㎖의 농도로 비타민 C를 첨가한 혼합물에 대하여 탁시폴린 함량 변화를 9주간 측정하고, 그 결과를 아래의 표 5에 나타내었다.The change in the taxifolin content was measured for 9 weeks for a mixture containing vitamin C at a concentration of 1 mg/ml to a powder mixed in a weight ratio of maltodextrin = 4:6, and the results are shown in Table 5 below. indicated.
(3) (3) 실시예Example 2-3: 2-3: 헛개나무hawthorn tree 과병peduncle 추출물 + β- extract + β- 사이클로덱스트린의of cyclodextrins 탁시폴린Taxifolin 함량 측정 content measurement
헛개나무 과병 추출물: β-사이클로덱스트린 =4:6의 중량비로 혼합한 분말에 대하여 탁시폴린 함량 변화를 9주간 측정하고, 그 결과를 아래의 표 6에 나타내었다.Honeysuckle fruit bottle extract: For the powder mixed in a weight ratio of β-cyclodextrin = 4:6, the change in taxifolin content was measured for 9 weeks, and the results are shown in Table 6 below.
실시예 2-1 내지 2-3에 따른 결과를 도 2에 나타냈다. 이에 따르면, 탁시폴린은 상온인 25℃에서 9주간 성분 변화가 거의 없었으며, 45℃에서도 성분의 변화가 서서히 나타나는 것으로 나타나 헛개나무 과병 추출물의 지표성분으로 매우 적절할 뿐 아니라, 헛개나무 과병 추출물을 포함하는 음료나 건강기능식품을 장기간 보관하여도 탁시폴린과 관련된 활성을 높게 유지할 수 있음을 알 수 있었다.
The results according to Examples 2-1 to 2-3 are shown in FIG. 2 . According to this, Taxifolin showed little change in composition for 9 weeks at room temperature of 25°C, and the change in component appeared gradually even at 45°C. It was found that the activity related to taxifolin can be maintained high even when beverages or health functional foods are stored for a long period of time.
실시예Example 3: 3: 미리세틴myricetin (( myricetinmyricetin ) 함량 측정) content measurement
실시예 1과 동일 조건에서 미리세틴 함량을 측정하였다.The paroxetine content was measured under the same conditions as in Example 1.
(1) (One) 실시예Example 3-1: 3-1: 헛개나무hawthorn tree 과병peduncle 추출물 + extract + 말토덱스트린의of maltodextrin 미리세틴myricetin 함량 측정 content measurement
헛개나무 과병 추출물:말토덱스트린=4:6의 중량비로 혼합한 분말에 대하여 미리세틴 함량 변화를 9주간 측정한 결과를 아래의 표 7에 나타내었다.Table 7 below shows the results of measuring the change in the paroxetine content for the powder mixed in a weight ratio of Heotgae tree fruit disease extract: maltodextrin = 4:6 for 9 weeks.
(2) (2) 실시예Example 3-2: 3-2: 헛개나무hawthorn tree 과병peduncle 추출물 + extract + 말토덱스트린maltodextrin + 비타민 C의 + Vitamin C 미리세틴myricetin 함량 측정 content measurement
헛개나무 과병 추출물: 말토덱스트린=4:6의 중량비로 혼합한 분말에 1mg/㎖의 농도로 비타민 C를 첨가한 혼합물에 대하여 미리세틴 함량 변화를 9주간 측정하고, 그 결과를 아래의 표 8에 나타내었다.Heotgae tree fruit disease extract: maltodextrin = 4:6 The change in the paroxetine content was measured for a mixture in which vitamin C was added at a concentration of 1mg/ml to a powder mixed in a weight ratio of 4:6 for 9 weeks, and the results are shown in Table 8 below. indicated.
(3) (3) 실시예Example 3-3: 3-3: 헛개나무hawthorn tree 과병peduncle 추출물 + β- extract + β- 사이클로덱스트린의of cyclodextrins 미리세틴myricetin 함량 측정 content measurement
헛개나무 과병 추출물: β-사이클로덱스트린 =4:6의 중량비로 혼합한 분말에 대하여 미리세틴 함량 변화를 9주간 측정하고, 그 결과를 아래의 표 9에 나타내었다.Honeysuckle fruit bottle extract: The change in the paroxetine content was measured for 9 weeks with respect to the powder mixed in a weight ratio of β-cyclodextrin = 4:6, and the results are shown in Table 9 below.
실시예 3-1 내지 3-3에 따른 결과를 도 3에 나타냈다. 이에 따르면, 미리세틴은 25℃와 45℃ 두 조건에서 모두 1주 경과시 성분이 현저히 감소하는 것으로 나타나 헛개나무 과병 추출물의 지표성분으로 부적합하며, 장기관 보관이 필요한 헛개나무 과병 추출물을 포함하는 음료나 건강기능식품에서 활성을 나타내기 어려운 것으로 보인다.
The results according to Examples 3-1 to 3-3 are shown in FIG. 3 . According to this, paroxetine was found to significantly decrease in components after 1 week at both 25 ℃ and 45 ℃ conditions, making it unsuitable as an indicator component of the genus cypress extract, and a beverage containing the cypress extract that requires long-term storage. It seems that it is difficult to show activity in health functional foods.
비교예comparative example 1: One: 퀘르세틴quercetin (( quercetinquercetin ) 함량 측정) content measurement
실시예 1과 동일 조건에서 퀘르세틴 함량을 측정하였다.The quercetin content was measured under the same conditions as in Example 1.
(1) (One) 비교예comparative example 1-1: 1-1: 헛개나무hawthorn tree 과병peduncle 추출물 + extract + 말토덱스트린의of maltodextrin 퀘르세틴quercetin 함량 측정 content measurement
헛개나무 과병 추출물:말토덱스트린=4:6의 중량비로 혼합한 분말에 대하여 퀘르세틴 함량 변화를 9주간 측정한 결과를 아래의 표 10에 나타내었다.Table 10 below shows the results of measuring the change in the quercetin content for 9 weeks for the powder mixed in a weight ratio of H. basil extract: maltodextrin = 4:6.
(2) (2) 비교예comparative example 1-2: 1-2: 헛개나무hawthorn tree 과병peduncle 추출물 + extract + 말토덱스트린maltodextrin + 비타민 C의 + Vitamin C 퀘르세틴quercetin 함량 측정 content measurement
헛개나무 과병 추출물:말토덱스트린=4:6의 중량비로 혼합한 분말에 1mg/㎖의 농도로 비타민 C를 첨가한 혼합물에 대하여 퀘르세틴 함량 변화를 9주간 측정하고, 그 결과를 아래의 표 11에 나타내었다.The change in the quercetin content was measured for 9 weeks for a mixture containing vitamin C at a concentration of 1 mg/ml to a powder mixed in a weight ratio of H. cypress extract: maltodextrin = 4:6, and the results are shown in Table 11 below. it was
(3) (3) 비교예comparative example 1-3: 1-3: 헛개나무hawthorn tree 과병peduncle 추출물 + β- extract + β- 사이클로덱스트린의of cyclodextrins 퀘르세틴quercetin 함량 측정 content measurement
헛개나무 과병 추출물:β-사이클로덱스트린=4:6의 중량비로 혼합한 분말에 대하여 퀘르세틴 함량 변화를 9주간 측정하고, 그 결과를 아래의 표 12에 나타내었다.The change in quercetin content was measured for 9 weeks for the powder mixed in a weight ratio of H. basil extract: β-cyclodextrin = 4:6, and the results are shown in Table 12 below.
비교예 1-1 내지 1-3에 따른 결과를 도 4에 나타냈다. 이에 따르면, 퀘르세틴은 25℃와 45℃ 두 조건에서 모두 1주 경과시 성분이 현저히 감소하는 것으로 나타나 헛개나무 과병 추출물의 지표성분으로 부적합하며, 장기관 보관이 필요한 헛개나무 과병 추출물을 포함하는 음료나 건강기능식품에서 활성을 나타내기 어려운 것으로 보인다.
The results according to Comparative Examples 1-1 to 1-3 are shown in FIG. 4 . According to this, quercetin was found to significantly decrease in components after 1 week at both 25 °C and 45 °C, making it unsuitable as an indicator component for extract It seems that it is difficult to show activity in health functional food.
[[ 실험예Experimental example ]]
실험예Experimental example 1: 액상 1: liquid 헛개나무hawthorn tree 과병peduncle 추출물의 보관 기간에 따른 알코올성 간질환 개선 효과 Alcoholic liver disease improvement effect according to the storage period of the extract
상기 실시예 1 내지 3, 및 비교예 1에 따라 암페롭신과 탁시폴린을 헛개나무 과병 추출물의 지표 성분으로 사용하는 것이 매우 효율적임을 확인하였다. 실험예 1에서는 액상 제형의 조성물에서 종래 지표성분으로 활용되었던 퀘르세틴의 함량 변화로 인해 알코올성 간질환 개선효과에 영향을 주는지에 대한 검증을 실시하였다.According to Examples 1 to 3 and Comparative Example 1, it was confirmed that it was very effective to use ampheropsin and taxifolin as indicator components of the extract of the genus serrata. In Experimental Example 1, it was verified whether the change in the content of quercetin, which was used as a conventional indicator component in the composition of the liquid formulation, affects the improvement effect of alcoholic liver disease.
(1) 실험방법(1) Experimental method
5주령 C57BL6 수컷생쥐 (Daehan Bio Link, Korea)를 구입하여 1주일간 순화시킨 후 체중을 측정하고 사용하였으며, 평균체중을 균등하도록 군당 10마리씩 음성대조군(이하 'Control'이라 함), 5 mg 알코올 투여군(이하, 'Alcohol'이라 함), 500 mg 헛개나무 과병 추출물+말토덱스트린(4:6) 및 5 mg 알코올 투여군(이하, 'HD'라 함), 500 mg 헛개나무 과병 추출물+β-사이클로덱스트린(4:6) 및 5 mg 알코올 투여군(이하, 'HCD'라 함) 총 4군으로 나누었다. 여기서 상기 헛개나무 과병 추출물+말토덱스트린 또는 헛개나무 과병 추출물+β-사이클로덱스트린은 3일 전 주사용수(1차 증류수)와 혼합한 액상 형태로 밀봉하여 상온에서 보관한 것이다.Five-week-old male C57BL6 mice (Daehan Bio Link, Korea) were purchased, acclimatized for one week, and then their weight was measured and used, and 10 mice per group were used as a negative control group (hereinafter referred to as 'Control'), and 5 mg alcohol was administered to equalize the average weight. (hereinafter referred to as 'Alcohol'), 500 mg H. asiatica extract + maltodextrin (4:6) and 5 mg alcohol group (hereinafter referred to as 'HD'), 500 mg H. cypress extract + β-cyclodextrin (4:6) and 5 mg alcohol administration group (hereinafter referred to as 'HCD') were divided into 4 groups. In this case, the Hugae tree fruit disease extract + maltodextrin or Heotgae tree fruit disease extract + β-cyclodextrin was sealed in a liquid form mixed with water for injection (primary distilled water) 3 days ago and stored at room temperature.
한편, 액상의 헛개 과병 추출물이 장기간 보관에 따라 간독성 효능이 얼마나 저하되는지 확인하기 위하여, 동일 조건으로 동물실험을 수행하되, 3일 대신에 30일 상온 보관한 후 실험을 수행하였다.On the other hand, in order to confirm how much the hepatotoxic efficacy of the liquid sagebrush extract decreases with long-term storage, an animal experiment was performed under the same conditions, but the experiment was performed after storage at room temperature for 30 days instead of 3 days.
사육조건은 케이지 당 4마리씩 사육하였으며, 온도는 20-25 ℃, 상대습도는 41.2-58.5%, 조도는 150-300 Lux로 오전 7시부터 오후 7시까지 12시간 명암주기(조명시간)로 사육하였으며, 건양대학교 의과대학 동물윤리위원회 규정을 준수하여 사육하였다.Breeding conditions were 4 animals per cage, temperature of 20-25 ℃, relative humidity of 41.2-58.5%, and illuminance of 150-300 Lux. They were bred in compliance with the regulations of the Animal Ethics Committee of Konyang University College of Medicine.
추출물은 7일간 경구투여 하였으며, 1일 1회 총 7회 반복 강제투여 하였으며, 투여용량은 kg 당 상기 투여군의 조건에 따라 투여하였고, 투여액량은 10 ㎖/kg으로 산출하였다. 음성대조군은 부형제인 주사용수를 투여하였다.The extract was orally administered for 7 days, and it was forcibly administered once a day for a total of 7 times, and the dose was administered per kg according to the conditions of the administration group, and the dose was calculated as 10 ml/kg. The negative control group was administered with water for injection as an excipient.
사료는 실험동물용 고형사료(Rodent diet 2918C; Harlan Teklad, Indianapolis, IN, USA)으며, 식이와 음료는 자유급식을 하였다. 체중측정은 투여시작일부터 조직 적출일까지 매일 1회 측정하였다.The feed was a solid feed for experimental animals (Rodent diet 2918C; Harlan Teklad, Indianapolis, IN, USA), and food and drinks were ad libitum. Body weight was measured once a day from the start of administration to the date of tissue extraction.
각 군별로 마지막 투여 후, isoflurane으로 마취하여 개복하고, 복대동맥에서 혈액을 채취하였다. 혈액을 채취한 후, 간 조직을 적출하고, 중량을 측정하였다. 중량을 측정한 간 조직은 액체질소를 이용하여 급속동결 시키고 초저온고(-80 내지 -60℃)에서 보관하였다. After the last administration for each group, anesthesia with isoflurane was performed, and blood was collected from the abdominal aorta. After blood was collected, liver tissue was removed and the weight was measured. The weighed liver tissue was rapidly frozen using liquid nitrogen and stored at a very low temperature (-80 to -60 °C).
채취한 혈액은 serum-separating tube 및 heparinized tube에서 혈청으로 각각 원심분리 (3,000 rpm, 10분, Smart R17, Hanil Science Ind., Korea) 하였다. 혈청은 혈액생화학분석기(7080, Hitachi, Japan)를 이용하여 간손상 지표인 alanine aminotransferase (ALT), aspartate aminotransferase (AST)를 측정하였다.The collected blood was centrifuged with serum in serum-separating tube and heparinized tube, respectively (3,000 rpm, 10 minutes, Smart R17, Hanil Science Ind., Korea). For serum, alanine aminotransferase (ALT) and aspartate aminotransferase (AST), liver damage indicators, were measured using a blood biochemical analyzer (7080, Hitachi, Japan).
실험결과는 SAS(Statistical Analysis System, Version 8.20, USA)를 사용하여 평균과 오차(mean SD)를 제시하였다. 대조군과 시험물질 투여군 간에 Folded-F 검정법을 실시하여 등분산성을 검정하였다 (유의수준: 0.05). 등분산성인 경우 Student t-test 를 실시하였고 (유의수준: 양측 0.05 및 0.01), 등분산성이 기각되면 Aspin-Welch t-test 를 실시하였다 (유의수준: 양측 0.05 및 0.01).
For experimental results, the mean and error (mean SD) were presented using SAS (Statistical Analysis System, Version 8.20, USA). Equal variance was tested by performing the Folded-F test between the control group and the test substance administration group (significance level: 0.05). In case of equal variance, Student's t-test was performed (significance level: 0.05 and 0.01 on both sides), and Aspin-Welch t-test was performed when equal variance was rejected (significance level: 0.05 and 0.01 on both sides).
(2) 실험결과(2) Experiment result
도 5는 간손상의 지표인 ALT 혈중 농도 측정결과를 3일 경과된 액상의 헛개나무 과병 추출물 투여군(A)과 30일 경과된 액상의 헛개나무 과병 추출물 투여군(B)을 비교하여 나타낸 것이다.5 is a comparison of the results of measurement of ALT blood concentration, which is an indicator of liver damage, in a group (A) administered with a liquid genus oleifera extract after 3 days and a group (B) administered with a liquid phylum extract after 30 days.
이에 따르면, 3일 경과 투여군(A)과 30일 경과 투여군(B)간에 유의한 차이가 없고, 두 가지 투여군 모두에서 음성대조군에 비해 알코올 투여군에서 각각 유의하게 증가하였으며 (ALT: p=0.016), 알코올만을 투여한 대조군에 비해 HD 투여군에서 유의하게 낮게 나타났고(ALT: p=0.009), HCD의 투여군에서도 유의하게 낮게 나타났다 (ALT: p=0.01).According to this, there was no significant difference between the 3-day administration group (A) and the 30-day administration group (B), and in both administration groups, the alcohol administration group significantly increased compared to the negative control group (ALT: p=0.016), Compared to the control group administered only with alcohol, it was significantly lower in the HD-administered group (ALT: p=0.009), and significantly lower in the HCD-administered group (ALT: p=0.01).
또한, 도 6은 간손상 지표인 AST의 혈중 농도 측정결과를 3일 경과된 액상의 헛개나무 과병 추출물 투여군(A)과 30일 경과된 액상의 헛개나무 과병 추출물 투여군(B)을 비교하여 나타낸 것이다.In addition, Figure 6 shows the blood concentration measurement result of AST, which is an indicator of liver damage, compared to the group (A) administered with the liquid genus hulliferae extract after 3 days and the group (B) administered with the liquid genus hullifera extract after 30 days. .
이에 따르면, 3일 경과 투여군(A)과 30일 경과 투여군(B)간에 유의한 차이가 없고, 두 가지 투여군 모두에서 음성대조군에 비해 알코올 투여군에서 각각 유의하게 증가하였으며 (AST: p=0.048), 알코올만을 투여한 대조군에 비해 HD 투여군에서 유의하게 낮게 나타났고(AST: p=0.024), HCD의 투여군에서도 유의하게 낮게 나타났다 (AST: p=0.04).According to this, there was no significant difference between the 3-day administration group (A) and the 30-day administration group (B), and in both administration groups, the alcohol administration group significantly increased compared to the negative control group (AST: p=0.048), Compared to the control group administered with alcohol alone, it was significantly lower in the HD-administered group (AST: p=0.024), and significantly lower in the HCD-administered group (AST: p=0.04).
이와 같은 결과를 볼 때, 종래 지표성분으로 사용되던 퀘르세틴의 함량이 장기간 보관 후 현저히 낮아졌음에도 불구하고, 액상의 헛개나무 과병 추출물의 알코올에 따른 간손상에 대한 개선효과에는 차이가 없는 것으로 나타났다. 따라서, 액상 제형의 헛개나무 과병 추출물에서 장기간 보관하여도 함량의 차이가 매우 적은 암페롭신 또는 탁시폴린을 지표성분으로 하는 것이 매우 적합함을 알 수 있다.
In view of these results, although the content of quercetin, which has been used as an indicator in the prior art, was significantly lowered after long-term storage, there was no difference in the improvement effect on liver damage caused by alcohol of the liquid extract of the genus oleifera fruit. Therefore, it can be seen that it is very suitable to use ampheropsin or taxifolin as an indicator component, which has a very small difference in content even when stored for a long period of time in the extract of the genus oleracea in liquid form.
실험예Experimental example 2: 피로회복 효과 분석 2: Fatigue recovery effect analysis
피험자는 무작위 배정을 받고 제조예 1의 헛개나무 과병 추출물:말토덱스트린=4:6의 중량비로 혼합한 분말을 수령 후 12주간 섭취하였다. 임상시험용 건강기능식품 섭취 후 피험자의 안정성 관련 데이터를 확인 후 총 55명의 피험자에 대해 분석을 실시하였다. 임상시험에 동의하여 무작위 배정을 받은 55명 중 진약집단은 28명, 위약집단은 27명이었다. 각 집단 연령의 평균과 표준편차는 진약집단이 50.4±6.4 세, 위약집단이 50.5±5.9 세이었으며 신장은 진약집단이 164.9±8.3 cm, 위약집단이 165.9±7.1 cm이었다. 체중의 평균과 표준편차는 진약집단이 66.1±11.1 kg, 위약집단이 66.1±10.6 kg으로, BMI는 진약집단이 24.9±2.2 kg/m2, 위약집단이 23.1±2.6 kg/m2로 나타났다. 독립 t-test 결과 진약집단과 위약집단 모두 통계적으로 유의한 차이는 없었다. 아래 표에는 각 집단을 성별로 구분하여 제시하였다Subjects were randomized and ingested for 12 weeks after receipt of the powder mixed in a weight ratio of the extract of the genus oleracea of Preparation Example 1 : maltodextrin = 4:6. After confirming the safety-related data of subjects after ingestion of health functional food for clinical trials, a total of 55 subjects were analyzed. Of the 55 patients who agreed to the clinical trial and were randomized, 28 were in the active drug group and 27 were in the placebo group. The mean and standard deviation of the age of each group were 50.4±6.4 years in the active drug group and 50.5±5.9 years in the placebo group, and the height was 164.9±8.3 cm in the active drug group and 165.9±7.1 cm in the placebo group. The mean and standard deviation of body weight were 66.1±11.1 kg and 66.1±10.6 kg in the active drug group, and the BMI was 24.9±2.2 kg/m2 in the active drug group and 23.1±2.6 kg/m2 in the placebo group. As a result of the independent t-test, there was no statistically significant difference between the take-up group and the placebo group. The table below presents each group by gender.
복용 8주 후 및 12주 후 집단간 피로 관련 혈중 변인 변화를 측정하여 그 결과를 도 7에 나타내었다. 이에 따르면, 진약집단과 위약집단의 섭취 시기별 혈중 피로 관련 혈중 변인 측정 결과 Ammonia의 섭취 시기별 집단 간 비교에서는 섭취 전, 섭취 8주, 섭취 12주 모두 유의한 차이가 나타나지 않았다. 섭취 시기에 따른 비교에서는 진약집단(섭취 전: 79.85±13.21 μg/dL, 섭취 8주: 87.07±13.48 μg/dL, 섭취 12주: 92.00±28.09 μg/dL)과 비교하여 위약집단(섭취 전63.69±17.08 μg/dL, 섭취 8주: 88.00±19.27 μg/dL, 섭취 12주: 103.08±23.40 μg/dL)이 혈중 Ammonia 농도가 더 많이 증가하였으나 유의한 차이는 없었다. 집단x섭취시기의 상호작용효과도 나타나지 않았다.Changes in blood variables related to fatigue were measured between groups after 8 weeks and 12 weeks after administration, and the results are shown in FIG. 7 . According to this, as a result of measurement of blood fatigue-related blood variables for each intake period of the herbal medicine group and the placebo group, there was no significant difference in the comparison between the groups by intake period of Ammonia before, 8 weeks, and 12 weeks of intake. In comparison according to intake period, compared to the placebo group (before intake: 79.85±13.21 μg/dL, 8 weeks intake: 87.07±13.48 μg/dL, 12 weeks intake: 92.00±28.09 μg/dL), the placebo group (63.69 before intake) ±17.08 μg/dL, 8 weeks of ingestion: 88.00±19.27 μg/dL, 12 weeks of intake: 103.08±23.40 μg/dL) increased the serum ammonia concentration more, but there was no significant difference. There was no interaction effect of group x intake time.
ACTH(adrenocorticotropic hormone)의 섭취 시기별 집단 간 비교에서는 유의한 차이가 나타나지 않았다. 섭취 시기에 따른 비교에서는 진약집단과 위약집단 모두 섭취 전(38.34±20.90 pg/mL, 45.39±21.35 pg/mL)과 비교하여 섭취 12주(22.01±13.08 pg/mL, 27.68±20.30 pg/mL)에 ACTH 농도가 감소하였다. 진약집단과 위약집단 모두 유의한 차이가 나타났다(p<0.001). 그러나 집단x측정시기의 상호작용 효과에서는 유의한 차이가 없었다.There was no significant difference in the comparison between groups by intake period of ACTH (adrenocorticotropic hormone). In the comparison according to intake period, 12 weeks of intake (22.01 ± 13.08 pg/mL, 27.68 ± 20.30 pg/mL) compared to before intake (38.34 ± 20.90 pg/mL, 45.39 ± 21.35 pg/mL) in both the active drug group and the placebo group ACTH concentration was decreased. There was a significant difference between the active drug group and the placebo group (p<0.001). However, there was no significant difference in the interaction effect of the group x measurement period.
Cortisol의 섭취 시기별 집단 간 비교에서는 유의한 차이가 나타나지 않았다. 섭취 시기에 따른 비교에서는 유의한 차이가 나타났으며(p<0.01) 이에 따른 사후검증 결과 진약집단의 섭취 8주(14.21±4.46 μg/dL)와 섭취 12주(12.86±3.81 μg/dL) 사이에서 Cortisol 농도가 증가하였다(p<0.01). 위약집단의 경우에는 섭취 시기별 비교에서 유의한 차이가 나타나지 않았다. 집단x섭취시기의 상호작용 효과는 나타나지 않았다.There was no significant difference in the comparison between groups by cortisol intake period. A significant difference was found in the comparison according to the intake period (p<0.01), and as a result of the post-mortem examination, it was between 8 weeks of intake (14.21±4.46 μg/dL) and 12 weeks of intake (12.86±3.81 μg/dL) of the Jinyak group. Cortisol concentration increased (p<0.01). In the case of the placebo group, there was no significant difference in the comparison by intake period. There was no interaction effect of group x intake time.
CRP(C-reactive protein)의 섭취 시기별 집단 간 비교는 섭취 전, 섭취 8주, 섭취 12주에서 유의한 차이나 나타나지 않았지만 섭취 시기에 따른 비교에서는 유의한 차이가 나타났다(p<0.05). 사후검증 결과 위약집단의 섭취 전과(0.99±1.02 mg/dL)와 섭취 8주(1.20±1.02 mg/dL) 사이에서 CRP농도가 유의하게 증가하였다(p<0.05). 집단x섭취시기의 상호작용 효과는 나타나지 않았다.
Comparison between groups by intake period of CRP (C-reactive protein) did not show any significant difference before intake, 8 weeks after intake, and 12 weeks after intake, but there was a significant difference in comparison according to intake period (p<0.05). As a result of the post-hoc test, the concentration of CRP significantly increased (p<0.05) in the placebo group before ingestion (0.99±1.02 mg/dL) and between 8 weeks of ingestion (1.20±1.02 mg/dL). There was no interaction effect of group x intake time.
실험예Experimental example 3: 유산소성 운동수행능력 분석 3: Analysis of aerobic exercise performance
실험예 2와 동일하게 위약집단과 진약집단으로 분류하고, 처치 전 진약집단과 위약집단의 유산소성 운동수행능력 변인을 분석한 결과를 도 8에 나타내었다. 이에 따르면, 최대산소섭취량은 진약집단(41.00±5.51)과 위약집단(41.13±4.49)은 유의한 차이는 나타나지 않았지만, 호흡교환율은 진약집단(0.96±0.05)에 비해 위약집단(1.06±0.05)이 낮게 나타났고, 유의한 차이가 나타났다(p<0.01). 한편, 최대심박수는 진약집단(166.64±19.45)과 위약집단(177.15±11.52)은 유의한 차이는 나타나지 않았다. METs는 진약집단(11.69±1.58)과 위약집단(11.76±1.28)은 유의한 차이는 나타나지 않았다.In the same manner as in Experimental Example 2, they were classified into a placebo group and an active drug group, and the results of analyzing the aerobic exercise performance variables of the active drug group and the placebo group before treatment are shown in FIG. 8 . According to this, there was no significant difference in the maximum oxygen uptake between the active drug group (41.00±5.51) and the placebo group (41.13±4.49), but the respiratory exchange rate was higher in the placebo group (1.06±0.05) than in the active drug group (0.96±0.05). was low, and there was a significant difference (p<0.01). On the other hand, there was no significant difference in maximum heart rate between the active drug group (166.64±19.45) and the placebo group (177.15±11.52). There was no significant difference in METs between the active drug group (11.69±1.58) and the placebo group (11.76±1.28).
또한, 처치 후의 진약집단과 위약집단이 유산소성 운동수행능력 변인 분석결과를 도 9에 나타내었다. 이에 따르면 최대산소섭취량은 진약집단(44.65±5.80)이 위약집단(39.23±5.06)에 비해 높게 나타났고, 유의한 차이가 나타났다(p<0.05). 호흡교환율에서는 진약집단(1.06±0.06)이 위약집단(1.11±0.05)에 비해 유의하게 낮게 나타났다(p<0.05). 최대심박수는 진약집단(172.78±17.32)과 위약집단(177.30±12.58)은 유의한 차이는 나타나지 않았다. METs는 진약집단(12.75±1.66)이 위약집단(11.20±1.44)에 비해 유의하게 높게 나타났다(p<0.05).
In addition, the analysis results of the aerobic exercise performance variables of the active drug group and the placebo group after treatment are shown in FIG. 9 . According to this, the maximum oxygen intake was higher in the herbal medicine group (44.65±5.80) than in the placebo group (39.23±5.06), and there was a significant difference (p<0.05). In the respiratory exchange rate, the active drug group (1.06±0.06) was significantly lower than the placebo group (1.11±0.05) (p<0.05). There was no significant difference in maximum heart rate between the active drug group (172.78±17.32) and the placebo group (177.30±12.58). METs were significantly higher in the active drug group (12.75±1.66) than in the placebo group (11.20±1.44) (p<0.05).
이상, 본 발명의 실시예들에 대하여 설명하였으나, 해당 기술 분야에서 통상의 지식을 가진 자라면 특허청구범위에 기재된 본 발명의 사상으로부터 벗어나지 않는 범위 내에서, 구성 요소의 부가, 변경, 삭제 또는 추가 등에 의해 본 발명을 다양하게 수정 및 변경시킬 수 있을 것이며, 이 또한 본 발명의 권리범위 내에 포함된다고 할 것이다.
Above, although embodiments of the present invention have been described, those of ordinary skill in the art can add, change, delete or add components within the scope that does not depart from the spirit of the present invention described in the claims. It will be possible to variously modify and change the present invention by, etc., which will also be included within the scope of the present invention.
Claims (5)
상기 헛개나무 과병 추출물은 말토덱스트린 및 β-사이클로덱스트린 중에서 선택된 어느 하나의 부형제와 혼합된 분말이고,
상기 암페롭신 또는 탁시폴린 함량의 측정은 상기 액상 제형의 건강기능식품 조성물을 25℃ 기준으로 1주 경과 내지 9주 이내로 장기 보관한 상태에서 수행되고,
상기 액상 제형의 건강기능식품의 헛개나무 과병 추출물 함량은 5 내지 2460 mg/100㎖ 이고,
상기 액상 제형의 건강기능식품 조성물에서 상기 암페롭신 함량이 60 내지 1000 ng/㎖이거나, 또는 상기 탁시폴린 함량은 20 내지 90 ng/㎖ 인 것을 특징으로 하는 헛개나무 과병 추출물을 유효성분으로 포함하는 액상 제형 건강기능식품 조성물의 기능성 확인방법.Measuring the content of ampheropsin or taxifolin as an indicator component of a health functional food composition in a liquid formulation containing the extract of the genus oleifera fruit as an active ingredient;
The fruit extract of Heotgae tree is a powder mixed with any one excipient selected from maltodextrin and β-cyclodextrin,
The measurement of the ampheropsin or taxifolin content is carried out in a state of long-term storage of the health functional food composition of the liquid formulation within 1 week to 9 weeks based on 25°C,
The content of the extract of Heotgae tree fruit disease of the health functional food of the liquid formulation is 5 to 2460 mg/100ml,
In the health functional food composition of the liquid formulation, the amperopsin content is 60 to 1000 ng/ml, or the taxifolin content is 20 to 90 ng/ml. A method for confirming the functionality of a formulated health functional food composition.
상기 기능성은 알코올성 간질환 개선 또는 예방 및 숙취해소 중에서 선택된 어느 하나인 것을 특징으로 하는 헛개나무 과병 추출물을 유효성분으로 포함하는 액상 제형 건강기능식품 조성물의 기능성 확인방법.According to claim 1,
The functionality is a method for confirming the functionality of a liquid health functional food composition comprising an extract from Heotgae tree fruit disease as an active ingredient, characterized in that any one selected from improvement or prevention of alcoholic liver disease and hangover relief.
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| KR20160092334A (en) * | 2015-01-27 | 2016-08-04 | 농업회사법인 주식회사 생명의나무 | Method for preparing powder of Hovenia dulcis fruit extract with activities for treatment, prevention or improvement of hepatotoxicity using beta-cyclodextrin, and powder of Hovenia dulcis fruit extract made therefrom |
| KR20160098982A (en) * | 2015-02-11 | 2016-08-19 | 한양대학교 에리카산학협력단 | Method for quality evaluation of hovenia dulcis extract |
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