KR20030065968A - Extracts of panax ginseng head and use of antiucler agent and anti-gastritis agent therewith - Google Patents
Extracts of panax ginseng head and use of antiucler agent and anti-gastritis agent therewith Download PDFInfo
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- KR20030065968A KR20030065968A KR1020020006070A KR20020006070A KR20030065968A KR 20030065968 A KR20030065968 A KR 20030065968A KR 1020020006070 A KR1020020006070 A KR 1020020006070A KR 20020006070 A KR20020006070 A KR 20020006070A KR 20030065968 A KR20030065968 A KR 20030065968A
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- South Korea
- Prior art keywords
- ginseng
- butanol
- layer
- methanol
- gastric
- Prior art date
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- A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
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- A—HUMAN NECESSITIES
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- A61K2236/30—Extraction of the material
- A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
- A61K2236/333—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using mixed solvents, e.g. 70% EtOH
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Abstract
Description
본 발명은 인삼노두 추출물 및 이를 유효성분으로 함유하는 위염 및 위궤양 치료제 및 기능성 식품에 관한 것으로, 보다 구체적으로 인삼노두를 메탄올 또는 메탄올과 물의 혼합용매로 추출하여 얻어진 인삼노두 메탄올 추출물과 상기 인삼노두 메탄올 추출물을 헥산, 클로로포름, 부탄올 및 증류수로 계통분획하여 얻어진 인삼노두 부탄올 분획물 및 이를 유효성분으로 함유하는 위염제 및 위궤양 치료제 및 기능성 식품에 관한 것이다.The present invention relates to a ginseng outgrowth extract, a gastritis and gastric ulcer therapeutic agent and functional food containing the same as an active ingredient, and more specifically, a ginseng outgrowth methanol extract obtained by extracting ginseng outgrowth with methanol or a mixed solvent of methanol and water and the ginseng outgrowth methanol The present invention relates to a ginseng bean butanol fraction obtained by systematically extracting the extract into hexane, chloroform, butanol and distilled water, and to a gastritis and gastric ulcer therapeutic agent and a functional food containing the same as an active ingredient.
사람의 위장관계 기능에 악영향을 미치는 요인은 그 성질이 극히 다양하다. 이와 같은 장해는 상부 위장관, 하부 위장관 또는 두 부분 모두에서 발생할 수 있으며, 유전적, 생리학적, 환경적 및 정신적 요인을 포함하여 광범위한 위장 장해 요인이 있다. 상부 위장관의 만성 질환 중에는 위염(ucler) 및 위궤양(gastritis)이 포함되어 있는데, 위염은 위점막의 염증을 나타내는 것이며, 위궤양은 소화성 산 및 펩신의 작용에 대한 조직의 손상으로서, 위액의 분비과다 또는 소화성 산 및 펩신에 대한 위내벽의 내성 감소에 의해 유발된다.Factors that adversely affect the functioning of the gastrointestinal system of humans are extremely diverse. Such disorders can occur in the upper gastrointestinal tract, lower gastrointestinal tract, or both, and there are a wide range of gastrointestinal disorders, including genetic, physiological, environmental, and mental factors. Chronic diseases of the upper gastrointestinal tract include gastritis and gastric ulcers, which indicate inflammation of the gastric mucosa, and gastric ulcers are tissue damage to the action of digestive acid and pepsin, resulting in excessive secretion of gastric juice or Caused by decreased resistance of the gastric lining to digestive acid and pepsin.
위염 및 위궤양의 치료 방법은 과다한 위분비액을 중화시키는 제산제, 산분비를 감소시키는 콜린 억제제, 위산의 방출을 억제하는 히스타민 길항제(histamine antagonist), 소화액에 대한 위내막의 내성을 증가시키고 또한 산 분비를 억제할 수 있는 프로스타글란딘(prostaglandin), 위장관 운동성을 증진시키는 프로키네틱 제제 및 위병소에 대한 보호 차단층을 형성하는 조성물을 이용한 약물 치료법 등이 있다.Treatments for gastritis and gastric ulcers include antacids that neutralize excessive gastric secretions, choline inhibitors that reduce acid secretion, histamine antagonists that inhibit the release of gastric acid, increase gastrointestinal resistance to digestive fluids, and also increase acid secretion. Prostaglandin that can be inhibited, prokinetic agents that enhance gastrointestinal motility, and drug therapies using compositions that form a protective barrier layer against gastric disease.
이 중에서 위궤양의 치료에 널리 사용되는 히스타민 수용기 차단 분비 억제제로서 시메디틴(cimetidine)이 사용되고 있는데, 상기 화합물은 위점막 내의 히스타민수용기를 차단하여 히스타민 분자를 위세포가 차단함으로써 히스타민 분자가위세포로 하여금 산을 분비 신호를 하지 못하도록 작용한다. 그러나, 재발율이 높은 단점이 있다.Among them, cimetidine is used as a histamine receptor blocking secretion inhibitor which is widely used in the treatment of gastric ulcer. The compound blocks histamine receptors in the gastric mucosa and blocks histamine molecules so that histamine molecular scissors cells It acts to prevent acid secretion signals. However, there is a disadvantage that the recurrence rate is high.
히스타민 길항제 및 프로톤 펌프(proton pump) 억제제와 같은 항분비제의 개발로 지금까지 수술을 필요로 하는 위염 및 위궤양을 약물 요법으로 치유할 수 있었다. 그러나, 치유된 위염 및 위궤양의 대부분은 재발하거나, 재현되어 완전히 치유된 후에도 장기간에 걸친 유지 요법이 필요하며, 또한 유지 요법 중에도 재발 또는 재현하는 현상이 빈번히 관찰되고 있다.The development of antisecretory agents, such as histamine antagonists and proton pump inhibitors, has been able to cure gastritis and gastric ulcers requiring surgery until now. However, most of the healed gastritis and gastric ulcers require long-term maintenance therapy even after recurrence, regeneration, and complete healing, and recurrence or regeneration during maintenance therapy is frequently observed.
또한, 1988년 마르셀 비.제이(Marrshall B.J.) 등은 헬리코박터 파이롤리(Helicobacter pylori, 이하 "H. 파이롤리"라 칭한다.) 양성 위/십이지장궤양에 대해 H. 파이롤리를 근절하려 시도하였으며, 그 결과 십이지장궤양의 재발하는 현상이 크게 감소하였다. 이에 더욱 H. 파이롤리에 대한 연구가 진행되었으며, 이러한 연구에 의해 H. 파이롤리에 대한 박테리아 근절 방법이 위암 및 위 악성림프종을 치료 및 예방할 수 있음을 알게 되었다. H. 파이롤리에 대한 박테리아에 대한 진단법 및 항생제 복합 투여를 통한 치료법 등의 적용으로 현재까지 많은 성과를 거두고 있으나, 효용성, 부작용 및 내성 균주의 출현과 같은 문제를 가지고 있으며, 안전하고 신뢰적인 박테리아 근절 방법이 확립되어 있지 않은 상태이다.Also, in 1988, Marcelshall BJ et al. Attempted to eradicate H. pyrroly for Helicobacter pylori (“H. pyrroli”) benign gastric / duodenal ulcer, and The recurrence of duodenal ulcers was significantly reduced. Further studies on H. pyrroli have been conducted, and these studies have shown that the method of eradicating bacteria against H. pyrroli can treat and prevent gastric cancer and gastric malignant lymphoma. The results of the diagnosis of bacteria against H. pyrroli and the treatment through the combination of antibiotics have been achieved so far, but they have problems such as the efficacy, side effects and emergence of resistant strains, and eradicate safe and reliable bacteria. The method is not established.
한편, 인삼(Panax ginsengRadix)은 중초약학에서 원기를 크게 보호하고, 폐를 튼튼하게 하며, 비장을 좋게 하고, 심장을 편안하게 해준다고 기록되어 있으며, 신농본초경에는 오장 즉, 간장, 심장, 폐장, 신장 및 비장의 양기를 돋구어 주는 주약으로 사용되고 정신을 안정시키고, 오부로 진입하는 병사를 제거하여 주며, 눈을 밝게하고 지혜롭게 하고, 오래 복용하면 몸이 가벼워지고 장수한다고 기록되어 있으며, 본초강목에는 비교적 광범위하게 인삼의 효능을 설명하고 있다. 오늘날에 이를 근거로 인삼이 각종 임상증상에 활용되고 있으며, 이외에도 많은 한의서에 인삼의 약효와 처방 예가 기술되어 있으며, 인삼은 처방의 중심적 역할을 하는 상약으로 되어 있다. 상기 상약은 평상시에도 병에 걸리지 않게 함은 물론 건강을 유지하기 위해 복용하는 생약으로서 무독해서 다량 복용하거나 장기간 복용해도 사람을 상하게 하지 않는 약을 의미한다. 또한, 동의보감에는 인삼 노두가 허인의 기력을 증강시킨다고 하였으며, 오늘날 한방에서는 최토제(催吐劑)로 사용되고 있으나, 그 치료효과는 확인된 바 없다. Panax ginseng Radix, on the other hand, has been documented in medium-term pharmacy as it greatly protects the energy, strengthens the lungs, improves the spleen, and makes the heart comfortable. It is used as a medicine to rejuvenate the kidneys and the spleen, and to stabilize the mind, to remove the soldiers who enter the fives, to brighten the eyes and make it wise, and to take longer to lighten the body and to record longevity. It explains the efficacy of ginseng extensively. Today, based on this, ginseng is used for various clinical symptoms, and in addition, many Chinese medicines describe the efficacy and prescription examples of ginseng, and ginseng is a medicine that plays a central role in prescription. The above medicine means a medicine that is used to maintain the health as well as not to get sick in ordinary times, and means a drug that is harmless and does not hurt a person even when taken in a large amount or for a long time. In addition, in the sense of consent, ginseng outcrop to increase the strength of the vanity, and today is used as a top soil (催吐 劑) in oriental medicine, but the therapeutic effect has not been confirmed.
이에, 본 발명자들은 위염 및 위궤양 치료제를 연구하던 중, 인삼노두 메탄올 추출물 및 부탄올 분획물이 위염 및 위궤양에 효과를 나타내며, 부작용이 없어 위염 및 위궤양을 예방하고 치료하는데 효과적임을 밝힘으로써 본 발명을 완성하였다.Accordingly, the present inventors completed the present invention by revealing that the ginseng outgrowth methanol extract and butanol fractions have an effect on gastritis and gastric ulcers and are effective in preventing and treating gastritis and gastric ulcers without side effects. .
본 발명의 목적은 위염 및 위궤양에 효과가 있는 인삼노두 메탄올과 그의 부탄올 분획물 및 이를 유효성분으로 하는 위염 및 위궤양 치료제 및 기능성 식품을 제공하는 것이다.An object of the present invention is to provide a ginseng outgoing methanol and its butanol fraction, which is effective in gastritis and gastric ulcer, and gastroenteritis and gastric ulcer therapeutic agent and functional food using the same as an active ingredient.
도 1은 염산-에탄올 유발 위손상 식염수 처리군을 육안으로 관찰한 것을 나타낸 광학사진이며, 1 is an optical photograph showing visual observation of hydrochloric acid-ethanol induced gastric saline treatment group,
도 2는 본 발명의 염산-에탄올 유발 위손상 인삼노두 부탄올 분획물 처리군을 육안으로 관찰한 것을 나타낸 광학사진이며, Figure 2 is an optical photograph showing the visual observation of the hydrochloric acid-ethanol induced gastric ginseng outdo butanol fraction treatment group of the present invention,
도 3은 염산-에탄올 유발 위손상 식염수 처리군을 광학현미경으로 관찰한 것을 나타낸 광학현미경 사진이며, 3 is an optical microscope photograph showing the observation of the hydrochloric acid-ethanol-induced gastric saline treated group with an optical microscope,
도 4는 본 발명의 염산-에탄올 유발 위손상 인삼노두 부탄올 분획물 처리군을 광학현미경으로 관찰한 것을 나타낸 광학현미경 사진이다. Figure 4 is an optical micrograph showing the observation of the hydrochloric acid-ethanol induced gastric ginseng outdo butanol fraction treatment group of the present invention with an optical microscope.
상기 목적을 달성하기 위하여,In order to achieve the above object,
본 발명은 인삼노두를 메탄올로 추출하여 얻어진 인삼노두 메탄올 추출물 및상기 인삼노두 메탄올 추출물을 다시 헥산, 클로로포름, 부탄올 및 증류수로 계통분획하여 얻어진 부탄올 분획물을 제공한다.The present invention provides a ginseng outgrowth methanol extract obtained by extracting ginseng outgrowth with methanol and a butanol fraction obtained by systematically separating the ginseng outgrowth methanol extract into hexane, chloroform, butanol and distilled water.
또한, 본 발명은 상기 인삼노두 부탄올 분획물을 유효성분으로 하는 위염 및 위궤양 치료제를 제공한다.The present invention also provides a gastritis and gastric ulcer therapeutic agent using the ginseng outo butanol fraction as an active ingredient.
또한, 본 발명은 상기 인삼노두 부탄올 분획물을 유효성분으로 하는 기능성 식품, 건강보조식품 또는 특수건강식품을 제공한다.In addition, the present invention provides a functional food, health supplement or special health foods using the ginseng gnome butanol fraction as an active ingredient.
이하 본 발명을 상세히 설명한다.Hereinafter, the present invention will be described in detail.
본 발명은 인삼노두를 메탄올로 추출하여 얻어진 인삼노두 메탄올 추출물 및 상기 인삼노두 메탄올 추출물을 다시 헥산, 클로로포름, 부탄올 및 증류수로 계통분획하여 얻어진 부탄올 분획물을 포함한다.The present invention includes a ginseng outgrowth methanol extract obtained by extracting ginseng outgrowth with methanol and a butanol fraction obtained by systematically separating the ginseng outgrowth methanol extract into hexane, chloroform, butanol and distilled water.
본 발명의 인삼노두 메탄올 추출물은 인삼노두 분쇄물에 메탄올 또는 메탄올 및 물의 혼합용매를 첨가하여 환류 상태에서 수차례 추출한 후 얻어진 여액을 감압 농축하고 동결건조하여 얻는다. 바람직하게는 메탄올을 첨가하고 4∼5 시간 동안 환류하여 3∼4회 반복 추출하여 인삼노두 메탄올 추출물을 얻는다.The ginseng outgrowth methanol extract of the present invention is obtained by adding methanol or a mixed solvent of methanol and water to the ginseng outcrop pulverized product and extracting it several times at reflux, followed by concentration under reduced pressure and lyophilization. Preferably, methanol is added and refluxed for 4 to 5 hours to extract 3 to 4 times to obtain a ginseng outgrowth methanol extract.
또한, 부탄올 분획물은 상기 인삼노두 메탄올 추출물을 헥산, 클로로포름, 부탄올 및 증류수로 계통분획하여 인삼노두 부탄올 분획물을 얻을 수 있다. 구체적으로, 상기 인삼노두 메탄올 추출물을 메탄올, 물 및 헥산의 혼합용매에 용해시켜 헥산층과 수용액층을 분리한 후 수용액층을 얻고, 얻어진 수용액층에 클로로포름을 첨가하여 클로로포름층과 수용액층을 분리한 후 수용액층을 얻고, 얻어진 수용액층에 부탄올을 첨가하여 부탄올층과 수용액층을 분리한 후 부탄올층을 얻고,얻어진 부탄올층을 감압농축하여 본 발명의 부탄올 분획물을 얻는다. 상기 메탄올 추출물에 첨가되는 혼합용매의 혼합비는 헥산:메탄올:물=10:1:9(w/w)가 바람직하다.In addition, the butanol fraction may be obtained by systematically fractionating the ginseng ethanol methanol extract with hexane, chloroform, butanol and distilled water to obtain a ginseng ethanol butanol fraction. Specifically, the methanol extract of Panax ginseng was dissolved in a mixed solvent of methanol, water, and hexane to separate the hexane layer and the aqueous layer, to obtain an aqueous layer, and to the obtained aqueous layer by adding chloroform to separate the chloroform layer and the aqueous layer. Thereafter, an aqueous solution layer was obtained, butanol was added to the obtained aqueous solution layer to separate the butanol layer and the aqueous solution layer, and a butanol layer was obtained. The obtained butanol layer was concentrated under reduced pressure to obtain a butanol fraction of the present invention. The mixing ratio of the mixed solvent added to the methanol extract is preferably hexane: methanol: water = 10: 1: 9 (w / w).
본 발명의 인삼노두 부탄올 분획물은 약 10 중량%의 단백질을 포함하고 있으며, 또한 몸에 필요한 아미노산인 아스파라긴산, 세린, 글루탐산, 글리신, 히스티딘, 트레오닌, 아르기닌, 알라닌, 프롤린, 시스테인, 티로신, 발린, 메티오닌, 리신, 이소루이신, 루이신 및 페닐알라닌을 포함하고 있다. 구체적으로, 하기 실시예에서 보는 바와 같이, 아스파라긴산 1.7 중량%, 세린 0.6 중량%, 글루탐산 26.2 중량%, 글리신 1.6 중량%, 히스티딘 1.7 중량%, 트레오닌 10 중량%, 아르기닌 2.1 중량%, 알라닌 4 중량%, 프롤린 1.5 중량%, 시스테인 0.4 중량%, 티로신 1.6 중량%, 발린 2.7 중량%, 메티오닌 0.6 중량%, 리신 0.3 중량%, 이소루이신 2.4 중량%, 루이신 3.6 중량%, 페닐알라닌 1.5 중량%을 포함하고 있다.The ginseng walnut butanol fraction of the present invention contains about 10% by weight of protein, and also the amino acids necessary for the body, aspartic acid, serine, glutamic acid, glycine, histidine, threonine, arginine, alanine, proline, cysteine, tyrosine, valine, methionine , Lysine, isoleucine, leucine and phenylalanine. Specifically, as shown in the following examples, 1.7% by weight aspartic acid, 0.6% by weight serine, 26.2% by weight glutamic acid, 1.6% by weight glycine, 1.7% by weight histidine, 10% by weight threonine, 2.1% by weight arginine, 4% by weight alanine 1.5% by weight of proline, 0.4% by weight cysteine, 1.6% by weight tyrosine, 2.7% by weight valine, 0.6% by weight methionine, 0.3% by weight lysine, 2.4% by weight isoleucine, 3.6% by weight leucine, 1.5% by weight phenylalanine Doing.
본 발명의 인삼노두 메탄올 추출물 및 부탄올 분획물은 항위염 및 항위궤양에 대한 활성을 나타내고 있으며, 특히 부탄올 분획물이 항위염 및 항위궤양에 대한 활성을 나타내고 있다.The ginseng ethanol methanol extract and butanol fraction of the present invention show activity against anti-gastritis and anti-gastric ulcers, in particular the butanol fraction shows activity against anti-gastritis and anti-gastric ulcers.
구체적으로, 본 발명의 인삼노두 부탄올 분획물에 대한 HCl·에탄올 위손상, 위액 분비량, 산 분비량, 아스피린에 의한 위궤양, 쉐이(Shay) 위궤양, 무수 에탄올 위손상, 초산에 의한 위궤양의 효과를 측정한 결과, 우수한 효과를 나타내고 있으며, 일반약리 작용에 대해서도 부작용이 나타나지 않으며, 이로 인해 항위염 및 항위궤양에 대한 활성이 우수함을 알 수 있다.Specifically, the results of measuring the effects of HCl-ethanol gastric damage, gastric fluid secretion, acid secretion, gastric ulcer by aspirin, Shay gastric ulcer, anhydrous ethanol gastric ulcer, acetic acid gastric ulcer on the ginseng outflow butanol fraction of the present invention In addition, it shows excellent effects, and does not show side effects in general pharmacological action, and thus it can be seen that the activity against anti-gastritis and anti-gastric ulcer is excellent.
하기 실시예에 따르면, HCl·에탄올 위손상에 대해 인삼노두 메탄올 추출물 및 부탄올 분획물은 종래 사용되는 시메티딘(cimetidine)에 비해 위손상 억제작용을 나타내고 있으며, 특히, 부탄올 분획물은 아스피린에 의한 위궤양에 대해 대조군에 비하여 유의성이 있는 억제효과를 나타내고 있다. 또한, 쉐이 위궤양, 무수 에탄올 위손상에 대해서도 유의적인 억제효과를 나타내고 있으며, 초산에 의한 위궤양에 대해서는 시메티딘에 비해 우수한 위손상억제율을 나타내고 있다.According to the following examples, the ginseng outgrowth methanol extract and butanol fraction showed a gastric injury inhibitory effect compared to cimetidine used in the past, and especially, the butanol fraction was a control against gastric ulcer by aspirin. It shows a significant inhibitory effect compared to the above. In addition, it has a significant inhibitory effect on the shade gastric ulcer and anhydrous ethanol gastric injury, and the gastric ulcer induced by acetic acid has a superior gastric injury inhibition rate compared to cimetidine.
또한, 본 발명은 상기 인삼노두 부탄올 분획물을 유효성분으로 하는 위염 및 위궤양 치료제를 포함한다.In addition, the present invention includes a gastritis and gastric ulcer therapeutic agent using the ginseng walnut butanol fraction as an active ingredient.
상기 인삼노두 부탄올 분획물은 항위염 및 항위궤양에 대한 활성이 우수하며, 부작용이 나타나지 않으므로 항위염 및 항위궤양에 대한 활성이 우수하다.The ginseng walnut butanol fraction has excellent activity against anti-gastritis and anti-gastric ulcers.
본 발명의 인삼노두 부탄올 분획물은 임상투여시에 경구 또는 비경구로 투여가 가능하며 일반적인 의약품 제제의 형태로 제공될 수 있다.Ginseng bean butanol fraction of the present invention can be administered orally or parenterally during clinical administration and can be provided in the form of a general pharmaceutical preparation.
본 발명의 인삼노두 추출물은 실제 임상투여시에 경구 및 비경구의 여러 가지 제형으로 투여될 수 있는데, 제제화할 경우에는 보통 사용하는 충진제, 증량제, 결합제, 습윤제, 붕해제, 계면활성제 등의 희석제 또는 부형제를 사용하여 조제된다. 경구투여를 위한 고형제제에는 정제, 환제, 산제, 과립제, 캡슐제 등이 포함되며 이러한 고형제제는 인삼노두 추출물에 적어도 하나 이상의 부형제 예를 들면, 전분, 칼슘 카보네이트(calcium carbonate), 수크로스(sucrose) 또는 락토오스(lactose), 젤라틴 등을 섞어 조제된다. 또한 단순한 부형제 이외에 마그네슘 스티레이크 탈크 같은 윤활제들도 사용된다. 경구를 위한 액상 제제로는 현탁제, 내용액제, 유제, 시럽제 등이 해당되는데 흔히 사용되는 단순 희석제인 물, 리퀴드 파라핀 이외에 여러 가지 부형제, 예를 들면 습윤제, 감미제, 방향제, 보존제 등이 포함될 수 있다. 경구투여를 위한 제제에는 멸균된 수용액, 비수성용제, 현탁제, 유제, 동결건조제, 좌제가 포함된다. 비수성용제, 현탁용제호는 프로필렌글리콜(propylene glycol), 폴리에틸렌 글리콜, 올리브 오일과 같은 식물성 기름, 에틸올레이트와 같은 주사 가능한 에스테르 등이 사용될 수 있다. 좌제의 기제로는 위텝솔(witepsol), 마크로골, 트윈(tween) 61, 카카오지, 라우린지, 글리세로제라틴 등이 사용될 수 있다.The ginseng extract of the present invention may be administered in various oral and parenteral formulations during actual clinical administration, and when formulated, diluents or excipients such as fillers, extenders, binders, wetting agents, disintegrating agents, surfactants, etc. that are commonly used. Is prepared using. Solid preparations for oral administration include tablets, pills, powders, granules, capsules and the like, and these solid preparations include at least one excipient such as starch, calcium carbonate and sucrose in ginseng extract. ) Or lactose, gelatin and the like are mixed. In addition to simple excipients, lubricants such as magnesium styrene talc are also used. Oral liquid preparations include suspensions, solvents, emulsions, and syrups, and may include various excipients, such as wetting agents, sweeteners, fragrances, and preservatives, in addition to commonly used simple diluents such as water and liquid paraffin. . Formulations for oral administration include sterile aqueous solutions, non-aqueous solvents, suspensions, emulsions, lyophilizers, suppositories. As the non-aqueous solvent and the suspension solvent, propylene glycol, polyethylene glycol, vegetable oil such as olive oil, injectable ester such as ethyl oleate, and the like can be used. As the base of the suppository, witepsol, macrogol, tween 61, cacao butter, laurin butter, glycerogelatin and the like can be used.
본 발명의 인삼노두 부탄올 분획물의 유효 용량은 1∼5000 mg/kg 이고, 5∼1000 mg/kg 이 바람직하다. 또한, 상기 인삼노두 분획물은 하루 1∼3 회 투여될 수 있다.The effective dose of the ginseng bean butanol fraction of the present invention is 1 to 5000 mg / kg, preferably 5 to 1000 mg / kg. In addition, the ginseng extract may be administered 1-3 times a day.
본 발명의 인삼노두 부탄올 분획물은 실험용 생쥐에 5000 ㎎/kg을 경구투여시 독성변화를 나타내지 않았으며 경구 투여 최소치사량(LD50)은 5000 ㎎/kg 이상으로 생체 안정성이 매우 높다는 것을 알 수 있으며, 따라서 본 발명의 인삼노두 부탄올 분획물은 생체에 대해 안전하게 투여될 수 있다.The ginseng ethanol butanol fraction of the present invention did not show a toxicity change when administered orally 5000 mg / kg in experimental mice, and the minimum lethal dose (LD 50 ) of oral administration was 5000 mg / kg or more. Therefore, the ginseng walnut butanol fraction of the present invention can be safely administered to a living body.
또한, 본 발명은 상기 인삼노두 부탄올 분획물을 유효성분으로 하는 기능성 식품, 건강보조 식품 또는 특수영양식품을 제공한다.In addition, the present invention provides a functional food, health supplement food or special nutritional foods using the ginseng gnome butanol fraction as an active ingredient.
본 명세서에서 '기능성 식품'이란, 일반 식품에 상기 인삼노두 부탄올 분획물을 첨가함으로써 일반 식품의 기능성을 향상시킨 식품을 의미한다.As used herein, the term "functional food" means a food product having improved functionality of a general food product by adding the ginseng bean butanol fraction to the general food product.
기능성 식품과 구별하여, 본 명세서에서 '건강보조식품' 또는 '특수영양식품'이란, 상기 인삼노두 부탄올 분획물을 일반식품에 첨가하거나, 캡슐화, 분말화, 현탁액 등으로 제조한 건강식품으로, 이를 섭취할 경우 건강상 특정한 효과를 가져오는 것을 의미하는 것으로 해석된다. 즉, 건강보조식품은 특정의 약리기능을 가지는 것을 의미하나, 일반 약품과는 달리 식품을 원료로하여 약품의 장기복용시 발생할 수 있는 부작용 등이 없는 장점이 있다.Distinguishing from functional foods, 'health supplement' or 'special dietary supplement' in the present specification is a health food prepared by adding the ginseng bean butanol fraction to a general food, or encapsulating, powdering, and suspension, and ingesting it. It is interpreted to mean that it has a certain health effect. That is, the health supplement means that it has a specific pharmacological function, but unlike general medicine, it has the advantage that there is no side effect that may occur when the long-term use of the drug using food as a raw material.
본 발명에 따른 인삼노두 부탄올 분획물을 함유하는 기능성 식품, 건강보조식품 및 특수건강식품의 함량은 사용되는 식품군에 따라 다양하게 변화시킬 수 있으며, 그 함량은 상기 약학적 조성물로의 용도시 측정된 독성 범위내에서 수행한다.The content of functional foods, health supplements, and specialty health foods containing the ginseng extract butanol fraction according to the present invention can be varied according to the food group used, the content of which is measured toxicity when used in the pharmaceutical composition. Perform within range.
이하, 본 발명을 실시예에 의해 상세히 설명한다.Hereinafter, the present invention will be described in detail by way of examples.
단, 하기 실시예는 본 발명을 예시하는 것일 뿐, 본 발명의 내용이 하기 실시예에 한정되는 것은 아니다.However, the following examples are merely to illustrate the invention, but the content of the present invention is not limited to the following examples.
<실시예 1> 인삼노두 메탄올 추출물의 제조Example 1 Preparation of Ginseng Outer Methanol Extract
환류장치가 장착된 용기에서 분쇄된 인삼노두 10 ㎏를 메탄올에 잠기도록 첨가한 후 수욕상에서 5 시간 동안 환류시켜 추출하였다. 상기 과정을 5 회 반복 한 후 얻어진 용액을 거름 종이로 여과하여 그 추출액을 감압농축하여 동결건조하였다. 얻어진 인삼노두 메탄올 추출물은 2,616 g이었다.In a vessel equipped with a reflux apparatus, 10 kg of ground ginseng gnome was added to submerge in methanol, and then extracted by refluxing for 5 hours in a water bath. After repeating the above procedure five times, the resulting solution was filtered through a filter paper and the extract was concentrated under reduced pressure and lyophilized. The obtained ginseng extract was 2,616 g methanol extract.
<실시예 2> 인삼노두 헥산 분획물의 제조Example 2 Preparation of Ginseng Outer Hexane Fraction
상기 실시예 1에서 얻어진 메탄올 추출물에 헥산:메탄올:물의 비율이 10:1:9인 혼합 용매를 첨가하여 헥산층과 수용액층 중에서 헥산층을 분리하였다. 상기와 같은 방법으로 5 회 추출한 후 감압농축하여 약 120 g의 헥산 분획물을 얻었다.To the methanol extract obtained in Example 1, a mixed solvent having a hexane: methanol: water ratio of 10: 1: 9 was added to separate the hexane layer from the hexane layer and the aqueous solution layer. Extraction was performed 5 times in the same manner as above, followed by concentration under reduced pressure to obtain a hexane fraction of about 120 g.
<실시예 3> 인삼노두 클로로포름 분획물의 제조Example 3 Preparation of Ginseng Outcrop Chloroform Fraction
상기 실시예 2의 헥산 분획물 추출에서 얻어진 수용액층에 클로로포름을 첨가하여 클로로포름층을 분리하였다. 상기와 같은 방법으로 5회 추출한 후 감압농축하여 약 220 g의 클로로포름 분획물을 얻었다.Chloroform was added to the aqueous solution layer obtained by extracting the hexane fraction of Example 2 to separate the chloroform layer. Extraction was performed 5 times in the same manner as described above, and then concentrated under reduced pressure to obtain about 220 g of a chloroform fraction.
<실시예 4> 인삼노두 부탄올 분획물의 제조Example 4 Preparation of Ginseng Outer Butanol Fraction
상기 실시예 3의 클로로포름 분획물 추출에서 얻어진 수용액층에 부탄올을 첨가하여 부탄올층을 분리하였다. 상기와 같은 방법으로 5 회 추출한 후 감압농축하여 약 923 g의 부탄올 분획물을 얻었다.The butanol layer was separated by adding butanol to the aqueous solution layer obtained by extracting the chloroform fraction of Example 3. Extraction was performed 5 times in the same manner as described above, and then concentrated under reduced pressure to obtain about 923 g of butanol fraction.
<실시예 5> 인삼노두 증류수 분획물의 제조Example 5 Preparation of Ginseng Outer Distilled Water Fraction
상기 실시예 4의 부탄올 분획물 추출에서 얻어진 잔사를 농축하여 약 1352 g의 증류수 분획물을 얻었다.The residue obtained in the butanol fraction extraction of Example 4 was concentrated to give about 1352 g of distilled water fraction.
<실험예 1> 인삼노두 메탄올 추출물 및 부탄올 분획물의 HCl·에탄올 위손상에 대한 작용Experimental Example 1 Effects of Ginseng Outer Methanol Extracts and Butanol Fractions on HCl-Ethanol Gastric Injury
체중 200 g 내외의 Spraque-Dawley계 수컷 흰쥐를 사용하여 24 시간 동안 절식시킨 후 하기와 같은 방법으로 실험하였다.After fasting for 24 hours using Spraque-Dawley male rats of about 200 g body weight, the experiment was performed as follows.
상기 실시예 1∼5의 추출물 및 분획물을 경구 투여하고 30 분 후에 HCl·에탄올(60 % 에탄올에 150 mM HCl 함유) 1 ㎖를 경구 투여하였다. 절식, 절수하에 1 시간 방치한 후 에테르로 치사시켜 위를 적출하고, 유문 및 분문부를 결찰하여 위내에 2 % 포르말린 용액 10 ㎖를 넣었다. 포르말린 용액에 10 분간 담그어 고정시키고, 대만부를 절개하여 발생된 손상 길이(㎜)를 현미경(10 배율)으로 측정하여 이를 위궤양 침식 지수로 사용하였다. 결과는 하기표 1에 나타내었으며, 비교예로 시메티딘 및 식염수를 사용하였다.After 30 minutes of oral administration of the extracts and fractions of Examples 1 to 5, 1 ml of HCl ethanol (containing 150 mM HCl in 60% ethanol) was orally administered. After leaving for 1 hour under fasting and water saving, the stomach was extracted by lethal with ether, ligation of the pylorus and the phalaenopsis was added, and 10 ml of 2% formalin solution was added to the stomach. It was immersed in formalin solution for 10 minutes and fixed, and the damage length (mm) generated by dissecting the Taiwan part was measured under a microscope (10 magnification) and used as an index of ulcer erosion. The results are shown in Table 1 below, and cimetidine and saline were used as comparative examples.
상기표 1에서 보는 바와 같이, 실시예 3(클로로포름 분획물) 및 실시예 4(부탄올 분획물) 투여군에서 각각 54.3(p<0.05) 및 56.2(p<0.01)의 위손상 억제작용을 나타내었다. 이는 시메티딘 150 ㎎/㎏을 경구투여한 것 보다 효과가 더욱 우수함을 알 수 있으며, 또한 식염수를 경구투여한 것보다 더욱 효과가 우수하였다.As shown in Table 1, in Example 3 (chloroform fraction) and Example 4 (butanol fraction) administration group, 54.3 (p <0.05) and 56.2 (p <0.01) showed gastric damage inhibitory activity, respectively. It can be seen that the effect is better than oral administration of cimetidine 150 mg / kg, and also more effective than oral administration of saline.
<실험예 2> 위액 분비량 및 pH, 산도 및 산 분비량의 측정Experimental Example 2 Measurement of Gastric Fluid Secretion and pH, Acidity and Acid Secretion
체중 200 g 내외의 수컷 흰쥐를 사용하여 24 시간 절식시킨 후 에테르 마치 하에 개복하고, 위의 유문부를 결찰하고 상기 실시예 2∼5의 분획물을 십이지장내로 주입하였다. 4시간 후에 치사시켜 위를 적출하고 위액을 체취하여 3,000 rpm에서 10 분간 윈심분리한 후 위액량, pH, 산도 및 산분비량을 측정하였다.After fasting for 24 hours using male rats with a body weight of about 200 g, the stomach was opened under an ether gusset, ligation of the pyloric region above, and the fractions of Examples 2 to 5 were injected into the duodenum. After 4 hours, the stomach was removed, the stomach was extracted, the stomach fluid was collected, and after centrifugation at 3,000 rpm for 10 minutes, the amount of gastric juice, pH, acidity and acid secretion were measured.
상기표 2에서 보는 바와 같이, 식염수의 위액 분비량은 5.5 ±0.7 ㎖/4시간을 나타낸 반면 본 발명의 실시예 4(부탄올 분획물)은 4.6 ±1.2 ㎖/4시간를 나타내었다. 또한, 4 시간 동안 산분비량을 관찰한 결과, 식염수는 592.6 ±113.6 μEq/㎖이었으며, 본 발명의 실시예 4의 추출물은 492.7 ±159.1 μEq/㎖이었다.As shown in Table 2 , the gastric juice secretion of saline was 5.5 ± 0.7 ml / 4 hours while Example 4 (butanol fraction) of the present invention was 4.6 ± 1.2 ml / 4 hours. In addition, the acid secretion was observed for 4 hours, saline was 592.6 ± 113.6 μEq / ㎖, the extract of Example 4 of the present invention was 492.7 ± 159.1 μEq / ㎖.
<실험예 3> 인삼노두 부탄올 분획물의 아스피린에 의한 위궤양에 대한 작용Experimental Example 3 Effect of Ginseng Root Butanol Fractions on Gastric Ulcer by Aspirin
체중 200 g 내외의 수컷 흰쥐를 사용하여 24 시간 절식시킨 후 에테르로 마취시켜 개복한 뒤 위의 유문부를 결찰하고 상기 실시예 4의 분획물을 십이지장에 주사하였다. 마취가 깨어나려고 할 때 아스피린 150 ㎎/㎏을 경구 투여하고 7 시간 경과 후 과량의 에테르로 치사시킨 뒤 선위부에 발생한 위손상 길이(㎜)를 산출하였다. 결과는 하기표 3에 나타내었다.After fasting for 24 hours using male rats of about 200 g in body weight, anesthesia was opened with ether, and then the ligation of the pyloric region was ligated and the fraction of Example 4 was injected into the duodenum. When anesthesia was about to wake up, 150 mg / kg of aspirin was orally administered, and after 7 hours, an excess of ether was killed and the length of the gastric injury in the stomach was calculated (mm). The results are shown in Table 3 below.
상기표 3에서 보는 바와 같이, 24 시간 절식시킨 후 흰쥐를 유문결찰시킨 후 실시예 4(부탄올 분획물) 투여군에서 250 ㎎/㎏의 용량을 투여하였을 때, 50.0 %(p<0.05)의 억제효과를 나타내었으며, 500 ㎎/㎏의 용량을 투여하였을 때, 60.6%(p<0.01)의 억제효과를 나타내었다. 대조약물인 시메티딘의 투여시 75.4 %의 억제효과와 비교하여 모두 대조군에 비하여 유의성 있는 억제효과를 나타내고 있다.As shown in Table 3 , after fasting for 24 hours, the rats were pylorlized, and the inhibitory effect of 50.0% (p <0.05) was observed when the dose of 250 mg / kg was administered in the Example 4 (butanol fraction) administration group. When administered at a dose of 500 mg / kg, the inhibitory effect was 60.6% (p <0.01). When the control drug cimetidine was administered, all showed a significant inhibitory effect compared to the control effect of 75.4%.
<실험예 4> 쉐이(Shay) 위궤양에 대한 작용Experimental Example 4 Action on Shay Gastric Ulcer
체중 200 g 내외의 수컷 흰쥐를 사용하여 24 시간 절식시킨 후 에테르 마취시켜 개복하고, 위의 유문부를 결찰한 후 상기 실시예 4의 분획물을 십이지장 내로 주입하고 봉입하였다. 14 시간 경과 후 에테르로 치사시켜 위를 적출한 후 2 % 포르말린 용액 10 ㎖를 첨가하고 포르말린 용액에 10 분간 담그어 고정시켰다. 고정이 완료되면 대만부를 절개하여 발생된 궤양 면적(㎟)을 측정하여 하기의 궤양 지수 6 단계 분류를 기준으로 표시하였다.After fasting for 24 hours using male rats with a body weight of about 200 g, the patient was opened by ether anesthesia, and after ligation of the pyloric region, the fraction of Example 4 was injected into the duodenum and encapsulated. After 14 hours, the mixture was lethal with ether, and the stomach was extracted. Then, 10 ml of 2% formalin solution was added, and the mixture was immersed in formalin solution for 10 minutes and fixed. When the fixation is completed, the ulceration area (mm 2) generated by cutting the Taiwan part was measured and displayed based on the following six levels of ulcer index.
선위부에 손상이 발생되지 않은 경우 0, 길이의 총화가 1∼5 ㎟인 경우 1, 6∼10 ㎟인 경우 2, 11∼15 ㎟인 경우 3, 16∼20 ㎟인 경우 4, 21∼25 ㎟인 경우 5, 26 ㎟이상 또는 천공인 경우 6으로 하여 지수(index)로 하였다. 결과는 하기표 4에 나타내었다.If no damage occurs at the top, 0, total length is 1-5 mm2, 1, 6-10 mm2, 11-15 mm2, 3, 16-20 mm2, 4, 21-25 5, 26 mm 2 or more in the case of mm 2 or 6 in the case of perforation was used as the index. The results are shown in Table 4 below.
상기표 4에서 보는 바와 같이, 대조군에서는 선위부에 반점형의 극심한 출혈성 위손상이 관찰되었고, 천공에 따른 사망수의 증가로 인해 3.9 ±0.8의 위궤양 지수를 나타내었으며, 본 발명의 실시예 4(부탄올 분획물) 500 ㎎/㎏을 십이지장에 투여하였을 경우 위궤양을 유의적으로 억제하였다.As shown in Table 4 , in the control group, a severe hemorrhagic gastrointestinal injury was observed in the distal part, and the gastric ulcer index of 3.9 ± 0.8 was increased due to an increase in the number of deaths due to perforation. Butanol fraction) significantly inhibited gastric ulceration when 500 mg / kg was administered to the duodenum.
<실시예 5> 무수 에탄올 위손상에 의한 점액 분비량 측정Example 5 Measurement of Mucus Secretion by Anhydrous Ethanol Gastric Injury
체중 200 g 내외의 수컷 휜쥐를 사용하여 24시간 절식시킨 후 상기 실시예 4의 분획물을 경구 투여하고 30 분 후에 무수 에탄올을 1 ㎖/100 g씩 경구 투여하였다. 투여 1시간 후에 에테르 치사시켜 적출한 위점액량을 기타가와(Kitagawa) 방법에 따라 측정하였다. 즉, 적출한 위의 대만부를 절개하고 뒤집어서 선위부 점막면을 노출시킨 후 냉 0.2 5M 수크로즈 용액으로 선위부를 세척한 후 0.1 % 알시안 블루(alcian blue)용액으로 실온에서 2시간 염색하였다. 염색된 점액층을 채취하고 부착된 알시안 블루 결합점액은 30 % 디옥틸 나트륨 설포쿠시네이트(dioctyl sodium sulfocuccinate)를 함유한 70 % 에탄올 용액 20 ㎖로 30℃에서 2 시간 추출 후 3,000 rpm에서 10 분간 원심분리하고 그 상등액을 취하여 620 ㎚에서 흡광도를 측정하였다. 결과는 하기표 5에 나타내었다.After fasting for 24 hours using male rats with a body weight of about 200 g, the fraction of Example 4 was orally administered, and after 30 minutes, 1 mL / 100 g of anhydrous ethanol was orally administered. After 1 hour of administration, the amount of gastric juice extracted by ether lethal was measured according to the Kitagawa method. That is, the extracted Taiwan incision was inverted and inverted to expose the distal mucosa surface, and then washed with cold 0.2 5M sucrose solution and stained at room temperature with 0.1% alkian blue solution for 2 hours. The stained mucus layer was harvested and the adherent alcian blue bound mucus was extracted with 20 ml of a 70% ethanol solution containing 30% dioctyl sodium sulfocuccinate and extracted for 2 hours at 30 ° C., followed by centrifugation at 3,000 rpm for 10 minutes. The supernatant was separated and the absorbance was measured at 620 nm. The results are shown in Table 5 below.
상기표 5에서 보는 바와 같이, 무수 에탄올 투여 후 대조군에서 위점액량이 142.7 ㎍인데 비해 실시예 4(부탄올 분획물) 500 ㎎/㎏을 경구투여한 군에서는 위점액량이 410.7 ㎍으로 유의적으로 증가하였다(p<0.05).As shown in Table 5 , the amount of gastric juice was 142.7 μg in the control group after anhydrous ethanol administration, whereas the amount of gastric juice in the oral administration of 500 mg / kg of Example 4 (butanol fraction) was significantly increased to 410.7 μg ( p <0.05).
<실험예 6> 초산궤양 실험Experimental Example 6 Acetic Acid Ulcer Experiment
체중 약 200 g 내외의 수컷 흰쥐를 절식시킨 후 하기와 같은 방법으로 실험하였다. 에테르 마취하에 개복하여 위를 노출시킨 후 20 ㎕의 20 % 초산을 전위벽의 선위부에서 장막하조직층(subserosal layer) 안으로 주입한 후 봉합하였다. 감염을 막기 위해 암피실린(ampicillin)을 3 일간 50 ㎎/㎏/일을 경구 투여하였다. 수술 15 일째 되는 날 에테르로 치사시켜 위를 적출한 후 2 % 포르말린으로 10 분간 고정한 후 선위부에 생성된 위궤양 부위의 면적(㎟)을 측정하여 궤양 지수로 하였다.The male rats about 200 g in weight were fasted and tested in the following manner. After opening under ether anesthesia to expose the stomach, 20 μl of 20% acetic acid was injected into the subserosal layer at the distal end of the dislocation wall and then sutured. Ampicillin was orally administered 50 mg / kg / day for 3 days to prevent infection. On the 15th day after surgery, the stomach was removed with ether and fixed with 2% formalin for 10 minutes, and the area (mm2) of gastric ulcers formed in the stomach was measured as an ulcer index.
상기 실험예에 의해 위염 및 위궤양을 유발시켰을 때 실험 약물에 의한 위염 및 위궤양의 억제 작용은 하기와 같이 그 지수 또는 면적의 억제율(%)로 나타낸다. 결과는 하기표 6에 나타내었다.When the gastritis and gastric ulcer were induced by the above experimental example, the inhibitory action of gastritis and gastric ulcer by the experimental drug is expressed by the index or area percent inhibition as follows. The results are shown in Table 6 below.
상기표 6에서 보는 바와 같이, 초산 위궤양을 유발시킨 후 11 일 동안 실시예 4(부탄올 분획물) 500 ㎎/㎏을 1일 1회 경구투여한 후 위손상억제 정도를 측정한 결과 88.3 %의 위손상 억제율을 나타내었다.As shown in Table 6 , after inducing oral administration of 500 mg / kg of Example 4 (butanol fraction) once a day for 11 days after induction of acetic acid gastric ulcer, the degree of inhibition of gastric damage was measured. Inhibition rate was shown.
<실험예 7> 조직학적 검정Experimental Example 7 Histological Assay
1% 포르말린액에서 고정시킨 검체를 위체부에서 육안손상이 관찰된 부위가 포함되도록 절취하여(trimming) 다시 10 % 포르말린액으로 후고정시킨 후 위조직절편을 파라핀으로 포매한 다음 5∼7 ㎛의 두께의 마이크로톰(microtome)으로 세절한 후 헤마토실린-에오신(hematoxyline-eosin)으로 염색하여 광학현미경(40 배)으로 관찰하였다. 결과는도 1∼4에 나타내었다.The specimen fixed in 1% formalin solution was trimmed to include the site where visual damage was observed in the gastric body portion, and after fixation with 10% formalin solution, the gastric tissue section was embedded with paraffin. After cutting into a thick microtome (microtome) and stained with hematoxyline-eosin (hematoxyline-eosin) was observed by an optical microscope (40 times). The results are shown in FIGS. 1 to 4 .
도 1은 염산-에탄올 유발 위손상 식염수 처리군을 육안으로 관찰한 광학사진으로 조직의 손상이 장막하 부위까지 침투하여 혈흔이 형성된 것이 뚜렷하게 나타나 있으며, 이를 광학현미경으로 관찰한도 3에서 보는 바와 같이, 조직의 손상이 장막하 부위까지 침투하여 조직의 손상이 세포 수준에서 나타남을 알 수 있다.도 2는 염산-에탄올 유발 위손상 인삼노두 부탄올 분획물 처리군을 광학현미경으로 관찰한 광학사진으로, 상기 대조군과 비교하여 손상된 부위가 회복됨을 볼 수 있으며, 광학현미경적 관찰(도 4)에서 보는 바와 같이, 대조군과 비교하여 장막하 부위까지 침투한 조직의 손상이 회복되어 있는 것을 볼 수 있다. 1 is a hydrochloric acid-penetration damage to the tissue by the optical photo observation of ethanol-induced stomach damage to saline-treated group it was visually tent up to site and blood is not shown distinctly formed, as shown it in Fig. 3 observed with an optical microscope In addition, it can be seen that tissue damage penetrates to the sub-substitial area and tissue damage appears at the cellular level. 2 is an optical photograph of a hydrochloric acid-ethanol-induced gastric intestinal ginseng outdo butanol fraction treated group using an optical microscope, which shows that the damaged area is recovered as compared to the control group, as shown in the optical microscope ( FIG. 4 ). Likewise, it can be seen that the damage of the tissue that penetrated to the subtidal site is restored as compared with the control group.
<실험예 8> 급성 독성 실험Experimental Example 8 Acute Toxicity Experiment
6 주령의 특정병원체부재(specific pathogen-free, SPF) SD계 랫트를 사용하여 급성독성실험을 실시하였다. 군당 2 마리씩의 동물에 본 발명의 인삼노두 부탄올 분획물을 각각 0.5 % 메틸세룰로즈 용액에 현탁하여 5 g/㎏/㎖의 용량으로 1 회 경구투여하였다. 시험 물질 투여 후 동물의 폐사여부, 임상증상, 체중변화를 관찰하고 혈액학적 검사와 혈액생화학적 검사를 실시하였으며, 부검하여 육안으로 복강장기와 흉강장기의 이상여부를 관찰하였다.Acute toxicity test was performed using 6-week-old specific pathogen-free (SPF) SD rats. Two animals per group were suspended orally administered in a 0.5% methyl cellulose solution of the ginseng bean butanol fraction of the present invention once at a dose of 5 g / kg / ml. After administration of the test substance, mortality, clinical symptoms, and changes in body weight were observed. Hematological and hematological examinations were performed. Necropsy was performed to observe abdominal and thoracic organ abnormalities.
그 결과, 시험물질을 투여한 모든 동물에서 특기할 만한 임상증상이나 폐사된 동물은 없었으며, 체중변화, 혈액검사, 혈액생화학 검사, 부검 소견 등에서도 독성변화는 관찰되지 않았다. 이상의 결과, 본 발명의 인삼노두 부탄올 분획물은 모두 랫트에서 5000 ㎎/㎏까지도 독성변화를 나타내지 않으며, 경구 투여 최소치사량(LD50)은 추출물 5000 ㎎/㎏ 이상인 안전한 물질로 판단되었다.As a result, no significant clinical symptoms or dead animals were noted in all animals treated with the test substance, and no toxic changes were observed in weight changes, blood tests, blood biochemical tests, and autopsy findings. As a result, all of the ginseng extract butanol fraction of the present invention does not show a toxicity change even in rats up to 5000 mg / kg, oral administration minimum dose (LD 50 ) was determined to be a safe substance of more than 5000 mg / kg extract.
<실험예 9> 일반약리 작용Experimental Example 9 General Pharmacological Actions
(1) 생쥐의 장관 수송능에 미치는 영향(1) Effect on Intestinal Transport Capacity of Mice
24 시간 동안 절식시킨 체중 20∼25 g 정도의 생쥐를 사용하여 타케모리(Takemori) 방법에 따라 실시하였다. 즉, 수컷 생쥐에 부탄올로 추출한 인삼노두 부탄올 분획물 500 ㎎/㎏을 경구투여하고, 30 분 후에 지표로서 카르코알 밀(charcoal meal)(0.5 % CMC에 용해)을 체중당 0.1 ㎖/㎏씩 경구투여하였다. 투여 30분 후에 생쥐를 치사시켜 소장을 적출하고 유문부에서 맹장입구까지의 이송율을 측정하여 백분율로 환산표시하였으며 대조약물로는 아트로핀 설페이트(atropine sulfate) 10 ㎎/㎏을 사용하였다. 결과는표 7에 나타내었다.Mice weighed 20-25 g fasted for 24 hours were used according to the Takemori method. In other words, 500 mg / kg of ginseng ethanol butanol fraction extracted with butanol was orally administered to male mice, and after 30 minutes, oral administration of charcoal meal (dissolved in 0.5% CMC) as an indicator by 0.1 ml / kg per body weight. It was. 30 minutes after administration, the small intestine was removed and the transfer rate from the pyloric region to the cecum entrance was measured and expressed as a percentage, and 10 mg / kg of atropine sulfate was used as a control drug. The results are shown in Table 7 .
상기표 7에서 보는 바와 같이, 식염수 투여군은 표식 화합물 투여 후 30 분에 소장 전체의 81.5 %까지 진행하였으며, 실시예 4(부탄올 분획물) 투여군은 76.9 %로 거의 영향을 미치지 않았다.As shown in Table 7 , the saline-administered group proceeded to 81.5% of the small intestine 30 minutes after the labeled compound administration, and Example 4 (butanol fraction) administered group had little effect at 76.9%.
(2) 체온에 미치는 영향 실험(2) effect on body temperature
체중 150∼190 g의 5∼6주령 수컷 랫트를 군당 6 마리로 하여 부탄올로 추출한 인삼노두 부탄올 분획물 500 ㎎/㎏을 경구 투여하기 15 분 전에 기초 체온을 측정하고, 경구 투여후, 30분, 1시간, 2시간, 3시간에 랫트용 직장수은 체온계로 체온을 측정하였다. 양성 대조물질은 아미노피린을 사용하였다. 결과는 하기표 8에 나타내었다.The basal body temperature was measured 15 minutes before oral administration of 500 mg / kg of ginseng outgrowth butanol fraction extracted with butanol using 6 rats of 5 to 6 week old rats weighing 150 to 190 g per group. Body temperature was measured at 2 hours and 3 hours by rectal mercury thermometer for rats. A positive control was used aminopyrin. The results are shown in Table 8 below.
상기표 8에서 보는 바와 같이, 실시예 4(부탄올 분획물) 투여군은 살린 투여군과 비교하였을 때, 체온에 미치는 영향은 없었으며, 양성대조물질로 사용한 아미노피린은 유의한(p<0.05) 체온 감소효과를 나타내었다.As shown in Table 8 , the administration group of Example 4 (butanol fraction) had no effect on body temperature when compared to the salin administration group, and aminopyrin used as a positive control material had a significant (p <0.05) body temperature reduction effect. Indicated.
(3) 수면에 미치는 영향 실험(3) Effect on sleep
카토(Kato) 방법에 따라 체중 20∼30 g의 5∼6 주령 수컷 생쥐를 군당 10마리로 하여 부탄올로 추출한 인삼노두 부탄올 분획물 500 ㎎/㎏을 경구 투여 한 후, 1 시간 후 페노바르비탈(phenobarbital) 50 ㎎/㎏을 복강 내에 주사하고 정향반사가 소실된 때부터 회복될 때 까지의 시간을 수면시간으로 하였다. 대조약물로 클로르포로마진·HCl(chlorpromazine·HCl)을 사용하였다. 결과는 하기표 9에 나타내었다.According to the Kato method, 5 to 6-week-old male mice with a body weight of 20 to 30 g were administered 10 times per group, orally administered 500 mg / kg of butanol butanol fraction extracted with butanol, and then 1 hour after phenobarbital 50 MG / kg was injected intraperitoneally and the time from the disappearance of the clove reflection to the recovery was the sleeping time. Chlorporomazine-HCl (chlorpromazine-HCl) was used as a control drug. The results are shown in Table 9 below.
상기표 9에서 보는 바와 같이, 실시예 4(부탄올 분획물) 500 ㎎/㎏을 투여한 경우, 수면 시간이 약 20 % 감소하였으나, 통계적인 유의성은 없었다. 클로르프로마진·HCl 4 ㎎/㎏을 경구투여한 경우 대조군 보다 약 1.2 배 정도의 수면 시간을 연장시켜 통계학적인 유의성(p<0.05)을 나타내었다. 따라서, 중추신경계에 미치는 작용은 거의 없음을 알 수 있었다.As shown in Table 9 , when administering Example 4 (butanol fraction) 500 mg / kg, the sleep time was reduced by about 20%, but there was no statistical significance. Oral administration of chlorpromazineHCl 4 mg / kg showed a prolonged sleep time of about 1.2 times that of the control group, indicating statistical significance (p <0.05). Therefore, it was found that little effect on the central nervous system.
(4) 자발운동량에 미치는 영향 실험(4) Influence experiment on spontaneous momentum
둔함(Dunham)방법에 따라 직경 1 인치의 회전봉에 1 분에 12 회전하는 로아로드 장치를 사용하였다. 체중 20∼30 g의 5∼6주령 수컷 생쥐를 군당 10 마리로 하여 사용하였다. 실험 전날 2 분 이상 낙하하지 않는 쥐를 미리 선발 하였다. 부탄올로 추출한 인삼노두 부탄올 분획물 500 ㎎/㎏을 경구투여 한 후 0.5, 1, 2, 4시간 후 로타로드 실험을 실시하여 2 분내에 낙하하는 쥐를 계수하였다. 대조약물로 클로르포로마진을 경구 투여하였다. 결과는 하기표 10에 나타내었다.According to the Dunham method, a roar rod device was used which rotates 12 times per minute on a rotating rod 1 inch in diameter. Five to six week old male mice having a body weight of 20 to 30 g were used as 10 animals per group. Mice that did not fall more than 2 minutes before the experiment were selected in advance. After oral administration of 500 mg / kg of ginseng outgrowth butanol fraction extracted with butanol, the rats were counted in 0.5 min, 1, 2 and 4 hours after the rotarod experiment. Chlorporoma was orally administered as a control drug. The results are shown in Table 10 below.
상기표 10에서 보는 바와 같이, 클로르프로마진에서는 약 90 %의 운동실조가 보이나, 본 발명의 실시예 4(부탄올 분획물) 투여군에서는 살린 투여군과 비교하였을 때 차이를 보이지 않았다.As shown in Table 10 , about 90% of ataxia was observed in chlorpromazine, but in Example 4 (butanol fraction) administration group of the present invention, there was no difference when compared with the saline administration group.
(5) 진통작용(5) analgesic action
체중 20∼30 g의 수컷 생쥐에 인삼노두 부탄올 분획물 500 ㎎/㎏을 경구투여 한 후 30 분 후에 코스터(Koster)방법에 의해 0.7 % 초산-생리식염액 0.1 ㎖/10 g을 복강내 주사한 후 10 분부터 20 분간의 뒤틀림 증상(writhing syndrom)의 발생수를 계수하였다. 대조약물로 아스피린 200 ㎎/㎏을 경구투여하였다.After 30 minutes after oral administration of 500 mg / kg of ginseng out-butanol fraction to male mice of 20-30 g body weight, intraperitoneal injection of 0.1 ml / 10 g of 0.7% acetic acid-physiological saline solution was performed by Koster method. The incidence of writhing syndrom from 10 to 20 minutes was counted. Aspirin 200 mg / kg was orally administered as a control drug.
상기 모든 실험 결과는 평균치 와 표준 오차를 계산하고, 각 실험 결과로부터 ANOVA를 구한 후 학생 t-실험과 튜칸스 다중 범위 실험을 이용하여 통계분석하였다. 결과는 하기표 11에 나타내었다.All the experimental results were calculated by calculating the mean and standard error, and ANOVA was obtained from each experimental result and statistically analyzed using the student t-test and the Tucans multi-range test. The results are shown in Table 11 below.
<제제예 1> 정제(직접 가압)의 제조방법Preparation Example 1 Manufacturing Method of Tablet (Direct Pressing)
인삼노두 부탄올 분획물 5.0 ㎎을 락토오스 14.1 ㎎, 크로스포비돈 USNF 0.8 ㎎ 및 마그네슘 스테아레이트 0.1 ㎎과 혼합하고 가압하여 정제로 만들었다.5.0 mg of ginseng endo butanol fraction was mixed with 14.1 mg of lactose, 0.8 mg of crospovidone USNF and 0.1 mg of magnesium stearate and pressed to make a tablet.
상기 정제의 구성성분은 다음과 같다.The components of the tablet are as follows.
인삼노두 부탄올 분획물············ 5.0 ㎎Ginseng Noodle Butanol Fraction ········· 5.0 mg
락토오스 ···················14.1 ㎎Lactose ... 14.1 mg
크로스포비돈 USNF ···············0.8 ㎎Crospovidone USNF 0.8 mg
마그네슘 스테아레이트············· 0.1 ㎎Magnesium Stearate 0.1 mg
<제제예 2> 정제(습식 조립)의 제조방법Preparation Example 2 Manufacturing Method of Tablet (Wet Granulation)
인삼노두 부탄올 분획물 5.0 ㎎을 락토오스 16.0 ㎎과 녹말 4.0 ㎎을 섞었다. 폴리솔베이트 80 0.3 ㎎을 순수한 물에 녹인 후 이 용액의 적당량을 첨가한 다음, 미립화하였다. 건조 후에 미립을 체질한 후 콜로이달 실리콘 디옥사이드 2.7 ㎎ 및 마그네슘 스테아레이트 2.0 ㎎과 섞었다. 미립을 가압하여 정제로 만들었다.5.0 mg of ginseng endo butanol fractions were mixed with 16.0 mg of lactose and 4.0 mg of starch. 0.3 mg of polysorbate 80 was dissolved in pure water and then an appropriate amount of this solution was added and then atomized. After drying, the fine particles were sieved and mixed with 2.7 mg of colloidal silicon dioxide and 2.0 mg of magnesium stearate. The granules were pressed into tablets.
상기 정제의 구성성분은 다음과 같다.The components of the tablet are as follows.
인삼노두 부탄올 분획물············ 5.0 ㎎Ginseng Noodle Butanol Fraction ········· 5.0 mg
락토오스 ···················16.0 ㎎Lactose ·················· 16.0 mg
녹말 ·····················4.0 ㎎Starch · ・ ・ ・ ・ ・ ・ ・ 4.0 mg
폴리솔베이트 80 ················0.3 ㎎Polysorbate 80 0.3 mg
증류수Distilled water
콜로이달 실리콘 디옥사이드 ·········· 2.7 ㎎Colloidal Silicon Dioxide ... 2.7 mg
마스네슘 스테아레이트 ·············2.0 ㎎Magnesium Stearate 2.0 mg
<제제예 3> 캡슐제의 제조방법Preparation Example 3 Manufacturing Method of Capsule
인삼노두 부탄올 분획물 5.0 ㎎을 락토오스 14.8 ㎎, 폴리비닐 피롤리돈 10.0 ㎎, 마그네슘 스테아레이트 0.2 ㎎와 함께 섞었다. 혼합물을 적당한 장치를 사용하여 단단한 No. 5 젤라틴 캡슐에 채웠다.5.0 mg of ginseng endo butanol fraction was mixed with 14.8 mg of lactose, 10.0 mg of polyvinyl pyrrolidone, and 0.2 mg of magnesium stearate. No. solid the mixture using a suitable device. Filled in 5 gelatin capsules.
상기 분말 및 캡슐제의 구성성분은 다음과 같다.The components of the powder and capsules are as follows.
인삼노두 부탄올 분획물············ 5.0 ㎎Ginseng Noodle Butanol Fraction ········· 5.0 mg
락토오스 ···················14.8 ㎎Lactose ······················· 14.8 mg
폴리비닐 피롤리돈 ·············· 10.0 ㎎Polyvinylpyrrolidone ······················ 10.0 mg
마스네슘 스테아레이트 ·············0.2 ㎎Magnesium Stearate0.2mg
<제제예 4> 주사제액제의 제조방법Preparation Example 4 Preparation of Injection Solution
인삼노두 부탄올 분획물 100 ㎎, 만니톨 180 ㎎, Na2HPO4·12H2O 26 ㎎ 및 증류수 2974 ㎎를 함유시켜 주사제를 제조하였다. 이 용액을 병에 넣고 20 ℃에서 30 분간 가열하여 멸균시켰다.Injectables were prepared by containing 100 mg of ginseng out butanol fraction, 180 mg of mannitol, 26 mg of Na 2 HPO 4 .12H 2 O and 2974 mg of distilled water. The solution was bottled and sterilized by heating at 20 ° C. for 30 minutes.
상기 주사액제의 구성성분은 다음과 같다.The components of the injection solution are as follows.
인삼노두 부탄올 분획물··········· 100.0 ㎎Ginseng Outer Butanol Fraction ·············· 100.0 mg
만니톨 ···················· 180 ㎎Mannitol 180 mg
Na2HPO4·12H2O ················· 26 ㎎Na 2 HPO 4 · 12H 2 O ···················· 26 mg
증류수 ····················2974 ㎎Distilled water ················· 2974 mg
<제제예 5> 음료의 제조Preparation Example 5 Preparation of Beverage
본 발명의 인삼노두 부탄올 분획물, 비타민 C, 분말비타민 E, 젓산철, 산화아연, 니코틴산아미드, 비타민 A, 비타민 B1및 비타민 B2를 잘 혼합하여 제조하였다.Ginseng walnut butanol fraction of the present invention, vitamin C, powdered vitamin E, ferric nitrate, zinc oxide, nicotinic acid amide, vitamin A, vitamin B 1 and vitamin B 2 were prepared by mixing well.
상기 음료의 구성성분은 다음과 같다.The components of the beverage are as follows.
인삼노두 부탄올 분획물············ 0.1 gGinseng Outer Butanol Fraction ·········· 0.1g
비타민 C ·················· 15 gVitamin C ... 15 g
분말비타민 E ················· 7.5 g7.5 g of powdered vitamin E ················
젓산철 ··················· 19.75 gFerrous iron ················· 19.75 g
산화아연 ··················· 3.5 gZinc Oxide · ・ ・ ・ ・ 3.5 g
니코틴산아미드················ 3.5 gNicotinic acid amide 3.5 g
비타민 A ··················· 0.2 g0.2 g of vitamin A
비타민 B1·················· 0.25 gVitamin B 1 0.25 g
비타민 B2··················· 0.3 g0.3 g of vitamin B 2
물 ······················ 적량·······················
따라서, 본 발명의 인삼노두 부탄올 분획물은 HCl·에탄올 위손상, 위액 분비량 및 산분비량, 아스피린에 의한 위궤양, 쉐이 위궤양, 무수 에탄올 위손상, 초산에 의한 위궤양에 대해 항위염 및 항위궤양에 대한 활성을 나타내고 있으며, 또한 쥐에 대한 장관수송능, 체온, 수면, 자발 운동량 및 진통작용에 대해서도 부작용이 나타나지 않으며 독성이 적어 새로운 항위염제 및 항위궤양제로 사용될 수 있으며, 이를 포함한 위염 및 위궤양 예방을 위한 기능성 식품으로 사용될 수 있다.Therefore, the ginseng ethanol butanol fraction of the present invention has an activity against anti-gastritis and anti-ulcer ulcers against gastric ulceration of HCl and ethanol, gastric secretion and acid secretion, gastric ulcer by aspirin, gastric ulcer, anhydrous ethanol gastric ulcer, and gastric ulcer by acetic acid. In addition, there are no side effects on intestinal transport capacity, temperature, sleep, spontaneous motility and analgesic effects on rats, and it is less toxic and can be used as a new anti- gastritis and anti-ulcer ulcer. Can be used as food.
Claims (4)
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| Publication number | Priority date | Publication date | Assignee | Title |
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| KR830000386A (en) * | 1974-01-04 | 1983-03-30 | 니시하라 소우이찌로우 | Flash camera |
| KR19980072722A (en) * | 1997-03-07 | 1998-11-05 | 한기학 | Chinese medicine composition |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| KR830000386A (en) * | 1974-01-04 | 1983-03-30 | 니시하라 소우이찌로우 | Flash camera |
| KR19980072722A (en) * | 1997-03-07 | 1998-11-05 | 한기학 | Chinese medicine composition |
Non-Patent Citations (2)
| Title |
|---|
| J Ethnopharmacol, Yamahara J. et al., 1987, vol 19(1), Page 95-101 * |
| Journal of Herbal Medicine, Chung Chun-sik et al., 1996, vol 27(4), Page 295-300 * |
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