KR101536231B1 - Composition for Preventing or Treating Insulin Resistance or Insulin Resistance-Related Diseases Comprising Eleutheroside E - Google Patents
Composition for Preventing or Treating Insulin Resistance or Insulin Resistance-Related Diseases Comprising Eleutheroside E Download PDFInfo
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- KR101536231B1 KR101536231B1 KR1020140118920A KR20140118920A KR101536231B1 KR 101536231 B1 KR101536231 B1 KR 101536231B1 KR 1020140118920 A KR1020140118920 A KR 1020140118920A KR 20140118920 A KR20140118920 A KR 20140118920A KR 101536231 B1 KR101536231 B1 KR 101536231B1
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- South Korea
- Prior art keywords
- insulin resistance
- insulin
- group
- diabetic
- eruceroside
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Abstract
본 발명은 유효성분으로서 엘루테로사이드 E(Eleutheroside E)를 포함하는 인슐린 저항성 또는 인슐린 저항성 관련 질환의 예방 또는 치료용 약학적 조성물, 및 건강기능식품에 관한 것이다. 본 발명은 혈당 조절, 내당능 개선, 인슐린 저항성 개선 및 혈중 인슐린 감소에 있어 유의한 효과를 나타내는 바, 인슐린 저항성 또는 인슐린 저항성 관련 질환의 예방 및 치료에 유용하게 사용될 수 있다. The present invention relates to a pharmaceutical composition for preventing or treating insulin resistance or an insulin resistance-related disease comprising Eleutheroside E as an active ingredient, and a health functional food. The present invention has a significant effect on controlling blood glucose, improving glucose tolerance, improving insulin resistance, and reducing blood insulin, and can be effectively used for the prevention and treatment of insulin resistance or insulin resistance-related diseases.
Description
본 발명은 유효성분으로서 엘루테로사이드 E(Eleutheroside E)를 포함하는 인슐린 저항성 또는 인슐린 저항성 관련 질환의 예방 또는 치료용 약학적 조성물, 및 건강기능식품에 관한 것이다.
The present invention relates to a pharmaceutical composition for preventing or treating insulin resistance or an insulin resistance-related disease comprising Eleutheroside E as an active ingredient, and a health functional food.
인슐린은 혈액에 있는 포도당을 에너지원으로 사용하는 데 중요한 역할을 하며, 각 세포막에 있는 인슐린 수용체를 통하여 포도당을 각 세포에 공급해준다. 인슐린저항성(insulin resistance)은 간, 지방 및 근육 조직이 정상적인 농도의 인슐린에 대해서 제대로 반응하지 않아 인슐린에 의한 포도당 및 영양분 대사조절에 이상이 나타나는 상태이다. 인슐린은 근육으로 포도당 섭취를 촉진하거나 간에서 포도당 생성을 억제함으로써 혈당을 조절하는데, 인슐린 저항성은 인슐린이 부족하지 않은 상태에서 이러한 인슐린 작용이 감소된 상태를 의미한다(Schulman GI, J. Clin . Invest. 106:171-176(2000)). 인슐린 저항성은 제2형 당뇨병, 비만, 고혈압, 고중성지방혈증, 저 HDL 콜레스테롤혈증, 관상동맥질환, 죽상동맥경화증 등의 질환을 일으키는 위험인자들의 중심적인 병인으로 알려져 있다.Insulin plays an important role in using glucose in the blood as an energy source and supplies glucose to each cell through the insulin receptor in each cell membrane. Insulin resistance is an abnormal state of glucose and nutrient metabolism control by insulin due to insufficient response of liver, fat and muscle tissues to normal levels of insulin. Insulin, which regulates blood sugar by stimulating glucose uptake in the muscle or by inhibiting glucose production in the liver, suggests that insulin resistance is reduced in insulin-deficient states (Schulman GI, J. Clin . Invest 106: 171-176 (2000)). Insulin resistance is known to be a central cause of risk factors for diseases such as
당뇨병은 다양한 이유에 의해 신체 항상성의 장애에 기인하여 혈장 포도당 수치가 정상 범위보다 높게 유지(단식 상태에서 126 mg/dl을 초과)되는 병 또는 다당증을 의미한다. 당뇨병에는 두 가지 타입이 있는데, 제1형 당뇨병은 β-세포의 파괴로 인하여 신체가 인슐린을 생산하지 않는 병이며, 제2형 당뇨병은 신체의 인슐린 저항성이 증가되어 신체가 인슐린을 완전히 활용하지 않는 병이다. 당뇨병 환자의 90% 이상이 제2형 당뇨 환자이다.Diabetes means a disease or polycythemia that causes plasma glucose levels to rise above the normal range (greater than 126 mg / dl in a fasting state) due to disorders of the body homeostatic for a variety of reasons. There are two types of diabetes:
현행 제2형 당뇨병의 경우 약물치료법을 살펴보면, 재평가된 메트포르민(metformin)과 티아졸리딘디온(thiazolidinedione, TZD)계열의 약물이 상당한 유용성을 보이고 있으나, 인슐린 저항성 발생 등 당뇨병의 근본적 원인 치료에는 이르지 못하고 있으며, 여러 부작용 또한 보고되고 있어 인슐린 저항성을 근본적으로 해결할 수 있는 보다 효능이 우수하고 안전한 약물의 개발이 필요하다. 현재 당뇨병 치료의 궁극적인 치료 목표는 지속적으로 혈당의 정상화를 유지하는 것이다. 이는 대부분의 당뇨합병증이 지속적인 고혈당에 의한 대사부전에 기인되며, 동물 및 임상에서 엄격한 혈당조절에 의해 합병증이 예방, 지연될 수 있다는 여러 실험예로부터 알 수 있다.In the case of
임상에서 사용되는 당뇨병 치료제는 크게 1) 인슐린분비를 촉진시키는 약물, 2) 인슐린 수용체의 감수성을 증강시키는 약물 및 3) 당분해를 억제하여 흡수를 억제하는 약물로 대별된다. 인슐린 제제는 생체 내의 인슐린과 동일한 생리작용을 나타내나 주사로 투여해야 하는 불편함이 있고 인슐린 내성이 문제가 되며, 설포닐우레아(Sulfonylurea)계 약물(글리벤클라미드(glibenclamide), 글리피지드 (glipizide), 글리퀴돈(gliquidone) 등)은 경구용이고 약가가 저렴하나 저혈당증 유발, 인슐린 분비능 상실 등의 문제가 있고, 비구아니드(Biguanide)계 약물(메트포르민(metformin), 펜포르민(phenformin) 등)은 위장장애 및 신장독성 등의 문제 가 있으며, 글리타존(Glitazone)계 약물(트로글리타존(troglitazone), 피오글리타존 (pioglitazone), 로시글리타존(rosiglitazone) 등)은 심부전, 빈혈 등의 부작용을 호소하거나 간부전으로 판매 금지되는 등 안전성과 약효에 문제가 있다. 따라서, 안전성과 약효를 동시에 확보할 수 있는 의약품의 개발이 절실한 상황이다.Drugs used for clinical use in diabetes are largely classified into 1) drugs that promote insulin secretion, 2) drugs that enhance insulin receptor sensitivity, and 3) drugs that inhibit glucose absorption and inhibit absorption. Insulin preparations exhibit the same physiological actions as insulin in vivo, but are inconvenient to be administered by injection, and insulin resistance is a problem. Sulfonylurea drugs (glibenclamide, glipizide glipizide and gliquidone are oral and low in cost, but they have problems such as hypoglycemia and loss of insulin secretion, and biguanide drugs such as metformin, phenformin, (Such as troglitazone, pioglitazone, rosiglitazone, etc.) may cause side effects such as heart failure or anemia, or may be caused by hepatic insufficiency There is a problem with safety and drug efficacy, such as being prohibited from selling. Therefore, the development of pharmaceuticals that can secure both safety and efficacy is urgently needed.
이와 같이 합성의약품의 부작용과 만성질환의 극복에 서양의학이 한계를 보임에 따라 천연물 신약에 대한 가치가 새롭게 부각되고 있다.As such, the value of new natural drugs has emerged as a result of the limited side effects of synthetic drugs and the overcoming of chronic diseases.
한편, 엘루테로사이드(Eleutheroside)는 가시오갈피(Eleutherococcus senticosus)의 뿌리로부터 분리된 화합물 그룹으로서, 엘루테로사이드 A, 엘루테로사이드 B, 엘루테로사이드 C, 엘루테로사이드 D, 엘루테로사이드 E, 엘루테로사이드 I, 엘루테로사이드 K, 엘루테로사이드 L 및 엘루테로사이드 M 등이 보고되었다. 또한, 가시오갈피에는 엘루테로사이드 외에 카페산(caffeic acid), 클로로겐산(chlorogenic acid), 캄페스테롤(campesterol), 비타민 및 미네랄 등의 다양한 성분을 포함하는 것으로 알려져 있다.On the other hand, Eleutheroside is a group of compounds separated from the root of Eleutherococcus senticosus, and is a group of compounds which are selected from the group consisting of Eluteroside A, Eluteroside B, Eluteroside C, Eluteroside D, Eluteroside E, Terroside I, Eluteroide K, Eluteroide L, and Eluteroide M have been reported. It is also known to contain various components such as caffeic acid, chlorogenic acid, campesterol, vitamins and minerals in addition to the eruceroside.
엘루테로사이드와 관련된 특허로는, 한국 특허 제10-0870893호는 엘루테로사이드 B를 포함하는 골 질환의 예방 및 개선용 건강기능식품을 개시하고 있고, 한국 특허 제10-0597564호는 골성장 촉진활성을 갖는 엘루테로사이드 E를 함유하는 약학 조성물을 개시하고 있다. 그러나, 엘루테로사이드 E의 인슐린 저항성 개선 효과, 내당능(Glucose tolerance) 개선 효과 및 혈당조절 효과에 대해서는 전혀 알려진 바 없다.
Korean Patent No. 10-0870893 discloses a health functional food for prevention and improvement of bone diseases including Eluteroside B, and Korean Patent No. 10-0597564 discloses a method for promoting bone growth Lt; RTI ID = 0.0 > E < / RTI > However, the effect of improving the insulin resistance, improving the glucose tolerance and controlling the blood glucose level of the eruceroside E is not known at all.
본 명세서 전체에 걸쳐 다수의 논문 및 특허문헌이 참조되고 그 인용이 표시되어 있다. 인용된 논문 및 특허문헌의 개시 내용은 그 전체로서 본 명세서에 참조로 삽입되어 본 발명이 속하는 기술 분야의 수준 및 본 발명의 내용이 보다 명확하게 설명된다.
Numerous papers and patent documents are referenced and cited throughout this specification. The disclosures of the cited papers and patent documents are incorporated herein by reference in their entirety to better understand the state of the art to which the present invention pertains and the content of the present invention.
본 발명자들은 당뇨병을 포함한 인슐린 저항성과 관련된 다양한 질환의 예방 및 치료에 유용한 물질을 찾기 위하여 노력하였다. 그 결과, 가시오갈피로부터 분리된 천연물질인 엘루테로사이드 E가 우수한 인슐린 저항성 개선 효과, 내당능 개선 효과, 혈당 조절 효과 및 혈중 인슐린 감소 효과를 나타낼 뿐만 아니라, 이의 활성이 가시오갈피 추출물보다 현저히 우수함을 확인함으로써, 본 발명을 완성하였다.The present inventors have sought to find substances useful for the prevention and treatment of various diseases related to insulin resistance including diabetes. As a result, it was confirmed that Eluteroside E, which is a natural substance separated from Ganoderma lucidum, shows excellent insulin resistance improving effect, glucose tolerance improving effect, blood glucose controlling effect and blood insulin reducing effect, Thereby completing the present invention.
따라서, 본 발명의 목적은 인슐린 저항성 또는 인슐린 저항성 관련 질환의 예방 또는 치료용 약학적 조성물을 제공하는 데 있다.Accordingly, an object of the present invention is to provide a pharmaceutical composition for preventing or treating insulin resistance or insulin resistance-related diseases.
본 발명의 다른 목적은 인슐린 저항성 또는 인슐린 저항성 관련 질환의 예방 또는 개선용 건강기능식품을 제공하는 데 있다.
Another object of the present invention is to provide a health functional food for preventing or ameliorating insulin resistance or insulin resistance-related diseases.
본 발명의 다른 목적 및 이점은 하기의 발명의 상세한 설명, 청구범위 및 도면에 의해 보다 명확하게 된다.
Other objects and advantages of the present invention will become more apparent from the following detailed description of the invention, claims and drawings.
본 발명의 일 양태에 따르면, 본 발명은 유효성분으로서 엘루테로사이드 E(Eleutheroside E)를 포함하는 인슐린 저항성 또는 인슐린 저항성 관련 질환의 예방 또는 치료용 약학적 조성물을 제공한다.
According to one aspect of the present invention, there is provided a pharmaceutical composition for preventing or treating an insulin resistance or an insulin resistance-related disease comprising Eleutheroside E as an active ingredient.
본 발명자들은 당뇨병을 포함한 인슐린 저항성과 관련된 다양한 질환의 예방 및 치료에 유용한 물질을 찾기 위하여 노력하였다. 그 결과, 가시오갈피로부터 분리된 천연물질인 엘루테로사이드 E가 우수한 인슐린 저항성 개선 효과, 내당능 개선 효과, 혈당 조절 효과 및 혈중 인슐린 감소 효과를 나타낼 뿐만 아니라, 이의 활성이 가시오갈피 추출물보다 현저히 우수함을 확인함으로써, 본 발명을 완성하였다.The present inventors have sought to find substances useful for the prevention and treatment of various diseases related to insulin resistance including diabetes. As a result, it was confirmed that Eluteroside E, which is a natural substance separated from Ganoderma lucidum, shows excellent insulin resistance improving effect, glucose tolerance improving effect, blood glucose controlling effect and blood insulin reducing effect, Thereby completing the present invention.
본 발명의 특징은 상기와 같이 가시오갈피 추출물보다 현저히 우수한 활성을 갖는 엘루테로사이드 E를 유효성분으로 포함하는 것이다.
A feature of the present invention is that it contains, as an active ingredient, eruceroside E, which has a remarkably excellent activity as compared with the extract of P. ganoderma, as described above.
본 명세서에서는 용어, "예방"은 본 발명의 조성물의 투여로 인슐린 저항성 및/또는 인슐린 저항성 관련 질환을 억제시키거나 진행을 지연시키는 모든 행위를 의미한다.As used herein, the term "prophylactic " means any action that inhibits or delays progression of insulin resistance and / or insulin resistance-related diseases upon administration of the composition of the present invention.
본 명세서에서 용어, "치료"는 인슐린 저항성 및/또는 인슐린 저항성 관련 질환의 발전의 억제; 인슐린 저항성 및/또는 인슐린 저항성 관련 질환의 경감; 및 인슐린 저항성 및/또는 인슐린 저항성 관련 질환의 제거를 의미한다.As used herein, the term "treatment" refers to the inhibition of the development of insulin resistance and / or insulin resistance related diseases; Alleviating insulin resistance and / or insulin resistance related diseases; And elimination of insulin resistance and / or insulin resistance related diseases.
본 명세서에서 용어, "인슐린 저항성"은 혈당을 낮추는 인슐린의 기능이 떨어져 세포가 포도당을 효과적으로 연소하지 못하는 것을 말한다. 인슐린 저항성이 높을 경우, 인체는 너무 많은 인슐린을 만들어 내고 이로 인해 고혈압이나 이상지방혈증은 물론 심장병, 당뇨병 등까지 초래할 수 있다. 특히, 제2형 당뇨병에서는 근육과 지방조직에서 인슐린의 증가를 알아채지 못하여, 인슐린의 작용이 일어나지 않는다.As used herein, the term "insulin resistance" refers to the inability of cells to burn glucose effectively because of insulin's ability to lower blood glucose. When the insulin resistance is high, the human body produces too much insulin, which can lead to hypertension and abnormal lipidemia as well as heart disease and diabetes. In particular,
본 명세서에서 용어, "인슐린 저항성 관련 질환"은 상기 인슐린 저항성이 직/간접적인 원인이 되어 유발되거나, 진행 및/또는 악화되는 질환을 총칭하는 개념이다.As used herein, the term "insulin resistance-related disease" is a concept collectively referred to as a disease caused, progressed and / or worsened by causing insulin resistance to be a direct / indirect cause.
본 발명의 바람직한 구현예에 따르면, 상기 인슐린 저항성 관련 질환은 당뇨병, 당뇨합병증, 고혈당증, 내당능 장애, 고인슐린혈증, 인슐린 저항성 증후군(Insulin resistance syndrome) 및 비만으로 구성된 군으로부터 선택된 하나 이상의 질환을 포함하나, 이에 의하여 제한되는 것은 아니다.According to a preferred embodiment of the present invention, the insulin resistance-related diseases include one or more diseases selected from the group consisting of diabetes, diabetic complications, hyperglycemia, impaired glucose tolerance, hyperinsulinemia, insulin resistance syndrome and obesity , But is not limited thereto.
인슐린 저항성은 제2형 당뇨병, 비만, 고혈압, 이상지질혈증, 저 HDL 콜레스테롤혈증 및 심혈관 질환을 일으키는 위험인자들의 중심적인 병인으로 알려져 있다. 또한, 전립선암(Barnard RJ et al., Obesity Reviews, 3:303-308(2002)), 제1형 당뇨병(Greenbaum, Diabetes Metab . Res . Rev, 18:192-200(2003)), 유방암(Stoll BA, Int . J. Obes . Relat . Metab . Disord. 26:747-753(2002)), 염증(Perseghin G et al., Int . J. Obes . Relat . Metab . Disord . 27 Suppl.3:S6-11( 2003)), 및 류마티스성 관절염(Dessen PH et al., J. Rheumatol. 30:1403-1405( 2003)) 등의 질환의 발생도 인슐린 저항성에 기인한다고 제시되고 있다.Insulin resistance is known to be a central cause of risk factors for
본 발명의 바람직한 구현예에 따르면, 상기 당뇨합병증은 당뇨성 망막병증, 당뇨성 백내장, 당뇨성 신증, 당뇨성 신경병증 및 골다공증으로 구성된 군으로부터 선택된 하나 이상의 질환을 포함하나, 이에 의하여 제한되는 것은 아니다. According to a preferred embodiment of the present invention, the diabetic complication includes, but is not limited to, one or more diseases selected from the group consisting of diabetic retinopathy, diabetic cataract, diabetic neuropathy, diabetic neuropathy and osteoporosis .
본 발명의 바람직한 구현예에 따르면, 상기 심혈관 질환은 고혈압, 심장병, 뇌졸중, 혈전증, 협심증, 심부전, 심근경색, 관상동맥질환, 동맥류, 색전증, 아테롬성 동맥경화증, 죽상경화증 및 동맥경화로 구성된 군으로부터 선택된 하나 이상의 질환을 포함하나, 이에 의하여 제한되는 것은 아니다.According to a preferred embodiment of the present invention, the cardiovascular disease is selected from the group consisting of hypertension, heart disease, stroke, thrombosis, angina pectoris, heart failure, myocardial infarction, coronary artery disease, aneurysm, embolism, atherosclerosis, atherosclerosis and arteriosclerosis Including, but not limited to, one or more diseases.
본 명세서에서 용어, "인슐린 저항성 증후군"은 상기 인슐린 저항성에 의하여 유발된 질환을 총칭하는 개념으로 인슐린 작용에 대한 세포의 저항성, 고인슐린혈증, 초저밀도지단백(very low density lipoprotein, VLDL)과 중성지방의 증가, 고밀도지단백(high density lipoprotein, HDL)의 감소 및 고혈압 등을 특징으로 하는 질환을 의미하며, 심혈관 질환과 제2형 당뇨병의 위험인자로 인식되고 있는 개념이다(Reaven GM., Role of insulin resistance in human disease, Diabetes, 37:1595-607(1988)).As used herein, the term "insulin resistance syndrome" is a generic term for the diseases caused by insulin resistance, and includes the cell resistance to insulin action, hyperinsulinemia, very low density lipoprotein (VLDL) (HDL) and hypertension, and is a concept recognized as a risk factor for cardiovascular disease and
또한, 인슐린 저항성은 고혈압, 당뇨, 흡연 등의 위험인자들과 함께 세포 내 산화스트레스를 증가시키고 신호전달체계를 변화시켜 염증반응을 유발하여 죽상경화증을 진행시킨다고 알려져 있다(Freeman BA et al., Biology of disease: free radicals and tissue injury, Lab . Invest. 47:412-26(1982), Kawamura M et al., Pathophysiological concentrations of glucose promote oxidative modification of low density lipoprotein by a superoxidedependent pathway, J. Clin . Invest. 94:771-8(1994)).In addition, it is known that insulin resistance increases risk factors such as hypertension, diabetes and smoking, thereby increasing intracellular oxidative stress and altering the signal transduction system to induce an inflammatory reaction (Freeman BA et al., Biology of disease: free radicals and tissue injury , Lab Invest 47:.... 412-26 (1982), Kawamura M et al, Pathophysiological concentrations of glucose promote oxidative modification of low density lipoprotein by a superoxidedependent pathway, J. Clin Invest. 94: 771-8 (1994)).
본 발명에 있어서, 유효성분인 엘루테로사이드 E는 가시오갈피(Eleutherococcus senticosus)의 뿌리로부터 분리된 엘루테로사이드(Eleutheroside)계 화합물 중 하나로 알려져 있으며, 구조식은 C34H46O18 이고, 분자량은 742.71이다. 상기 가시오갈피의 뿌리에는 엘루테로사이드 E 외에도 엘루테로사이드 A, 엘루테로사이드 B, 엘루테로사이드 C, 엘루테로사이드 D, 엘루테로사이드 I, 엘루테로사이드 K, 엘루테로사이드 L 및 엘루테로사이드 M 등 다양한 종류의 엘루테로사이드가 함유되어 있다.In the present invention, the active ingredient, eruceroside E, is an active ingredient, such as Eleutherococcus (Eleutheroside) compounds isolated from the roots of C. senticosus , the structural formula being C 34 H 46 O 18 , And the molecular weight is 742.71. In addition to the eruceroside E, the roots of the erythroroside E include Eluteroside A, Eluteroside B, Eluteroside C, Eluteroside D, Eluteroside I, Eluteroside K, Eluteroside L and Eluteroside M And various types of eruceroside.
본 발명의 바람직한 구현예에 따르면, 상기 엘루테로사이드 E는 혈액의 포도당 수치를 감소시키는 활성을 나타낸다.According to a preferred embodiment of the present invention, the above-mentioned eruceroside E exhibits an activity of reducing blood glucose levels.
본 발명의 바람직한 구현예에 따르면, 상기 엘루테로사이드 E는 내당능(glucose tolerance) 개선 활성을 나타낸다.According to a preferred embodiment of the present invention, the eruceroside E exhibits glucose tolerance improving activity.
본 발명의 바람직한 구현예에 따르면, 상기 엘루테로사이드 E는 인슐린 저항성 개선 활성 및 인슐린 민감도 증진 활성을 나타낸다.According to a preferred embodiment of the present invention, said eruceroside E exhibits insulin resistance improving activity and insulin sensitivity enhancing activity.
본 발명의 바람직한 구현예에 따르면, 상기 엘루테로사이드 E는 혈액의 인슐린 수치를 감소시키는 활성을 나타낸다.According to a preferred embodiment of the present invention, said eruceroside E exhibits an activity of reducing blood insulin levels.
하기 실시예에서 입증된 바와 같이, 엘루테로사이드 E는 혈중 포도당 감소 (도 1 참조), 내당능 개선(도 3 참조), 인슐린 저항성 개선(도 5 참조) 및 혈중 인슐린 감소(도 7 참조)에 있어 우수한 활성을 나타낸다. 특히, 이러한 엘루테로사이드 E의 활성은 엘루테로사이드 E를 비롯한 다양한 활성물질을 함유하는 가시오갈피 추출물보다 현저히 우수하다(도 2, 도 4 및 도 6 참조).As demonstrated in the following examples, Eluteroside E has been shown to be effective in reducing blood glucose (see Figure 1), improving glucose tolerance (see Figure 3), improving insulin resistance (see Figure 5) and reducing blood insulin (see Figure 7) Exhibit excellent activity. In particular, the activity of such eruceroside E is significantly better than that of the erythroroside E-containing visceral extract containing various active substances (see Figures 2, 4 and 6).
본 발명에 있어서, 상기 엘루테로사이드 E는 엘루테로사이드 E를 함유하는 식물, 바람직하게는 가시오갈피로부터 분리한 엘루테로사이드 E, 또는 화학적으로 합성하여 제조된 엘루테로사이드 E를 포함한다.In the present invention, the above-mentioned eruceroside E comprises a plant containing eruceroside E, preferably eruceroside E separated from the glacialus or chemotherily synthesized eruceroside E.
본 발명의 약학적 조성물은 약제학적으로 허용되는 담체를 포함한다. 본 발명의 약학적 조성물에 포함되는 약제학적으로 허용되는 담체는 제제시에 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. 본 발명의 약학적 조성물은 상기 성분들 이외에 윤활제, 습윤제, 감미제, 향미제, 유화제, 현탁제, 보존제 등을 추가로 포함할 수 있다. 적합한 약제학적으로 허용되는 담체 및 제제는 Remington's Pharmaceutical Sciences (19th ed., 1995)에 상세히 기재되어 있다.The pharmaceutical composition of the present invention includes a pharmaceutically acceptable carrier. The pharmaceutically acceptable carriers to be contained in the pharmaceutical composition of the present invention are those conventionally used in the present invention and include lactose, dextrose, sucrose, sorbitol, mannitol, starch, acacia rubber, calcium phosphate, alginate, gelatin, But are not limited to, calcium silicate, microcrystalline cellulose, polyvinylpyrrolidone, cellulose, water, syrups, methylcellulose, methylhydroxybenzoate, propylhydroxybenzoate, talc, magnesium stearate and mineral oil. It is not. The pharmaceutical composition of the present invention may further contain a lubricant, a wetting agent, a sweetening agent, a flavoring agent, an emulsifying agent, a suspending agent, a preservative, etc., in addition to the above components. Suitable pharmaceutically acceptable carriers and formulations are described in detail in Remington ' s Pharmaceutical Sciences (19th ed., 1995).
본 발명의 약학적 조성물은 경구 또는 비경구 투여할 수 있으며, 바람직하게는 경구 투여방식으로 적용된다.The pharmaceutical composition of the present invention can be administered orally or parenterally, and is preferably administered orally.
본 발명의 약학적 조성물의 적합한 투여량은 제제화 방법, 투여 방식, 환자의 연령, 체중, 성, 병적 상태, 음식, 투여 시간, 투여 경로, 배설 속도 및 반응 감응성과 같은 요인들에 의해 다양하게 처방될 수 있다. 본 발명의 약학적 조성물에 포함된 생리활성물질인 엘루테로사이드 E의 투여량은 성인 기준으로 0.001-100 ㎎/kg, 바람직하게는 0.1-100 ㎎/kg, 보다 바람직하게는 1-50 mg/kg 범위 내이다.The appropriate dosage of the pharmaceutical composition of the present invention may vary depending on such factors as formulation method, administration method, age, body weight, sex, pathological condition, food, administration time, route of administration, excretion rate, . The dose of eruceroside E, which is a physiologically active substance contained in the pharmaceutical composition of the present invention, is 0.001-100 mg / kg, preferably 0.1-100 mg / kg, more preferably 1-50 mg / kg. < / RTI >
본 발명의 약학적 조성물은 당해 발명이 속하는 기술분야에서 통상의 지식을 가진 자가 용이하게 실시할 수 있는 방법에 따라, 약제학적으로 허용되는 담체 및/또는 부형제를 이용하여 제제화함으로써 단위 용량 형태로 제조되거나 또는 다용량 용기 내에 내입시켜 제조될 수 있다. 이때, 제형은 오일 또는 수성 매질중의 용액, 현탁액, 시럽제 또는 유화액 형태이거나 엑스제, 산제, 분말제, 과립제, 정제 또는 캅셀제 형태일 수도 있으며, 분산제 또는 안정화제를 추가적으로 포함할 수 있다.
The pharmaceutical composition of the present invention may be formulated into a unit dosage form by formulating it using a pharmaceutically acceptable carrier and / or excipient according to a method which can be easily carried out by a person having ordinary skill in the art to which the present invention belongs. Or by intrusion into a multi-dose container. Here, the formulations may be in the form of solutions, suspensions, syrups or emulsions in an oil or aqueous medium, or in the form of excipients, powders, powders, granules, tablets or capsules, and may additionally contain dispersing or stabilizing agents.
다른 하나의 양태에 따르면, 본 발명은 유효성분으로서 엘루테로사이드 E(Eleutheroside E)를 포함하는 인슐린 저항성 또는 인슐린 저항성 관련 질환의 예방 또는 개선용 건강기능식품을 제공한다.According to another aspect, the present invention provides a health functional food for preventing or ameliorating insulin resistance or insulin resistance-related diseases, which comprises Eleutheroside E as an active ingredient.
상기 건강기능식품은 특별히 이에 제한되지 않으나, 건강 기능성 식품, 영양 보조제, 영양제, 파머푸드(pharmafood), 건강 식품, 뉴트라슈티칼(nutraceutical), 디자이너 푸드, 식품 첨가제 등의 모든 형태의 식품이 될 수 있는데, 바람직하게는 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 될 수 있다.The health functional food may be any type of food such as health functional food, nutritional supplement, nutritional product, pharmafood, health food, nutraceutical, designer food, food additive, etc. Preferably dairy products such as meat, sausage, bread, chocolates, candies, snacks, confectionery, pizza, ramen, other noodles, gums and ice cream, various soups, drinks, tea, drinks, alcoholic beverages and vitamins .
본 발명의 건강기능식품은 유효성분으로서 엘루테로사이드 E 뿐만 아니라, 식품 제조 시에 통상적으로 첨가되는 성분을 포함하며, 예를 들어, 단백질, 탄수화물, 지방, 영양소, 조미제 및 향미제를 포함한다. 상술한 탄수화물의 예는 모노사카라이드, 예를 들어, 포도당, 과당 등; 디사카라이드, 예를 들어 말토 스, 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.The health functional food of the present invention includes not only eruceroside E as an active ingredient, but also components that are ordinarily added in food production, and includes, for example, proteins, carbohydrates, fats, nutrients, flavoring agents, and flavoring agents . Examples of the above-mentioned carbohydrates are monosaccharides such as glucose, fructose, and the like; Disaccharides such as maltose, sucrose, oligosaccharides and the like; And polysaccharides such as dextrin, cyclodextrin and the like, and sugar alcohols such as xylitol, sorbitol and erythritol. Natural flavorings such as tau martin and stevia extract (e.g., rebaudioside A and glycyrrhizin) and synthetic flavorings (saccharine, aspartame, etc.) can be used as flavorings.
상기 외에 본 발명의 식품은 여러 가지 영양제, 비타민류, 광물(전해질), 식이성분, 합성 풍미제 및 천연 풍미제 등의 풍미제, 착색제 및 중진제(치즈, 초콜릿 등), 펙트산 및 그의 염, 알긴산 및 그의 염, 유기산, 보호성 콜로이드 증점제, pH 조절제, 안정화제, 방부제, 글리세린, 알콜, 탄산음료에 사용되는 탄산화제 등을 함유할 수 있다.In addition to the above-mentioned food, the food of the present invention can be used as a flavoring agent such as various nutrients, vitamins, minerals (electrolytes), dietary components, synthetic flavors and natural flavors, coloring agents and thickening agents (cheese, chocolate etc.) , Alginic acid and its salts, organic acids, protective colloid thickeners, pH adjusting agents, stabilizers, preservatives, glycerin, alcohols, carbonating agents used in carbonated drinks and the like.
예컨대, 본 발명의 식품 조성물이 드링크제로 제조되는 경우에는 본 발명의 유효성분인 엘루테로사이드 E 이외에 구연산, 액상과당, 설탕, 포도당, 초산, 사과산, 과즙, 각 종 식물 추출액 등을 추가로 포함시킬 수 있다.For example, when the food composition of the present invention is prepared as a drink, it may further contain citric acid, liquid fructose, sugar, glucose, acetic acid, malic acid, fruit juice, various plant extracts and the like in addition to the active ingredient, .
식품에 대한 용이한 접근성을 고려한다면, 본 발명의 식품은 인슐린 저항성 또는 인슐린 저항성 관련 질환의 예방 및 개선에 매우 유용하다.
Considering the easy accessibility to food, the food of the present invention is very useful for prevention and improvement of insulin resistance or insulin resistance-related diseases.
본 발명의 특징 및 이점을 요약하면 다음과 같다:The features and advantages of the present invention are summarized as follows:
(ⅰ) 본 발명의 엘루테로사이드 E를 유효성분으로 포함하는 약학적 조성물 및 건강기능식품은 혈당 조절, 내당능 개선, 인슐린 저항성 개선 및 혈중 인슐린 감소에 있어 유의한 효과를 나타낸다.(I) The pharmaceutical compositions and health functional foods comprising the inventive eruceroside E as an active ingredient show significant effects on controlling blood glucose, improving glucose tolerance, improving insulin resistance, and reducing blood insulin.
(ⅱ) 특히, 상기 효과에 있어 엘루테로사이드 E는 다양한 유효성분을 포함하는 가시오갈피 추출물에 비하여 현저히 우수한 효과를 나타낸다.(Ii) In particular, in the above-mentioned effect, the eruceroside E exhibits a remarkably excellent effect as compared with the astringent skin extract containing various active ingredients.
(ⅲ) 본 발명에 의하면, 인슐린 저항성 및 인슐린 저항성과 관련된 다양한 질환을 예방 및 치료할 수 있다.
(Iii) According to the present invention, various diseases related to insulin resistance and insulin resistance can be prevented and treated.
도 1은 당뇨대조군 및 엘루테로사이드 E 투여군의 시간흐름에 따른 혈당 변화를 나타낸다.
도 2는 당뇨대조군, 가시오갈피 추출물 투여군 및 엘루테로사이드 E 투여군의 시간흐름에 따른 혈당 변화를 나타낸다.
도 3은 당뇨대조군 및 엘루테로사이드 E 투여군에 포도당 용액을 복강 내 투여한 후의 시간흐름에 따른 혈당 변화를 나타낸다.
도 4는 당뇨대조군, 가시오갈피 추출물 투여군 및 엘루테로사이드 E 투여군에 포도당 용액을 복강 내 투여한 후의 시간흐름에 따른 혈당 변화를 나타낸다.
도 5는 당뇨대조군 및 엘루테로사이드 E 투여군에 인슐린 용액을 복강 내 투여한 후의 시간흐름에 따른 혈당 변화를 나타낸다.
도 6은 당뇨대조군, 가시오갈피 추출물 투여군 및 엘루테로사이드 E 투여군에 인슐린 용액을 복강 내 투여한 후의 시간흐름에 따른 혈당 변화를 나타낸다.
도 7은 당뇨대조군 및 엘루테로사이드 E 투여군의 혈중 인슐린 수치를 나타낸다.Fig. 1 shows blood glucose changes with time in the diabetic control group and the eruceroside E administration group.
FIG. 2 shows blood glucose changes with time in the diabetic control group, Acanthopanax senticosus extract-administered group, and Eluteroide E treated group.
Fig. 3 shows blood glucose changes with time after intraperitoneal administration of a glucose solution to the diabetic control group and the eruceroside E administration group.
FIG. 4 shows blood glucose changes according to time after intraperitoneal administration of a glucose solution to the diabetic control group, the extract of Acanthopanax senticosus extract, and the group administered with eruceroside E.
FIG. 5 shows blood glucose changes with time after the insulin solution was intraperitoneally administered to the diabetic control group and the eruceroside E administration group.
FIG. 6 shows blood glucose changes according to time after intraperitoneal administration of an insulin solution to a diabetic control group, a ganorrhoea extract-administered group, and an eruceroside E-administered group.
FIG. 7 shows blood insulin levels in the diabetic control group and the eruceroside E administration group.
이하, 실시예를 통하여 본 발명을 더욱 상세히 설명하고자 한다. 이들 실시예는 오로지 본 발명을 보다 구체적으로 설명하기 위한 것으로, 본 발명의 요지에 따라 본 발명의 범위가 이들 실시예에 의해 제한되지 않는다는 것은 당업계에서 통상의 지식을 가진 자에 있어서 자명할 것이다.
Hereinafter, the present invention will be described in more detail with reference to Examples. It is to be understood by those skilled in the art that these embodiments are only for describing the present invention in more detail and that the scope of the present invention is not limited by these embodiments in accordance with the gist of the present invention .
실시예Example
본 명세서 전체에 걸쳐, 특정 물질의 농도를 나타내기 위하여 사용되는 "%"는 별도의 언급이 없는 경우, 고체/고체는 (중량/중량) %, 고체/액체는 (중량/부피) %, 그리고 액체/액체는 (부피/부피) %이다.
Throughout this specification, "%" used to denote the concentration of a particular substance is intended to include solids / solids (wt / wt), solid / liquid (wt / The liquid / liquid is (vol / vol)%.
실시예Example 1. One. 엘루테로사이드Eluteroside Ｅ의 혈당조절 효과 Effect of E on Blood Glucose
<1-1> <1-1> 엘루테로사이드Eluteroside Ｅ의 혈당 감소 효과 확인 E to check blood sugar reduction effect
5주령 된 C57BLKS/J Iar-+Leprdb/ + Leprdb 마우스를 1주일 동안 안정화시킨 뒤 일반식이 급여군(DM) 및 0.003% 엘루테로사이드 E(Chromodextm, RSS-3195-00)를 포함하는 실험식이 급여군(DM + EE)(식이 1Kg 당 0.03g 함유)으로 분류하여 실험을 진행하였다. 5주 동안 각 식이를 공급하였으며, 매 주마다 동일한 시간에 혈당 수치를 측정하였다. 혈당은 실험동물을 4시간 절식시킨 후(식이를 빼줄 때에는 케이지 안에 남아있는 식이가 있으므로 케이지도 함께 교체하였다), 실험동물의 눈을 가린 상태에서 움직이지 않도록 고정시킨 다음 꼬리 정맥에서 채취한 혈액을 혈당측정기를 사용하여 측정하였다. 실험결과는 도 1에 나타내었다.Five-week-old C57BLKS / J Iar- + Lepr db / + Lepr db mice were stabilized for one week and given empirical equations including the general diet group (DM) and 0.003% erloteroside E (Chromodextm, RSS-3195-00) (DM + EE) (containing 0.03 g per 1 kg of the diet). Each diet was fed for 5 weeks and blood glucose levels were measured at the same time every week. Blood glucose was measured by fasting the experimental animals for 4 hours (when the diets were withdrawn, the cages were also changed because there was a diet in the cage) Using a blood glucose meter. The experimental results are shown in Fig.
도 1 에 나타난 바와 같이, 당뇨대조군(DM)은 시간이 지남에 따라 혈당수치가 현저히 상승하였으나, 엘루테로사이드 E 포함 실험식이 급여군(DM+EE)은 당뇨대조군에 비해 주 별 혈당 상승이 유의적으로 감소하였다. 이러한 결과는 엘루테로사이드 E가 혈당을 조절할 수 있음을 의미한다.
As shown in FIG. 1, the blood glucose level of the DM group increased significantly over time. However, in the EM group containing the eruteroside E, the diabetes control group (DM + EE) Respectively. These results indicate that eruceroside E can regulate blood sugar.
<1-2> 가시오갈피 추출물과 ≪ 1-2 > 엘루테로사이드Eluteroside E의 혈당 감소 효과 비교 Comparison of blood glucose reduction effect of E
5주령 된 C57BLKS/J Iar-+Leprdb/ + Leprdb 마우스를 1주일 동안 안정화시킨 뒤 일반식이 급여군(당뇨군), 가시오갈피 추출물을 포함하는 실험식이 급여군(당뇨군 + 가시오갈피)(식이 1Kg 당 0.5g 함유) 및 0.003% 엘루테로사이드 E를 포함하는 실험식이 급여군(당뇨군 + 엘루테로사이드 E)(식이 1Kg 당 0.03g 함유) 등 세 그룹으로 분류하였다. 실험은 상기 실시예 1-1과 동일하게 실시하였으며, 결과는 도 2에 나타내었다.Five weeks old C57BLKS / J Iar- + Lepr db / + Lepr db mice were stabilized for 1 week and fed diet group (diabetic group + diabetic group) (Diabetic group + eruteroside E) (containing 0.03 g per 1 kg of the diet) were included in the empirical formula containing 0.003% eruteroside E (containing 0.5 g per 1 kg of diet). The experiment was carried out in the same manner as in Example 1-1, and the results are shown in Fig.
도 2에 나타난 바와 같이, 당뇨군 + 엘루테로사이드 E 군은 당뇨군에 비하여 주별 혈당이 유의적으로 감소하였다. 반면, 당뇨군 + 가시오갈피군은 주별 혈당에 있어 당뇨군에 비하여 유의적인 차이를 보이지 않았다. 이상의 결과를 통하여 가시오갈피 추출물보다 가시오갈피 단일물질인 엘루테로사이드 E의 혈당 감소 효과가 현저히 우수함을 확인할 수 있었다.
As shown in FIG. 2, diabetes + eruceroside E group showed significantly lower weekly blood sugar than diabetic group. On the other hand, diabetic group + astigmatism group showed no significant difference in weekly blood glucose compared to diabetic group. From the above results, it was confirmed that the blood glucose lowering effect of eruceroside E, which is a single substance of astaxanthin,
실시예Example 2. 2. 엘루테로사이드Eluteroside Ｅ의 Of E 내당능Glucose tolerance 개선 효과 Improvement effect
<2-1> <2-1> 엘루테로사이드Eluteroside Ｅ의 Of E 내당능Glucose tolerance 개선 효과 확인 Check the improvement
당뇨병으로 인해 나타나는 고혈당증은 포도당을 대사할 수 있는 능력이 저하됨에 따라 나타나게 되는데 이러한 내당능(glucose tolerance)을 측정하기 위하여, 포도당 용액을 복막(Intraperitoneal) 내로 투여한 후 시간별로 혈당을 측정하였다. 이를 위하여, 5주령 된 C57BLKS/J Iar-+Leprdb/ + Leprdb 마우스를 1주일 동안 안정화시킨 뒤 일반식이 급여군(DM) 및 0.003% 엘루테로사이드 E를 포함하는 실험식이 급여군(DM + EE)으로 분류하여 실험을 진행하였다. 5주 동안 식이를 공급하였다. 멸균 주사용수를 사용하여 2 g/kg 농도로 포도당 용액을 제조하였으며, 복강 내 투여하기 전까지 4℃에서 보관하였다. 실험동물은 IP GTT(Glucose tolerance test)를 측정하기 위하여 4시간 절식시킨 뒤(식이를 빼줄 때에는 케이지 안에 남아있는 식이가 있으므로 케이지도 함께 교체하였다), 절식이 끝나면 0분 혈당을 혈당 측정기를 사용하여 측정하였다. 이후, 미리 준비해 둔 포도당 용액을 복강 내에 투여한 후, 혈당측정기를 사용하여 15, 30, 60, 90, 120 및 150분의 시간별로 혈당을 측정하였다. 측정결과는 도 3에 나타내었다.Hyperglycemia due to diabetes occurs as the ability to metabolize glucose decreases. To measure glucose tolerance, glucose solution was administered intraperitoneally and blood glucose was measured over time. For this purpose, 5 week old C57BLKS / J Iar- + Lepr db / + Lepr db mice were stabilized for 1 week and fed diet (DM + 0.003% EE). The diets were fed for 5 weeks. The glucose solution was prepared at a concentration of 2 g / kg using sterile water for injection and stored at 4 ° C until intraperitoneal administration. The animals were fasted for 4 hours to measure the IP GTT (Glucose tolerance test). After the fasting was completed, the blood glucose was measured using a glucose meter Respectively. Thereafter, a glucose solution prepared in advance was administered into the abdominal cavity, and blood glucose was measured at time points of 15, 30, 60, 90, 120 and 150 minutes using a blood glucose meter. The measurement results are shown in Fig.
도 3에 나타난 바와 같이, 엘루테로사이드 E 포함 실험식이 급여군(DM+EE)은 당뇨대조군(DM)에 비해 포도당 투입에 의한 시간별 혈당 상승을 유의적으로 억제시켰다. 또한, AUC(area under curve)도 당뇨대조군(DM)에 비해 유의적인 차이를 보였다. 이러한 결과는 엘루테로사이드 E가 혈당상승을 효과적으로 억제할 수 있음을 나타내며, 이는 엘루테로사이드 E 섭취에 의하여 인슐린 민감도가 증가된 것으로 볼 수 있다.
As shown in FIG. 3, the feeding group (DM + EE) containing the eruteroside E significantly inhibited the glucose uptake by glucose injection by time, as compared with the diabetes control group (DM). In addition, the area under curve (AUC) was significantly different from that of the control group (DM). These results indicate that eruceroside E can effectively inhibit blood glucose elevation, which can be seen as an increase in insulin sensitivity due to eruceroside E ingestion.
<2-2> 가시오갈피 추출물과 ≪ 2-2 > 엘루테로사이드Eluteroside E의 Of E 내당능Glucose tolerance 개선 효과 비교 Comparison of Improvement Effects
5주령 된 C57BLKS/J Iar-+Leprdb/ + Leprdb 마우스를 1주일 동안 안정화시킨 뒤 일반식이 급여군(당뇨군), 가시오갈피 추출물을 포함하는 실험식이 급여군(당뇨군 + 가시오갈피)(식이 1Kg 당 0.5g 함유) 및 0.003% 엘루테로사이드 E를 포함하는 실험식이 급여군(당뇨군 + 엘루테로사이드 E) 등 세 그룹으로 분류하였다. 실험은 상기 실시예 2-1과 동일하게 실시하였으며, 결과는 도 4에 나타내었다.Five weeks old C57BLKS / J Iar- + Lepr db / + Lepr db mice were stabilized for 1 week and fed diet group (diabetic group + diabetic group) (Containing 0.5 g per 1 kg of diet) and 0.003% of eruceroside E were divided into three groups: diabetic group + eluteroside E. The experiment was carried out in the same manner as in Example 2-1, and the results are shown in FIG.
도 4에 나타난 바와 같이, 당뇨군 + 엘루테로사이드 E 군은 당뇨군에 비하여 시간별 혈당이 유의적으로 감소하였다. 또한, AUC도 당뇨군에 비해 유의적인 차이를 보였다. 반면, 당뇨군 + 가시오갈피군은 시간별 혈당 및 AUC에 있어 당뇨군에 비하여 유의적인 차이를 보이지 않았다. 본 실험결과를 통하여 가시오갈피 단일물질인 엘루테로사이드 E가 가시오갈피 추출물보다 현저히 우수한 내당능 개선 효과 및 인슐린 민감도 증가 효과를 나타냄을 확인할 수 있었다.
As shown in FIG. 4, in the diabetic group + Eluteroside E group, the blood glucose level was significantly decreased with time compared to the diabetic group. In addition, AUC was significantly different from diabetic group. On the other hand, the blood glucose and AUC of the diabetic group + astigmatism group did not show any significant difference compared to the diabetic group. From the results of this experiment, it was confirmed that the eruceroside E, which is a single substance of astringent scabbard, exhibits a remarkably superior glucose tolerance and insulin sensitivity enhancement.
실시예Example 3. 3. 엘루테로사이드Eluteroside Ｅ의 인슐린 저항성 개선 효과 Effect of E on insulin resistance
<3-1> <3-1> 엘루테로사이드Eluteroside Ｅ의 인슐린 저항성 개선 효과 확인 E to improve insulin resistance
혈액에 있는 포도당을 에너지원으로 사용하기 위해서는 인슐린이 중요한 역할을 하는데, 각 세포막에 있는 인슐린 수용체를 통해 포도당을 각 세포에 공급해준다. 그러나, 각 세포들의 인슐린 수용체의 민감도가 떨어지게 되면 세포가 포도당이 도착한 것을 인지하지 못하고 포도당을 제대로 흡수할 수가 없어 결국 남은 포도당이 혈액을 떠돌아다니게 되어 혈당을 높이게 된다. 인슐린 민감도가 낮은 상태인 인슐린 저항성이 오랜 기간 심하게 지속이 되면, 우리 몸에서 인슐린을 만들어 내는 능력이 한계에 부딪히게 되어 인슐린 분비가 줄어들게 된다. 이렇게 균형이 깨지게 되면 부족한 인슐린 분비로 인하여 혈당이 올라가게 되어 인슐린 저항성이 더 높아지게 된다. 이에 따라, 본 발명자들은 엘루테로사이드 E의 인슐린 저항성 개선 효과를 확인하고자 하였다.Insulin plays an important role in using glucose in the blood as an energy source, supplying glucose to each cell through the insulin receptor in each cell membrane. However, if the sensitivity of insulin receptor in each cell drops, the cell does not recognize the arrival of glucose and can not absorb glucose properly. Eventually, the remaining glucose moves around the blood and increases blood sugar. If the insulin resistance, which is low in insulin sensitivity, persists for a long time, the ability to produce insulin in our body will be limited and the insulin secretion will be reduced. When this balance is broken, insulin secretion causes insulin resistance to rise because of the increase in blood sugar. Accordingly, the present inventors tried to confirm the effect of improving the insulin resistance of the eruceroside E.
이를 위하여, 5주령 된 C57BLKS/J Iar-+Leprdb/ + Leprdb 마우스를 1주일 동안 안정화시킨 뒤 DM군(당뇨대조군) 및 0.003% 엘루테로사이드 E 급여군(DM+EE)으로 분류한 후 5주 동안 식이를 공급하였다. 멸균주사용수를 사용하여 1.3 unit/kg 농도의 인슐린 용액을 제조한 후, 복강 내 투여하기 전까지 만들어 4℃에서 보관하였다. 실험동물은 IP ITT(insulin tolerance test)를 측정하기 위하여 4시간 절식시킨 후(식이를 빼줄 때에는 케이지 안에 남아있는 식이가 있으므로 케이지도 함께 교체하였다), 절식이 끝나면 0분 혈당을 혈당측정기를 사용하여 측정하였다. 이후, 미리 준비해 둔 인슐린 용액을 복강 내에 투여한 후, 혈당측정기를 사용하여 15, 30, 60, 90 및 120분의 시간별로 혈당을 측정하였다. 측정결과는 도 5에 나타내었다.For this, 5-week-old C57BLKS / J Iar- + Lepr db / + Lepr db mice were stabilized for 1 week and classified into DM group (diabetic control group) and 0.003% eluteroside E group (DM + EE) The diets were fed for 5 weeks. Insulin solutions were prepared at a concentration of 1.3 unit / kg using sterile water for injection and stored at 4 ° C until intraperitoneal administration. The animals were fasted for 4 hours to measure the IP ITT (insulin tolerance test) (the cage was also replaced because the diet remained in the cage when the diet was withdrawn). After the fasting, 0 min of blood glucose was measured using a glucose meter Respectively. Thereafter, the previously prepared insulin solution was administered into the abdominal cavity, and then blood glucose was measured at 15, 30, 60, 90 and 120 minutes using a blood glucose meter. The measurement results are shown in Fig.
도 5에 나타난 바와 같이, 인슐린 급여 시 시간별 혈당량에 있어 엘루테로사이드 E 포함 실험식이 급여군(DM+EE)은 당뇨대조군(DM)에 비해 혈당량이 유의적으로 낮았다. 또한, AUC(area under curve)도 당뇨대조군(DM)에 비해 유의적인 차이를 보였다. 본 실험결과를 통하여 엘루테로사이드 E가 인슐린 민감도를 증가시킬 수 있음을 확인할 수 있었다.
As shown in FIG. 5, the blood glucose level of the dietary group (DM + EE) was significantly lower than that of the diabetic control group (DM) in the experimental formula containing the eruceroside E in the hourly blood glucose level at the time of insulin administration. In addition, the area under curve (AUC) was significantly different from that of the control group (DM). The results of this experiment confirmed that the eruceroside E can increase the insulin sensitivity.
<3-2> 가시오갈피 추출물과 ≪ 3-2 > 엘루테로사이드Eluteroside E의 인슐린 저항성 개선 효과 비교 Comparison of insulin resistance improvement effect of E
5주령 된 C57BLKS/J Iar-+Leprdb/ + Leprdb 마우스를 1주일 동안 안정화시킨 뒤 일반식이 급여군(당뇨군), 가시오갈피 추출물을 포함하는 실험식이 급여군(당뇨군 + 가시오갈피)(식이 1Kg 당 0.5g 함유) 및 0.003% 엘루테로사이드 E를 포함하는 실험식이 급여군(당뇨군 + 엘루테로사이드 E) 등 세 그룹으로 분류하였다. 실험은 상기 실시예 3-1과 동일한 방법으로 실시하였으며, 결과는 도 6에 나타내었다.Five weeks old C57BLKS / J Iar- + Lepr db / + Lepr db mice were stabilized for 1 week and fed diet group (diabetic group + diabetic group) (Containing 0.5 g per 1 kg of diet) and 0.003% of eruceroside E were divided into three groups: diabetic group + eluteroside E. The experiment was carried out in the same manner as in Example 3-1, and the results are shown in FIG.
도 6에 나타난 바와 같이, 당뇨군 + 엘루테로사이드 E 군은 당뇨군에 비하여 시간별 혈당이 유의적으로 감소하였다. 또한, AUC도 당뇨군에 비하여 유의적인 차이를 나타내었다. 반면, 당뇨군 + 가시오갈피군은 시간별 혈당 및 AUC에 있어 당뇨군에 비하여 유의적인 차이를 보이지 않았다. 본 실험결과를 통하여 가시오갈피 단일물질인 엘루테로사이드 E가 가시오갈피 추출물보다 현저히 우수한 인슐린 민감도 증가 효과(인슐린 저항성 개선 효과)를 가지고 있음을 확인할 수 있었다.
As shown in FIG. 6, the blood glucose level in the group of the diabetic + the group of the eruceroside E was significantly lower than that of the diabetic group. In addition, AUC was significantly different from diabetic group. On the other hand, the blood glucose and AUC of the diabetic group + astigmatism group did not show any significant difference compared to the diabetic group. From the results of this experiment, it was confirmed that the eruceroside E, a single substance of astringent skin, has a remarkably superior insulin sensitivity (insulin resistance improving effect)
실시예Example 4. 인슐린 측정 - 인슐린 저항성 개선 효과 확인 4. Measuring Insulin - Checking Insulin Resistance Improvement Effect
포도당이 간으로 들어가면 글리코겐, 지방, 단백질로 합성이 되는데 이렇게 인슐린의 도움으로 근육과 간으로 포도당이 이동하면 혈중 포도당 수준은 떨어지게 되고 인슐린의 분비는 감소하게 된다. 반대로 혈당이 떨어지게 되면 췌장의 알파세포에서 글루카곤을 분비해서 간에 글리코겐 형태로 저장되어 있던 글루코스가 다시 혈액으로 분비되고 이렇게 해서 혈당 레벨을 올리게 된다. 따라서, 췌장에서 정상적인 인슐린 분비가 일어나지 못하게 되면 체내의 혈당을 조절하지 못하게 된다. 따라서, 항당뇨 소재를 공급한 실험동물에서 췌장 인슐린을 측정하여 당뇨조절에 관한 바이오마커로 활용할 수 있다. 이에 따라, 본 발명자들은 엘루테로사이드 E 섭취 후의 혈중 인슐린 양을 측정하고자 하였다.When glucose enters the liver, it is synthesized as glycogen, fat, and protein. With the help of insulin, the glucose level in the blood drops and the secretion of insulin decreases when glucose moves through muscle and liver. Conversely, when the blood sugar level drops, the glucose, which is stored in the glycogen form in the liver, is secreted from the alpha cell of the pancreas and secreted again into the blood, thereby raising the blood glucose level. Therefore, if the normal insulin secretion does not occur in the pancreas, the blood sugar in the body can not be controlled. Therefore, it can be used as a biomarker for diabetic control by measuring pancreatic insulin in an animal fed with anti-diabetic material. Accordingly, the present inventors tried to measure the amount of insulin in the blood after the ingestion of the eruceroside E.
이를 위하여 5주령 된 C57BLKS/J Iar-+Leprdb/ + Leprdb 마우스를 1주일 동안 안정화시킨 뒤 일반식이 급여군(DM) 및 0.003% 엘루테로사이드 E를 포함하는 실험식이 급여군(DM+EE)으로 분류하여 실험을 진행하였다. 5주 동안 식이를 공급한 후 실험동물로부터 혈액 10 ㎕를 채취하였다. 인슐린 측정 키트(Insulin(Mouse) Ultrasensitive ELISA, Alpco)의 모든 시약들은 분석하기 전에 미리 상온에 꺼내어 두었다. 비오틴 컨쥬게이트 항-인슐린 항체(Biotin conjugated anti-Insulin)는 비오틴(×4000) 2 ㎕와 버퍼 7.998 ㎖를 섞어 준비하였다. HRP-컨쥬게이트 스트렙타비딘(HRP-conjugated streptavidin)은 HRP(x2000) 4 ㎕와 버퍼 용액 7.996 ㎖를 섞어 준비하였다. 세척 버퍼(Washing buffer)는 세척 버퍼(x10) 10 ㎖와 증류수 90 ㎖을 넣어 1x로 희석하였다. 표준 스톡 용액(standard stock solution, 200 ng/㎖)은 표준(standard) 10 ng/㎖가 되도록 표준 스톡 (200 ng/㎖) 10 ㎕와 버퍼 용액 190 ㎕를 넣어 제조하였다. 그 다음 1/2씩 희석하였다(10, 5, 2.5, 1.25, 0.625, 0.313 및 0.156 ng/㎖). 블랭크(Blank)는 버퍼 용액으로 하였다. 세척 버퍼를 200 ㎕씩 각 웰에 넣어 4번 반복하여 세척하였다. 이후, 비오틴 컨쥬게이트 항-인슐린 항체를 100 ㎕씩 멀티피펫을 사용하여 첨가한 후 상온에서 2시간 동안 반응시켰다. 표준 용액 및 시료를 순서대로 각 웰에 10 ㎕씩 넣고 교반한 후 상온에서 2시간 동안 반응시켰다. 세척 버퍼 200 ㎕를 혈청, 대조군 및 표준 웰에 각각 넣어 4번 반복하여 세척하였다. HRP-컨쥬게이트 스트렙타비딘 용액을 혈청, 대조군 및 표준 웰에 첨가한 후 상온에서 30분간 반응시켰다. 세척 버퍼 200 ㎕를 혈청, 대조군 및 표준 웰에 넣어 각각 4번 반복하여 세척하였다. 기질 발색체 시약(Substrate chromogen reagent, TMB)을 혈청, 대조군 및 표준 웰에 100 ㎕씩 넣고 쉐이킹 한 후, 상온에서 30분간 반응시켰다. 반응 종결액(Reaction stopper)을 혈청, 대조군 및 표준 웰에 100 ㎕씩 넣은 후 쉐이킹하여 반응을 정지시켰다. 이후, ELISA 리더를 이용하여 450 nm 파장에서 30분 이내로 측정하였으며, 측정한 인슐린 수치는 췌장의 무게로 나눠서 계산하였다. 결과는 도 7에 나타내었다.For this purpose, 5 week old C57BLKS / J Iar- + Lepr db / + Lepr db mice were stabilized for 1 week and fed diet group containing DM diet and 0.003% ), And the experiment was conducted. After feeding for 5 weeks, 10 μl of blood was collected from the experimental animals. All reagents from the Insulin (Mouse) Ultrasensitive ELISA, Alpco) were taken out at room temperature before analysis. Biotin conjugated anti-insulin antibody was prepared by mixing 2 μl of biotin (× 4000) and 7.998 ml of buffer. HRP-conjugated streptavidin (HRP-conjugated streptavidin) was prepared by mixing 4 μl of HRP (x2000) and 7.996 ml of buffer solution. Washing buffer was diluted 1x with 10 ml of wash buffer (x10) and 90 ml of distilled water. Standard stock solution (200 ng / ml) was prepared by adding 10 μl of standard stock (200 ng / ml) and 190 μl of buffer solution to standard 10 ng / ml. Then diluted 1/2 (10, 5, 2.5, 1.25, 0.625, 0.313 and 0.156 ng / ml). Blank was prepared as a buffer solution. 200 μl of wash buffer was added to each well and washed 4 times. Then, 100 μl of the biotin conjugated anti-insulin antibody was added using a multipipette, and reacted at room temperature for 2 hours. The standard solution and the sample were added in the order of 10 μl into each well, stirred, and reacted at room temperature for 2 hours. 200 [mu] l of wash buffer was added to each of the serum, control and standard wells and washed 4 times repeatedly. The HRP-conjugated streptavidin solution was added to the serum, control, and standard wells, followed by reaction at room temperature for 30 minutes. 200 [mu] l of wash buffer was added to the serum, control and standard wells and washed four times each. Substrate chromogen reagent (TMB) was added to the serum, control and standard wells in an amount of 100 μl, followed by shaking, followed by reaction at room temperature for 30 minutes. Reaction stoppers were added to the serum, control and standard wells in an amount of 100 占 퐇, and the reaction was stopped by shaking. Thereafter, measurements were taken using an ELISA reader at a wavelength of 450 nm within 30 minutes, and the measured insulin levels were calculated by dividing by the weight of the pancreas. The results are shown in Fig.
도 7에 나타난 바와 같이, 엘루테로사이드 E 포함 실험식이 급여군(DM+EE)은 당뇨대조군(DM)에 비해 혈중 인슐린의 농도가 감소하는 것을 확인할 수 있었다. 이러한 결과는 당뇨군에서 나타난 인슐린 저항성이 엘루테로사이드 E에 의하여 효과적으로 개선되었음을 의미한다.
As shown in FIG. 7, it was confirmed that the experimental group containing the eruceroside E showed a decrease in blood insulin concentration in the DM group (DM + EE) compared to the diabetic control group (DM). These results indicate that the insulin resistance in the diabetic group was effectively improved by the eruceroside E.
이상으로 본 발명의 특정한 부분을 상세히 기술하였는 바, 당업계의 통상의 지식을 가진 자에게 있어서 이러한 구체적인 기술은 단지 바람직한 구현 예일 뿐이며, 이에 본 발명의 범위가 제한되는 것이 아닌 점은 명백하다. 따라서, 본 발명의 실질적인 범위는 첨부된 청구항과 그의 등가물에 의하여 정의된다고 할 것이다.
While the present invention has been particularly shown and described with reference to exemplary embodiments thereof, it is to be understood that the same is by way of illustration and example only and is not to be construed as limiting the scope of the present invention. Accordingly, the actual scope of the present invention will be defined by the appended claims and their equivalents.
Claims (6)
(a) 엘루테로사이드 E(Eleutheroside E)의 약제학적 유효량; 및 (b) 약제학적으로 허용되는 담체.
A pharmaceutical composition for the prevention or treatment of one or more diseases selected from the group consisting of diabetes, diabetic complications, hyperglycemia, impaired glucose tolerance, hyperinsulinemia, insulin resistance syndrome and obesity, including:
(a) a pharmaceutically effective amount of Eleutheroside E; And (b) a pharmaceutically acceptable carrier.
The composition according to claim 1, wherein the diabetic complication is at least one disease selected from the group consisting of diabetic retinopathy, diabetic cataract, diabetic neuropathy, diabetic neuropathy and osteoporosis.
2. The composition of claim 1, wherein said eruceroside E reduces blood glucose levels.
2. The composition of claim 1, wherein the eruceroside E has glucose tolerance improving activity.
2. The composition of claim 1, wherein said eruceroside E reduces the level of insulin in the blood.
(a) 엘루테로사이드 E(Eleutheroside E)의 식품학적 유효량; 및 (b) 식품학적으로 허용되는 담체.A health functional food for preventing or ameliorating at least one disease selected from the group consisting of diabetes, diabetic complications, hyperglycemia, impaired glucose tolerance, hyperinsulinemia, insulin resistance syndrome and obesity including:
(a) a foodstuff effective amount of Eleutheroside E; And (b) a pharmaceutically acceptable carrier.
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