KR101420270B1 - Composition comprising reacted mixture of red ginseng extract and persimmon vinegar for preventing or treating benign prostatic hyperplasia - Google Patents
Composition comprising reacted mixture of red ginseng extract and persimmon vinegar for preventing or treating benign prostatic hyperplasia Download PDFInfo
- Publication number
- KR101420270B1 KR101420270B1 KR1020130114293A KR20130114293A KR101420270B1 KR 101420270 B1 KR101420270 B1 KR 101420270B1 KR 1020130114293 A KR1020130114293 A KR 1020130114293A KR 20130114293 A KR20130114293 A KR 20130114293A KR 101420270 B1 KR101420270 B1 KR 101420270B1
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- KR
- South Korea
- Prior art keywords
- red ginseng
- ginseng extract
- extract
- persimmon vinegar
- reaction mixture
- Prior art date
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Abstract
Description
본 발명은 홍삼 추출물의 감식초 반응 혼합물을 함유한 전립선 비대증의 예방 또는 치료용 조성물에 관한 것이다. The present invention relates to a composition for preventing or treating enlargement of the prostate gland containing a ginseng reaction mixture of red ginseng extract.
전립선비대증은 노인층에서 나타나는 가장 흔한 질환이며 이들의 발병은 나이가 듦에 따라 증가한다는 점과 교감신경계 기능 항진이라는 공통점을 가지고 있다. 이러한 교감신경계의 항진은 심장, 혈관 및 신장을 자극함으로써 혈압을 상승시키는 본태성 고혈압의 중요한 병인 중 하나이며, 요도 괄약근과 전립선 간질의 평활근에 영향을 미쳐 전립선비대증에서 배뇨 증상을 유발한다고 보고되었다(Landsberg 1994). 전립선 조직의 성장에 관여하는 주된 남성호르몬(androgen)은 디하이드로테스토스테론(dihydrotestosterone)이며, 전립선 내에서는 테스토스테론(testosterone)의 약 90%가 디하이드로테스토스테론으로 전환된다(Zhu et al., 1998). 테스토스테론은 부신에서도 분비되지만, 약 90%가 고환의 라이디히 세포(Leydig cell, 정자 형성 과정 생식세포의 일종)에서 합성되고 분비되는 일차 남성 호르몬이며, 전립선에서는 호르몬의 전구물질로서 5α-환원효소(5α-reductase)에 의해 비가역적으로 디하이드로테스토스테론으로 전환된다(Zhu et al., 1998; Veltri and Rodriguez 2006).Prostate hyperplasia is the most common disease in the elderly, and their onset increases with age and has sympathetic nervous system hyperactivity. This sympathetic nervous system hyperactivity is one of the important etiologic factors of essential hypertension that raises blood pressure by stimulating the heart, blood vessels and kidneys, and it has been reported that it affects the smooth muscle of the urethral sphincter and prostate epilepsy and induces voiding symptoms in the hyperplasia of the prostate Landsberg 1994). The major male hormone (androgen) involved in the growth of prostate tissue is dihydrotestosterone, and about 90% of the testosterone in the prostate is converted to dihydrotestosterone (Zhu et al., 1998). Testosterone is also secreted in the adrenal gland, but about 90% is the primary male hormone synthesized and secreted in the testicular Leydig cell (a type of spermatogonial reproductive cell), and in the prostate the 5α-reductase 5α-reductase) (Zhu et al., 1998; Veltri and Rodriguez 2006).
전립선비대증(Benign Prostatic Hyperplasia)의 경우 기질세포(stroma cell)와 상피세포(epithelial cell)가 과형성 되는 병태 생리를 가지는 질환으로, 노화와 남성호르몬이 주요 원인이며, 인슐린 저항성, 지질대사 이상, 고혈압, 복부비만 등의 대사증후군과도 관련 있음이 보고되었다(Ozden et al., 2007; Dahle et al., 2002). 이러한 요소들은 전립선비대증 발달의 위험인자로 전립선비대증과 대사증후군은 유사한 병태생리학적 기전을 공유하는 것으로 추정되고 있다. 전립선 비대증의 정확한 발병 기전은 아직 밝혀지지 않았으나, 일반적인 가설 중의 하나는 과다한 디하이드로테스토스테론의 생성에 의한 전립선 세포의 비대를 원인으로 보고 있다(Clark et al., 2004; Isaacs 1984). 즉, 혈액 내에서 테스토스테론이 과다하게 존재하면 전립선에서 5α-환원효소(5α-reductase)에 의해 디하이드로테스토스테론을 다량 합성하게 되고, 합성된 디하이드로테스토스테론은 전립선 세포에 있는 안드로겐 수용체(androgen receptor)에 결합하여 전립선 비대를 유발하게 된다. 또한 남성의 노화에 의해 남성 호르몬의 분비가 줄게 되고, 그로 인해 내분비계 균형을 유지하기 위해 전립선 세포의 안드로겐 수용체가 증가하게 되어, 디하이드로테스토스테론이 더 많은 부위에 결합함으로써 전립선의 비대가 유발하게 된다(Nixon 1997). 따라서 혈장과 전립선 내의 디하이드로테스토스테론 수치를 감소시키면서 테스토스테론의 증가를 유발하지 않는 5α-환원효소 억제제는 임상적으로 전립선의 과성장을 억제하고, 전립선 용적을 감소시켜 배뇨 증상을 감소시킨다(Gormley 1996; Boyle et al., 1996). 이러한 5α-환원효소 억제제와 함께 배뇨 평활근의 수축력을 향상시켜 주는 알파차단제는 수술에서 약물치료의 전환을 야기하는 획기적인 변화를 가져왔지만, 부작용이 있어 주의가 요구된다. 알파차단제의 경우에는 혈관에 분포하는 알파 수용체의 차단으로 인해 심혈관계 및 중추신경계의 기립성 저혈압, 두통, 어지러움, 무기력, 코막힘 등의 부작용이 나타나며, 5α-환원효소 억제제는 발기부전, 성욕장애, 사정장애 등의 성기능 장애가 나타나는 것으로 알려져 있어(Oh et al., 2002; Choi and Moon 2004), 좀 더 안전한 대체 치료물의 필요성이 제기되고 있다.In the case of Benign Prostatic Hyperplasia, stomach cells and epithelial cells are hyperplasia. It is a major cause of aging and male hormone. Insulin resistance, lipid metabolism abnormality, hypertension, (Ozden et al., 2007; Dahle et al., 2002). It has been reported that the metabolic syndrome is associated with abdominal obesity. These factors are a risk factor for the development of the enlarged prostate, and it is presumed that the hyperplasia of the prostate and the metabolic syndrome share a similar pathophysiological mechanism. The precise mechanism of the enlargement of the prostate gland has not been elucidated yet, but one of the common hypotheses is that it causes hypertrophy of the prostate cells due to the production of excessive dihydrotestosterone (Clark et al., 2004; Isaacs, 1984). That is, if testosterone is present in the blood excessively, a large amount of dihydrotestosterone is synthesized by the 5α-reductase (5α-reductase) in the prostate, and the synthesized dihydrotestosterone is converted into an androgen receptor Thereby causing prostate hypertrophy. In addition, men's aging reduces the secretion of male hormones, which in turn increases the androgen receptors of the prostate cells to maintain endocrine balance, leading to hypertrophy of the prostate by binding to more sites of dihydrotestosterone (Nixon 1997). Thus, 5α-reductase inhibitors that do not cause an increase in testosterone while reducing dihydrootestosterone levels in plasma and prostate clinically inhibit the overgrowth of the prostate gland, reduce prostate volume and reduce voiding symptoms (Gormley 1996; Boyle et al., 1996). Alpha-blockers, which improve the contractility of mucus smooth muscle with these 5α-reductase inhibitors, have led to dramatic changes that lead to the conversion of medication to surgery, but they are side effects and require caution. In the case of alpha-blockers, side effects such as orthostatic hypotension, headache, dizziness, lethargy, nasal congestion and cardiovascular and central nervous system disorders due to blockage of alpha-receptors distributed in blood vessels occur. (Oh et al., 2002; Choi and Moon, 2004), there is a need for more safe alternative therapies.
홍삼(紅衫, red ginseng)은 인삼(人蔘, ginseng)의 뿌리를 쪄서 제조한 붉은 인삼이며, 홍삼의 제조에 이용될 수 있는 인삼은 파낙스(Panax) 속에 속하는 다년생 식물로, 고려인삼(Panax ginseng), 화기삼(Panax quinquefolia), 전칠삼(삼칠, Panax notoginseng), 죽절삼(Panax vietnamensis), 파낙스 엘레가티오르(Panax elegatior), 파낙스 완지아누스(Panax wangianus) 또는 파낙스 비핀라티피두스(Panax bipinratifidus), 파낙스 안구스티폴리움(Panax angustifolium) 등이 있다. 홍삼은 사포닌을 많이 함유하고 있는데, 식물계에서 존재하는 대부분의 사포닌은 올레아난(oleanane) 계열이고 홍삼 사포닌은 타 식물계에 거의 존재하지 않는 담마란(dammarane) 계열의 트리테르페노이드(triterpenoid) 사포닌으로서, 홍삼 특유의 사포닌 성분으로는 진세노사이드(ginsenoside) Rh2, Rg2, Rg3, Rg1, Rh1 등이 있다. 사포닌의 일반적인 특징은 물, 알코올에 잘 녹고 지속적으로 거품이 나며 생리적으로 해독작용이 있으며 과량 투여에 독성이 없다고 밝혀져 있다. 특히, 진세노사이드는 중추신경계를 비롯하여 내분비계, 면역계, 대사계 등에 영향을 미쳐 신체조절기능에 다양한 효과를 발휘한다고 알려져 있다. 프로토파낙사디올(protopanaxadiol, PPD) 사포닌인 진세노사이드 Ra1, Ra2, Ra3, Rb1, Rb2, Rc, Rd 등은 탄소 3번과 20번에 글루코오스, 아라비노오스, 자일로오스 등이 결합한 배당체로써 홍삼의 전체 사포닌 중 약 70~80%를 차지하는 사포닌 그룹이다. 이러한 사포닌 그룹을 초산으로 산가수분해하면 탄소 20번에 결합한 당 부분이 떨어져 나가면서 진세노사이드 Rg3가 생성되며 더 나아가 진세노사이드 Rg3의 탄소 3번에 결합한 글루코오스 1분자가 떨어져 진세노사이드 Rh2가 생성됨이 보고된 바 있다(김신일 et al., 1991;Baek et al., 1995;한국등록특허 제78500호)Red ginseng is a red ginseng produced by steaming the roots of ginseng. The ginseng that can be used for the production of red ginseng is a perennial plant belonging to the genus Panax, ginseng), hwagisam (Panax quinquefolia), jeonchilsam (thirty-seven, Panax notoginseng), jukjeol three (Panax vietnamensis), Panax elegans tee climb (Panax elegatior), Panax Wan Jia Augustine (Panax wangianus) or Panax non pinra Tippi Douce (Panax bipinratifidus , Panax angustifolium , and the like. Red ginseng contains a large amount of saponin. Most saponin present in the plant is oleanane, and red ginseng saponin is triterpenoid saponin of the dammarane family And ginsenoside Rh 2 , Rg 2 , Rg 3 , Rg 1 , Rh 1 and the like as the saponin component peculiar to red ginseng. The general characteristic of saponin is that it is soluble in water, alcohol, it is consistently bubbling, physiologically detoxifying, and is not toxic to overdose. In particular, ginsenoside has been known to exert various effects on the body control function by affecting the central nervous system, the endocrine system, the immune system, and the metabolic system. The ginsenosides Ra 1 , Ra 2 , Ra 3 , Rb 1 , Rb 2 , Rc, Rd and the like, which are protopanaxadiol (PPD) saponins, are found on carbon 3 and 20 in the presence of glucose, arabinose, xylose , Which is a saponin group which accounts for about 70 ~ 80% of total saponin of red ginseng. Acid hydrolysis of this saponin group with acetic acid results in the formation of ginsenoside Rg 3 with the saccharide moiety bound to carbon 20 being cleaved off. Further, one molecule of glucose bound to carbon 3 of ginsenoside Rg 3 is removed, Rh 2 has been reported to be produced (Kim Shin et al., 1991; Baek et al., 1995; Korean Patent No. 78500)
한편, 감(persimmon)은 감나무(Diospyros kaki)의 익은 열매로 가을에 따서 식용으로 사용한다. 한방적으로 성미(性味)는 맛은 달고 성질은 차고 독이 없는 것이 특징이다. 귀경(歸經)은 심경(心經), 폐경(肺經), 대장경(大腸經)에 작용한다. 열을 내리고 폐를 촉촉하게 하여 갈증을 가시게 하고 알코올 중독을 없애며 설사를 멈추게 하는 작용을 한다. 감의 다양한 원료 부위를 기반으로 한 한방적인 가공 처방명을 살펴보면 시근(枾根), 시목피(枾木皮), 시엽(枾葉), 시화(枾花), 시자(枾子), 시병(枾餠), 시상(枾霜), 시피(枾皮), 시칠(枾漆) 등이 있다. 이중에서 본초강목(本草綱目)에 기재되어 있는 시칠(枾漆)은 감의 미숙한 과실을 가공하여 얻은 교상액(膠狀液)이다. 파랗고 떫은 미숙한 과실을 따 가지고 짓찧어서 독 안에 넣고 적당량의 물을 부은 후, 여러 번 잘 저어 혼합하고, 그대로 실온에서 약 20일 정도 방치하였다가 숙성을 진행한 후 찌꺼기를 짜내고 남은 무색의 교상액(膠狀液)이 시칠(枾漆)인 것이다. 시칠(枾漆)은 고혈압에 효과가 있다고 기록되어 있다(정보섭 등, 향약대사전, 2003, 915~918). 일본에서도 감즙은 전통적으로 고혈압을 치료하고, 심장발작을 억제한다고 알려져 있다(Uchida et al., 1990). 이러한 시칠이나 감즙의 가공과정과 유사하게 제조한 것이 감식초라고 할 수 있다. 감식초(─食醋)는 탄닌과 아스코르브산(비타민 C)이 풍부해 음식물의 산성농도를 저하시켜 보존력을 높이고, 신맛을 통해 소화액의 분비를 자극시켜 입맛을 돋우며, 인체의 에너지 대사에 관여하여 피로를 빠르게 회복시켜 준다고 알려져 있다. 감식초를 간단히 만들려면 소쿠리나 체에 감을 담고 밑에 그릇을 받친 뒤 벌레가 들어가지 않도록 잘 덮어두면 시간이 지나면서 밑에 받쳐둔 그릇에 감물이 고인다. 이 감물을 병이나 다른 용기에 담아 밀폐하여 1년 정도 숙성시키면 신맛과 함께 풍미가 짙은 식초가 만들어진다. 숙성 기간이 길수록 검은색으로 바뀌며, 맛이 부드럽고 유기산 함량이 많아진다. 감식초는 무좀이나 벌레에 물려 가려운 데에 바르면 효과가 있고, 기름기 있는 음식이나 인스턴트 식품을 먹고 난 뒤에 마시면 개운한 맛을 내며, 피로회복, 숙취예방, 스트레스 해소, 살균효과, 영양소 상승효과, 성인병 예방에도 효과적이라고 알려져 있다.On the other hand, a sense (persimmon) is persimmon (Diospyros kaki ) is a ripe fruit that is used for food after autumn. The one-sided sexuality is characterized by taste, sweetness, and lack of poison. The 貴 经 (归 经), the heart (经经), menopause (肺 经), and the Tripitaka (大肠 经) will work. It lowers fever and moistens the lungs, causing thirst, eliminating alcoholism, and stopping diarrhea. Based on the various raw material parts of persimmon, the oriental processing prescription name is 枾 根, 목 皮), 枾 葉, 枾 葉, 枾), 枾 子, 枾 子,枾, 枾 霜, 枾 skin, and 枾 漆. Among them, ichirushi (lacquer), which is described in the Bonchosugamu (草草 根 目), is a colloidal solution obtained by processing an immature fruit of persimmon. It is poured into the poison with the blue and fine unripe fruit, put in the poison, pour an appropriate amount of water, mix well and mix it several times, leave it at room temperature for about 20 days, and after ripening, squeeze out the residue, (Colloidal solution) is ichil (枾 漆) is. It has been reported that ichireishi is effective for hypertension (Iwasubo et al., Encyclopedia of Contemplation, 2003, 915-918). In Japan, juice is traditionally known to treat hypertension and inhibit heart attack (Uchida et al., 1990). It can be said that persimmon vinegar is produced similar to the process of sicil or juice. Persimmon (─ 食醋) is rich in tannin and ascorbic acid (vitamin C) to lower the acidic concentration of food to enhance preservation, stimulates the secretion of digestive juice through the sour taste, enhances the taste and is involved in the energy metabolism of the human body It is known to restore fatigue quickly. To make a persimmon vinegar, simply put a sieve or a sieve in a sieve and put a bowl under it and cover it well so that insects do not get in it. When this object is sealed in a bottle or other container and sealed for about a year, a vinegar with a rich flavor is produced. The longer the ripening period, the more blackish the taste becomes, the more the organic acid content becomes. Persimmon vinegar is effective against itching and itchy bite, and it is effective when it is applied to it. After eating greasy food or instant food, it gives a refreshing taste, and it restores fatigue, prevents hangover, relieves stress, sterilizing effect, It is known to be effective.
본 발명자들은 홍삼 추출물과 감식초를 이용하여 전립선 비대증의 치료제로 이용할 수 있는 방법을 연구하던 중, 홍삼과 감식초를 혼합하여 적절한 온도 및 시간에 따라 반응시켜 제조한 홍삼 추출물의 감식초 반응 혼합물이 전립선 비대증의 치료제로 이용될 수 있음을 확인함으로써, 본 발명을 완성할 수 있었다.The present inventors investigated a method of using red ginseng extract and persimmon vinegar as a therapeutic agent for benign prostatic hyperplasia, and found that the persimmon vinegar reaction mixture of red ginseng extract, prepared by mixing red ginseng and persimmon vinegar at appropriate temperature and time, The present invention can be completed by confirming that it can be used as a therapeutic agent.
한편, 한국등록특허 제759222호에 감초, 오가피 및 둥글레의 추출물, 홍삼 과립과 감식초 및 올리고당이 함유된 홍삼 식초 음료수가 개시되어 있고, 한국등록특허 제992800호에는 인삼의 발효물에 산 처리를 하여 진세노사이드 Rg3 및 Rh2의 함량이 증가된 가공인삼 및 이의 추출물이 개시되어 있고, 한국등록특허 제635025호에 인삼 또는 인삼 엑스에 양조식초를 가하여 90~120℃에서 6~24시간 가열 추출하여 진세노사이드 Rg3가 강화된 인삼 추출물이 개시되어 있기는 하지만, 상기 선행문헌들에는 상기 홍삼 또는 인삼에 감식초가 혼합된 조성물들이 전립선 비대증의 치료제로 이용될 수 있다는 것에 대해서는 전혀 개시되어 있지 않다. On the other hand, Korean Patent No. 759222 discloses a red ginseng vinegar drink containing an extract of licorice, ginseng and oriental ginseng, red ginseng granules, persimmon ginseng and oligosaccharides, and Korean Patent No. 992800 discloses a ginseng fermentation product Ginsenoside Rg 3 and Rh 2 are increased and Korean ginseng or ginseng extract is added with brewing vinegar to Korean ginseng extract to be heated and extracted at 90 to 120 ° C for 6 to 24 hours Although ginsenoside extract having enhanced ginsenoside Rg 3 has been disclosed, it is not disclosed in the above-mentioned prior arts that compositions in which red ginseng or ginseng is mixed with persimmon vinegar can be used as a therapeutic agent for enlargement of the prostate gland .
또한 진세노사이드 Rg3가 전립선 비대증에 치료효과가 있다고 보고된 바가 있지만(Bae et al., 2012), 본 발명의 조성물은 홍삼 추출물의 가공을 통해 얻어지는 조성물이기에, 상기 선행기술과는 다른 구성을 갖는 발명이라고 할 수 있다. In addition, although ginsenoside Rg 3 has been reported to have a therapeutic effect on benign prostatic hyperplasia (Bae et al., 2012), the composition of the present invention is a composition obtained through processing of red ginseng extract, It can be said that the invention has.
본 발명의 목적은 홍삼 추출물의 감식초 반응 혼합물을 함유한 전립선 비대증의 예방 또는 치료용 조성물을 제공하는 데에 있다. It is an object of the present invention to provide a composition for preventing or treating prostatic hyperplasia containing a persimmon reaction mixture of red ginseng extract.
본 발명은 홍삼 추출물의 감식초 반응 혼합물을 함유하는 전립선 비대증의 예방 또는 치료용 조성물에 관한 것이다. The present invention relates to a composition for preventing or treating prostatic hyperplasia containing a persimmon reaction mixture of red ginseng extract.
상기 홍삼 추출물은, 홍삼의 탄소수 1 내지 4개의 알코올 또는 이의 알코올 수용액 추출물을 농축하여 제조한 것일 수 있다. The red ginseng extract may be one prepared by concentrating an alcohol having 1 to 4 carbon atoms in the red ginseng or an aqueous solution of an aqueous solution thereof.
상기 홍삼 추출물의 감식초 반응 혼합물은, 홍삼 추출물에 홍삼 추출물 중량의 5~20배의 pH 3.0~3.5인 감식초를 가하고 70~90℃에서 1~24시간 동안 반응하여 제조한 것일 수 있다.The persimmon vinegar reaction mixture of the red ginseng extract may be prepared by adding a persimmon vinegar having a pH of 3.0 to 3.5, which is 5 to 20 times the weight of the red ginseng extract, to the red ginseng extract and reacting at 70 to 90 ° C for 1 to 24 hours.
본 발명은 또한, 상기 홍삼 추출물의 감식초 반응 혼합물을 함유하는 전립선 비대증의 예방 또는 개선용 건강기능식품을 제공한다.The present invention also provides a health functional food for preventing or improving prostate gland enlargement containing the persimmon reaction mixture of red ginseng extract.
이하 본 발명을 상세하게 설명한다.Hereinafter, the present invention will be described in detail.
상기 홍삼 추출물은 바람직하게는 홍삼의 탄소수 1 내지 4개의 알코올 또는 이의 알코올 수용액 추출액을 농축하여 제조한 것일 수 있다. The red ginseng extract may be one prepared by concentrating an alcohol having from 1 to 4 carbon atoms in red ginseng or an aqueous solution of an aqueous alcohol solution thereof.
상기 알코올은 바람직하게는 에탄올, 메탄올, 프로판올, 이소프로판올 및 부탄올 중에서 선택될 수 있다. The alcohol may preferably be selected from ethanol, methanol, propanol, isopropanol and butanol.
가장 바람직하게는 70~90%(v/v) 알코올 수용액을 사용하여 홍삼 추출물을 제조하는 것이 좋다. Most preferably, the red ginseng extract is prepared by using an aqueous 70 to 90% (v / v) alcohol solution.
상기 홍삼 추출물은 홍삼에 탄소수 1 내지 4개의 알코올 또는 이의 알코올 수용액을 가하여 가열 추출하여 얻은 여과 액상(홍삼 추출액)을 농축한 것으로서, 상기 탄소수 1 내지 4개의 알코올 또는 이의 알코올 수용액은 홍삼에 어떤 중량으로 가해도 좋으나, 바람직하게는 홍삼 중량의 5~20배를 가하는 것이 좋다. The red ginseng extract is obtained by concentrating red ginseng to a filtrate (red ginseng extract) obtained by adding an alcohol having 1 to 4 carbon atoms or an aqueous alcohol solution thereof to heating and extracting. The alcohol having 1 to 4 carbon atoms or an aqueous alcohol solution thereof is added to red ginseng However, it is preferable to add 5 to 20 times the weight of red ginseng.
또한, 가열 온도와 가열 시간도 어느 조건을 이용하여도 좋으나, 바람직하게는 70~90℃에서 4~8시간 동안 가열 추출한 것이 좋다. The heating temperature and heating time may be any conditions, but it is preferable to heat and extract at 70 to 90 ° C for 4 to 8 hours.
상기 여과 액상을 농축한 것은 바람직하게는 고형분 함량이 60%(w/w) 이상이 되도록 농축하여 제조하는 것이 더 좋다. Preferably, the filtrate phase is concentrated so that the solid content is at least 60% (w / w).
또한, 상기 홍삼 추출액을 여과하고 남은 홍삼에 다시 홍삼 중량의 5~20배의 탄소수 1 내지 4개의 알코올 또는 이의 알코올 수용액을 가하고 70~90℃에서 4~8시간 동안 가열 추출하는 과정을 1~5회 반복한 후, 반복 추출된 추출액의 여과 액상을 첫번째로 얻은 액상과 함께 농축하여 사용할 수 있다.Further, the red ginseng extract is filtered, and the red ginseng is added again with an alcohol having 1 to 4 carbon atoms or an aqueous alcohol solution thereof at 5 to 20 times the weight of red ginseng and heated at 70 to 90 ° C for 4 to 8 hours. After repeatedly repeating, the filtered liquid phase of the extracted extract can be used together with the liquid phase obtained first.
상기 홍삼 추출물은 통상적으로 사용되는 모든 추출방법을 사용하여 제조할 수 있으며, 예컨대, 상기 홍삼 추출물을 제조하기 위해 침지(냉침, 온침), 열수 추출, 초음파 추출 또는 환류 냉각 추출법을 사용할 수 있으나, 이에 한정되는 것은 아니다. The red ginseng extract may be prepared by any conventional extraction method. For example, the red ginseng extract may be dipped (cold-pressed, warmed), hot water extraction, ultrasonic extraction or reflux cooling extraction method. But is not limited thereto.
상기 홍삼 추출물은 단독으로 또는 허용 가능한 생약재를 추가하여 제조될 수도 있다. The red ginseng extract may be prepared singly or by adding an acceptable herb medicine.
본 발명의 홍삼 추출물의 감식초 반응 혼합물은, 상기 홍삼 추출물에 감식초를 가한 것으로서, 이 때 감식초는 어떤 조건으로 가해도 홍삼 추출물의 감식초 반응 혼합물을 제조할 수는 있지만, 바람직하게는 상기 홍삼 추출물 중량의 5~20배(가장 바람직하게는, 8~12배)의 감식초를 가하는 것이 좋다. The persimmon vinegar reaction mixture of the red ginseng extract of the present invention is obtained by adding persimmon vinegar to the red ginseng extract. At this time, the persimmon vinegar reaction mixture of red ginseng extract may be prepared under any condition, It is preferable to add 5 to 20 times (most preferably, 8 to 12 times) persimmon vinegar.
또한, 상기 조건에서 반응 온도는 70~90℃에서 1~24시간 동안 반응시켜 제조할 수 있다. 이 때 반응온도가 70℃ 미만이거나 90℃를 초과한 조건, 반응시간이 1시간 미만, 24시간을 초과한 조건에서 홍삼 추출물의 감식초 반응 혼합물을 제조할 경우, 이들이 갖는 각종 생리활성, 예를 들어, 전립선 비대증 억제 활성 등이 낮아질 수 있다. Also, the reaction can be carried out at 70 to 90 ° C for 1 to 24 hours under the above conditions. When the reaction temperature is less than 70 ° C, more than 90 ° C, the reaction time is less than 1 hour, and the reaction time is more than 24 hours, the persimmon reaction mixture of red ginseng extract is prepared, , Prostatic hyperplasia inhibitory activity, and the like.
상기 홍삼 추출물의 감식초 반응 혼합물은, 건조하여 분말로 제조할 수 있으며, 이를 위해, 감압건조, 분무건조, 열풍건조, 냉풍건조 또는 동결건조 등의 통상적인 건조 방법을 이용할 수 있다. The persimmon vinegar reaction mixture of the red ginseng extract may be dried to prepare a powder. For this purpose, conventional drying methods such as vacuum drying, spray drying, hot air drying, cold air drying or freeze drying may be used.
본 발명에 이용되는 감식초는 통상적으로 이용되는 감식초를 사용할 수 있으며, 바람직하게는 고형분이 2~4%(w/w)이며, pH 3.0~3.5인 감식초를 사용할 수 있다. The persimmon vinegar used in the present invention can be commonly used persimmon vinegar, preferably persimmon vinegar having a solid content of 2 to 4% (w / w) and a pH of 3.0 to 3.5.
따라서, 본 발명의 홍삼 추출물의 감식초 반응 혼합물은 바람직하게는, Therefore, the persimmon vinegar reaction mixture of the red ginseng extract of the present invention is preferably,
(1공정) 홍삼에 홍삼 중량의 5~20배의 70~90%(v/v) 알코올 수용액을 가하고 70~90℃에서 4~8시간 동안 가열 추출하고 이를 여과하여 액상을 얻는 단계; (Step 1) A 70 to 90% (v / v) alcohol aqueous solution of 5 to 20 times the weight of red ginseng is added to red ginseng, heated and extracted at 70 to 90 ° C for 4 to 8 hours and filtered to obtain a liquid phase;
(2공정) 상기 여과 액상의 알코올 성분을 모두 제거한 뒤 고형분 함량이 60%(w/w) 이상이 되도록 농축하여 홍삼 추출물을 제조하는 단계; (Step 2) After removing all of the alcohol components on the filtrate, concentrating the solution to a solid content of 60% (w / w) or more to prepare a red ginseng extract;
(3공정) 상기 홍삼 추출물에 홍삼 추출물 중량의 5~20배의 감식초를 가하고 70~90℃에서 1~24시간 동안 반응시키는 단계; 및,(Step 3) adding persimmon vinegar 5-20 times the weight of the red ginseng extract to the red ginseng extract and reacting at 70 ~ 90 ° C for 1 ~ 24 hours; And
(4공정) 상기 반응물을 건조하여 분말로 제조하는 단계;(Step 4) drying the reactant to prepare a powder;
를 포함하여 제조할 수 있다.. ≪ / RTI >
또한, 1공정에서 상기 홍삼 추출액을 여과하고 남은 홍삼에, 다시 홍삼 중량의 5~20배의 70~90%(v/v) 알코올 수용액을 가하고 70~90℃에서 4~8시간 동안 가열 추출하는 과정을 1~5회 반복한 후, 상기 반복 추출된 추출액의 여과 액상을 첫 번째로 얻은 상기 1공정의 액상과 함께 농축하여 사용할 수 있다. In addition, the red ginseng extract is filtered in step 1, and a 70 to 90% (v / v) alcohol aqueous solution of 5 to 20 times the weight of red ginseng is added to the remaining red ginseng and heated and extracted at 70 to 90 ° C for 4 to 8 hours The filtrate phase of the extracted extract may be used together with the liquid phase of the first step obtained above.
상기 2공정의 농축 방법은 통상의 추출물 농축 과정을 이용하여 수행할 수 있다.The concentration process of the above two processes can be carried out by using a conventional extract concentration process.
상기 3공정에서 사용되는 감식초의 pH는 3.0~3.5 범위, 고형분 함량 2~4%(w/w)를 사용하는 것이 바람직하다.The pH of persimmon vinegar used in step 3 is preferably in the range of 3.0 to 3.5, and the solid content of 2 to 4% (w / w) is preferably used.
또한 3공정의 가열시간이 24시간을 벗어나면 홍삼의 각종 기능성 생리활성 성분의 변화가 일어날 수 있어 약리활성이 낮아질 수 있다.In addition, if the heating time of the three steps exceeds 24 hours, various functional physiologically active components of red ginseng may be changed, and the pharmacological activity may be lowered.
4공정의 건조는 감압건조, 분무건조, 열풍건조, 냉풍건조 또는 동결건조 등의 통상적인 건조 방법을 이용할 수 있다.The drying of the four steps may be carried out by conventional drying methods such as vacuum drying, spray drying, hot air drying, cold air drying or freeze drying.
본 발명에 따른 전립선 비대증의 예방 또는 치료용 조성물 내의 유효성분으로서의 홍삼 추출물의 감식초 반응 혼합물의 함량은 사용 형태 및 목적, 환자의 중증도 등에 따라 적절히 조절할 수 있으며, 고형분의 중량 기준으로 0.01~99.9 중량%, 바람직하게는 0.1~50 중량%일 수 있으나, 이에 한정되지 않는다.The content of the persimmon vinegar reaction mixture of the red ginseng extract as an active ingredient in the composition for preventing or treating enlargement of the prostate gland according to the present invention can be appropriately controlled depending on the mode and purpose of use and the severity of the patient and is preferably 0.01 to 99.9% By weight, preferably 0.1 to 50% by weight, based on the total weight of the composition.
또한 상기의 조성물은 실제 임상투여 시에 경구 및 비경구의 여러 가지 제형으로 투여될 수 있으며, 제제화할 경우에는 보통 사용하는 충진제, 중량제, 결합제, 습윤제, 붕해제, 계면활성제 등의 희석제 또는 부형제를 사용할 수 있다. 경구 투여를 위한 고형 제제에는 정제, 환제, 산제, 과립제, 캡슐제 등이 포함되며, 이러한 고형 제제는 홍삼 추출물의 감식초 반응 혼합물을 함유한 조성물에 적어도 하나 이상의 부형제, 예컨대, 전분, 셀락토오스, 탄산칼슘, 크로스포비돈, 경질무수규산, 유당, 스테아린산 마그네슘, 탈크, 효소처리스테비아, 미결정 셀룰로오스, 마그네슘 스테아레이트, 젤라틴 등을 섞어 사용될 수 있다. 경구 투여를 위한 액상 제제로는 현탁제, 내용액제, 유제, 시럽제 등이 해당되는데 흔히 사용되는 단순희석제인 물, 리퀴드 파라핀 이외에 여러 가지 부형제, 예를 들면 습윤제, 감미제, 방향제, 보존제 등이 포함될 수 있다. 비경구 투여를 위한 제제에는 멸균된 수용액, 비수성용제, 현탁제, 유제, 동결건조제제가 포함될 수 있다. 비수성용제, 현탁용제로는 프로필렌글리콜, 폴리에틸렌 글리콜, 올리브 오일과 같은 식물성 기름, 에틸올레이트와 같은 주사 가능한 에스테르 등이 사용될 수 있다.In addition, the above composition may be administered in various formulations of oral and parenteral administration in actual clinical administration. In the case of formulation, a diluent or excipient such as a filler, a weight agent, a binder, a wetting agent, a disintegrant, Can be used. Solid formulations for oral administration include tablets, pills, powders, granules, capsules and the like, and such solid preparations may contain at least one excipient such as starch, celluloses, carbonates Calcium stearate, crospovidone, light anhydrous silicic acid, lactose, magnesium stearate, talc, enzyme-treated stevia, microcrystalline cellulose, magnesium stearate, gelatin and the like. Liquid preparations for oral administration include suspensions, solutions, emulsions, syrups and the like. Various excipients such as wetting agents, sweeteners, fragrances, preservatives and the like may be included in addition to water and liquid paraffin, which are simple diluents commonly used. have. Formulations for parenteral administration may include sterilized aqueous solutions, non-aqueous solutions, suspensions, emulsions, and freeze-drying agents. Examples of the non-aqueous solvent and suspending agent include propylene glycol, polyethylene glycol, vegetable oil such as olive oil, injectable ester such as ethyl oleate, and the like.
본 발명의 홍삼 추출물의 감식초 반응 혼합물을 함유하는 조성물의 투여 용량은 환자의 체충, 연령, 성별, 건강상태, 식이, 투여시간, 투여방법, 배설율 및 질환의 중증도에 따라 달라질 수 있으며, 의사 또는 약사의 판단에 따라 일정 시간 간격으로 1일 1회~수회로 분할 투여할 수도 있다. 예컨대, 유효성분 함량 기준으로 1일 투여량이 0.001~500㎎/㎏, 바람직하게는 0.1~200㎎/㎏일 수 있다.The dose of the composition containing the persimmon vinegar reaction mixture of the present invention may vary depending on the patient's body weight, age, sex, health condition, diet, administration time, administration method, excretion rate and severity of disease, Depending on the judgment of the pharmacist, it may be administered once or several times a day at intervals of a certain time. For example, the daily dose may be 0.001 to 500 mg / kg, preferably 0.1 to 200 mg / kg, based on the active ingredient.
또 다른 측면에 있어서, 본 발명은 홍삼 추출물의 감식초 반응 혼합물을 함유하는 전립선 비대증의 예방 또는 개선용 건강기능식품을 제공한다. 상기 건강기능식품은 각종 식품, 음료, 식품 첨가물 등일 수 있다.In another aspect, the present invention provides a health functional food for preventing or ameliorating prostate hyperplasia containing a persimmon reaction mixture of red ginseng extract. The health functional food may be various foods, beverages, food additives, and the like.
상기 건강기능식품에 함유된 유효성분으로서의 추출물의 함량은 식품의 형태, 사용하고자 하는 용도에 따라 적절하게 함유될 수 있으며, 예컨대, 전체 식품 중량의 0.01~50 중량%로 가할 수 있으며, 바람직하게는 0.1~10 중량%의 비율로 가할 수 있다. 또한 건강음료 조성물은 100㎖을 기준으로 0.02~10g, 바람직하게는 0.1~5g의 비율로 가할 수 있다. The content of the extract as an active ingredient contained in the health functional food may be appropriately determined depending on the form of the food and the intended use. For example, the extract may be added in an amount of 0.01 to 50% by weight, 0.1 to 10% by weight. The health drink composition may be added at a ratio of 0.02 to 10 g, preferably 0.1 to 5 g, based on 100 ml.
본 발명의 건강음료 조성물은 지시된 비율로 필수 성분으로서 상기 추출물을 함유하는 것 외에 액체성분에는 특별한 제한점은 없으며 통상의 음료와 같이 여러 가지 향미제 또는 천연 탄수화물 등을 추가 성분으로서 함유할 수 있다. 상술한 천연 탄수화물의 예는 모노사카라이드, 예를 들어, 포도당, 과당 등의 디사카라이드, 예를 들어 말토스, 슈크로스 등의 폴리사카라이드, 예를 들어 덱스트린, 시클로덱스트린 등과 같은 통상적인 당 및 자일리톨, 소르비톨, 에리트리톨 등의 당알콜이다. 상술한 것 이외의 향미제로서 천연 향미제(타우마틴, 스테비아 추출물(예를 들어 레바우디오시드 A, 글리시르히진 등) 및 합성 향미제(사카린, 아스파르탐 등)를 사용할 수 있다. 상기 천연 탄수화물의 비율은 본 발명의 조성물 100㎖당 일반적으로 1~20g, 바람직하게는 5~12g이다.The health beverage composition of the present invention may contain various flavors or natural carbohydrates such as ordinary beverages as an additional ingredient, as long as it contains the extract as an essential ingredient at the indicated ratio, and there is no particular limitation to the liquid ingredient. Examples of the above-mentioned natural carbohydrates include monosaccharides such as disaccharides such as glucose and fructose, polysaccharides such as maltose, sucrose and the like, such as dextrin, cyclodextrin and the like And sugar alcohols such as xylitol, sorbitol and erythritol. As a flavor other than the above, a natural flavoring agent (tautatin, stevia extract (for example, rebaudioside A, glycyrrhizin, etc.) and synthetic flavorings (saccharin, aspartame, etc.) The ratio of the natural carbohydrate is generally 1 to 20 g, preferably 5 to 12 g per 100 ml of the composition of the present invention.
상기 외에 본 발명의 조성물은 여러 가지 영양제, 비타민, 광물(전해질), 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, 알코올, 탄산음료에 사용되는 탄산화제 등을 함유할 수 있다. 그밖에 본 발명의 조성물들은 천연 과일 주스 및 과일 주스 음료 및 야채 음료의 제조를 위한 과육을 함유할 수 있다. 이러한 성분은 독립적으로 또는 조합하여 사용할 수 있다. 이러한 첨가제의 비율은 그렇게 중요하진 않지만 본 발명의 조성물 100 중량부당 0.001~20 중량부의 범위에서 선택되는 것이 일반적이다.In addition to the above-mentioned composition, the composition of the present invention can be used as a flavoring agent such as various nutrients, vitamins, minerals (electrolytes), synthetic flavors and natural flavors, coloring agents and intermediates (cheese, chocolate etc.), pectic acid and its salts, Salts, organic acids, protective colloid thickeners, pH adjusting agents, stabilizers, preservatives, glycerin, alcohols, carbonating agents used in carbonated beverages and the like. In addition, the compositions of the present invention may contain flesh for the production of natural fruit juices and fruit juice drinks and vegetable drinks. These components may be used independently or in combination. The proportion of such additives is not so critical, but is generally selected in the range of 0.001 to 20 parts by weight per 100 parts by weight of the composition of the present invention.
특히, 본 발명의 홍삼 추출물의 감식초 반응 혼합물의 원료인 홍삼이나 감은 예로부터 한방에서 사용되어 왔던 것으로서, 인체에 투여할 경우 다른 합성 의약품에 비해 부작용의 염려가 없을 것으로 사료되며, 동물 실험을 통해 실제로 규격화된 독성 시험 결과 생체 내 아무런 영향이 없는 것으로 판명되었다. In particular, the red ginseng or persimmon which is the raw material of the persimmon vinegar reaction mixture of the present invention has been used in oriental medicine since it has no side effects compared with other synthetic medicines when administered to human body. Standardized toxicity tests have shown that there is no effect in vivo.
홍삼 추출물의 감식초 반응 혼합물을 함유한 전립선 비대증의 예방 또는 치료용 조성물에 관한 것으로서, 상기 홍삼 추출물의 감식초 반응 혼합물은 기존의 홍삼 추출물이나 인삼 추출물에 비해 전립선 비대 증상을 저해하는 효과가 우수하여, 남성 전립선 관련 질환을 예방 또는 억제할 수 있는 조성물로 유용하게 사용될 수 있다.The present invention relates to a composition for preventing or treating enlargement of the prostate gland, which comprises a persimmon vinegar reaction mixture of red ginseng extract. The ginseng reaction mixture of the red ginseng extract is superior to the conventional ginseng extract or ginseng extract, Can be effectively used as a composition capable of preventing or inhibiting prostate-related diseases.
도 1은 본 발명의 실시예 1 및 2에 개시된 홍삼 추출물의 감식초 반응 혼합물을 제조하는 방법을 나타낸 순서도이다.1 is a flow chart showing a method for preparing a persimmon vinegar reaction mixture of red ginseng extract disclosed in Examples 1 and 2 of the present invention.
이하 본 발명의 바람직한 실시예를 상세히 설명하기로 한다. 그러나, 본 발명은 여기서 설명되는 실시예에 한정되지 않고 다른 형태로 구체화될 수도 있다. 오히려, 여기서 소개되는 내용이 철저하고 완전해지고, 당업자에게 본 발명의 사상을 충분히 전달하기 위해 제공하는 것이다. Hereinafter, preferred embodiments of the present invention will be described in detail. However, the present invention is not limited to the embodiments described herein but may be embodied in other forms. Rather, the intention is to provide an exhaustive, complete, and complete disclosure of the principles of the invention to those skilled in the art.
<실시예 1. 홍삼 추출물의 제조>≪ Example 1: Preparation of red ginseng extract >
홍삼 10kg에 50kg의 70%(v/v) 에탄올 수용액을 가하고 80℃에서 6시간 동안 가열 추출하였다. 상기 홍삼 추출액을 여과하고 남은 홍삼에 다시 50kg의 70%(v/v) 에탄올 수용액을 가하여 80℃에서 6시간 동안 가열 추출하였으며 이와 같은 과정을 한번 더 반복하여, 총 3회 홍삼에서 80℃에서 6시간 동안 가열 추출하였다. 이렇게 하여 모은 추출액을 100μm 필터로 여과한 여과액에서 에탄올 성분을 제거한 뒤, 농축기를 이용하여 고형분 함량이 60%(w/w)가 되도록 농축하여 7.2kg의 홍삼 추출물을 제조하였다.50 kg of a 70% (v / v) aqueous ethanol solution was added to 10 kg of red ginseng and the mixture was heated at 80 ° C for 6 hours. The red ginseng extract was filtered, and 50 kg of a 70% (v / v) aqueous ethanol solution was added to the remaining red ginseng and the mixture was heated at 80 ° C for 6 hours. The procedure was repeated one more time, Lt; / RTI > The extract thus obtained was filtered through a 100 μm filter, and the ethanol component was removed from the filtrate, and then 7.2 kg of red ginseng extract was prepared by concentrating the extract to a solid content of 60% (w / w) using a concentrator.
<실시예 2. 홍삼 추출물의 감식초 반응 혼합물의 제조><Example 2: Preparation of persimmon vinegar reaction mixture of red ginseng extract>
실시예 1의 홍삼 추출물 100g과 감식초 1200g을 혼합한 후, 하기 표 1의 조건으로 70~90℃ 온도에서 1~24시간 동안 상기 홍삼 추출물과 감식초를 반응시켜, 홍삼 추출물의 감식초 반응 혼합물을 제조하고 이를 감압농축하여 건조하고 분말로 제조하였다. 감식초는 pH 3.0, 고형분 함량 3%(w/w)인 것을 구입하여 사용하였다.100 g of the red ginseng extract of Example 1 and 1200 g of persimmon vinegar were mixed and reacted with the ginseng extract and persimmon vinegar at 70 to 90 ° C for 1 to 24 hours under the conditions shown in Table 1 to prepare a persimmon vinegar reaction mixture of red ginseng extract This was concentrated under reduced pressure and dried to prepare a powder. Persimmon vinegar was purchased with a pH of 3.0 and a solid content of 3% (w / w).
<비교예 1. 비교대상 홍삼 추출물의 감식초 반응 혼합물의 제조><Comparative Example 1> Preparation of persimmon vinegar reaction mixture of comparative red ginseng extract>
상기 실시예 2의 조건과 동일하게 홍삼 추출물의 감식초 반응 혼합물을 제조하되 하기 표 2의 조건으로 온도 및 시간 조건을 달리하였다.The ginseng reaction mixture of red ginseng extract was prepared in the same manner as in Example 2, except that temperature and time conditions were changed under the conditions shown in Table 2 below.
<비교예 2. 인삼 추출물의 감식초 반응 혼합물의 제조>≪ Comparative Example 2: Preparation of persimmon vinegar reaction mixture of ginseng extract >
상기 실시예 1의 조건과 동일하게 인삼 추출물을 제조하고, 이를 홍삼 추출물 대신 이용하여, 상기 실시예 2-5의 조건으로 인삼 추출물의 감식초 반응 혼합물을 제조하였다. The ginseng extract was prepared in the same manner as in Example 1 and was used instead of the red ginseng extract to prepare a persimmon vinegar reaction mixture of the ginseng extract under the conditions of Example 2-5.
<비교예 3. 가온하지 않은 홍삼 추출물과 감식초의 혼합물><Comparative Example 3> A mixture of red ginseng extract and persimmon vinegar which were not warmed>
실시예 1의 홍삼 추출물 100g과 감식초 1200g을 혼합하고, 가온하지 않은 채로 이를 감압농축하여 건조하고 분말로 제조하였다. 100 g of the red ginseng extract of Example 1 and 1200 g of persimmon vinegar were mixed, and the mixture was concentrated under reduced pressure without heating and dried to prepare a powder.
<비교예 4. 인삼 추출물><Comparative Example 4: Ginseng extract>
비교예 2에서 인삼 추출물의 감식초 반응 혼합물을 제조하기 위해 만들었던 것과 같은 인삼 추출물 제조하고 감압농축하여 건조하고 분말로 제조하였다. In Comparative Example 2, the same ginseng extract as that made to prepare the persimmon vinegar reaction mixture of ginseng extract was prepared and dried under reduced pressure to prepare powder.
<비교예 5. 홍삼 추출물><Comparative Example 5> Red ginseng extract>
실시예 1의 홍삼 추출물과 같은 홍삼 추출물 제조하고 이를 감압농축하여 건조하고 분말로 제조하였다. Red ginseng extracts such as the red ginseng extract of Example 1 were prepared and concentrated under reduced pressure to dryness to prepare powder.
<실험예 1. 홍삼 추출물의 감식초 반응 혼합물의 전립선 비대증 치료 효과 확인> Experimental Example 1. Confirmation of therapeutic effect of ginseng extract on persimmon vinegar treatment of persimmon vinegar reaction mixture.
3개월령의 수컷 SD(Sprague Dawley)계 레트를 중앙실험동물에서 공급받아 사용하였다. 고형사료와 물은 상시 공급하고 실온 22±2℃, 상대습도 50~65%, 조도 200lux(8시 점등, 20시 소등)를 계속 유지하면서 1주간 실험실 환경에 적응시킨 후 실험에 사용하였다. 실험에 사용된 SD 레트에게 공급된 사료는 일반식이(18% protein, 2018S, Hanlan Laboratories. Inc, USA)를 제공하였으며, 음수는 필터와 유수살균기를 이용하여 여과, 살균된 정제수를 폴리설폰(polysulfone) 재질의 500㎖ 음수병에 넣어 사용하였다. 사료와 음수는 자유 섭취시켰다(ad libitum). 체중의 변화는 1주일에 한번씩 측정하였다. Three-month-old male SD (Sprague Dawley) -sets were used in the central experimental animals. Solid feed and water were supplied at all times and used for experiments after being acclimated to the laboratory environment for 1 week while maintaining the room temperature of 22 ± 2 ° C, the relative humidity of 50 ~ 65%, and the illumination of 200lux (8 o'clock, 20 o'clock off). The feeds fed to the SDLET used in the experiment were fed a normal diet (18% protein, 2018S, Hanlan Laboratories. Inc, USA) and the filtered water was filtered using a filter and a water sterilizer, and the sterilized purified water was treated with polysulfone ) ≪ / RTI > Feed and negative water were ad libitum. Changes in body weight were measured once a week.
실험에 사용된 SD 레트는 테스토스테론(testosterone)과 시료를 투여하지 않은 무처리군, 테스토스테론을 투여하되 시료는 투여하지 않은 전립선 비대증 대조군, 테스토스테론과 함께 실시예 2, 비교예 1~5의 시료를 먹인 실험군 그룹을 나누었으며, 군 당 8마리씩 배정하였다.The SD retorts used in the experiment were fed with the testosterone and the untreated group without the sample, with the testosterone-treated group, the untreated prostatic hypertrophy control group, and testosterone with the sample of Example 2 and Comparative Examples 1 to 5 Experimental groups were divided and 8 mice were assigned per group.
전립선 비대증 대조군은 0.3㎖의 목화씨 오일에 녹인 테스토스테론 3mg/kg을 실험 시작일부터 2주째까지 2일에 한 번씩 오후 4시에 피하주사를 하였고, 실험 2주째부터 종료일인 8주째까지는 테스토스테론 1.5mg/kg으로 3일에 한 번 오후 4시에 피하주사하였으며, 2주째부터는 시료 대신 0.3㎖의 생리식염수를 투여하였다. In the control group, 3 mg / kg of testosterone dissolved in 0.3 ml of cottonseed oil was subcutaneously injected at 4:00 pm every 2 days from the start of the experiment until the end of the 8th week of the experiment, and 1.5 mg / kg of testosterone At 3, 4, and 0.3 ml of physiological saline was administered at 2 weeks.
실시예 2, 비교예 1~5의 시료를 먹인 실험군은 상기 전립선 비대증 대조군과 동일하게 테스토스테론을 투여하면서, 실험 2주째부터 종료일까지 각 시료를 0.3㎖의 생리식염수에 20mg/kg의 농도로 녹여 매일 경구투여하였다. In the experimental group fed with the samples of Example 2 and Comparative Examples 1 to 5, each test sample was dissolved in 0.3 ml of physiological saline at a concentration of 20 mg / kg from the second week to the end of the experiment while administering testosterone in the same manner as the control group of the above- Orally.
무처리군은 테스토스테론 대신, 전립선 비대증 대조군에서 테스토스테론을 투여하는 것과 동일한 방법으로, 목화씨 오일 0.3㎖을 피하주사하였으며, 실험 2주째부터 종료일까지 각 시료 대신 0.3㎖의 생리식염수를 매일 경구투여하였다.In the untreated group, 0.3 ml of cottonseed oil was injected subcutaneously in the same manner as in the testosterone administration in the control group for prostate hypertrophy, and 0.3 ml of physiological saline was orally administered daily instead of each sample from the second week to the end of the experiment.
실험 8주째에 모든 쥐를 24시간 절식시키고 이소푸르란/질소/산소를 이용하여 흡입 마취시킨 후 개복하여 전립선의 무게를 측정하였다. 전립선 적출시, 전립선에서 요도와 방광, 정낭선이 파열되지 않도록 또한 전립선이 파열되어 선액이 빠져나가지 않도록 주의하였다. 적출된 전립선은 생리식염수로 혈액을 제거한 후 여지로 남은 수분과 혈액을 제거한 후 무게를 측정하였으며, 체중과 함께 표 3에 이 결과값을 나타내었다. 각 시료의 효과를 판별하기 위한 최종 데이터는 전립선 무게에서 체중을 나눈 후 1000을 곱한 값으로 하였다. At 8 weeks of the experiment, all rats were fasted for 24 hours and inhaled with isoflurane / nitrogen / oxygen and anesthetized, and the weight of the prostate gland was measured. During prostate extraction, the urethra, bladder, and seminal vesicle were not ruptured in the prostate, and the prostate was ruptured so that the nasal fluid could not escape. The extracted prostate gland was removed with physiological saline, and the weight of the prostate gland was measured after removing the remaining water and blood. The results are shown in Table 3 together with the body weight. The final data to determine the effect of each sample was weight divided by prostate weight and then multiplied by 1000.
표 3을 참고하면, 각 시료 투여군 또는 무처리군이나 전립선 비대증 대조군에 의한 SD 레트의 식이섭취량의 변화는 각 그룹간에 있어 관찰되지 않았으며, 체중의 변화도 거의 없는 것으로 확인되었다(데이터 미포함). 또한, 하기 표 3을 참고하면, 실험 종료 시의 체중에서도 거의 차이가 나지 않는 것을 알 수 있었다. 한편, 모든 군을 부검하여 전립선 무게를 체중을 나눈 후 1000을 곱한 결과, 무처리군 3.39일 때, 테스토스테론을 투여한 전립선 비대증 대조군에서 4.99로 전립선 무게가 증가하여 테스토스테론의 과다 투여로 인해 전립선 비대증이 유발되었다는 것을 알 수 있었다. 실시예 2의 홍삼 추출물의 감식초 반응 혼합물 처리군은 평균값 3.46으로, 전립선 비대증 대조군의 수치와 비교하여 전립선 비대 증상이 현저하게 개선되었으며, 이는 무처리군과 거의 유사한 값임을 알 수 있었다. 또한, 상기 실시예 2의 홍삼 추출물의 감식초 반응 혼합물은, 실시예 2와는 다른 온도 및 시간 조건에서 제조한 비교예 1의 홍삼 추출물의 감식초 반응 혼합물, 비교예 2의 인삼 추출물의 감식초 반응 혼합물, 비교예 3의 홍삼 추출물과 감식초와의 단순 혼합물, 비교예 4의 인삼 추출물, 비교예 5의 홍삼 추출물 등에 비해 아주 현저한 전립선 비대 증상의 억제 효과가 있었다. As shown in Table 3, changes in dietary intake of SDLET by each sample-treated group or the untreated group or the prostate hypertrophic control group were not observed between the groups and there was little change in body weight (data not shown). Further, referring to the following Table 3, it was found that there was almost no difference in the body weight at the end of the experiment. All groups were autopsied, and the weight of the prostate gland was divided by body weight and then multiplied by 1000. As a result, the prostate weight was increased to 3.99 in the untreated group, 4.99 in the testosterone-administered group, and the enlargement of the prostate due to overdosage of testosterone . The average value of the red ginseng extract mixture of the ginseng extract of Example 2 was 3.46 and the prostate hyperplasia was significantly improved compared to the control group of the hyperplasia of the prostate. In addition, the persimmon vinegar reaction mixture of the red ginseng extract of Example 2 was prepared by mixing the persimmon vinegar reaction mixture of the red ginseng extract of Comparative Example 1 and the persimmon vinegar reaction mixture of the ginseng extract of Comparative Example 2 under the conditions of temperature and time different from those of Example 2 The ginseng extract of Comparative Example 4 and the red ginseng extract of Comparative Example 5 showed remarkable inhibitory effects on prostate hyperplasia, compared to the simple mixture of red ginseng extract and persimmon extract of Example 3,
(20mg/kg b.w.)Condition
(20 mg / kg bw)
×1000(prostate / body weight)
× 1000
<실험예 2. 독성실험> <Experimental Example 2> Toxicity test>
실험예 2-1. 급성독성Experimental Example 2-1. Acute toxicity
본 발명의 홍삼 추출물의 감식초 반응 혼합물을 단기간에 과량을 섭취하였을 때 급성적(24시간 이내)으로 동물체내에 미치는 독성을 조사하고, 치사율을 결정하기 위하여 본 실험을 수행하였다. 일반적인 마우스인 ICR 마우스 계통 20마리를 대조군과 실험군에 각각 10마리씩 배정하였다. 대조군에는 PEG-400/tween-80/에탄올(8/1/1, v/v/v) 만을 투여하고, 실험군은 본 발명의 실시예 2-5의 홍삼 추출물의 감식초 반응 혼합물을 상기 PEG-400/tween-80/에탄올(8/1/1, v/v/v)에 녹여 2g/㎏/day의 농도로 각각 경구투여하였다. 투여 24시간 후에 각각의 치사율을 조사한 결과, 대조군과 2g/㎏/day 농도의 홍삼 추출물의 감식초 반응 혼합물을 투여한 실험군에서 마우스가 모두 생존하는 것으로 확인되었다.The toxicity of the red ginseng extract of the present invention to the veterinary body was investigated acutely (within 24 hours) when the persimmon vinegar reaction mixture was consumed in a short period of time and the mortality was determined. Twenty ICR mice were injected into each of the control and experimental groups. In the control group, only the PEG-400 / tween-80 / ethanol (8/1/1, v / v / v) was administered and in the experimental group, the persimmon reaction mixture of the red ginseng extract of Example 2-5 of the present invention was administered to the PEG- / tween-80 / ethanol (8/1/1, v / v / v) for oral administration at a concentration of 2 g / kg / day. After 24 hours of administration, the mice were found to survive in the control group and in the experimental group administered with the persimmon reaction mixture of red ginseng extract at a concentration of 2 g / kg / day.
실험예 2-2. 실험군 및 대조군의 장기 및 조직 독성 실험Experimental Example 2-2. Organ organs toxicity test in experimental group and control group
장기 독성 실험은 본 발명의 홍삼 추출물의 감식초 반응 혼합물을 각 농도로(최종농도 2g/㎏/day) 8주 동안 C57BL/6J 마우스(각 군당 10마리)에 투여하여 실험하였다. 동물의 각 장기(조직)에 미치는 영향을 조사하기 위하여 본 발명의 실시예 2-5의 홍삼 추출물의 감식초 반응 혼합물을 투여한 실험군과 PEG-400/tween-80/에탄올(8/1/1, v/v/v)만을 투여한 대조군의 동물들로부터 8주 후 혈액을 채취하여 GPT(glutamate-pyruvate transferase) 및 BUN(blood urea nitrogen)의 혈액 내 농도를 Select E(Vital Scientific NV, Netherland) 기기를 이용하여 측정하였다. 그 결과, 간독성과 관계있는 것으로 알려진 GPT와 신장독성과 관계있는 것으로 알려진 BUN의 경우, 대조군과 비교하여 실험군은 별다른 차이를 보이지 않았다. 또한, 각 동물로부터 간과 신장을 절취하여 통상적인 조직절편 제작과정을 거쳐 광학현미경으로 조직학적 관찰을 시행하였으며 모든 조직에서 특이한 이상이 관찰되지 않았다. In the long-term toxicity test, the persimmon reaction mixture of red ginseng extract of the present invention was administered to C57BL / 6J mice (10 per group) for 8 weeks at each concentration (final concentration 2 g / kg / day). In order to investigate the effect on the organs (tissues) of animals, the experimental group administered the persimmon vinegar reaction mixture of Example 2-5 of the present invention and PEG-400 / tween-80 / ethanol (8/1/1, After 8 weeks from the control animals receiving only v / v / v, blood was collected and the blood levels of GPT (glutamate-pyruvate transferase) and BUN (blood urea nitrogen) were measured by Select E (Vital Scientific NV, . As a result, GPT, which is known to be related to hepatotoxicity, and BUN, which is known to be related to renal toxicity, showed no significant difference compared to the control group. In addition, liver and kidney were cut from each animal, followed by a general tissue section preparation, histological observation with an optical microscope, and no abnormalities were observed in all tissues.
<< 제제예Formulation example 1. 약학적 제제> 1. Pharmaceutical preparations>
제제예 1-1. 정제의 제조Formulation Example 1-1. Manufacture of tablets
본 발명의 실시예 2-5의 홍삼 추출물의 감식초 반응 혼합물 200g을 락토오스 175.9g, 감자전분 180g 및 콜로이드성 규산 32g과 혼합하였다. 이 혼합물에 10% 젤라틴 용액을 첨가시킨 후, 분쇄해서 14 메쉬체를 통과시켰다. 이것을 건조시키고 여기에 감자전분 160g, 활석 50g 및 스테아린산 마그네슘 5g을 첨가해서 얻은 혼합물을 정제로 만들었다. 200 g of the persimmon vinegar reaction mixture of Example 2-5 of the present invention was mixed with 175.9 g of lactose, 180 g of potato starch and 32 g of colloidal silicic acid. To this mixture was added a 10% gelatin solution, which was pulverized and passed through a 14-mesh sieve. This was dried, and a mixture obtained by adding 160 g of potato starch, 50 g of talc and 5 g of magnesium stearate was made into tablets.
제제예 1-2. 주사액제의 제조Formulation Example 1-2. Injection preparation
본 발명의 실시예 2-5의 홍삼 추출물의 감식초 반응 혼합물 1g, 염화나트륨 0.6g 및 아스코르브산 0.1g을 증류수에 용해시켜서 100㎖를 만들었다. 이 용액을 병에 넣고 20℃에서 30분간 가열하여 멸균시켰다.1 g of the red ginseng reaction mixture of Example 2-5 of the present invention, 0.6 g of sodium chloride and 0.1 g of ascorbic acid were dissolved in distilled water to make 100 ml. This solution was placed in a bottle and sterilized by heating at 20 DEG C for 30 minutes.
<제제예 2. 식품 제조><Formulation Example 2: Food Preparation>
제제예 2-1. 조리용 양념의 제조Formulation Example 2-1. Manufacture of cooking seasonings
본 발명의 실시예 2-5의 홍삼 추출물의 감식초 반응 혼합물을 조리용 양념에 1 중량%로 첨가하여 건강 증진용 조리용 양념을 제조하였다.The persimmon vinegar reaction mixture of the red ginseng extract of Example 2-5 of the present invention was added to the cooking seasoning at 1 wt% to prepare a cooking sauce for health promotion.
제제예 2-2. 밀가루 식품의 제조Formulation Example 2-2. Manufacture of flour food products
본 발명의 실시예 2-5의 홍삼 추출물의 감식초 반응 혼합물을 밀가루에 0.1 중량%로 첨가하고, 이 혼합물을 이용하여 빵, 케이크, 쿠키, 크래커 및 면류를 제조하여 건강 증진용 식품을 제조하였다.A food for health promotion was prepared by adding the persimmon vinegar reaction mixture of Example 2-5 of the present invention to wheat flour at 0.1 wt% and preparing bread, cake, cookies, crackers and noodles using the mixture.
제제예 2-3. 스프 및 육즙(gravies)의 제조Preparation Example 2-3. Manufacture of soups and gravies
본 발명의 실시예 2-5의 홍삼 추출물의 감식초 반응 혼합물을 스프 및 육즙에 0.1 중량%로 첨가하여 건강 증진용 수프 및 육즙을 제조하였다.Health enhancing soup and juice were prepared by adding the persimmon vinegar reaction mixture of red ginseng extract of Example 2-5 of the present invention to the soup and juice at 0.1 wt%.
제제예 2-4. 유제품(dairy products)의 제조Formulation Example 2-4. Manufacture of dairy products
본 발명의 실시예 2-5의 홍삼 추출물의 감식초 반응 혼합물을 우유에 0.1 중량%로 첨가하고, 상기 우유를 이용하여 버터 및 아이스크림과 같은 다양한 유제품을 제조하였다.The persimmon vinegar reaction mixture of red ginseng extract of Example 2-5 of the present invention was added to milk in an amount of 0.1% by weight and various dairy products such as butter and ice cream were prepared using the milk.
제제예 2-5. 야채주스 제조Formulation Example 2-5. Vegetable juice manufacturing
본 발명의 실시예 2-5의 홍삼 추출물의 감식초 반응 혼합물 0.5g을 토마토 주스 또는 당근주스 1,000㎖에 가하여 건강 증진용 야채주스를 제조하였다.0.5 g of the persimmon vinegar reaction mixture of Example 2-5 of the present invention was added to 1,000 ml of tomato juice or carrot juice to prepare vegetable juice for health promotion.
제제예 2-6. 과일주스 제조Formulation Example 2-6. Manufacture of fruit juice
본 발명의 실시예 2-5의 홍삼 추출물의 감식초 반응 혼합물 0.1g을 사과주스 또는 포도주스 1,000㎖에 가하여 건강 증진용 과일주스를 제조하였다.
0.1 g of the persimmon vinegar reaction mixture of Example 2-5 of the present invention was added to 1,000 ml of apple juice or grape juice to prepare fruit juice for health promotion.
Claims (6)
상기 홍삼 추출물은, 홍삼의 탄소수 1 내지 4개의 알코올 또는 이의 알코올 수용액 추출물을 농축하여 제조한 것을 특징으로 하는 전립선 비대증의 예방 또는 치료용 조성물.The method according to claim 1,
Wherein the red ginseng extract is prepared by concentrating an alcohol having 1 to 4 carbon atoms or an aqueous solution of an alcohol thereof in red ginseng.
상기 홍삼 추출물은, 홍삼의 C1~C4 알코올 또는 이의 알코올 수용액 추출물을 농축하여 제조한 홍삼 추출물인 것을 특징으로 하는 전립선 비대증의 예방 또는 개선용 건강기능식품.5. The method of claim 4,
Wherein the red ginseng extract is a red ginseng extract prepared by concentrating a C1-C4 alcohol or its aqueous alcoholic solution extract of red ginseng, to prevent or ameliorate the enlargement of the prostate gland.
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KR20210030193A (en) | 2019-09-09 | 2021-03-17 | (주)리즈바이오텍 | Pharmaceutical composition containing single or mixture of extract of Rubus crataegifolius, extract of Lespedeza cuneata and extract of Crataegus pinnatifida for prevention or treatment benign prostatic hyperplasia |
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KR20160068401A (en) | 2014-12-05 | 2016-06-15 | 충남대학교산학협력단 | Pharmaceutical Composition for Prevention or Treatment of Benign Prostatic Hyperplasia Comprising Natural Product Extract |
KR20210030193A (en) | 2019-09-09 | 2021-03-17 | (주)리즈바이오텍 | Pharmaceutical composition containing single or mixture of extract of Rubus crataegifolius, extract of Lespedeza cuneata and extract of Crataegus pinnatifida for prevention or treatment benign prostatic hyperplasia |
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