KR101330688B1 - Composition for treating and preventing prediabetes and diabetes containing oriental herbal extracts - Google Patents
Composition for treating and preventing prediabetes and diabetes containing oriental herbal extracts Download PDFInfo
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- KR101330688B1 KR101330688B1 KR1020110095395A KR20110095395A KR101330688B1 KR 101330688 B1 KR101330688 B1 KR 101330688B1 KR 1020110095395 A KR1020110095395 A KR 1020110095395A KR 20110095395 A KR20110095395 A KR 20110095395A KR 101330688 B1 KR101330688 B1 KR 101330688B1
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Abstract
본 발명은 산수유, 산약, 지각 및 상엽의 추출물을 유효성분으로 포함하는 당뇨병 전증 및 당뇨병의 예방 및 치료용 조성물에 관한 것이다. 상기 조성물은 생체 내 독성이 없으면서도, 인슐린의 분비를 촉진하고 혈당 강하 효능을 가지므로, 당뇨병 전증 및 당뇨병의 예방 또는 치료에 효과적인 의약품 및 건강기능식품으로 사용할 수 있다. The present invention relates to a composition for the prevention and treatment of prediabetes mellitus and diabetes comprising an extract of cornus milk, powder, perception and upper leaf as an active ingredient. The composition promotes the secretion of insulin and has a hypoglycemic effect without in vivo toxicity, and thus can be used as an effective medicine and health functional food for preventing or treating prediabetes and diabetes.
Description
본 발명은 산수유, 산약, 지각 및 상엽의 추출물을 유효성분으로 포함하는 당뇨병전증 및 당뇨병의 예방 및 치료용 조성물에 관한 것이다.
The present invention relates to a composition for the prevention and treatment of prediabetes and diabetes comprising cornus milk, powder, perception and extract of the upper leaf as an active ingredient.
당뇨병 (Diabetes)은 혈액 내에 존재하는 포도당이 소변을 통해 배출되는 질환으로서, 근본적인 치유가 되지 않는 만성퇴행성질환중의 하나이다. 현대에 들어와서 식생활의 변화와 운동 부족 등으로 인하여, 인체 고유의 에너지 대사과정에 커다란 변화가 발생하였으며, 이에 따라 당뇨병 등의 만성 퇴행성질환은 증가하는 현상을 보이고 있다. 국내에서는 당뇨 유병율이 5-10%에 달하는 것으로 알려져 있으며 지속적인 증가를 보이고 있다. 미국의 경우, 지난 40년간, 당뇨병은 6배가 증가 하였으며 이와 같은 수준의 증가에 의하여 2050년에 이르러서는 환자수가 2600 만 명에 이르게 될 것으로 전망되고 있다.Diabetes is a disease in which glucose in the blood is excreted through the urine and is one of the chronic degenerative diseases that does not heal fundamentally. Due to changes in diet and lack of exercise, a major change has occurred in the energy metabolism of the human body, and chronic degenerative diseases such as diabetes are increasing. In Korea, the prevalence of diabetes is known to reach 5-10% and shows a continuous increase. In the United States, diabetes has increased six-fold over the last 40 years, and this increase is expected to reach 26 million patients by 2050.
당뇨병의 95% 이상을 차지하는 제 2형 (인슐린 비 의존형) 당뇨병의 병인은 두 가지 원인, 즉 인슐린 분비장애 및 인슐린 저항성의 복합 장애로 알려져 있다. 즉 당뇨병은 이 복합적인 장애로 인해 만성 고혈당 증상을 보이는 질환이다.The etiology of type 2 (insulin-independent) diabetes, which accounts for more than 95% of diabetes, is known to be a combined disorder of two causes: insulin secretion disorder and insulin resistance. Diabetes mellitus is a chronic hyperglycemia due to this complex disorder.
인슐린 분비장애란 혈당 농도에 따라 췌장의 베타세포에서 적절한 양의 인슐린이 분비되지 않는 상황을 말하며, 이는 인슐린을 분비하는 베타세포의 양적인 감소나 기능적인 분배장애를 모두 포함한다. 인슐린 저항성이란 분비된 인슐린이 혈류를 타고 표적장기에 도달했으나 그 표적세포에서 인슐린 작용 및 민감성이 저하된 상황을 의미하는데, 일반적으로 세포막 수용체 결합 후의 신호전달장애로 생각되며, 그 원인으로 유전적인 소인, 비만, 육체적 활동저하 및 고혈당 또는 이상지질혈증 등이 있다. 인슐린 저항성이 있으면 저항성을 극복하기 위해 더 많은 양의 인슐린이 분비되어야 하고, 반대로 인슐린 분비가 충분하지 않아 생긴 고혈당 자체가 다시 인슐린 저항성을 악화시킬 수 있다.Insulin secretion disorder refers to a situation in which an appropriate amount of insulin is not secreted from the beta cells of the pancreas according to the blood glucose level, which includes both a quantitative decrease in insulin secreting beta cells and a functional distribution disorder. Insulin resistance is a condition in which secreted insulin reaches the target organs in the bloodstream, but the insulin action and sensitivity of the target cells are lowered. It is generally considered to be a signal transduction disorder after cell membrane receptor binding, , Obesity, decreased physical activity, and hyperglycemia or dyslipidemia. Insulin resistance requires higher levels of insulin to overcome resistance, and conversely, hyperglycemia caused by insufficient insulin secretion may worsen insulin resistance again.
현재 인슐린 비의존형 당뇨병의 치료법으로는 식사요법, 운동요법, 설폰요소제, 비구아니드 (biguanide)계 약물, α-글루코시다아제 억제제, 인슐린 등이 이용되고 있으며 새로운 약물의 개발에 대한 많은 연구를 통해 메그리티니드계나 티아졸리디니디온계 약물, 작용시간이 다양한 인슐린 등이 개발되어 임상에 적용되고 있다. 그러나 이들 치료제들은 약효가 낮거나 간 기능 장애, 저혈당, 유산혈증 등과 같은 많은 부작용을 일으키는 문제점이 있다. 따라서 이와 같은 부작용을 줄이고 대사이상 증세 등을 개선시켜 주며 장기복용 시에도 안전성이 우수한 당뇨병 치료제의 개발이 절실히 요구된다.Currently, the treatment of insulin-independent diabetes mellitus, diet therapy, exercise therapy, sulfonurea drug, biguanide drug, α-glucosidase inhibitor, insulin, etc. are used. Linidin- or thiazolidinidione-based drugs, insulins with various action times have been developed and applied in clinical practice. However, these therapeutic agents have a problem of causing low side effects or many side effects such as liver dysfunction, hypoglycemia, lactic acidosis and the like. Therefore, it is necessary to reduce the side effects, improve the metabolic disorders, and the like, and to develop an excellent diabetes treatment agent for long-term use.
당뇨병전증 (Prediabetes)이란 당뇨병의 전단계에 해당하는 혈당 조절 이상으로 당뇨병으로 갈 수 있는 고위험군을 의미한다. 전당뇨병은 향후 당뇨병으로 갈 위험성이 정상인에 비해 3~5배 높다. 또한, 혈당이 당뇨병 정도까지 높지는 않지만, 정상인보다는 높기 때문에 혈관에 대한 스트레스가 증가하여 뇌졸증, 심근경색등의 심혈관 질환의 위험성이 정상인에 비해 3~5배 높다. 전당뇨병의 종류로는 공복고혈당(impaired fasting lycemia,IFG), 내당능장애 (Impaired glucose tolerance,IGT), 대사증후군(metabolic syndrome) 등이 있다. Prediabetes refers to a high risk group of people with diabetes who can go beyond diabetes to control their blood sugar levels. Prediabetes is three to five times higher than normal people at risk of developing diabetes. In addition, the blood sugar level is not high to diabetes, but because it is higher than a normal person increases the stress on the blood vessels, the risk of cardiovascular diseases such as stroke,
한편, 산수유 (山茱萸, Corni Fructus)는 층층나무과의 낙엽교목인 산수유나무의 열매이다. 타원형의 핵과로서 처음에는 녹색이었다가 8~10월에 붉게 익는다. 종자는 긴 타원형이며, 능선이 있다. 약간의 단맛과 함께 떫고 강한 신맛이 나며, 육질과 씨앗을 분리하여 육질은 술과 차 및 한약의 재료로 사용한다. 과육(果肉)에는 코르닌(cornin), 모로니사이드(Morroniside), 로가닌(Loganin), 타닌(tannin), 사포닌(Saponin) 등의 배당체와 포도주산, 사과산, 주석산 등의 유기산이 함유되어 있고, 그밖에 비타민 A와 다량의 당도 포함되어 있다. 종자에는 팔미틴산, 올레인산, 리놀산 등이 함유되어 있다. 《동의보감》 《향약집성방》 등에 의하면 강음(强陰), 신정(腎精)과 신기(腎氣)보강, 수렴 등의 효능이 있다고 하며, 두통, 이명, 해수병, 해열, 월경과다 등에 약재로 쓰이며 식은땀, 야뇨증 등의 민간요법에도 사용된다. Corni Fructus, on the other hand, is the fruit of Cornus, a deciduous tree of the dogwood family. Oval nucleus, initially green, ripens red in August-October. Seeds are long oval, with ridges. With a little sweetness, it has a strong and strong sour taste. The meat and seeds are separated and the meat is used as an ingredient for alcohol, tea and herbal medicine. The flesh contains glycosides such as cornin, moroniside, loganin, tannin, saponin, and organic acids such as wine, malic acid, tartaric acid, etc. It also contains vitamin A and large amounts of sugar. Seeds contain palmitic acid, oleic acid, linoleic acid, and the like. According to 『Agreement Bogam』 and 《Hyang Drug Collection Room 』, it is effective in strengthening sound tone, Shinjeong and Shingi, and converging.It is used as a medicine for headache, tinnitus, seawater disease, fever and excessive menstruation. It is also used for folk remedies such as cold sweats and nocturnal enuresis.
산약 (山藥)은 마과(科: Dioscoreaceae)에 속한 덩굴성 참마(Dioscorea japonica) 또는 마(Disocorea batatas)의 덩이뿌리이다. 외면은 흰색 또는 황갈색을 띠고 내부는 분질(粉質) 또는 호화(糊化)된 각질(角質)로 단단하다. 성분은 전분, 점액질, 단백질, 지방, 아르지닌콜린 등과 디아스타제를 함유하고 있으며, 지라, 폐, 신장, 위, 간의 경락(經絡)에도 작용한다. The mountain herb is a tuber of the Dioscorea japonica or Deisocorea batatas belonging to the family Dioscoreaceae. The outer surface is white or yellowish brown and the inside is hard with powdered or gelatinized keratin. Ingredients contain starch, mucus, protein, fat, arginine choline and other diastases, and act on the meridians of the spleen, lungs, kidneys, stomach and liver.
지각(枳殼)은 운향과에 속하는 상록성의 작은 키나무인 탱자나무(Poncirus trifaliata RAFIN.)와 광귤나무(Citrus aurantium L.)의 성숙한 과실로 만든 약재이다. 정유와 후라보노이드 물질이 들어 있는데, 광귤나무에는 네오헤스페리딘(Neohesperidin), 나린진(Naringin), 비타민C 등이 들어 있다. 기운을 내려주면서 거담작용을 보이고 적취를 제거하고, 건위소화작용을 보이므로 소화장애가 있으면서 옆구리가 결리고 아픈 증상, 구역 등에 효능이 있다.The crust is a medicinal herb made from the mature fruit of the evergreen small key tree, Poncirus trifaliata RAFIN. And Citrus aurantium L. It contains essential oils and flavonoids. The tangerines contain Neohesperidin, Naringin, and Vitamin C. Giving down energy, showing expectoration, eliminating trappings, and showing the digestive effect of digestive disorders, side effects, stiff side, sick symptoms, nausea and is effective.
상엽(桑葉)은 뽕나무과의 뽕나무(Morus alba L.) 또는 동속 근연식물의 잎을 말린 약재이다. 이 약은 냄새가 거의 없고 맛은 달고 쓰며 성질은 차다. 상엽은 발열, 두통, 안구충혈, 해수, 구갈, 피부 두드러기 등에 쓰인다. The upper leaf (桑葉) is a dried herb of the mulberry (Morus alba L.) of the mulberry family or related genera. This drug has little smell, tastes sweet and bitter, and is cold. The upper lobe is used for fever, headache, eye redness, sea water, dry mouth and skin urticaria.
그러나 아직까지 산수유, 산약, 지각 및 상엽의 추출물의 항당뇨 효과에 관해서는 보고된 바가 없다. However, no antidiabetic effects of extracts of cornus, medicinal herb, crust and upper leaf have been reported.
이에 본 발명자들은 당뇨병 치료제를 개발하기 위한 연구를 수행한 결과, 산수유, 산약, 지각 및 상엽의 추출물이 세포 내에서 인크레틴 호르몬의 분비를 촉진하고, 인슐린의 분비를 촉진시키며, 동물 모델에서 혈당 강하 효과가 있다는 사실을 확인함으로써 본 발명을 완성하였다.
Therefore, the present inventors have conducted research for the development of a therapeutic agent for diabetes, and as a result, extracts of cornus, powder, crust and upper lobe promote secretion of incretin hormones, promote insulin secretion, and lower blood sugar in animal models. The present invention has been completed by confirming that there is an effect.
본 발명의 목적은 산수유, 산약, 지각 및 상엽의 추출물을 유효성분으로 포함하는 당뇨병전증 및 당뇨병의 예방 및 치료용 약학적 조성물을 제공하고자 하는 것이다. An object of the present invention is to provide a pharmaceutical composition for the prevention and treatment of prediabetes and diabetes comprising cornus milk, powder, perception and extract of the upper leaf as an active ingredient.
또한, 본 발명의 목적은 산수유, 산약, 지각 및 상엽의 추출물을 유효성분으로 포함하는 당뇨병전증 및 당뇨병의 예방 및 개선용 건강기능식품을 제공하고자 하는 것이다.
In addition, an object of the present invention is to provide a health functional food for the prevention and improvement of prediabetes and diabetes comprising cornus milk, powder, perception and extract of the upper leaf as an active ingredient.
상기 목적을 달성하기 위하여 본 발명은 산수유, 산약, 지각 및 상엽의 추출물을 유효성분으로 포함하는 당뇨병전증 및 당뇨병의 예방 및 치료용 약학적 조성물을 제공한다. In order to achieve the above object, the present invention provides a pharmaceutical composition for the prevention and treatment of prediabetes and diabetes comprising cornus milk, powder, perception and extract of the upper leaf as an active ingredient.
또한, 본 발명은 산수유, 산약, 지각 및 상엽의 추출물을 유효성분으로 포함하는 당뇨병전증 및 당뇨병의 예방 및 개선용 건강기능식품을 제공한다.
In addition, the present invention provides a functional food for the prevention and improvement of prediabetes and diabetes comprising cornus milk, powder, perception and extract of the upper leaf as an active ingredient.
본 발명에 의한, 산수유, 산약, 지각 및 상엽의 추출물은 세포에 독성이 없으면서 세포 내에서 인크레틴 호르몬의 분비를 촉진하고, 인슐린의 분비를 촉진시키며, 동물 모델에서 혈당 강하 효과가 있어, 당뇨병전증 및 당뇨병의 현저한 치료 효능이 있다.
According to the present invention, the extract of cornus, caustic, crust and upper lobe promotes the secretion of incretin hormone in the cell, promotes the secretion of insulin, and has a hypoglycemic effect in the animal model without being toxic to the cell, prediabetic And significant therapeutic efficacy of diabetes.
도 1은 산수유, 산약, 지각 및 상엽 추출물의 GLP-1 분비 촉진 효과를 확인한 그래프이다.
도 2는 산수유, 산약, 지각 및 상엽 추출물의 인슐린 분비 촉진 효과를 확인한 그래프이다.
도 3은 산수유, 산약, 지각 및 상엽 추출물의 체중 변화에 미치는 영향을 확인한 그래프이다.
도 4는 산수유, 산약, 지각 및 상엽 추출물의 지방 무게 변화에 미치는 영향을 확인한 그래프이다.
도 5는 산수유, 산약, 지각 및 상엽 추출물의 혈당 강하 효과를 확인한 그래프이다. 1 is a graph confirming the effect of promoting GLP-1 secretion of cornus, corn, crust and upper leaf extract.
Figure 2 is a graph confirming the insulin secretion promoting effect of cornus milk, powder, crust and upper leaf extract.
Figure 3 is a graph confirming the effect on the weight change of cornus, cayenne, crust and upper leaf extract.
Figure 4 is a graph confirming the effect on the change of fat weight of cornus, corn, crust and upper leaf extract.
Figure 5 is a graph confirming the hypoglycemic effect of cornus, corn, crust and upper leaf extract.
이하, 본 발명에 대하여 보다 상세히 설명한다. Hereinafter, the present invention will be described in more detail.
본 발명의 한 양태에 따르면, 산수유, 산약, 지각 및 상엽의 추출물을 유효성분으로 포함하는 당뇨병전증 및 당뇨병의 예방 및 치료용 약학적 조성물을 제공한다.According to an aspect of the present invention, there is provided a pharmaceutical composition for the prevention and treatment of prediabetes and diabetes comprising cornus milk, powder, perception and extract of the upper leaf as an active ingredient.
본 발명의 조성물은 하기와 같은 방법으로 제조된다. The composition of the present invention is prepared by the following method.
산수유, 산약, 지각 및 상엽을 물로 세척하여 이물질을 제거한 후 그늘에서 건조하고 분쇄한다. 산수유, 산약, 지각 및 상엽은 재배한 것 또는 시판되는 것 등 제한 없이 사용할 수 있다. 분쇄된 산수유, 산약, 지각 및 상엽에 적당한 양의 용매를 첨가하여 완전히 침지되도록 한다. 산수유, 산약, 지각 및 상엽은 각각 물, 탄소수 1 내지 4의 저급 알코올 또는 이들의 혼합용매로부터 선택된 용매를 이용하여 추출한다. 바람직하게는 에탄올과 물의 혼합용매에 가용한 추출물, 바람직하게는 30~90% 에탄올을 이용한다. 30% 이하의 저농도 에탄올 추출법은 상대적으로 부피가 큰 다당류 등의 수용성분이 다량 추출이 되어 생약의 유효성분이 효율적으로 추출되지 않았으며 90% 이상의 고농도 에탄올 추출법은 보다 적은 양의 수성성분이 추출되어 효능에 영향을 줄 수 있다. 산수유, 산약, 지각, 및 상엽의 건조 생약 또는 분쇄 생약 중량의 약 2 내지 20배. 바람직하게는 3 내지 10배 분량의 용매를 넣고 50 내지 100℃, 바람직하게는 60 내지 90 ℃의 추출온도에서 약 1시간 내지 8시간 동안, 바람직하게는 2시간 내지 6시간 동안 환류 추출하여 여과한 후 동결 건조하여 산수유, 산약, 지각 및 상엽 각각의 추출물을 수득한다. Corn, milk, crust, and upper leaves are washed with water to remove debris, dried in the shade and crushed. Cornus, medicinal herb, crust and upper leaf may be used without limitation, such as those grown or marketed. Appropriate amount of solvent is added to the ground cornus, powder, crust and upper leaf so that it is completely immersed. Cornus, cauliflower, crust and upper leaf are extracted using a solvent selected from water, a lower alcohol having 1 to 4 carbon atoms or a mixed solvent thereof. Preferably, an extract available in a mixed solvent of ethanol and water, preferably 30 to 90% ethanol is used. Less than 30% ethanol extraction method was extracted with a large amount of water-soluble components such as relatively large volume of polysaccharides, and the active ingredient of the herbal medicine was not extracted efficiently, and more than 90% high concentration ethanol extraction method was extracted with less amount of aqueous components. May affect About 2 to 20 times the weight of dry or ground crude or ground crude of cornus, corn, crust, and upper leaves. Preferably, 3 to 10 times the amount of solvent is added, and the mixture is extracted by filtering under reflux for about 1 hour to 8 hours, preferably 2 hours to 6 hours at an extraction temperature of 50 to 100 ° C, preferably 60 to 90 ° C. After freeze-drying to obtain an extract of cornus, medicinal herb, crust and upper leaf.
본 발명의 조성물에서, 상기 산수유, 산약, 지각 및 상엽 추출물의 혼합비는 각각10% 내지 50% 의 중량비, 바람직하게는 15 내지 30% 의 중량비이며, 더욱 바람직하게는 1:1:1:1 중량비이다. 상기 혼합비율의 범위를 벗어나는 경우에는 산수유, 산약, 지각 및 상엽 추출물을 단독으로 사용한 경우와 비교할 때 항당뇨 효과 면에서 큰 차이가 없으며, 부작용의 우려가 있다. In the composition of the present invention, the mixing ratio of the cornus oil, powder, crust and upper leaf extract is 10% to 50% by weight, preferably 15 to 30% by weight, and more preferably 1: 1: 1: 1 weight ratio. to be. When it is out of the range of the mixing ratio, there is no significant difference in terms of antidiabetic effect compared to the case of using cornus milk, powder, crust and upper leaf extract alone, there is a concern of side effects.
본 발명의 조성물은 산수유, 산약, 지각 및 상엽의 추출물과 함께 당뇨병전증 또는 당뇨병의 억제 및 치료 효과를 갖는 공지의 유효성분을 1종 이상 함유할 수 있다. The composition of the present invention may contain at least one known active ingredient having an inhibitory and therapeutic effect of prediabetes or diabetes mellitus together with extracts of cornus, cauliflower, perception and upper lobe.
본 발명의 조성물은 임상 투여 시에 경구 또는 비경구로 투여가 가능하며 일반적인 의약품 제제의 형태로 사용될 수 있다. 제제화할 경우에는 보통 사용하는 충진제, 증량제, 결합제, 습윤제, 붕해제 및 계면활성제 등의 희석제 또는 부형제를 사용하여 조제된다. 경구 투여를 위한 고형 제제에는 정제, 환제, 산제, 과립제, 캡슐제 및 액상 캡슐제 등을 섞어 조제된다. 또한 단순한 부형제 이외에 마그네슘 스티레이트 탈크 같은 윤활제들도 사용된다. 경구 투여를 위한 액상 제제로는 현탁제, 내용액제, 유제 및 시럽제 등이 해당되는데 흔히 사용되는 단순 희석제인 물, 리퀴드 파라핀 이외에 여러 가지 부형제, 예를 들면 습윤제, 감미제, 방향제 및 보존제 등이 포함될 수 있다. 비경구 투여를 위한 제제에는 멸균된 수용액, 비수성용제, 현탁제, 유제, 동결건조제제 및 좌제가 포함된다. 비수성용제와 현탁용제로는 프로필렌글리콜, 폴리에틸렌 글리콜, 올리브 오일과 같은 식물성 기름, 에틸올레이트와 같은 주사 가능한 에스테르 등이 사용될 수 있다. 좌제의 기제로는 위텝솔 (witepsol), 마크로골, 트윈 (tween) 61, 카카오지, 라우린지, 글리세롤 및 젤라틴 등이 사용될 수 있다.The composition of the present invention can be administered orally or parenterally at the time of clinical administration and can be used in the form of a general pharmaceutical preparation. In the case of formulation, a diluent or excipient such as a filler, an extender, a binder, a wetting agent, a disintegrating agent and a surfactant is usually used. Solid preparations for oral administration are prepared by mixing tablets, pills, powders, granules, capsules, liquid capsules and the like. In addition to simple excipients, lubricants such as magnesium stearate talc are also used. Liquid preparations for oral administration include suspensions, solutions, emulsions and syrups. Various excipients such as wetting agents, sweeteners, fragrances and preservatives may be included in addition to water and liquid paraffin, which are commonly used simple diluents. have. Formulations for parenteral administration include sterile aqueous solutions, non-aqueous solutions, suspensions, emulsions, freeze-dried preparations and suppositories. Examples of the non-aqueous solvent and the suspending agent include propylene glycol, polyethylene glycol, vegetable oil such as olive oil, injectable ester such as ethyl oleate, and the like. As the base of the suppository, witepsol, macrogol, tween 61, cacao paper, laurin, glycerol and gelatin can be used.
투약 단위는, 예를 들면 개별 투약량의 1, 2, 3 또는 4 배를 포함하거나 또는 1/2, 1/3 또는 1/4 배를 포함할 수 있다. 개별 투약량은 바람직하게는 유효 약물이 1 회에 투여되는 양을 포함하며, 이는 통상 1 일 투여량의 전부, 1/2, 2/3 또는 1/4 배에 해당한다. 본 발명의 조성물의 유효용량은 0.1 내지 1000 mg/kg(체중)이고, 하루 1 내지 6 회 투여될 수 있다.Dosage units may include, for example, one, two, three or four times the individual dosage or may include one, two, one third or one quarter times. Individual dosages preferably include the amount in which the effective drug is administered at one time, which usually corresponds to all, 1/2, 2/3 or 1/4 times the daily dose. The effective dose of the composition of the present invention is 0.1 to 1000 mg / kg (body weight), may be administered 1 to 6 times a day.
본 발명의 조성물은 당뇨병전증 및 당뇨병의 예방 및 치료를 위하여 단독으로, 또는 수술, 방사선 치료, 호르몬 치료, 화학 치료 및 생물학적 반응 조절제를 사용하는 방법들과 병용하여 사용할 수 있다.The composition of the present invention can be used alone or in combination with methods using surgery, radiation therapy, hormone therapy, chemotherapy and biological response modifiers for the prevention and treatment of prediabetes and diabetes.
본 발명의 다른 양태에 따르면, 산수유, 산약, 지각 및 상엽의 추출물을 유효성분으로 포함하는 당뇨병전증 및 당뇨병의 예방 및 개선용 건강기능식품을 제공한다.According to another aspect of the present invention, it provides a dietary supplement for the prevention and improvement of prediabetes and diabetes comprising cornus milk, powder, perception and extract of the upper leaf as an active ingredient.
본 발명에서, ‘건강기능식품’이란 질병의 예방 및 치료, 생체방어, 면역, 병후의 회복, 노화 억제 등 생체조절기능을 가지는 식품을 말하는 것으로, 장기적으로 복용하였을 때 인체에 무해하여야 한다.In the present invention, "health functional food" refers to a food having a bioregulatory function, such as prevention and treatment of diseases, biological defense, immunity, recovery of symptoms, inhibition of aging, and should be harmless to the human body when taken in the long term.
본 발명의 조성물을 식품 첨가물로 사용할 경우, 상기 조성물을 그대로 첨가하거나 다른 식품 또는 식품 성분과 함께 사용될 수 있고, 통상적인 방법에 따라 적절하게 사용될 수 있다. 유효성분의 혼합양은 사용 목적 (예방, 건강 또는 치료적 처치)에 따라 적합하게 결정될 수 있다. 일반적으로, 식품 또는 음료의 제조 시에 본 발명의 조성물은 원료에 대하여 15중량 % 이하, 바람직하게는 10 중량 % 이하의 양으로 첨가된다. 그러나, 건강 및 위생을 목적으로 하거나 또는 건강 조절을 목적으로 하는 장기간의 섭취의 경우에는 상기 범위 이하일 수 있으며, 안전성 면에서 아무런 문제가 없기 때문에 유효성분은 상기 범위 이상의 양으로도 사용될 수 있다.When the composition of the present invention is used as a food additive, the composition can be added as it is or can be used together with other food or food ingredients, and can be suitably used according to a conventional method. The amount of the active ingredient to be mixed can be suitably determined according to the intended use (prevention, health or therapeutic treatment). In general, the composition of the present invention is added in an amount of not more than 15% by weight, preferably not more than 10% by weight based on the raw material, in the production of food or beverage. However, in the case of long-term intake for the purpose of health and hygiene or for the purpose of controlling health, the amount may be less than the above range, and since there is no problem in terms of safety, the active ingredient may be used in an amount exceeding the above range.
상기 식품의 종류에는 특별한 제한은 없다. 상기 물질을 첨가할 수 있는 식품의 예로는 육류, 소시지, 빵, 초콜릿, 캔디류, 스낵류, 과자류, 피자, 라면, 기타 면류, 껌류, 아이스크림류를 포함한 낙농제품, 각종 스프, 음료수, 차, 드링크제, 알코올 음료 및 비타민 복합제 등이 있으며, 통상적인 의미에서의 건강식품을 모두 포함한다.There is no particular limitation on the kind of the food. Examples of foods to which the above substances can be added include dairy products including meats, sausages, breads, chocolates, candies, snacks, confectionery, pizza, ramen noodles, gums, ice cream, soups, drinks, tea, Alcoholic beverages, and vitamin complexes, all of which include health foods in a conventional sense.
본 발명의 건강음료 조성물은 통상의 음료와 같이 여러 가지 향미제 또는 천연 탄수화물 등을 추가 성분으로서 포함할 수 있다. 상술한 천연 탄수화물은 포도당, 과당과 같은 모노사카라이드, 말토스, 슈크로스와 같은 디사카라이드, 및 덱스트린, 사이클로덱스트린과 같은 천연 감미제나, 사카린, 아스파르탐과 같은 합성 감미제 등을 사용할 수 있다. 상기 천연 탄수화물의 비율은 본 발명의 조성물 100 ml 당 일반적으로 약 0.01 내지 10 g, 바람직하게는 약 0.01 내지 0.1 g 이다.The health beverage composition of the present invention may contain various flavors or natural carbohydrates as an additional ingredient such as ordinary beverages. Such natural carbohydrates include monosaccharides such as glucose and fructose, disaccharides such as maltose and sucrose, and natural sweeteners such as dextrin and cyclodextrin, synthetic sweeteners such as saccharine and aspartame, and the like . The ratio of the natural carbohydrate is generally about 0.01 to 10 g, preferably about 0.01 to 0.1 g per 100 ml of the composition of the present invention.
상기 외에 본 발명의 조성물은 여러 가지 영양제, 비타민, 전해질, 풍미제, 착색제, 펙트산 및 그의 염, 알긴산 및 그의 염, 유기산, 보호성 콜로이드 증점제, pH 조절제, 안정화제, 방부제, 글리세린, 알코올, 탄산 음료에 사용되는 탄산화제 등을 포함할 수 있다. 그 밖에 본 발명의 조성물은 천연 과일주스, 과일주스 음료 및 야채 음료의 제조를 위한 과육을 포함할 수 있다. 이러한 성분은 독립적으로 또는 조합하여 사용할 수 있다. 이러한 첨가제의 비율은 크게 중요하진 않지만 본 발명의 조성물 100중량부 당 0.01 내지 0.1 중량부의 범위에서 선택되는 것이 일반적이다.In addition to the above, the composition of the present invention may further contain various nutrients, vitamins, electrolytes, flavors, colorants, pectic acid and salts thereof, alginic acid and salts thereof, organic acids, protective colloid thickeners, pH adjusters, stabilizers, preservatives, glycerin, A carbonating agent used in a carbonated beverage, and the like. In addition, the composition of the present invention may comprise flesh for the production of natural fruit juices, fruit juice drinks and vegetable drinks. These components can be used independently or in combination. The proportion of such additives is not critical but is generally selected in the range of 0.01 to 0.1 parts by weight per 100 parts by weight of the composition of the present invention.
이하 본 발명의 이해를 돕기 위하여 바람직한 실시예를 제시한다. 그러나 하기의 실시예는 본 발명을 보다 쉽게 이해하기 위하여 제공되는 것일 뿐, 실시예에 의해 본 발명의 내용이 한정되는 것은 아니다.
Hereinafter, preferred embodiments of the present invention will be described in order to facilitate understanding of the present invention. However, the following examples are provided only for the purpose of easier understanding of the present invention, and the present invention is not limited by the examples.
실room 시예Example 1: 산수유, 1: cornus, 산약Medicine , 지각 및 , Crust and 상엽의Upper lobe 추 sinker 출물Exhibit 의 수득Get
1-1. 산수유 추출물의 제조1-1. Preparation of Cornus Extract
산수유를 물로 세척하여 이물질을 제거한 후, 그늘에서 건조하고 분쇄한 생약을 실험에 사용하였다. 분쇄된 산수유 3 kg에 15 l의 80% EtOH 추출물을 가한 후 70 ℃에서 2시간 20분 동안 추출 한 후 여과하였다. 남은 잔사에 10 l 의 80% EtOH 추출물을 가한 후 상기와 같은 방법으로 추출한 후 여과하여 추출물을 합한 후 45~65 ℃로 감압 농축하여 EtOH 성분을 제거한 다음 동결건조시켜 산수유 분말 엑스(추출물)를 수득하였다.
After washing the cornus oil with water to remove the foreign substance, dried and ground herbal medicine in the shade was used for the experiment. 15 l of 80% EtOH extract was added to 3 kg of ground cornus oil, followed by extraction at 70 ° C. for 2 hours and 20 minutes, followed by filtration. 10 l of 80% EtOH extract was added to the remaining residue, followed by extraction as above. It was.
1-2. 산약 추출물의 제조1-2. Preparation of Acid Extract
산약을 물로 세척하여 이물질을 제거한 후, 그늘에서 건조하고 분쇄한 생약을 실험에 사용하였다. 분쇄된 산약 3 kg에 15 l의 80% EtOH 추출물을 가한 후 70 ℃에서 2시간 20분 동안 추출 한 후 여과하였다. 남은 잔사에 10 l의 80% EtOH 추출물을 가한 후 상기와 같은 방법으로 추출한 후 여과하여 추출물을 합한 후 45~65 ℃로 감압 농축하여 EtOH 성분을 제거한 다음 동결건조시켜 산약 분말 엑스(추출물)를 수득하였다.
After washing the powder with water to remove foreign substances, dried and ground herbal medicine in the shade was used for the experiment. 15 l of 80% EtOH extract was added to 3 kg of the ground powder, followed by extraction at 70 ° C. for 2 hours and 20 minutes, followed by filtration. 10 l of 80% EtOH extract was added to the remaining residue, followed by extraction as above. It was.
1-3. 지각 추출물의 제조1-3. Preparation of Crust Extracts
지각을 물로 세척하여 이물질을 제거한 후, 그늘에서 건조하고 분쇄한 생약을 실험에 사용하였다. 분쇄된 지각 3 kg에 15 l의 80% EtOH 추출물을 가한 후 70 ℃에서 2시간 20분 동안 추출 한 후 여과하였다. 남은 잔사에 10 l의 80% EtOH 추출물을 가한 후 상기와 같은 방법으로 추출한 후 여과하여 추출물을 합한 후 45~65 ℃로 감압 농축하여 EtOH 성분을 제거한 다음 동결건조시켜 지각 분말 엑스(추출물)를 수득하였다.
After washing the crust with water to remove the foreign matter, dried and crushed herbal medicine in the shade was used in the experiment. 15 l of 80% EtOH extract was added to 3 kg of the ground crust and then extracted at 70 ° C. for 2 hours and 20 minutes, followed by filtration. 10 l of 80% EtOH extract was added to the remaining residue, followed by extraction as above. It was.
1-4. 상엽 추출물의 제조1-4. Preparation of Morus Leaf Extract
상엽을 물로 세척하여 이물질을 제거한 후, 그늘에서 건조하고 분쇄한 생약을 실험에 사용하였다. 분쇄된 상엽 3 kg에 25 l의 80% EtOH 추출물을 가한 후 70 ℃에서 2시간 20분 동안 추출 한 후 여과하였다. 남은 잔사에 15 l의 80% EtOH 추출물을 가한 후 상기와 같은 방법으로 추출한 후 여과하여 추출물을 합한 후 45~65 ℃로 감압 농축하여 EtOH 성분을 제거한 다음 동결건조시켜 상엽 분말 엑스(추출물)를 수득하였다.
After the upper leaves were washed with water to remove foreign substances, dried and crushed herbal medicines were used for the experiment. 25 l of 80% EtOH extract was added to 3 kg of crushed upper leaves, followed by extraction at 70 ° C. for 2 hours and 20 minutes, followed by filtration. 15 l of 80% EtOH extract was added to the remaining residue, followed by extraction in the same manner as above. After filtration, the extracts were combined, concentrated under reduced pressure at 45-65 ° C. to remove the EtOH component, and lyophilized to obtain an upper leaf powder extract (extract). It was.
1-5. 생약 분말 엑스(추출물)의 혼합1-5. Mix of herbal powder extract (extract)
상기 추출된 각각의 생약 분말 엑스(추출물)을 산수유 : 산약 : 지각 : 상엽 = 1 : 1 : 1 : 1의 중량비(w/w)로 균질 하게 혼합하여 분말상태의 혼합물 JUL04를 제조하였다.
Each of the extracted herbal powder extracts (extracts) was mixed homogeneously in a weight ratio (w / w) of cornus oil: powder: crust: upper leaf = 1: 1: 1: 1 to prepare a powder mixture JUL04.
실room 시예Example 2: 2: 인크레틴Incretin 호르몬hormone 조절 효과 확인 Check the adjustment effect
본 발명의 조성물에 의한 항당뇨 기작을 확인하기 위하여, 인간 장내분비세포 (Human enteroendocrine cell)에 산수유, 산약, 지각 및 상엽의 추출물 각각 0.5mg/ml과 1mg/ml 을 처리하였다. In order to confirm the anti-diabetic mechanism by the composition of the present invention, human enteroendocrine cells (Human enteroendocrine cells) were treated with 0.5mg / ml and 1mg / ml, respectively, extracts of cornus, cauliflower, crust and upper lobe.
그 결과, 도 1에 나타낸 바와 같이 본 발명의 추출물이 GLP-1의 분비를 촉진하는 것을 확인하였다. As a result, as shown in Figure 1, it was confirmed that the extract of the present invention promotes the secretion of GLP-1.
실room 시예Example 3. Insulin assay를 통한 3. Insulin assay 인슐린insulin 분비 촉진 효과 확인 Confirmation of secretory promoting effect
본 발명의 조성물에 의한 insulin 분비 기작을 확인하기 위하여, 마우스인슐린 분비세포 (Mouse insulinoma cell)에 산수유, 산약, 지각 및 상엽의 추출물을 각각 0.5mg/ml과 1mg/ml 처리하였다. In order to confirm the mechanism of insulin secretion by the composition of the present invention, mouse insulin secretion cells (Mouse insulinoma cell) were treated with 0.5mg / ml and 1mg / ml extracts of cornus, cauliflower, crust and upper leaf, respectively.
그 결과, 도 2에 나타낸 바와 같이, 본 발명의 혼합 추출물이 인슐린 분비를 촉진시키는 효과가 있음을 확인하였다.
As a result, as shown in Figure 2, it was confirmed that the mixed extract of the present invention has the effect of promoting insulin secretion.
실room 시예Example 5. 동 5. Copper 물모델에서In the water model 혈 hole 당강Danggang 하 효과 확인HA effect check
male ICR mice (22g-23g)에게 정상식이, 고지방 고탄수화물식이(Surwit's high fat, high sucrose diet(HFD, Research Diets #D 08020201, 45 kcal% Fat and 32 kcal% Sucrose)를 투여하여 비만형 당뇨병을 유발시켰다. 산수유, 산약, 지각 및 상엽의 혼합 추출물을 5%의 비율로 식이에 섞어 투여하고, 양성 대조군으로 알려진 당뇨병 치료제인metformin을 0.5%의 비율로 식이에 섞어 투여하며 체중, 경구당부하 검사 및 지방무게를 측정하였다.Male ICR mice (22g-23g) were administered a normal diet, high fat, high carbohydrate diet (Surwit's high fat, high sucrose diet (HFD, Research Diets #D 08020201, 45 kcal% Fat and 32 kcal% Sucrose) Mixed extracts of cornus, caustic, crust and upper lobe were mixed and administered in the diet at a rate of 5%, and metformin, a diabetes treatment known as a positive control, was mixed and administered in the diet at a rate of 0.5%. Fat weight was measured.
그 결과, 산수유, 산약, 지각 및 상엽의 혼합 추출물은 체중 및 지방무게에는 별다른 변화를 유발시키지 않았으나 (도 3 및 도 4), 경구당부하검사 (OGTT)에서 혈당을 감소시키는 효과가 있음을 확인하였다 (도 5).
As a result, the mixed extract of cornus, medicinal herb, crust and upper leaf did not cause any change in body weight and fat weight (Figs. 3 and 4), but it was confirmed that the oral glucose loading test (OGTT) has an effect of reducing blood glucose. (FIG. 5).
이하 본 발명의 상기 조성물을 함유하는 약학적 조성물 및 건강기능식품의 제제예를 설명하나, 본 발명을 한정하고자 함이 아닌 단지 구체적으로 설명하고자 함이다.
Hereinafter will be described a pharmaceutical composition containing the composition of the present invention and a preparation example of a health functional food, but is not intended to limit the present invention only intended to be described in detail.
제My 제예Example 1. One. 산제Powder 의 제조Manufacturing
산수유, 산약, 지각 및 상엽의 혼합 추출물 20 mg20 mg of mixed extract of cornus, medicinal herb, crust and upper leaf
유당 100 mg
탈크 10 mgTalc 10 mg
상기의 성분들을 혼합하고 기밀포에 충진하여 산제를 제조한다.
The above components are mixed and filled in airtight bags to prepare powders.
제My 제예Example 2. 정제의 제조 2. Preparation of tablets
산수유, 산약, 지각 및 상엽의 혼합 추출물 10 mgMixed extract of Cornus, Pomegranate, Crust and Upper Leaf 10 mg
옥수수전분 100 mg
유당 100 mg
스테아린산 마그네슘 2 mgMagnesium stearate 2 mg
상기의 성분들을 혼합한 후 통상의 정제의 제조방법에 따라서 타정하여 정제를 제조한다.
After mixing the above components, tablets are prepared by tableting according to the usual preparation method of tablets.
제My 제예Example 3. 캅 3. Cop 셀제Celje 의 제조Manufacturing
산수유, 산약, 지각 및 상엽의 혼합 추출물 10 mgMixed extract of Cornus, Pomegranate, Crust and Upper Leaf 10 mg
결정성 셀룰로오스 3 mg
락토오스 14.8 mgLactose 14.8 mg
마그네슘 스테아레이트 0.2 mgMagnesium stearate 0.2 mg
통상의 캡슐제 제조방법에 따라 상기의 성분을 혼합하고 젤라틴 캡슐에 충전하여 캡슐제를 제조한다.
The above components are mixed according to a conventional capsule preparation method and filled in gelatin capsules to prepare capsules.
제My 제예Example 4. 액상 캡 4. Liquid Cap 슐제Schulze
산수유, 산약, 지각 및 상엽의 혼합 추출물 10mg10 mg of mixed extract of cornus, corn, crust and upper leaf
폴리에틸렌글리콜 600 100mgPolyethylene Glycol 600 100mg
디에틸렌글리콜 모노 에틸에테르 30mgDiethylene Glycol Monoethyl Ether 30mg
폴리소르베이트 80 15mg
한국콜마㈜의 리드캡 기술을 적용하여 상기의 성분을 혼합하고 액상을 충전하여 액상 캡슐제를 제조한다.
By applying lead cap technology of Kolmar Korea, the above ingredients are mixed and the liquid is filled to prepare a liquid capsule.
제My 제예Example 5. 주사제의 제조 5. Preparation of Injectables
산수유, 산약, 지각 및 상엽의 혼합 추출물 10 mgMixed extract of Cornus, Pomegranate, Crust and Upper Leaf 10 mg
만니톨 180 mg180 mg mannitol
주사용 멸균 증류수 2974 mgSterile sterilized water for injection 2974 mg
Na2HPO42H2O 26 mgNa 2 HPO 4 2H 2 O 26 mg
통상의 주사제의 제조방법에 따라 1 앰플당 (2 ml) 상기의 성분 함량으로 제조한다.
(2 ml) per 1 ampoule in accordance with the usual injection preparation method.
제My 제예Example 6. 6. 액제Liquid 의 제조Manufacturing
산수유, 산약, 지각 및 상엽의 혼합 추출물 20 mg20 mg of mixed extract of cornus, medicinal herb, crust and upper leaf
이성화당 10 g10 g per isomer
만니톨 5 g5 g mannitol
정제수 적량Purified water quantity
통상의 액제의 제조방법에 따라 정제수에 각각의 성분을 가하여 용해시키고 레몬향을 적량 가한 다음 상기의 성분을 혼합한 다음 정제수를 가하여 전체를 정제수를 가하여 전체 100 ml로 조절한 후 갈색병에 충진하여 멸균시켜 액제를 제조한다.
Each component was added and dissolved in purified water according to the usual liquid preparation method, and the lemon flavor was added in an appropriate amount. Then, the above components were mixed, and purified water was added thereto. The whole was added with purified water to adjust the total volume to 100 ml, And sterilized to prepare a liquid preparation.
제My 제예Example 7. 건 7. Gun 강식Formula 품의 제조Manufacturing
산수유, 산약, 지각 및 상엽의 혼합 추출물 100 mg100 mg of mixed extract of cornus, medicinal herb, crust and upper leaf
비타민 혼합물 적량Vitamin mixture quantity
비타민 A 아세테이트 70 μg Vitamin A acetate 70 μg
비타민 E 1.0 mgVitamin E 1.0 mg
비타민 B1 0.13 mgVitamin B1 0.13 mg
비타민 B2 0.15 mg0.15 mg of vitamin B2
비타민 B6 0.5 mgVitamin B6 0.5 mg
비타민 B12 0.2 μg Vitamin B12 0.2 μg
비타민 C 10 mgVitamin C 10 mg
비오틴 10 μg Biotin 10 μg
니코틴산아미드 1.7 mgNicotinic acid amide 1.7 mg
엽산 50 μg
판토텐산 칼슘 0.5 mgCalcium pantothenate 0.5 mg
무기질 혼합물 적량Mineral mixture quantity
황산제1철 1.75 mg1.75 mg of ferrous sulfate
산화아연 0.82 mg0.82 mg of zinc oxide
탄산마그네슘 25.3 mgMagnesium carbonate 25.3 mg
제1인산칼륨 15 mgPotassium monophosphate 15 mg
제2인산칼슘 55 mgSecondary calcium phosphate 55 mg
구연산칼륨 90 mg
탄산칼슘 100 mg
염화마그네슘 24.8 mgMagnesium chloride 24.8 mg
상기의 비타민 및 미네랄 혼합물의 조성비는 비교적 건강식품에 적합한 성분을 바람직한 실시예로 혼합 조성하였지만, 그 배합비를 임의로 변형 실시하여도 무방하며, 통상의 건강식품 제조방법에 따라 상기의 성분을 혼합한 다음, 과립을 제조하고, 통상의 방법에 따라 건강식품 조성물 제조에 사용할 수 있다.
Although the composition ratio of the above-mentioned vitamin and mineral mixture is comparatively mixed with a composition suitable for health food as a preferred embodiment, the compounding ratio may be arbitrarily modified, and the above ingredients are mixed according to a conventional method for producing healthy foods , Granules can be prepared and used in the manufacture of health food compositions according to conventional methods.
제My 제예Example 8. 건강음 8. Sound 료의Medical 제조 Produce
산수유, 산약, 지각 및 상엽의 혼합 추출물 100 mg100 mg of mixed extract of cornus, medicinal herb, crust and upper leaf
비타민 C 15 gVitamin C 15 g
비타민 E(분말) 100 gVitamin E (powder) 100 g
젖산철 19.75 g19.75 g of ferrous lactate
산화아연 3.5 g3.5 g of zinc oxide
니코틴산아미드 3.5 gNicotinic acid amide 3.5 g
비타민 A 0.2 gVitamin A 0.2 g
비타민 B1 0.25 gVitamin B1 0.25 g
비타민 B2 0.3gVitamin B2 0.3g
물 정량Water quantification
통상의 건강음료 제조방법에 따라 상기의 성분을 혼합한 다음, 약 1시간 동안 85 ℃에서 교반 가열한 후, 만들어진 용액을 여과하여 멸균된 2 l 용기에 취득하여 밀봉 멸균한 뒤 냉장 보관한 다음 본 발명의 건강음료 조성물 제조에 사용한다.The above components were mixed according to a conventional health drink manufacturing method, and the mixture was stirred and heated at 85 DEG C for about 1 hour. The solution thus prepared was filtered and sterilized in a sterilized 2 liter container, It is used in the production of the health beverage composition of the invention.
상기 조성비는 비교적 기호음료에 적합한 성분을 바람직한 실시예로 혼합 조성하였지만 수요계층이나, 수요국가, 사용용도 등 지역적, 민족적 기호도에 따라서 그 배합비를 임의로 변형 실시하여도 무방하다.
Although the compositional ratio is relatively mixed with a component suitable for a favorite drink, it is also possible to arbitrarily modify the compounding ratio according to the regional or national preference such as the demand class, the demanding country, and the use purpose.
Claims (7)
The composition of claim 2 wherein the solvent is 30 to 90% ethanol.
The composition of claim 1, wherein the composition inhibits the secretion of glucagon-likepeptide-1 (GLP-1).
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| Title |
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| 박정섭 외 5명. Streptozotocin 유발 당뇨 백서에 상엽 지각(桑葉 枳殼) 혼합물의 항당뇨 및 혈관탄성개선 효과. 대한한방내과학회지. 2007년 9월, 제28권 제3호, 제544면 내지 제559면. * |
| 박정섭 외 5명. Streptozotocin 유발 당뇨 백서에 상엽 지각(桑葉 枳殼) 혼합물의 항당뇨 및 혈관탄성개선 효과. 대한한방내과학회지. 2007년 9월, 제28권 제3호, 제544면 내지 제559면.* |
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