KR102590559B1 - Composition comprising slugs extract as an active ingredient for preventing, improving or treating insomnia - Google Patents
Composition comprising slugs extract as an active ingredient for preventing, improving or treating insomnia Download PDFInfo
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Abstract
본 발명에 따른 굼벵이 추출물을 포함하는 조성물은 수면에 들어가는데 소요되는 수면 유도 시간을 감소시키고, 수면 지속 시간을 향상시켜 질 좋은 수면을 가능하게 하며, 더더욱 수면 유도 후 잠이 깬 다음에 다시 수면을 유도하는 효과까지 뛰어나 불면증 및 수면장애의 예방, 완화, 개선 내지 치료 효과가 우수하여 약학적 조성물 또는 건강식품 조성물로 가치가 매우 높다.The composition containing the snail extract according to the present invention reduces the sleep induction time required to enter sleep, improves sleep duration, enables quality sleep, and further induces sleep again after waking up after inducing sleep. It is highly effective in preventing, alleviating, improving, or treating insomnia and sleep disorders, making it of great value as a pharmaceutical composition or health food composition.
Description
본 발명은 불면증 및 수명장애 질환에 유용한 조성물에 관한 것으로서, 보다 상세하게는 불면증 및 수면 장애를 예방, 개선 내지 치료할 수 있는 효과적인 수단이 되는 약학적 조성물 또는 건강식품 조성물에 관한 것이다.The present invention relates to a composition useful for insomnia and lifespan disorders, and more specifically, to a pharmaceutical composition or health food composition that serves as an effective means of preventing, improving, or treating insomnia and sleep disorders.
현대사회에서는 많은 이들이 스트레스와 불안, 초조 때문에 수면 장애를 겪고 있지만, 그 기간이 짧고 약할 때에는 약물치료가 필요하지 않으나 업무 등의 일상생활에 지장을 초래하게 되면 약물 등의 치료가 필요하다. In modern society, many people suffer from sleep disorders due to stress, anxiety, and nervousness. However, when the period is short and mild, drug treatment is not necessary, but when it interferes with daily life such as work, drug treatment is necessary.
불면증을 겪는 개인에서 원인을 정의하는 것은 복잡한 일이다. 일시적 혹은 급성 불면증은 보통 며칠 동안 또는 몇 주 동안 증상이 지속되며 생활사(life cycle) 혹은 수면 일정이나 수면 환경의 급격한 변화와 관련이 있는 경우가 흔하다. 이 경우 처음의 유발 원인이 사라지면 증상이 해소되거나 완화되기도 한다. Defining the cause in individuals suffering from insomnia is complex. Transient or acute insomnia usually lasts for several days or weeks and is often associated with sudden changes in the life cycle, sleep schedule, or sleep environment. In this case, the symptoms may be resolved or alleviated once the initial trigger disappears.
일반적인 불면증의 원인은 잘못된 생활습관의 경우가 많습니다. 평소 잠자는 시간이나 습관이 불규칙한 사람에게 많이 생기고, 환경 변화, 지나친 걱정, 긴장, 공포와 심리적인 스트레스를 겪으면서 증상이 악화되는 경우가 많다. The common cause of insomnia is often incorrect lifestyle habits. It often occurs in people who have irregular sleeping times or habits, and symptoms often worsen due to environmental changes, excessive worry, tension, fear, and psychological stress.
불면증이란 정신 흥분, 신경 쇠약, 심신 과로 따위로 말미암아 밤에 잠이 잘 오지 않는 병증 또는 이러한 병증을 갖는 질환을 의미하며, 수면 장애라 표현될 수 있다. Insomnia refers to a condition in which one cannot sleep well at night due to mental excitement, nervous breakdown, or mental and physical exhaustion, or a disease having these conditions, and can be expressed as a sleep disorder.
불면증은 상당히 오랜 시간 동안 지속되는 잠의 양 및 질의 면에서 불만족인 상태이다. 불면증은 임상적으로 흔하며 종종 발생하는 질병으로, 그것의 임상적 증상은 잠드는데 어려움, 잠에서 쉽게 깨는 것, 깬 후에 다시 잠들 수 없는 것, 아침에 너무 일찍 깨는 것, 쪽잠, 밤새 자지 못하는 것, 깊게 자지 못하는 것 또는 졸리지 않는 것을 나타내며, 꿈이 많은 것을 동반할 수 있다. 또한, 불면증은 잠에서 깬 후 불편함, 피로, 정신적 활동의 효율 저하 또는 사회적 기능의 방해를 야기할 수 있다.Insomnia is a condition of dissatisfaction with the quantity and quality of sleep that lasts for a considerable period of time. Insomnia is a clinically common and frequently occurring disease, and its clinical symptoms include difficulty falling asleep, waking up easily, not being able to fall back to sleep after waking up, waking up too early in the morning, napping, and not being able to sleep all night. It indicates not being able to sleep deeply or feeling sleepy, and may be accompanied by many dreams. Additionally, insomnia can cause discomfort after waking up, fatigue, decreased mental efficiency, or interference with social functioning.
수면이 부족하게 되면 졸리고 짜증이 나거나 활력이 없어져 삶의 질이 손실된다. 경우에 따라서는 생명유지에 중대한 지장을 초래할 수도 있다. 수면이란 상기와 같은 상태를 초래하지 않게 하기 위한 기능으로, 숙면을 취한다는 것은 단순히 삶의 질 차원의 문제가 아니라 생명유지 및 경제적 생산성의 측면에서도 매우 중요한 요소이다.If you lack sleep, you may feel drowsy, irritable, or lack energy, which will result in loss of quality of life. In some cases, it may cause serious disruption to life support. Sleep is a function to prevent the above-mentioned conditions from occurring, and getting a good night's sleep is not simply a matter of quality of life, but is also a very important factor in terms of life maintenance and economic productivity.
이와 같이 불면증으로 고통을 받고 있는 환자 중 일부는 그 심각성으로 인해 극단적인 선택을 하게 되는 원인이 될 정도이며, 대부분의 환자는 일상생활을 영위하는 것 자체가 어려워지는 개인적 고통의 문제를 겪으며, 또한 불면증으로 인한 작업효율 저하, 안전사고 유발 등으로 사회적 생산성 저하, 사회적 비용 증가 등의 문제가 발생한다.For some patients suffering from insomnia, the severity of the condition causes them to make extreme choices, and most patients experience personal pain that makes it difficult to carry out their daily lives. Problems such as reduced social productivity and increased social costs arise due to reduced work efficiency due to insomnia and safety accidents.
따라서 본 발명이 해결하고자 하는 과제는 불면증을 해결할 수 있는 유효한 수단이 되는 약학적 조성물 또는 건강식품 조성물에 제공하는 것이다.Therefore, the problem to be solved by the present invention is to provide a pharmaceutical composition or health food composition that is an effective means of solving insomnia.
상기 기술적 과제를 달성하기 위하여, 본 발명은 굼벵이 추출물을 활성 성분으로 포함하는 불면증 예방, 완화, 개선 내지 치료용 조성물을 제공한다.In order to achieve the above technical problem, the present invention provides a composition for preventing, alleviating, improving or treating insomnia containing snail extract as an active ingredient.
상술한 바와 같은 본 발명에 따른 조성물은 약학적 조성물일 수 있으며, 그 투여 제형은 정제, 시럽제 등과 같은 경구 투여 제형, 패치제, 연고제 등과 같은 경피 투여 제형, 주사제 등 본 발명이 속하는 기술 분야에 알려진 것이라는 특별한 제한은 없다.As described above, the composition according to the present invention may be a pharmaceutical composition, and the dosage form may be an oral dosage form such as tablets or syrups, a transdermal dosage form such as a patch or ointment, or an injection, known in the art to which the present invention pertains. There are no special restrictions.
상술한 바와 같은 본 발명에 따른 조성물은 건강식품 조성물일 수 있으며, 본 발명의 건강식품 조성물을 이용하여 제조할 수 있는 식품의 형태는 본 발명이 속하는 기술 분야에 알려진 것이라는 특별한 제한은 없다.As described above, the composition according to the present invention may be a health food composition, and there is no particular limitation as to the form of food that can be manufactured using the health food composition of the present invention as long as it is known in the technical field to which the present invention pertains.
상술한 바와 같은 본 발명에 따른 조성물에 있어서, 상기 굼벵이 추출물은In the composition according to the present invention as described above, the snail extract is
도라지 껍질 분말, 상추 분말, 매생이 분말 및 이들의 혼합물로 이루어진 군에서 선택되는 어나 하나의 사료를 먹인 굼벵이,Slugs fed with a single feed selected from the group consisting of bellflower shell powder, lettuce powder, seaweed powder, and mixtures thereof,
더욱 바람직하게는 More preferably
도라지 껍질 분말, 상추 분말, 매생이 분말 및 이들의 혼합물로 이루어진 군에서 선택되는 어나 하나의 사료에 락토바실러스 카제이(Lactobacillus Casei)를 중량 대비 5중량부가 되도록 투입하여 37℃에서 7일간 발효 처리하여 얻은 고상 발효물을 100℃에서 30분간 다시 스팀 살균 처리하여 발효를 억제한 사료를 먹인 굼벵이로 추출한 것임을 특징으로 한다. Lactobacillus Casei was added in an amount of 5 parts by weight to a feed selected from the group consisting of bellflower shell powder, lettuce powder, seaweed powder, and mixtures thereof, and fermented at 37°C for 7 days. It is characterized in that the solid-state fermented product is steam-sterilized again at 100°C for 30 minutes and extracted from slugs fed with feed that inhibits fermentation.
본 발명에 따른 굼벵이 추출물을 포함하는 조성물은 수면에 들어가는데 소요되는 수면 유도 시간을 감소시키고, 수면 지속 시간을 향상시켜 질 좋은 수면을 가능하게 하며, 더더욱 수면 유도 후 잠이 깬 다음에 다시 수면을 유도하는 효과까지 뛰어나 불면증의 예방, 완화, 개선 내지 치료 효과가 우수하여 불면증에 대한 약학적 조성물 또는 건강식품 조성물로 가치가 매우 높다.The composition containing the snail extract according to the present invention reduces the sleep induction time required to enter sleep, improves sleep duration, enables quality sleep, and further induces sleep again after waking up after inducing sleep. It is highly effective in preventing, relieving, improving, or treating insomnia, making it of great value as a pharmaceutical composition or health food composition for insomnia.
본 발명은 굼벵이 추출물을 포함하는 불면증 예방, 완화, 개선 내지 치료에 유용한 조성물을 제공한다.The present invention provides a composition useful for preventing, alleviating, improving, or treating insomnia containing a snail extract.
상기 굼벵이는 흰점박이 꽃무지(Protaetia brevitarsis)의 유충으로서 동의보감에서 간암, 간경화, 간염, 누적된 피로 해소 등을 포함하여 시력 감퇴, 백내장, 악성종기, 구내염, 파상풍, 중풍 등의 성인병을 치료하는 데 효과가 있다고 적혀 있는 등 전통 한약재이다.The slug is a larva of Protaetia brevitarsis, which is used in Donguibogam to treat adult diseases such as liver cancer, cirrhosis, hepatitis, and relieving accumulated fatigue, as well as decreased vision, cataracts, malignant boils, stomatitis, tetanus, and stroke. It is a traditional herbal medicine that is said to be effective.
상기 굼벵이를 추출하여 얻어진 추출물에 대해서는 대한민국 등록특허공보 10-1852840호에 굼벵이 효소 처리물, 갈색거저리 유충의 효소처리물, 인진쑥 추출물, 민들레 추출물 및 엉겅퀴 추출물을 함유함으로써 간 보호의 효과를 나타내는 조성물이 개시되어 있으며, 대한민국 등록특허공보 10-0377252호에는 굼벵이류(매미, 풍뎅이, 사슴벌레, 뽕나무나 방의 유충)에서 열수 침출한 추출물과 영지버섯의 열수침출 추출물을 포함하는 항암용 식품이 개시되어 있다.Regarding the extract obtained by extracting the slugs, Republic of Korea Patent Publication No. 10-1852840 discloses a composition showing a liver protection effect by containing enzyme treatment of slugs, enzyme treatment of brown mealworm larvae, mugwort extract, dandelion extract, and thistle extract. It is disclosed in Republic of Korea Patent Publication No. 10-0377252, which discloses an anti-cancer food containing a hot-water leached extract from slugs (cicadas, beetles, stag beetles, mulberry or room larvae) and a hot-water leached extract of reishi mushrooms. .
상기 선행기술을 살펴보면, 굼벵이를 플라보자임(Flavozyme), 알칼라아제(Alcalase) 또는 프로테아제(Protease)에서 선택되는 효소로 처리하거나 열수침출함으로써 추출물을 얻고 있으며, 이를 통하여 간 보호 및 항암 효과를 얻고 있다.Looking at the above prior art, extracts are obtained by treating slugs with enzymes selected from Flavozyme, Alcalase, or Protease or by hot water leaching, through which liver protection and anticancer effects are obtained. there is.
이와는 별도로 굼벵이가 당뇨와 관련한 효과가 있다는 점이 민간에 널리 알려져 있으며, 혈당 강하 효과에 대한 보고가 이루어지고 있다(곤충 프로테오글라이칸 분리정제 및 의약 소재화 연구, 국립농업과학원, 2013). 또한, 대한민국 등록특허공보 10-1888549호에는 굼벵이를 주원료로 하여 늙은 호박 추출액, 구기자 추출액, 백복령 추출액, 차전자 추출액, 당귀 추출액 및 칡 추출액을 조성 비율에 따라 일정량씩 조합한 혼합 추출액을 키토산으로 표면 코팅하여 집적화한 혈중 콜레스테롤 및 중성지질 저하 효과가 우수한 다이어트 음료를 개시하고 있다.Separately from this, it is widely known in the public that snails have diabetes-related effects, and reports are being made about their blood sugar-lowering effects (Research on isolation and purification of insect proteoglycans and pharmaceutical materials, National Institute of Agricultural Sciences, 2013). In addition, in Republic of Korea Patent Publication No. 10-1888549, a mixed extract of aged pumpkin extract, goji berry extract, Baekbokryeong extract, psyllium extract, angelica root extract, and kudzu extract was combined in certain amounts according to the composition ratio using slugs as the main ingredient, and was surfaced with chitosan. A diet drink that is coated and integrated and has excellent blood cholesterol and neutral lipid lowering effects is being disclosed.
다만, 불면증 완화 및 치료 효과에 대해서는 전혀 개시되어 있지 않다,However, there is no disclosure at all about insomnia relief and treatment effects.
상기 굼벵이 추출물은 하기의 단계를 포함하는 방법에 의해 제조할 수 있으나, 이에 한정하지 않는다:The snail extract can be prepared by a method comprising the following steps, but is not limited to this:
(1) 굼벵이에 추출용매를 가하여 추출하는 단계;(1) Extracting slugs by adding an extraction solvent;
(2) 단계 (1)의 추출물을 여과하는 단계; 및(2) filtering the extract of step (1); and
(3) 단계 (2)의 여과한 추출물을 감압 농축하고 건조하여 추출물을 제조하는 단계.(3) Concentrating the filtered extract of step (2) under reduced pressure and drying it to prepare an extract.
상기 단계 (1)에서 추출용매는 물, C1~C4의 저급 알코올 또는 이들의 혼합물 중에서 선택하는 것이 바람직하며, 더 바람직하게는 C1~C4의 저급 알코올이고, 더욱더 바람직하게는 70%(v/v) 에탄올이지만 이에 한정하지 않는다.In step (1), the extraction solvent is preferably selected from water, C1 to C4 lower alcohol, or a mixture thereof, more preferably C1 to C4 lower alcohol, and even more preferably 70% (v/v). ) Ethanol, but is not limited to this.
상기 제조방법에 있어서, 추출방법은 여과법, 열수 추출, 침지 추출, 환류 냉각 추출 및 초음파 추출 등의 당업계에 공지된 모든 통상적인 방법을 이용할 수 있다. 상기 추출용매는 건조된 굼벵이 중량의 1~20배 첨가하여 추출하는 것이 바람직하며, 더 바람직하게는 5~15배 첨가하는 것이다. 추출온도는 4 내지 50℃인 것이 바람직하나 이에 한정하지 않는다. 또한, 추출시간은 0.5~10시간인 것이 바람직하며, 0.5~5시간이 더욱 바람직하나 이에 한정하지 않는다. In the above manufacturing method, all conventional methods known in the art can be used as the extraction method, such as filtration, hot water extraction, immersion extraction, reflux cooling extraction, and ultrasonic extraction. The extraction solvent is preferably added 1 to 20 times the weight of the dried slugs for extraction, and more preferably 5 to 15 times the weight of the dried slugs. The extraction temperature is preferably 4 to 50°C, but is not limited thereto. In addition, the extraction time is preferably 0.5 to 10 hours, and more preferably 0.5 to 5 hours, but is not limited thereto.
상기 방법에 있어서, 단계 (3)의 감압농축은 진공 감압 농축기 또는 진공회전증발기를 이용하는 것이 바람직하나 이에 한정하지 않는다. 또한, 건조는 감압건조, 진공건조, 비등건조, 분무 건조 또는 동결 건조하는 것이 바람직하나 이에 한정하지 않는다. In the above method, the vacuum concentration in step (3) is preferably performed using a vacuum vacuum concentrator or a vacuum rotary evaporator, but is not limited thereto. In addition, drying is preferably performed by reduced pressure drying, vacuum drying, boiling drying, spray drying, or freeze drying, but is not limited thereto.
본 발명에 따른 조성물은 약제학적으로 유효한 양으로 투여한다. 본 발명에 있어서, "약제학적으로 유효한 양"은 의학적 치료에 적용 가능한 합리적인 수혜/위험 비율로 질환을 치료하기에 충분한 양을 의미하며, 유효용량 수준은 환자의 질환의 종류, 중증도, 약물의 활성, 약물에 대한 민감도, 투여 시간, 투여 경로 및 배출 비율, 치료기간, 동시 사용되는 약물을 포함한 요소 및 기타 의학 분야에 잘 알려진 요소에 따라 결정될 수 있다. 본 발명의 조성물은 개별 치료제로 투여하거나 다른 치료제와 병용하여 투여될 수 있고 종래의 치료제와는 순차적 또는 동시에 투여될 수 있으며, 단일 또는 다중 투여될 수 있다. 상기한 요소들을 모두 고려하여 부작용 없이 최소한의 양으로 최대 효과를 얻을 수 있는 양을 투여하는 것이 중요하며, 이는 당업자에 의해 용이하게 결정될 수 있다.The composition according to the present invention is administered in a pharmaceutically effective amount. In the present invention, “pharmaceutically effective amount” means an amount sufficient to treat the disease with a reasonable benefit/risk ratio applicable to medical treatment, and the effective dose level is determined by the type, severity, and activity of the patient's disease. , can be determined based on factors including sensitivity to the drug, time of administration, route of administration and excretion rate, duration of treatment, drugs used simultaneously, and other factors well known in the field of medicine. The composition of the present invention may be administered as an individual therapeutic agent or in combination with other therapeutic agents, may be administered sequentially or simultaneously with conventional therapeutic agents, and may be administered singly or multiple times. Considering all of the above factors, it is important to administer an amount that can achieve maximum effect with the minimum amount without side effects, and this can be easily determined by a person skilled in the art.
본 발명의 조성물의 투여량은 환자의 체중, 연령, 성별, 건강상태, 식이, 투여시간, 투여방법, 질환의 정도 등에 따라 그 범위가 다양하게 사용할 수 있다.The dosage of the composition of the present invention can vary depending on the patient's weight, age, gender, health condition, diet, administration time, administration method, degree of disease, etc.
또한, 상기 굼벵이 추출물을 제조하기 위한 굼벵이는 In addition, the slugs for producing the slug extract are
도라지 껍질 분말, 상추 분말, 매생이 분말 및 이들의 혼합물로 이루어진 군에서 선택되는 어나 하나의 사료를 먹인 굼벵이,Slugs fed with a single feed selected from the group consisting of bellflower shell powder, lettuce powder, seaweed powder, and mixtures thereof,
더욱 바람직하게는 More preferably
도라지 껍질 분말, 상추 분말, 매생이 분말 및 이들의 혼합물로 이루어진 군에서 선택되는 어나 하나의 사료에 락토바실러스 카제이(Lactobacillus Casei)를 중량 대비 5중량부가 되도록 투입하여 37℃에서 7일간 발효 처리하여 얻은 고상 발효물을 100℃에서 30분간 다시 스팀 살균 처리하여 발효를 억제한 사료를 먹인 굼벵이로 추출한 것임을 특징으로 한다. Lactobacillus Casei was added in an amount of 5 parts by weight to a feed selected from the group consisting of bellflower shell powder, lettuce powder, seaweed powder, and mixtures thereof, and fermented at 37°C for 7 days. It is characterized in that the solid-state fermented product is steam-sterilized again at 100°C for 30 minutes and extracted from slugs fed with feed that inhibits fermentation.
이와 같은 사료는 굼벵이용 톱밥 사료에 혼합하여 굼벵이에게 섭취시키는 방식이며, 이 때 굼벵이용 톱밥 사료에 본 발명에서 제조한 사료를 중량대비 1/25 포함시키는 것이 바람직하다.This type of feed is mixed with sawdust feed for slugs and ingested by slugs. At this time, it is preferable to include 1/25 by weight of the feed prepared in the present invention in the sawdust feed for slugs.
또한, 본 발명에서는 굼벵이 출하 7 ~ 14일 전에 굼벵이 톱밥 사료를 공급을 중지하면서 본 발명에서 제조한 사료만을 굼벵이에게 섭취시키는 방식으로 하여 그 효과를 더욱 높일 수 있다.In addition, in the present invention, the effect can be further increased by stopping the supply of sawdust feed to the slugs 7 to 14 days before shipping to the slugs and allowing the slugs to consume only the feed prepared in the present invention.
본 발명에 따른 조성물은 약학 조성물일 수 있는데, 이 경우 통상적으로 사용하는 적절한 담체, 부형제 및 희석제를 더 포함하여 산제, 과립제, 정제, 캡슐제, 시럽제 등의 경구 투여 제형, 연고제, 패치제, 좌제 형태의 경피 투여 제제, 주사제 등의 제형으로 사용될 수 있다. 그러나 이에 한정되는 것은 아니며 본 발명이 속하는 기술 분야에 알려진 제제 기술이라면 특별한 제한 없이 이용 가능하다. The composition according to the present invention may be a pharmaceutical composition, in which case it may further include commonly used appropriate carriers, excipients, and diluents, and may be used in oral dosage forms such as powders, granules, tablets, capsules, syrups, ointments, patches, and suppositories. It can be used in formulations such as transdermal administration formulations and injections. However, it is not limited to this, and any preparation technology known in the technical field to which the present invention pertains can be used without particular limitation.
또한, 본 발명에 따른 조성물은 건강식품 조성물일 수 있는데, 이 경우 통상적으로 이용되는 식품 첨가물을 함유하여 다양한 형태의 식품으로 제조될 수 있는 것으로서 본 발명이 속하는 기술 분야에 알려진 것이라는 특별한 제한은 없다.In addition, the composition according to the present invention may be a health food composition, in which case it can be manufactured into various types of food by containing commonly used food additives, and there is no particular limitation as it is known in the art to which the present invention pertains.
이하, 구체적인 실시예 및 비교예를 통하여 본 발명을 보다 상세히 설명하기로 한다. 그러나 하기 실시예는 본 발명을 보다 명확하기 이해시키기 위한 것일 뿐하기 실시예로 본 발명의 보호 범위가 한정되는 것은 아니며, 본 발명의 보호 범위는 특허 청구 범위에 의하여 해석되어야 하고, 그와 균등한 범위 내에 있는 모든 기술 사상은 본 발명의 권리범위에 포함되는 것으로 해석되어야 한다.Hereinafter, the present invention will be described in more detail through specific examples and comparative examples. However, the following examples are only for a clearer understanding of the present invention, and the scope of protection of the present invention is not limited to the examples. The scope of protection of the present invention should be interpreted in accordance with the scope of the patent claims, and equivalents thereof. All technical ideas within the scope should be construed as being included in the scope of rights of the present invention.
<실시예 1><Example 1>
1. 실험동물 준비1. Preparation of experimental animals
오리엔트바이오에서 구입한 평균 체중 20g의 수컷 ICR 마우스를 각 시험군 별로 5마리씩 총 60마리를 구입하여 실험 전까지 일반 실험동물용 사료 및 음수는 임의대로 섭취할 수 있도록 하였으며, 22 ~ 24℃의 온도와 60 ~ 70% 상대습도의 환경을 유지하였다.A total of 60 male ICR mice with an average weight of 20 g were purchased from Orient Bio, 5 for each test group, and were allowed to freely consume food and drinking water for general laboratory animals until the experiment. The mice were kept at a temperature of 22 to 24°C. An environment of 60 to 70% relative humidity was maintained.
실험 1주일 전에 낮과 밤의 사이클을 12시간 간격으로 설정하였으며, 실험 전 24시간 동안 절식시켜 실험 준비를 완료하였다.One week before the experiment, the day and night cycle was set to 12-hour intervals, and preparation for the experiment was completed by fasting for 24 hours before the experiment.
2. 실험 방법2. Experimental method
상술한 방법으로 준비된 실험동물을 이용하여 잠이 들 때까지 걸린 시간 즉, 수면 유도 시간(Sleep latency)과 잠이 든 시간 즉, 수면 지속 시간(Sleep duration)을 측정하였다. Using experimental animals prepared in the above-described manner, the time taken to fall asleep, i.e., sleep induction time (Sleep latency), and the time to fall asleep, i.e., sleep duration, were measured.
수면 유도 시간은 실험 약물을 복강 내 투여한 다음 정향 반사(righting reflex)를 1분 이상 상실할 때까지의 경과시간으로 설정하였고, 수면 지속 시간은 동물이 다시 정향 반사를 회복할 때까지의 시간으로 설정하였다. 15분 이내에 수면을 취하지 않는 동물은 실험 결과의 측정에서 배제하였다.The sleep induction time was set as the time elapsed until the righting reflex was lost for more than 1 minute after intraperitoneal administration of the experimental drug, and the sleep duration was set as the time until the animal regained the righting reflex. set. Animals that did not sleep within 15 minutes were excluded from measuring experimental results.
수면 유도 시간과 수면 지속 시간을 측정하기 위한 시험군은 다음과 같이 설정하였으며, 음성대조군은 생리 식염수, 양성대조군은 소듐펜토바르비탈, 본 발명에 따른 시험군은 굼벵이 추출물을 사용하였으며, 추출은 동결 건조한 굼벵이를 에탄올로 추출하였다. The test group for measuring sleep induction time and sleep duration was set as follows, the negative control group used physiological saline, the positive control group used sodium pentobarbital, and the test group according to the present invention used snail extract, and the extraction was frozen. Dried slugs were extracted with ethanol.
상기 굼벵이 추출물은 실시에 1 내지 3에서는 일반 사료, 실시예 4 내지 6에서는 건조한 도라지 껌질 분말 사료, 실시에 7 내지 9에서는 상추 분말 사료, 실시에 10 내지 12에서는 매생이 분말 사료를 먹인 굼벵이를 이용하여 제조하였다.The slug extract was used in Examples 1 to 3 using general feed, in Examples 4 to 6, dried bellflower gum powder feed, in Examples 7 to 9, lettuce powder feed, and in Examples 10 to 12, slugs fed with seaweed powder feed. Manufactured.
* 음성 대조군: 5마리 * Negative control group: 5 animals
생리 식염수 30㎎/㎏을 복강 내 투여Administer 30 mg/kg of physiological saline intraperitoneally
* 양성대조군 1: 5마리* Positive control group 1: 5 animals
소듐펜토바르비탈 45㎎/㎏을 복강 내 투여Sodium pentobarbital 45 mg/kg administered intraperitoneally
* 본 발명의 시험군 1, 4, 7, 10: 5마리* Test groups 1, 4, 7, 10 of the present invention: 5 animals
굼벵이 추출물 100㎎/㎏을 복강 내 투여Intraperitoneal administration of 100 mg/kg of slug extract
* 본 발명의 시험군 2, 5, 8, 11: 5마리* Test groups 2, 5, 8, 11 of the present invention: 5 animals
굼벵이 추출물 200㎎/㎏을 복강 내 투여Intraperitoneal administration of 200 mg/kg of slug extract
* 본 발명의 시험군 3, 6, 9, 12: 5마리* Test group 3, 6, 9, 12 of the present invention: 5 animals
굼벵이 추출물 300㎎/㎏을 복강 내 투여Intraperitoneal administration of 300 mg/kg of slug extract
3. 실험 결과3. Experimental results
상술한 실험 방법에 따라 각 시험군 별 수면 유도 시간과 수면 유지 시간을 측정하여 그 평균값을 표 1 및 표 2에 나타냈다.According to the experimental method described above, the sleep induction time and sleep maintenance time were measured for each test group, and the average values are shown in Tables 1 and 2.
먼저, 수면 유도 시간을 나타낸 표 1을 보면, 생리 식염수를 투여한 음성대조군과 비교하여 소듐펜토바르비탈을 투여한 양성대조군 1는 대략 수면 유도 시간 감축 효과가 27%로 나타났다.First, looking at Table 1 showing the sleep induction time, compared to the negative control group administered saline solution, the positive control group 1 administered sodium pentobarbital showed a sleep induction time reduction effect of approximately 27%.
이와 비교하여 본 발명에 따른 시험군 중에서 일반 사료를 먹인 시험군 1, 2 및 3을 보면 저 용량인 시험군 1에서는 양성대조군보다는 감축 효과가 우수하지는 않았지만, 음성대조군과 비교해서는 유의미한 효과를 나타냈으며, 시험군 2 및 3에서는 양성대조군과 거의 대등한 효과를 보여 본 발명에 따른 조성물의 우수성을 확인할 수 있었다.In comparison, among the test groups according to the present invention, test groups 1, 2, and 3 fed with regular feed showed that test group 1, which had a low dose, did not have a better reduction effect than the positive control group, but showed a significant effect compared to the negative control group. , Test groups 2 and 3 showed almost equivalent effects to the positive control group, confirming the superiority of the composition according to the present invention.
또한 도라지 껍질, 상추, 매생이 사료를 먹인 굼벵이 추출물의 시험군 4 내지 12를 보면, 모두 양성 대조군 1보다 우수한 효과를 보여 사료 변화의 효과를 확인할 수 있었다.In addition, looking at test groups 4 to 12 of the slug extract fed with bellflower bark, lettuce, and columbine feed, all showed better effects than the positive control group 1, confirming the effect of the change in feed.
이어서, 수면 지속 시간을 나타낸 표 2를 보면, 생리 식염수를 투여한 음성대조군과 비교하여 소듐펜토바르비탈을 투여한 양성대조군 1은 대략 수면 지속 시간 증가 효과가 25%로 나타났다.Next, looking at Table 2 showing the sleep duration, compared to the negative control group administered saline solution, the positive control group 1 administered sodium pentobarbital showed an increase in sleep duration of approximately 25%.
이와 비교하여 본 발명에 따른 시험군 중에서 일반 사료를 먹인 시험군 1, 2 및 3을 보면 저 용량인 시험군 1에서는 양성대조군보다는 감축 효과가 우수하지는 않았지만, 음성대조군과 비교해서는 유의미한 효과를 나타냈으며, 시험군 2 및 3에서는 양성대조군과 거의 대등한 효과를 보여 본 발명에 따른 조성물의 우수성을 확인할 수 있었다.In comparison, among the test groups according to the present invention, test groups 1, 2, and 3 fed with regular feed showed that test group 1, which had a low dose, did not have a better reduction effect than the positive control group, but showed a significant effect compared to the negative control group. , Test groups 2 and 3 showed almost equivalent effects to the positive control group, confirming the superiority of the composition according to the present invention.
또한 도라지 껍질, 상추, 매생이 사료를 먹인 굼벵이 추출물의 시험군 4 내지 12를 보면, 모두 양성 대조군 1보다 우수한 효과를 보여 사료 변화의 효과를 확인할 수 있었다.In addition, looking at test groups 4 to 12 of the slug extract fed with bellflower bark, lettuce, and columbine feed, all showed better effects than the positive control group 1, confirming the effect of the change in feed.
4. 실험 결론4. Experiment conclusion
활성 성분으로 굼벵이 추출물을 사용한 본 발명에 따른 조성물은 불면증 치료 약물로 처방되는 소듐펜토바르비탈과 비교할 때 일반 사료 굼벵이 추출물 100mg/㎏(시험군 1)을 투여하였을 때만 수면 유도 시간 단축 효과 및 수면 지속 시간 증가 효과에서 조금 미치지 못하였을 뿐 그 이상의 용량에서 대등하거나 우수한 효과를 보였으며, 100mg/㎏을 투여하였을 때도 그 효과가 소듐펜토바르비탈보다 작은 것일 뿐 수면 유도 시간 단축 효과 및 수면 지속 시간 증가 효과는 유의미하다.The composition according to the present invention using snail extract as an active ingredient has the effect of shortening sleep induction time and maintaining sleep only when 100 mg/kg of general feed slug extract (test group 1) is administered compared to sodium pentobarbital, which is prescribed as an insomnia treatment drug. Although it was only slightly less effective in increasing time, it showed comparable or superior effects at higher doses, and even when administered at 100 mg/kg, the effect was smaller than that of sodium pentobarbital, but had the effect of shortening sleep induction time and increasing sleep duration. is significant.
<실시예 2><Example 2>
실시예 1과 동일한 방법으로 진행하였으면 다만, 상기 굼벵이 추출물은If carried out in the same manner as Example 1, however, the snail extract was
건조한 도리지 껍질 분말, 상추 분말, 매생이 분말 각각 100중량부에 5중량부의 락토바실러스 카제이(Lactobacillus Casei)을 첨가하여 품온 36℃에서 7일간 발효처리를 수행한 후 100℃에서 30분간 스팀가열처리하여 멸균시켜 제조한 사료 먹인 굼벵이와 일반 톱밥 사료를 먹인 굼벵이를 이용하여 제조한 것에 차이가 있다.5 parts by weight of Lactobacillus Casei was added to each 100 parts by weight of dried radish bark powder, lettuce powder, and columbine powder, fermented at a temperature of 36°C for 7 days, and then steam heated at 100°C for 30 minutes. There is a difference between slugs fed with sterilized feed and slugs fed with regular sawdust feed.
구체적으로 실시예 2에서 시험군 13은 도라지 껍질 발효 사료, 시험군 14는 상추 발효 사료, 실시에 15는 매생이 발효 사료를 먹인 굼벵이 추출물이며, 이 추출물 100㎎/㎏을 복강 내 투여하였다.Specifically, in Example 2, test group 13 was a fermented bellflower bark feed, test group 14 was a lettuce fermented feed, and test group 15 was an extract of snails fed a fermented seaweed feed, and 100 mg/kg of this extract was administered intraperitoneally.
각 시험군 별 수면 유도 시간과 수면 유지 시간을 측정하여 그 평균값을 표 3 및 표 4에 나타냈다.The sleep induction time and sleep maintenance time for each test group were measured, and the average values are shown in Tables 3 and 4.
표 3 및 표 4의 결과를 보면, 발효 사료를 먹인 시험군 13 내지 15는 추출물을 100mg/kg을 사용하여도 발효하지 않은 사료를 먹인 굼벵이 추출물 300mg/kg 사용한 시험군 6, 9, 12와 유사한 결과를 보여 발효 사료의 효과 현저성을 확인할 수있엇다.Looking at the results in Tables 3 and 4, test groups 13 to 15 fed fermented feed were similar to test groups 6, 9, and 12 fed unfermented feed and 300 mg/kg of slug extract even when 100 mg/kg of extract was used. The results showed that the effectiveness of fermented feed was significant.
<실시예 3: 재수면 유도 시간 측정><Example 3: Measurement of re-sleep induction time>
불면증 치료를 위한 약물을 복용 후 수면에 들었지만 어떠한 자극을 인하여 잠이 깬 후 약물의 복용 없이 용이하게 다시 수면에 들어갈 수 있다면 그 약물은 불면증 예방, 완화, 개선 내지 치료에 매우 유용하다.If you fall asleep after taking a drug to treat insomnia, but wake up due to some stimulus and can easily go back to sleep without taking the drug, the drug is very useful in preventing, alleviating, improving, or treating insomnia.
이에 따라 본 실험에서는 앞서 실험 것을 바탕으로 하여 재수면 유도 시간을 측정을 하여 그 결과를 표 5에 나타냈으며, 재수면 유도 시간은 실험 약물을 복강 내 투여한 다음 정향 반사(righting reflex)를 1분 이상 상실한 다음에 충분 수면 시간을 주지 않고 500초 경과 후에 자극을 주어 다시 정향 반사를 회복시킨 다음 다시 실험 약물은 다시 투여하지 않은 상태에서 수면이 유도될 때까지의 시간을 측정한 결과이다.Accordingly, in this experiment, the re-sleep induction time was measured based on the previous experiment, and the results are shown in Table 5. The re-sleep induction time was 1 minute after intraperitoneal administration of the experimental drug and the righting reflex. This is the result of measuring the time until sleep is induced without providing sufficient sleep time after the loss of abnormality, restoring the righting reflex again by stimulating it after 500 seconds, and then not administering the experimental drug again.
수면 재유도 시간을 측정하기 위한 시험군은 설정은 수면 유도 시간 측정한 결과를 참조하여 다음과 같이 설정하였으며, 본 발명에 따른 시험군은 양성대조군인 소듐펜토바르비탈과 거의 동등한 수준의 수면 유도 시간 단축 효과를 보인 시험군의 용량으로 설정하였다.The test group for measuring the sleep re-induction time was set as follows with reference to the results of measuring the sleep induction time, and the test group according to the present invention had a sleep induction time almost equivalent to that of sodium pentobarbital, the positive control group. It was set at the dose of the test group that showed a shortening effect.
* 음성 대조군: 5마리 * Negative control group: 5 animals
생리 식염수 30㎎/㎏을 복강 내 투여Administer 30 mg/kg of physiological saline intraperitoneally
* 양성대조군: 5마리* Positive control group: 5 animals
소듐펜토바르비탈 45㎎/㎏을 복강 내 투여Sodium pentobarbital 45 mg/kg administered intraperitoneally
* 본 발명의 시험군 16: 5마리* Test group 16 of the present invention: 5 animals
굼벵이 추출물 200㎎/㎏ 복강 내 투여Intraperitoneal administration of snail extract 200㎎/㎏
* 본 발명의 시험군 17: 5마리* Test group 17 of the present invention: 5 animals
굼벵이(도라지 껍질 사료) 추출물 100㎎/㎏을 복강 내 투여Intraperitoneal administration of 100 mg/kg of snail (bellflower bark feed) extract
* 본 발명의 시험군 18: 5마리* Test group 18 of the present invention: 5 animals
굼벵이(상추 사료) 추출물 100㎎/㎏을 복강 내 투여Intraperitoneal administration of 100 mg/kg of snail (lettuce feed) extract
* 본 발명의 시험군 19: 5마리* Test group 19 of the present invention: 5 animals
굼벵이(매생이 사료) 추출물 100㎎/㎏을 복강 내 투여Intraperitoneal administration of 100 mg/kg of snail (maesaeng feed) extract
* 본 발명의 시험군 20: 5마리* Test group 20 of the present invention: 5 animals
굼벵이(도라지 껍질 발효 사료) 추출물 100㎎/㎏을 복강 내 투여Intraperitoneal administration of 100 mg/kg of slug (fermented bellflower bark feed) extract
* 본 발명의 시험군 21: 5마리* Test group 21 of the present invention: 5 animals
굼벵이(상추 발효 사료) 추출물 100㎎/㎏을 복강 내 투여Intraperitoneal administration of 100 mg/kg of snail (fermented lettuce feed) extract
* 본 발명의 시험군 22: 5마리* Test group 22 of the present invention: 5 animals
굼벵이(매생이 발효 사료) 추출물 100㎎/㎏을 복강 내 투여Intraperitoneal administration of 100 mg/kg of snail (fermented seaweed feed) extract
실험 결과를 나타낸 표 5를 보면 표 1의 수면 유도 시간보다는 다시 수면이 유도되는데 더 긴 시간이 필요함을 확인할 수 있었으며, 양성대조군의 경우는 음성대조군보다 재수면 유도 시간이 감소되었는데, 그 감소 수치는 약 1.4%로서 음성대조군과 큰 차이를 보이지 않았다. 즉 충분한 수면을 취하지 못하고 깬 후에 다시 수면에 드는 것을 유도하는 재수면 유도에서는 양성대조군으로 사용되는 소듐펜토바르비탈은 효과를 보이지 못한 것으로 볼 수 있다.Looking at Table 5 showing the experimental results, it was confirmed that a longer time was needed to induce sleep again than the sleep induction time in Table 1. In the case of the positive control group, the re-sleep induction time was reduced compared to the negative control group, and the reduction value was It was about 1.4%, showing no significant difference from the negative control group. In other words, sodium pentobarbital, which is used as a positive control, can be seen as not showing any effect in re-sleep induction, which induces people to go back to sleep after waking up without sufficient sleep.
이에 비하여 본 발명에 따른 시험군은 모두에서 충분히 수면을 취하지 못하고 도중에 잠이 깬 경우에도 쉽게 다시 수면에 들어갈 수 있는 가능성 높아 불면증 예방, 완화, 개선 내지 치료에 매우 뛰어난 조성물임을 확인할 수 있었다. In contrast, all test groups according to the present invention did not get enough sleep and had a high possibility of easily returning to sleep even if they woke up midway, confirming that it is an excellent composition for preventing, alleviating, improving or treating insomnia.
Claims (4)
A pharmaceutical for preventing, alleviating, improving or treating insomnia, comprising as an active ingredient a slug extract extracted from slugs fed any feed selected from the group consisting of bellflower shell powder, lettuce powder, columbine powder and mixtures thereof. enemy composition.
Solid-state fermentation obtained by adding 5 parts by weight of Lactobacillus Casei to any one selected from the group consisting of bellflower peel powder, lettuce powder, seaweed powder, and mixtures thereof and fermenting at 37°C for 7 days. A pharmaceutical composition for preventing, alleviating, improving or treating insomnia, comprising a slug extract extracted from slugs fed feed whose fermentation was suppressed by steam sterilizing water at 100°C for 30 minutes.
A health food composition for preventing, alleviating or improving insomnia, comprising as an active ingredient a slug extract extracted from slugs fed any feed selected from the group consisting of bellflower shell powder, lettuce powder, columbine powder and mixtures thereof. .
Solid-state fermentation obtained by adding 5 parts by weight of Lactobacillus Casei to any one selected from the group consisting of bellflower peel powder, lettuce powder, seaweed powder, and mixtures thereof and fermenting at 37°C for 7 days. A health food composition for preventing, alleviating or improving insomnia, comprising slug extract extracted from slugs fed feed whose fermentation was suppressed by steam sterilizing water at 100°C for 30 minutes.
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