KR20240006283A - A composition for improving, preventing and treating of depression containing Eriobotrya japonica fruit extract - Google Patents
A composition for improving, preventing and treating of depression containing Eriobotrya japonica fruit extract Download PDFInfo
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- KR20240006283A KR20240006283A KR1020220083148A KR20220083148A KR20240006283A KR 20240006283 A KR20240006283 A KR 20240006283A KR 1020220083148 A KR1020220083148 A KR 1020220083148A KR 20220083148 A KR20220083148 A KR 20220083148A KR 20240006283 A KR20240006283 A KR 20240006283A
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Classifications
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- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
- A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
- A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
- A23L33/105—Plant extracts, their artificial duplicates or their derivatives
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/73—Rosaceae (Rose family), e.g. strawberry, chokeberry, blackberry, pear or firethorn
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/24—Antidepressants
-
- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23V—INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
- A23V2002/00—Food compositions, function of food ingredients or processes for food or foodstuffs
-
- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23V—INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
- A23V2200/00—Function of food ingredients
- A23V2200/30—Foods, ingredients or supplements having a functional effect on health
- A23V2200/322—Foods, ingredients or supplements having a functional effect on health having an effect on the health of the nervous system or on mental function
Abstract
본 발명은 스트레스로 인한 우울증의 개선, 예방 또는 치료용 조성물에 관한 것으로 비파나무(Eriobotrya japonica) 열매 추출물을 유효성분으로 함유함으로써, 스트레스로 인한 우울증을 개선, 예방 또는 치료할 수 있다. 또한, 독성이 없으므로 식품의 형태로 섭취할 수 있다. The present invention relates to a composition for improving, preventing or treating depression caused by stress, and can improve, prevent or treat depression caused by stress by containing extract of loquat trees ( Eriobotrya japonica ) fruit as an active ingredient. Additionally, since it is non-toxic, it can be consumed in food form.
Description
본 발명은 비파나무 열매 추출물을 유효성분으로 함유하여 우울증을 개선, 예방 또는 치료할 수 있는 조성물에 관한 것이다.The present invention relates to a composition that can improve, prevent, or treat depression by containing loquat tree fruit extract as an active ingredient.
사회가 급격히 발전하고 다변화됨에 따라 현대인들은 여러 가지 역할을 요구받고 있다. 이에 따라, 각종 스트레스로 인한 우울증, 불안장애 또는 수면장애 등 정신질환을 호소하는 사람들이 증가하고 있다. 보건복지부에서 18~64세 이하의 성인을 대상으로 시행한 2006년도 정신질환실태 역학조사에 따르면, '정신질환 1년 유병률'이 17.1%인 것으로 나타났다. As society develops and diversifies rapidly, modern people are required to take on various roles. Accordingly, the number of people complaining of mental illnesses such as depression, anxiety disorders, or sleep disorders caused by various types of stress is increasing. According to the 2006 epidemiological survey on mental disorders conducted by the Ministry of Health and Welfare on adults aged 18 to 64, the 'one-year prevalence rate of mental disorders' was found to be 17.1%.
또한, 평생 동안 한가지 이상의 정신질환 경험 인구비율인 '정신질환 평생 유병률'도 성인 3명 중 1명인 30%로 나타났다(2006년 기준). 아울러, 최근 과도한 학구열 등의 원인으로 인해 청소년 정신질환이 증가하는 추세이다.In addition, the 'lifetime prevalence of mental illness', which is the proportion of the population experiencing at least one mental illness during their lifetime, was found to be 30%, or 1 in 3 adults (as of 2006). In addition, mental illness in adolescents has recently been on the rise due to causes such as excessive academic enthusiasm.
스트레스는 인간이 심리적 혹은 신체적으로 감당하기 어려운 상황에 처했을 때 느끼는 불안과 위협의 감정이다. 이와 같은 스트레스는 인간의 모든 삶의 영역에 존재하기에 누구도 스트레스를 피할 수 없다. 인간이 스트레스 상황에 처하면 스트레스에 대한 신체 반응으로 자율신경계의 교감부가 활성화되고, 응급상황에 반응하도록 신체의 자원들이 동원된다. Stress is a feeling of anxiety and threat that a person feels when faced with a situation that is psychologically or physically difficult to handle. No one can avoid stress because this type of stress exists in all areas of human life. When humans are in a stressful situation, the sympathetic part of the autonomic nervous system is activated as a physical response to stress, and the body's resources are mobilized to respond to the emergency situation.
스트레스에 대처하지 못하고 그대로 방치하게 되면 우울, 불안, 피로, 분노, 기분변화와 같은 심리반응이 초래되고, 뇌파 중 α-파 감소, 혈압과 맥박수의 증가 등의 생리 반응을 초래하게 되는데 이러한 반응이 계속 반복되면 우울증, 불안증, 수면 장애와 같은 질병이 나타나고 개인, 가족 및 사회적 손실을 야기하며, 개인의 삶의 질을 낮추는 원인이 된다.If stress is not dealt with and left untreated, psychological reactions such as depression, anxiety, fatigue, anger, and mood changes result, as well as physiological reactions such as a decrease in α-waves among brain waves and an increase in blood pressure and pulse rate. If this happens over and over again, it causes diseases such as depression, anxiety, and sleep disorders, causes personal, family, and social losses, and lowers the individual's quality of life.
스트레스로 인한 질환 중에서 우울증은 슬픔, 절망감 및 좌절감의 감정을 특징으로 하는 침체된 기분의 심리적 상태를 말하는 것이다. 즉, 정상적인 감정인 "울적함", 감정부전 장애(dysthymic disorder)를 거쳐 주요 우울 장애(major depressive disorder)로 발전한 상태를 의미한다. Among diseases caused by stress, depression refers to a psychological state of depressed mood characterized by feelings of sadness, hopelessness, and frustration. In other words, it refers to a condition that progresses from the normal emotions of “depression” and dysthymic disorder to major depressive disorder.
상기 우울증에 대한 주요 증상으로는 입맛, 체중 또는 수면 패턴의 변화, 정신운동 초조 또는 지체(psychomotor agitation or retardation), 사고 능력, 집중력 또는 결정능력의 감소, 활력의 부족 및 피로감, 무가치함의 감정, 자책감 또는 죄책감, 빈번한 죽음 또는 자살 생각, 자살할 계획 또는 시도 중 일부와 조합된, 일상적인 기분의 침체 또는 대부분의 활동에서의 흥미 또는 즐거움의 상실을 나타내는 기간인, 주요 우울 에피소드(major depressive episode)를 특징으로 한다.The main symptoms of depression include changes in appetite, weight, or sleep patterns, psychomotor agitation or retardation, decreased thinking ability, concentration, or decision-making ability, lack of energy and fatigue, feelings of worthlessness, and self-blame. or a major depressive episode, a period of low mood or loss of interest or pleasure in most activities, combined with feelings of guilt, frequent thoughts of death or suicide, or some of the following plans or attempts to commit suicide. It is characterized by
뇌유도 신경인자 영양인자(BDNF)는 신경성장촉진인자 중의 하나인 작은 이합체 단백질(dimeric protein)이며, 성장한 포유동물의 뇌에서 광범위하게 발현된다. BDNF는 신경계통의 유지와 발달에 관여하며, 특히 신경전달물질의 조절이나 신경가소성에 중요한 역할을 하는 것으로 알려져 있다. 따라서 BDNF와 신경학적 질환 또는 정신과적 질환과의 연관성이 여러 연구자들에 의해서 연구되어졌으며, 최근의 여러 연구에서 BDNF의 유전적 다형성이 정신분열병, 양국성 장애, 우울증, 강박장애와 관련이 있음이 보고되었다.Brain-derived neurotrophic factor (BDNF) is a small dimeric protein that is one of the nerve growth promoting factors, and is widely expressed in the brain of grown mammals. BDNF is involved in the maintenance and development of the nervous system, and is known to play an important role in the regulation of neurotransmitters and neuroplasticity. Therefore, the association between BDNF and neurological or psychiatric diseases has been studied by several researchers, and several recent studies have shown that BDNF genetic polymorphisms are associated with schizophrenia, biphasic disorder, depression, and obsessive-compulsive disorder. It has been reported.
특히, 동물모델에서 만성적인 스트레스가 해마(hippocampus)의 손상 및 위축을 유발한다는 사실이 보고되었고, 해마에서의 손상이 BDNF의 발현감소와 관련이 있다는 결과가 보고되어 우울증의 병태생리적 기전에 미치는 BDNF의 역할에 대한 여러 연구결과들이 보고되었다. Karege 등(2002)은 주요우울증 환자 군에서 정상 대조군에 비해 BDNF 농도가 낮은 것을 발견하였다.In particular, it has been reported that chronic stress causes damage and atrophy of the hippocampus in animal models, and that damage to the hippocampus is related to decreased expression of BDNF, suggesting that BDNF influences the pathophysiological mechanism of depression. Several research results have been reported on the role of . Karege et al. (2002) found that BDNF concentration was lower in the major depression patient group compared to the normal control group.
국민건강보험공단이 최근 발표한 우울증 진료 통계를 보면 2007년에 비해 2011년의 우울증 환자가 12.4% 증가했고, 2009~2010년 자살원인 유형별 현황을 살펴보면 정신적, 정신과적 문제로 인한 자살이 자살원인 1위이며, 해당 원인으로 자살을 한 사람이 2009년에 4,132명(28.1%), 2010년엔 4,357명(29.5%)으로 증가하고 있는 추세를 보인다. 우울증뿐만 아니라 주의력 결핍/과잉행동 장애인 ADHD(Attention Deficit/Hyperactivity Disorder) 환자도 2007년 4만 8천명에서 2012년 5만 7천명으로 5년간 9천명이 증가하였고, 연 평균 4.4%의 증가율을 보이고 있다. According to depression treatment statistics recently announced by the National Health Insurance Corporation, the number of patients with depression increased by 12.4% in 2011 compared to 2007, and looking at the current status by type of suicide cause from 2009 to 2010, suicide due to mental and psychiatric problems is the 1st cause of suicide. As shown above, the number of people who committed suicide for this reason shows an increasing trend, reaching 4,132 people (28.1%) in 2009 and 4,357 people (29.5%) in 2010. In addition to depression, the number of patients with ADHD (Attention Deficit/Hyperactivity Disorder) also increased by 9,000 over 5 years from 48,000 in 2007 to 57,000 in 2012, showing an average annual increase rate of 4.4%. .
따라서, 스트레스로 인한 우울증을 신속하게 개선, 예방 또는 치료할 수 있으며, 안전하고 부작용이 없는 천연물로부터의 추출물이 요구되고 있다.Therefore, there is a need for extracts from natural products that can quickly improve, prevent, or treat depression caused by stress, and are safe and have no side effects.
본 발명의 목적은 비파나무 열매 추출물을 유효성분으로 함유하여 우울증을 개선 또는 예방할 수 있는 식품 조성물을 제공하는데 있다.The purpose of the present invention is to provide a food composition that can improve or prevent depression by containing loquat tree fruit extract as an active ingredient.
또한, 본 발명의 다른 목적은 비파나무 열매 추출물을 유효성분으로 함유하여 우울증을 예방 또는 치료할 수 있는 약학 조성물을 제공하는데 있다.In addition, another object of the present invention is to provide a pharmaceutical composition that can prevent or treat depression by containing loquat tree fruit extract as an active ingredient.
상기한 목적을 달성하기 위한 본 발명의 우울증의 개선 또는 예방용 식품 조성물은 비파나무 열매 추출물을 유효성분으로 함유할 수 있다.The food composition for improving or preventing depression of the present invention to achieve the above object may contain loquat tree fruit extract as an active ingredient.
상기 우울증의 개선 또는 예방용 식품 조성물은 스트레스로 인한 우울증의 개선 또는 예방용 식품 조성물일 수 있다.The food composition for improving or preventing depression may be a food composition for improving or preventing depression caused by stress.
상기 비파나무 열매 추출물은 물, 탄소수 1 내지 4의 저급알코올, 에틸렌글리콜, 에틸에테르 또는 이들의 혼합용매로 추출된 것일 수 있다.The loquat fruit extract may be extracted with water, lower alcohol having 1 to 4 carbon atoms, ethylene glycol, ethyl ether, or a mixed solvent thereof.
상기 탄소수 1 내지 4의 저급알코올은 20 내지 80%의 메탄올, 에탄올, 부탄올 또는 프로판올일 수 있다.The lower alcohol having 1 to 4 carbon atoms may be 20 to 80% methanol, ethanol, butanol, or propanol.
상기 식품 조성물을 섭취 후 자당 섭취량이 70 내지 85%일 수 있다.After consuming the food composition, sucrose intake may be 70 to 85%.
상기 식품 조성물을 섭취 후 강제수영 시 부동 시간(immobility time)은 50 내지 80초일 수 있다.The immobility time during forced swimming after ingesting the food composition may be 50 to 80 seconds.
상기 식품 조성물을 섭취 후 꼬리현수법으로 측정 시 부동 시간(immobility time)이 70 내지 100초일 수 있다.When measured using the tail suspension method after ingesting the food composition, the immobility time may be 70 to 100 seconds.
상기 식품 조성물을 섭취 후 로타로드(rotarod)에 머무는 시간은 110 내지 150초일 수 있다.The time spent on the rotarod after ingesting the food composition may be 110 to 150 seconds.
또한, 상기한 다른 목적을 달성하기 위한 본 발명의 스트레스로 인한 우울증의 예방 또는 치료용 약학 조성물은 비파나무 열매 추출물을 유효성분으로 함유할 수 있다.In addition, the pharmaceutical composition for preventing or treating depression caused by stress of the present invention to achieve the above-mentioned other purposes may contain loquat tree fruit extract as an active ingredient.
본 발명의 비파나무 열매 추출물을 유효성분으로 함유하는 우울증의 개선, 예방 또는 치료용 조성물은 독성이 없으며, 스트레스로 인한 우울증에 대한 개선, 예방 또는 치료 효과가 매우 뛰어나 경쟁력 있는 식품 조성물 및 의약 조성물의 제조에 효과적이다.The composition for improving, preventing or treating depression containing the loquat fruit extract of the present invention as an active ingredient is non-toxic and has an excellent effect on improving, preventing or treating depression caused by stress, making it a competitive food composition and pharmaceutical composition. Effective in manufacturing.
도 1은 정상군, 대조군, IMI군, 실시예 1군 및 비교예 1군의 자당 선호도를 나타낸 그래프이다.
도 2는 정상군, 대조군, IMI군, 실시예 1군 및 비교예 1군의 FST 부동 시간을 나타낸 그래프이다.
도 3은 정상군, 대조군, IMI군, 실시예 1군 및 비교예 1군의 TST 부동 시간을 나타낸 그래프이다.
도 4는 정상군, 대조군, IMI군, 실시예 1군 및 비교예 1군이 로타로드 레일에 머무는 시간을 측정한 그래프이다. Figure 1 is a graph showing sucrose preference in the normal group, control group, IMI group, Example 1 group, and Comparative Example 1 group.
Figure 2 is a graph showing the FST immobility time of the normal group, control group, IMI group, Example 1 group, and Comparative Example 1 group.
Figure 3 is a graph showing the TST immobility time of the normal group, control group, IMI group, Example 1 group, and Comparative Example 1 group.
Figure 4 is a graph measuring the time the normal group, control group, IMI group, Example 1 group, and Comparative Example 1 group stayed on the rotarod rail.
본 발명은 비파나무 열매 추출물을 유효성분으로 함유하여 스트레스로 인한 우울증을 개선, 예방 또는 치료할 수 있는 조성물에 관한 것이다.The present invention relates to a composition that can improve, prevent, or treat depression caused by stress by containing loquat tree fruit extract as an active ingredient.
이하, 본 발명을 상세하게 설명한다. Hereinafter, the present invention will be described in detail.
본 발명의 스트레스로 인한 우울증을 개선, 예방 또는 치료할 수 있는 조성물은 비파나무 열매 추출물을 유효성분으로 함유한다.The composition of the present invention that can improve, prevent, or treat depression caused by stress contains loquat tree fruit extract as an active ingredient.
상기 비파나무(Eriobotrya japonica)는 장미과의 상록 교목으로서, 잎은 비파엽이라하여 청폐, 진해, 거담, 이뇨 등 작용으로 민간요법으로 사용되어 왔으며, 열매는 식용이 가능하다. 비파나무 열매 또는 잎 추출물은 다양한 in vivo 및 in vitro 실험을 통해 항산화, 항염증, 항암, 항바이러스 등 다양한 생리활성이 보고되었으며, 특히 잎 추출물은 아미로이드 베타(Aβ) 로 인지기능이 저하된 마우스의 행동을 유의적으로 개선시켰음이 보고되었다.The loquat tree ( Eriobotrya japonica ) is an evergreen tree of the Rosaceae family. The leaves are called loquat leaves and have been used as folk remedies for their purifying, antitussive, expectorant, and diuretic effects, and the fruits are edible. Loquat fruit or leaf extracts have been reported to have various physiological activities such as antioxidant, anti-inflammatory, anticancer, and antiviral through various in vivo and in vitro experiments. In particular, the leaf extract contains amyloid beta (A β ), which is effective in reducing cognitive function. It was reported that the mouse's behavior was significantly improved.
상기 비파나무 열매는 추출용매와 1 : 5 내지 25의 중량비, 바람직하게는 1 : 8 내지 15의 중량비로 혼합하여 80 내지 110 ℃에서 5 내지 15시간, 바람직하게는 7 내지 10시간 동안 추출한 후 50 내지 60 ℃에서 감압농축을 수행하여 추출물을 제조한다. 상기 비파나무 열매와 추출용매의 중량비가 상기 범위를 벗어나는 경우에는 추출물에 비파나무 열매의 유효성분이 적은 양으로 추출될 수 있다.The loquat fruit is mixed with the extraction solvent at a weight ratio of 1:5 to 25, preferably 1:8 to 15, extracted at 80 to 110 ° C. for 5 to 15 hours, preferably 7 to 10 hours, and then extracted for 50 hours. The extract is prepared by performing reduced pressure concentration at 60°C. If the weight ratio of the loquat tree fruit and the extraction solvent is outside the above range, the active ingredient of the loquat tree fruit may be extracted in a small amount in the extract.
추출온도가 상기 하한치 미만인 경우에는 비파나무 열매의 유효성분이 적은 양으로 추출될 수 있으며, 상기 상한치 초과인 경우에는 독성물질이 발생할 수 있다.If the extraction temperature is below the above lower limit, the active ingredients of the loquat tree fruit may be extracted in a small amount, and if the extraction temperature is above the above upper limit, toxic substances may be generated.
상기 각 추출물을 추출하는 추출용매는 물, 탄소수 1 내지 4의 저급알코올, 에틸렌글리콜, 에틸에테르 또는 이들의 혼합용매이다. 상기 저급알코올로는 20 내지 80%의 메탄올, 에탄올, 부탄올 또는 프로판올을 들 수 있다.The extraction solvent for extracting each of the above extracts is water, lower alcohol having 1 to 4 carbon atoms, ethylene glycol, ethyl ether, or a mixed solvent thereof. The lower alcohol may include 20 to 80% methanol, ethanol, butanol, or propanol.
상기 추출용매로는 특별히 한정하는 것은 아니지만 20 내지 80%의 에탄올 수용액으로 추출된 추출물이 스트레스로 인한 우울증의 개선, 예방 또는 치료에 바람직하게 작용한다. The extraction solvent is not particularly limited, but extracts extracted with a 20 to 80% aqueous ethanol solution are preferred for improving, preventing or treating depression caused by stress.
본 발명의 비파나무 열매 추출물을 섭취하면 자당 섭취량이 70 내지 85%, 바람직하게는 72 내지 78%로 증가하여 스트레스 또는 우울증의 개선, 예방 또는 치료에 바람직하게 작용하는 것을 확인하였다.It was confirmed that when the loquat tree fruit extract of the present invention is ingested, sucrose intake increases to 70 to 85%, preferably 72 to 78%, thereby acting preferably in improving, preventing or treating stress or depression.
또한, 본 발명의 비파나무 열매 추출물을 섭취하면 강제수영 시 부동 시간(immobility time)은 50 내지 80초, 바람직하게는 60 내지 75초로 짧으며, 꼬리현수법으로 측정 시 부동 시간(immobility time)이 70 내지 100초, 바람직하게는 75 내지 95초로 짧고, 로타로드(rotarod)에 머무는 시간이 110 내지 150초, 바람직하게는 120 내지 140초로 길므로 스트레스로 인한 우울증의 개선, 예방 또는 치료에 바람직하게 작용하는 것을 확인하였다.In addition, when the loquat fruit extract of the present invention is ingested, the immobility time during forced swimming is shortened to 50 to 80 seconds, preferably 60 to 75 seconds, and the immobility time when measured by the tail suspension method is shortened to 50 to 80 seconds, preferably 60 to 75 seconds. It is short, 70 to 100 seconds, preferably 75 to 95 seconds, and the time spent on the rotarod is long, 110 to 150 seconds, preferably 120 to 140 seconds, so it is preferable for improving, preventing or treating depression caused by stress. It was confirmed that it worked.
본 명세서에서 비파나무 열매를 언급하면서 사용되는 용어 ‘추출물’은 추출용매를 처리하여 얻은 조추출물뿐만 아니라 비파나무 열매 추출물의 가공물도 포함한다. 예를 들어, 비파나무 열매 추출물은 감압 증류 및 동결 건조 또는 분무 건조 등과 같은 추가적인 과정에 의해 분말 상태로 제조될 수 있다.The term ‘extract’ used in this specification when referring to loquat tree fruit includes not only the crude extract obtained by treatment with an extraction solvent, but also processed products of the loquat tree fruit extract. For example, loquat fruit extract can be prepared in powder form by additional processes such as reduced pressure distillation and freeze-drying or spray-drying.
또한, 본 발명의 비파나무 열매 추출물은 광의로는 비파나무 열매를 동물에게 투여할 수 있도록 제형화된 비파나무 열매 가공물, 예컨대, 비파나무 열매 분말도 포함하는 의미를 갖는다. 비록 본 발명에서 비파나무 열매로 실험을 진행하긴 하였으나, 비파나무 열매 가공물과 같은 형태로도 목적하는 효과를 달성할 수 있음은 당업자라면 예상가능할 것이다.In addition, the loquat tree fruit extract of the present invention, in a broad sense, also includes loquat tree fruit processed products formulated so that the loquat tree fruit can be administered to animals, such as loquat tree fruit powder. Although experiments were conducted with loquat tree fruit in the present invention, those skilled in the art would be able to predict that the desired effect can be achieved even in the form of a loquat tree fruit processed product.
한편, 본 명세서에서 용어 ‘유효성분으로 함유하는’이란 비파나무 열매 추출물의 효능 또는 활성을 달성하는 데 충분한 양을 포함하는 것을 의미한다. 일예로, 상기 비파나무 열매 추출물은 10 내지 1500 ㎍/㎖, 바람직하게는 100 내지 1000 ㎍/㎖의 농도로 사용된다. 비파나무 열매 추출물은 천연물로서 과량 투여하여도 인체에 부작용이 없으므로 본 발명의 조성물 내에 포함되는 비파나무 열매 추출물의 양적 상한은 당업자가 적절한 범위 내에서 선택하여 실시할 수 있다.Meanwhile, in this specification, the term ‘containing as an active ingredient’ means containing a sufficient amount to achieve the efficacy or activity of the loquat tree fruit extract. For example, the loquat fruit extract is used at a concentration of 10 to 1500 μg/ml, preferably 100 to 1000 μg/ml. Since the loquat tree fruit extract is a natural product and has no side effects on the human body even when administered in excessive amounts, the upper quantitative limit of the loquat tree fruit extract contained in the composition of the present invention can be selected within an appropriate range by a person skilled in the art.
본 발명의 약제학적 조성물은 상기 유효 성분 이외에 약제학적으로 적합하고 생리학적으로 허용되는 보조제를 사용하여 제조될 수 있으며, 상기 보조제로는 부형제, 붕해제, 감미제, 결합제, 피복제, 팽창제, 윤활제, 활택제 또는 향미제 등을 사용할 수 있다.The pharmaceutical composition of the present invention can be prepared using pharmaceutically suitable and physiologically acceptable auxiliaries in addition to the active ingredients, and the auxiliaries include excipients, disintegrants, sweeteners, binders, coating agents, swelling agents, lubricants, Lubricants or flavoring agents can be used.
상기 약제학적 조성물은 투여를 위해서 상기 기재한 유효 성분 이외에 추가로 약제학적으로 허용 가능한 담체를 1종 이상 포함하여 약제학적 조성물로 바람직하게 제제화할 수 있다.For administration, the pharmaceutical composition may be preferably formulated as a pharmaceutical composition containing one or more pharmaceutically acceptable carriers in addition to the active ingredients described above.
상기 약제학적 조성물의 제제 형태는 과립제, 산제, 정제, 피복정, 캡슐제, 좌제, 액제, 시럽, 즙, 현탁제, 유제, 점적제 또는 주사 가능한 액제 등이 될 수 있다. 예를 들어, 정제 또는 캡슐제의 형태로의 제제화를 위해, 유효 성분은 에탄올, 글리세롤, 물 등과 같은 경구, 무독성의 약제학적으로 허용 가능한 불활성 담체와 결합될 수 있다. 또한, 원하거나 필요한 경우, 적합한 결합제, 윤활제, 붕해제 및 발색제 또한 혼합물로 포함될 수 있다. 적합한 결합제는 이에 제한되는 것은 아니나, 녹말, 젤라틴, 글루코스 또는 베타-락토오스와 같은 천연 당, 옥수수 감미제, 아카시아, 트래커캔스 또는 소듐올레이트와 같은 천연 및 합성 검, 소듐 스테아레이트, 마그네슘 스테아레이트, 소듐 벤조에이트, 소듐 아세테이트, 소듐 클로라이드 등을 포함한다. 붕해제는 이에 제한되는 것은 아니나, 녹말, 메틸 셀룰로스, 아가, 벤토니트, 잔탄 검 등을 포함한다.The pharmaceutical composition may be in the form of granules, powders, tablets, coated tablets, capsules, suppositories, solutions, syrups, juices, suspensions, emulsions, drops, or injectable solutions. For example, for formulation in the form of tablets or capsules, the active ingredient may be combined with an oral, non-toxic, pharmaceutically acceptable inert carrier such as ethanol, glycerol, water, etc. Additionally, if desired or necessary, suitable binders, lubricants, disintegrants and coloring agents may also be included in the mixture. Suitable binders include, but are not limited to, starch, gelatin, natural sugars such as glucose or beta-lactose, corn sweeteners, natural and synthetic gums such as acacia, tracacance or sodium oleate, sodium stearate, magnesium stearate, sodium Includes benzoate, sodium acetate, sodium chloride, etc. Disintegrants include, but are not limited to, starch, methyl cellulose, agar, bentonite, xanthan gum, etc.
액상 용액으로 제제화되는 조성물에 있어서 허용 가능한 약제학적 담체로는, 멸균 및 생체에 적합한 것으로서, 식염수, 멸균수, 링거액, 완충 식염수, 알부민 주사용액, 덱스트로즈 용액, 말토 덱스트린 용액, 글리세롤, 에탄올 및 이들 성분 중 1 성분 이상을 혼합하여 사용할 수 있으며, 필요에 따라 항산화제, 완충액, 정균제 등 다른 통상의 첨가제를 첨가할 수 있다. 또한 희석제, 분산제, 계면활성제, 결합제 및 윤활제를 부가적으로 첨가하여 수용액, 현탁액, 유탁액 등과 같은 주사용 제형, 환약, 캡슐, 과립 또는 정제로 제제화할 수 있다.Acceptable pharmaceutical carriers for compositions formulated as liquid solutions include those that are sterile and biocompatible, such as saline solution, sterile water, Ringer's solution, buffered saline solution, albumin injection solution, dextrose solution, maltodextrin solution, glycerol, ethanol, and One or more of these ingredients can be mixed and used, and other common additives such as antioxidants, buffers, and bacteriostatic agents can be added as needed. In addition, diluents, dispersants, surfactants, binders, and lubricants can be additionally added to formulate injectable formulations such as aqueous solutions, suspensions, emulsions, etc., pills, capsules, granules, or tablets.
더 나아가 해당분야의 적절한 방법으로 Remington's Pharmaceutical Science, Mack Publishing Company, Easton PA에 개시되어 있는 방법을 이용하여 각 질환에 따라 또는 성분에 따라 바람직하게 제제화할 수 있다.Furthermore, it can be preferably formulated according to each disease or ingredient using a method disclosed by Remington's Pharmaceutical Science, Mack Publishing Company, Easton PA, as an appropriate method in the field.
본 발명의 약제학적 조성물은 경구 또는 비경구로 투여할 수 있고, 비경구 투여인 경우에는 정맥내 주입, 피하 주입, 근육 주입, 복강 주입, 경피 투여 등으로 투여할 수 있으며, 바람직하게는 경구 투여이다.The pharmaceutical composition of the present invention can be administered orally or parenterally, and in the case of parenteral administration, it can be administered by intravenous injection, subcutaneous injection, intramuscular injection, intraperitoneal injection, transdermal administration, etc., and is preferably administered orally. .
본 발명의 약제학적 조성물의 적합한 투여량은 제제화 방법, 투여 방식, 환자의 연령, 체중, 성, 병적 상태, 음식, 투여 시간, 투여 경로, 배설 속도 및 반응 감응성과 같은 요인들에 의해 다양하며, 보통으로 숙련된 의사는 소망하는 치료 또는 예방에 효과적인 투여량을 용이하게 결정 및 처방할 수 있다. 본 발명의 바람직한 구현예에 따르면, 본 발명의 약제학적 조성물의 1일 투여량은 0.001-10 g/㎏이다.The appropriate dosage of the pharmaceutical composition of the present invention varies depending on factors such as formulation method, administration method, patient's age, weight, sex, pathological condition, food, administration time, administration route, excretion rate, and reaction sensitivity. Usually, a skilled physician can easily determine and prescribe an effective dosage for the desired treatment or prevention. According to a preferred embodiment of the present invention, the daily dosage of the pharmaceutical composition of the present invention is 0.001-10 g/kg.
본 발명의 약제학적 조성물은 약제학적으로 허용되는 담체 및/또는 부형제를 이용하여 제제화함으로써 단위 용량 형태로 제조되거나 또는 다용량 용기 내에 내입시켜 제조될 수 있다. 이때 제형은 오일 또는 수성 매질중의 용액, 현탁액 또는 유화액 형태이거나 엑스제, 분말제, 과립제, 정제 또는 캅셀제 형태일 수도 있으며, 분산제 또는 안정화제를 추가적으로 포함할 수 있다.The pharmaceutical composition of the present invention can be prepared in unit dosage form by formulation using a pharmaceutically acceptable carrier and/or excipient, or can be prepared by placing it in a multi-dose container. At this time, the formulation may be in the form of a solution, suspension, or emulsion in an oil or aqueous medium, or may be in the form of an extract, powder, granule, tablet, or capsule, and may additionally contain a dispersant or stabilizer.
또한, 본 발명은 비파나무 열매 추출물을 유효성분으로 함유하는 스트레스로 인한 우울증의 개선, 예방 또는 치료용 식품 조성물을 제공한다.In addition, the present invention provides a food composition for improving, preventing, or treating depression caused by stress, containing loquat tree fruit extract as an active ingredient.
본 발명에 따른 식품 조성물은 상기 약제학적 조성물과 동일한 방식으로 제제화되어 기능성 식품으로 이용하거나, 각종 식품에 첨가할 수 있다. 본 발명의 조성물을 첨가할 수 있는 식품으로는 예를 들어, 음료류, 알코올 음료류, 과자류, 다이어트바, 유제품, 육류, 초코렛, 피자, 라면, 기타 면류, 껌류, 아이스크림류, 비타민 복합제, 건강보조식품류 등이 있다.The food composition according to the present invention can be formulated in the same way as the pharmaceutical composition and used as a functional food or added to various foods. Foods to which the composition of the present invention can be added include, for example, beverages, alcoholic beverages, confectionery, diet bars, dairy products, meat, chocolate, pizza, ramen, other noodles, gum, ice cream, vitamin complexes, and health supplements. etc.
본 발명의 식품 조성물은 유효성분으로서 비파나무 열매 추출물뿐만 아니라, 식품 제조 시에 통상적으로 첨가되는 성분을 포함할 수 있으며, 예를 들어, 단백질, 탄수화물, 지방, 영양소, 조미제 및 향미제를 포함한다. 상술한 탄수화물의 예는 모노사카라이드, 예를 들어, 포도당, 과당 등; 디사카라이드, 예를 들어 말토스, 슈크로스, 올리고당 등; 및 폴리사카라이드, 예를 들어 덱스트린, 사이클로덱스트린 등과 같은 통상적인 당 및 자일리톨, 소르비톨, 에리트리톨 등의 당알콜이다. 향미제로서 천연 향미제 [타우마틴, 스테비아 추출물 (예를 들어 레바우디오시드 A, 글리시르히진 등]) 및 합성 향미제(사카린, 아스파르탐 등)를 사용할 수 있다. 예컨대, 본 발명의 식품 조성물이 드링크제와 음료류로 제조되는 경우에는 본 발명의 비파나무 열매 추출물 이외에 구연산, 액상과당, 설탕, 포도당, 초산, 사과산, 과즙, 및 각종 식물 추출액 등을 추가로 포함시킬 수 있다.The food composition of the present invention may contain not only loquat tree fruit extract as an active ingredient, but also ingredients commonly added during food production, including, for example, proteins, carbohydrates, fats, nutrients, seasonings, and flavoring agents. do. Examples of the above-mentioned carbohydrates include monosaccharides such as glucose, fructose, etc.; Disaccharides such as maltose, sucrose, oligosaccharides, etc.; and polysaccharides, such as common sugars such as dextrin and cyclodextrin, and sugar alcohols such as xylitol, sorbitol, and erythritol. As flavoring agents, natural flavoring agents (thaumatin, stevia extract (e.g., rebaudioside A, glycyrrhizin, etc.)) and synthetic flavoring agents (saccharin, aspartame, etc.) can be used. For example, when the food composition of the present invention is manufactured as a drink or beverage, in addition to the loquat tree fruit extract of the present invention, citric acid, high fructose corn syrup, sugar, glucose, acetic acid, malic acid, fruit juice, and various plant extracts may be additionally included. there is.
본 발명은 상기 비파나무 열매 추출물을 유효성분으로 포함하는 스트레스로 인한 우울증의 개선, 예방 또는 치료용 식품 조성물을 포함하는 건강기능식품을 제공한다. 건강기능식품이란, 비파나무 열매 추출물을 음료, 차류, 향신료, 껌, 과자류 등의 식품소재에 첨가하거나, 캡슐화, 분말화, 현탁액 등으로 제조한 식품으로, 이를 섭취할 경우 건강상 특정한 효과를 가져오는 것을 의미하나, 일반 약품과는 달리 식품을 원료로 하여 약품의 장기 복용시 발생할 수 있는 부작용 등이 없는 장점이 있다. 이와 같이 하여 얻어지는 본 발명의 건강기능식품은, 일상적으로 섭취하는 것이 가능하기 때문에 매우 유용하다. 이와 같은 건강기능식품에 있어서의 비파나무 열매 추출물의 첨가량은, 대상인 건강기능식품의 종류에 따라 달라 일률적으로 규정할 수 없지만, 식품 본래의 맛을 손상시키지 않는 범위에서 첨가하면 되며, 대상 식품에 대하여 통상 0.01 내지 50 중량%, 바람직하기로는 0.1 내지 20 중량%의 범위이다. 또한, 환제, 과립제, 정제 또는 캡슐제 형태의 건강기능식품의 경우에는 통상 0.1 내지 100 중량% 바람직하기로는 0.5 내지 80 중량%의 범위에서 첨가하면 된다. 한 구체예에서, 본 발명의 건강기능식품은 환제, 정제, 캡슐제 또는 음료의 형태일 수 있다.The present invention provides a health functional food containing a food composition for improving, preventing, or treating depression caused by stress, containing the loquat tree fruit extract as an active ingredient. Health functional foods are foods manufactured by adding loquat fruit extract to food ingredients such as beverages, teas, spices, gums, and confectionery, or by encapsulating, powdering, or suspending them, and have specific health effects when consumed. However, unlike regular drugs, it has the advantage of not having any side effects that may occur when taking the drug for a long time since it is made from food. The health functional food of the present invention obtained in this way is very useful because it can be consumed on a daily basis. The amount of loquat fruit extract added in such health functional foods cannot be uniformly specified as it depends on the type of health functional food being targeted, but it can be added within the range that does not damage the original taste of the food. It is usually in the range of 0.01 to 50% by weight, preferably 0.1 to 20% by weight. In addition, in the case of health functional foods in the form of pills, granules, tablets, or capsules, it is usually added in the range of 0.1 to 100% by weight, preferably 0.5 to 80% by weight. In one embodiment, the health functional food of the present invention may be in the form of a pill, tablet, capsule, or beverage.
또한, 본 발명은 스트레스로 인한 우울증의 개선, 예방 또는 치료용 의약 또는 식품의 제조를 위한 비파나무 열매 추출물의 용도를 제공한다. 상기한 바와 같이 비파나무 열매 추출물은 스트레스로 인한 우울증의 개선, 예방 또는 치료를 위한 용도로 이용될 수 있다.In addition, the present invention provides the use of loquat fruit extract for the production of medicine or food for improving, preventing, or treating depression caused by stress. As mentioned above, loquat fruit extract can be used to improve, prevent, or treat depression caused by stress.
또한, 본 발명은 포유동물에게 유효량의 비파나무 열매 추출물을 투여하는 것을 포함하는 스트레스로 인한 우울증의 개선, 예방 또는 치료 방법을 제공한다.Additionally, the present invention provides a method for improving, preventing, or treating depression caused by stress, comprising administering an effective amount of loquat fruit extract to a mammal.
여기에서 사용된 용어 "포유동물"은 치료, 관찰 또는 실험의 대상인 포유동물을 말하며, 바람직하게는 인간을 말한다.As used herein, the term “mammal” refers to a mammal, preferably a human, that is the subject of treatment, observation or experiment.
여기에서 사용된 용어 "유효량"은 연구자, 수의사, 의사 또는 기타 임상의에 의해 생각되는 조직계, 동물 또는 인간에서 생물학적 또는 의학적 반응을 유도하는 유효 성분 또는 약학적 조성물의 양을 의미하는 것으로, 이는 해당 질환 또는 장애의 증상의 완화를 유도하는 양을 포함한다. 본 발명의 유효 성분에 대한 유효량 및 투여횟수는 원하는 효과에 따라 변화될 수 있다. 그러므로, 투여될 최적의 투여량은 당업자에 의해 쉽게 결정될 수 있으며, 질환의 종류, 질환의 중증도, 조성물에 함유된 유효성분 및 다른 성분의 함량, 제형의 종류, 및 환자의 연령, 체중, 일반 건강 상태, 성별 및 식이, 투여 시간, 투여 경로 및 조성물의 분비율, 치료기간, 동시 사용되는 약물을 비롯한 다양한 인자에 따라 조절될 수 있다. 본 발명의 예방, 치료 또는 개선 방법에 있어서, 성인의 경우, 목단피, 백복령, 택사 및 단삼의 혼합 추출물을 1일 1회 내지 수회 투여시, 0.001 g/kg 내지 10 g/kg의 용량으로 투여하는 것이 바람직하다.As used herein, the term “effective amount” means the amount of an active ingredient or pharmaceutical composition that is believed by a researcher, veterinarian, physician, or other clinician to induce a biological or medical response in a tissue system, animal, or human, which means that It includes amounts that induce relief of symptoms of a disease or disorder. The effective amount and frequency of administration of the active ingredient of the present invention may vary depending on the desired effect. Therefore, the optimal dosage to be administered can be easily determined by a person skilled in the art, and can be determined based on the type of disease, the severity of the disease, the content of the active ingredient and other ingredients contained in the composition, the type of dosage form, and the patient's age, weight, and general health. It can be adjusted according to various factors, including condition, gender and diet, administration time, administration route and secretion rate of the composition, treatment period, and concurrently used drugs. In the prevention, treatment or improvement method of the present invention, in adults, the mixed extract of Mokdanpi, Baekbokryeong, Taxa and Salvia Salvia is administered at a dose of 0.001 g/kg to 10 g/kg once or several times a day. It is desirable.
본 발명의 치료방법에서 비파나무 열매 추출물을 유효 성분으로 포함하는 조성물은 경구, 직장, 정맥내, 동맥내, 복강내, 근육내, 흉골내, 경피, 국소, 안구내 또는 피내 경로를 통해 통상적인 방식으로 투여할 수 있다.In the treatment method of the present invention, the composition containing the loquat tree fruit extract as an active ingredient is administered through conventional routes through oral, rectal, intravenous, intraarterial, intraperitoneal, intramuscular, intrasternal, transdermal, topical, intraocular or intradermal routes. It can be administered in any way.
이하, 본 발명의 이해를 돕기 위하여 바람직한 실시예를 제시하나, 하기 실시예는 본 발명을 예시하는 것일 뿐 본 발명의 범주 및 기술사상 범위 내에서 다양한 변경 및 수정이 가능함은 당업자에게 있어서 명백한 것이며, 이러한 변형 및 수정이 첨부된 특허청구범위에 속하는 것도 당연한 것이다.Hereinafter, preferred embodiments are presented to aid understanding of the present invention. However, the following examples are merely illustrative of the present invention, and it is clear to those skilled in the art that various changes and modifications are possible within the scope and spirit of the present invention. It is natural that such variations and modifications fall within the scope of the attached patent claims.
실시예 1. Example 1.
비파나무 열매(씨앗제거)와 70% 에탄올 수용액을 1 : 10의 중량비로 혼합하여 80 ℃에서 8시간 동안 환류추출하여 비파나무 열매 추출물을 수득하였다.Loquat fruit (seeds removed) and 70% ethanol aqueous solution were mixed at a weight ratio of 1:10 and extracted under reflux at 80°C for 8 hours to obtain loquat fruit extract.
비교예 1.Comparative Example 1.
비파나무 잎과 70% 에탄올 수용액을 1 : 10의 중량비로 혼합하여 80 ℃에서 8시간 동안 환류추출하여 비파나무 잎 추출물을 수득하였다.Loquat tree leaves and 70% ethanol aqueous solution were mixed at a weight ratio of 1:10 and extracted under reflux at 80°C for 8 hours to obtain loquat leaf extract.
<시험예><Test example>
실시예 및 비교예에서 제조된 추출액을 여과한 후 여액을 60 ℃ 이하에서 감압농축하여 이용하였다.Prepared in Examples and Comparative Examples After filtering the extract, the filtrate was concentrated under reduced pressure below 60°C and used.
동물실험animal testing
20~25 g의 ICR 마우스(5주령, 코아텍, 한국, 숫컷)를 실험에 사용하였다. 아크릴 케이지(45 X 60 X 25 cm)에서 사육되었으며, 충분한 사료와 물이 공급되며 적절한 인공조도로 12시간의 낮, 밤을 조절하였다(am 8:00부터 낮). 그리고 일정한 온도(20~24 ℃) 및 습도(45~65%)를 유지시켜 주었다. 바뀐 환경에 적응하도록 일주일간 살펴보며 수면주기를 유지하고, 이상행동을 확인하였다. ICR mice (5 weeks old, Coretech, Korea, male) weighing 20 to 25 g were used in the experiment. They were raised in acrylic cages (45 And constant temperature (20-24 ℃) and humidity (45-65%) were maintained. We monitored them for a week to help them adapt to the changed environment, maintained their sleep cycle, and checked for abnormal behavior.
동물의 프로토콜은 한국식품연구원의 기관 동물 관리 및 사용위원회(IACUC)에 의해 승인되었다. The animal protocol was approved by the Institutional Animal Care and Use Committee (IACUC) of the Korea Food Research Institute.
실험동물은 체중변화가 일정하고 건강한 동물만을 선별하여 임의 배치법에 의해 생리식염수를 투여한 정상군, 스트레스 호르몬인 코르티코스테론(corticosterone, CORT)을 투여한 대조군, 코르티코스테론(corticosterone, CORT)을 투여한 후 기존 항우울제인 imipramine을 투여한 군, 코르티코스테론(corticosterone, CORT)을 투여한 후 실시예 1의 추출물을 투여한 시료 투여군 및 코르티코스테론(corticosterone, CORT)을 투여한 후 비교예 1의 추출물을 투여한 시료 투여군으로 나누었으며 실험군마다 5마리씩 사용하였다. The experimental animals were selected only from healthy animals with consistent body weight changes, and were randomly assigned to a normal group administered saline solution, a control group administered the stress hormone corticosterone (CORT), and a control group administered corticosterone (CORT). After administration, a group administered imipramine, a conventional antidepressant, a sample group administered the extract of Example 1 after administration of corticosterone (CORT), and Comparative Example 1 after administration of corticosterone (CORT) The samples were divided into groups administered the extract, and 5 animals were used in each experimental group.
동물 모델을 이용한 실험은 총 21일 동안 매일 40 mg/kg의 농도의 스트레스 호르몬(corticosteron, CORT)을 피하주사하였다. 과도한 스트레스 호르몬(corticosteron, CORT)의 투여는 HPA-axis dysfunction을 유도시켜 우울증과 유사한 행동 증상을 나타나게 한다. 이러한 ‘CORT-induced depressive-like behavior model’은 기능성 소재의 우울증 개선 효능을 평가하기 위해 주로 사용되어지는 실험동물모델이다.In an experiment using an animal model, stress hormone (corticosteron, CORT) was injected subcutaneously at a concentration of 40 mg/kg every day for a total of 21 days. Excessive administration of stress hormones (corticosteron, CORT) induces HPA-axis dysfunction, resulting in behavioral symptoms similar to depression. This ‘CORT-induced depressive-like behavior model’ is an experimental animal model mainly used to evaluate the efficacy of functional materials in improving depression.
-5개 군의 마우스--5 groups of mice-
정상군: 생리식염수 투여 5마리Normal group: 5 animals administered saline solution
대조군: 스트레스 호르몬(corticosteron, CORT) 투여 5마리Control group: 5 rats administered stress hormone (corticosteron, CORT)
IMI군(양성대조군): 스트레스 호르몬(corticosteron, CORT) 투여 후 기존 항우울제인 imipramine 30 mg/kg 경구투여IMI group (positive control group): After stress hormone (corticosteron, CORT) administration, imipramine, a conventional antidepressant, was administered orally at 30 mg/kg.
실시예 1군: 스트레스 호르몬(corticosteron, CORT) 투여 후 실시예 1의 추출물 300 mg/kg 경구투여Example Group 1: Oral administration of 300 mg/kg of the extract of Example 1 after administration of stress hormone (corticosteron, CORT)
비교예 1군: 스트레스 호르몬(corticosteron, CORT) 투여 후 비교예 1의 추출물 300 mg/kg 경구투여Comparative Example Group 1: Oral administration of 300 mg/kg of extract of Comparative Example 1 after administration of stress hormone (corticosteron, CORT)
시험예 1. 자당 선호도(sucrose preference test) 측정Test Example 1. Measurement of sucrose preference test
자당 섭취량은 스트레스 또는 우울증 증상 중 하나인 무쾌감(anhedonia) 반응에 대한 대표적인 지표로서, 우울증 유사 행동을 나타내는 마우스의 경우에는 자당 선호도가 유의적으로 낮아지게 된다.Sucrose intake is a representative indicator of anhedonia response, which is one of the symptoms of stress or depression, and in mice showing depression-like behavior, sucrose preference is significantly lower.
도 1은 정상군, 대조군, IMI군, 실시예 1군 및 비교예 1군의 자당 선호도를 나타낸 그래프이다.Figure 1 is a graph showing sucrose preference in the normal group, control group, IMI group, Example 1 group, and Comparative Example 1 group.
도 1에 도시된 바와 같이, 실시예 1군은 대조군 및 비교예 1군에 비하여 자당 선호도가 유의적으로 증가한 것을 확인하였으며, 이는 항우울제를 투여한 IMI군과 유사한 것을 확인하였다.As shown in Figure 1, it was confirmed that the preference for sucrose in Example 1 group was significantly increased compared to the control group and Comparative Example 1 group, and this was confirmed to be similar to the IMI group administered an antidepressant.
반면, 비교예 1군은 대조군보다도 낮은 자당 선호도를 보이는 것을 확인하였다. On the other hand, it was confirmed that Comparative Example Group 1 showed a lower preference for sucrose than the control group.
시험예 2. 부동 시간(immobility time) 측정Test Example 2. Immobility time measurement
강제 수영 실험을 통해 긴급 상황에서의 회피 능력에 대한 항우울 실험을 행동 약리학적 관점에서 수행하였다. An antidepressant experiment on avoidance ability in emergency situations was conducted from a behavioral pharmacology perspective through a forced swimming experiment.
강제 수영 행동 실험(forced swim test, FST)을 측정하기 위해 높이 30 cm 이상의 투명 비이커에 15 cm만큼 물(온도 23-25 ℃)로 채우고 마우스를 입수시켜 6분 동안 강제 수영을 시켰다. 입수시켜 6분 동안 디지털 비디오파일로 녹화하여 행동분석 프로그램(SMART v3.0, Panlab SL, Barcelona, Spain)을 사용하여 부동 및 수영 시간을 분석하였다. 각각의 결과는 처음 2분간을 제외한 나머지 4분 동안을 기준으로 마우스가 수면위에 움직임 없이 가만히 있는 부동 시간(immobility time)과 움직이는 시간(swimming time)을 각각 분석하였다.To measure the forced swim test (FST), a transparent beaker over 30 cm high was filled with 15 cm of water (temperature 23-25°C), mice were brought in, and forced to swim for 6 minutes. They were captured and recorded as digital video files for 6 minutes, and immobility and swimming times were analyzed using a behavior analysis program (SMART v3.0, Panlab SL, Barcelona, Spain). Each result was analyzed based on the immobility time and swimming time when the mouse remained motionless on the water for the remaining 4 minutes excluding the first 2 minutes.
도 2는 정상군, 대조군, IMI군, 실시예 1군 및 비교예 1군의 FST 부동 시간을 나타낸 그래프이다.Figure 2 is a graph showing the FST immobility time of the normal group, control group, IMI group, Example 1 group, and Comparative Example 1 group.
도 2에 도시된 바와 같이, 실시예 1군은 대조군 및 비교예 1군에 비하여 움직임 없이 가만히 있는 시간(immobility time)이 유의적으로 감소하고 움직이는 시간(swimming time)이 증가한 것을 확인하였으며, 이는 정상군과 유사하며 IMI군에 비해서도 유의적으로 감소한 것이다.As shown in Figure 2, it was confirmed that Example 1 group had a significant decrease in immobility time and an increase in swimming time compared to the control group and Comparative Example 1 group, which is normal. group and significantly decreased compared to the IMI group.
이에 따라, 비파나무 잎 추출물에 비하여 비파나무 열매 추출물(실시예 1)이 항우울에 더욱 효능이 있다는 것을 확인하였다.Accordingly, it was confirmed that the loquat tree fruit extract (Example 1) was more effective in antidepressant treatment than the loquat tree leaf extract.
시험예 3. TST 부동시간(TST immobility time) 측정_꼬리현수법Test Example 3. TST immobility time measurement_tail suspension method
스트레스 유도 후 Tail suspension test (Bioseb) 장비를 사용하여 안정화된 쥐 꼬리 끝에 테이프를 붙여 벽에 거꾸로 메달아 놓았다. 총 7분간 움직임을 관찰하였으며, 움직이지 않고 부동 상태인 시간을 측정하여 스트레스 등의 정도를 측정하였다. After inducing stress, tape was attached to the end of the rat's tail, which was stabilized using a tail suspension test (Bioseb) device, and was hung upside down on the wall. Movement was observed for a total of 7 minutes, and the level of stress, etc., was measured by measuring the time the subject remained immobile.
마우스의 우울증 유사 행동이 나타나게 되면 TST 부동 시간이 유의적으로 증가한다.When mice develop depression-like behavior, TST immobility time significantly increases.
도 3은 정상군, 대조군, IMI군, 실시예 1군 및 비교예 1군의 TST 부동 시간을 나타낸 그래프이다.Figure 3 is a graph showing the TST immobility time of the normal group, control group, IMI group, Example 1 group, and Comparative Example 1 group.
도 3에 도시된 바와 같이, 실시예 1군은 대조군 및 비교예 1군에 비하여 움직임 없이 가만히 있는 시간(immobility time)이 유의적으로 감소하는 것을 확인하였다.As shown in Figure 3, it was confirmed that the immobility time of Example 1 group was significantly reduced compared to the control group and Comparative Example 1 group.
상기 실시예 1군은 IMI군과 유사한 우울증 완화 효능을 보이는 것으로 확인되었다.The Example 1 group was confirmed to have similar depression alleviating efficacy as the IMI group.
시험예 4. 로타로드(rotarod) 측정Test Example 4. Rotarod measurement
로타로드 실험(Rotarod test)을 이용하여 스트레스 호르몬(corticosteron, CORT) 투여를 통해 우울증 마우스 모델의 운동저하증(hypokinesia) 등의 행동장애를 측정하고, 실시예 1 추출물의 우울증 완화 효능을 측정하고자 하였다.Using the Rotarod test, we attempted to measure behavioral disorders such as hypokinesia in a mouse model of depression by administering stress hormones (corticosteron, CORT) and measure the depression-alleviating efficacy of the extract of Example 1.
구체적으로, 마우스를 마지막 CORT 주사 후 1 일째 로타로드로 감각 운동 조정을 평가하였다. 로타로드 장치(Ugo Basile, Comerio Varese, Italy)는 직경 3 cm의 회전 스핀들과 5 마리의 마우스를 동시에 테스트할 수 있는 5개의 개별 구획으로 구성하였다. 투여 종료 후 첫째 날은 4 rpm으로, 둘째 날은 20 rpm의 회전 속도로 트레이닝 시킨 후 셋째 날에 25 rpm에서 본 실험을 시행하였으며 이때 낙하 시간을 측정하였다. 연습은 회당 300초의 제한 시간을 두고 5분 간격으로 2회 시행하였고, 본 실험은 5분 간격으로 3회 실행하여 평균값을 사용하였다.Specifically, mice were assessed for sensorimotor coordination with a rotarod 1 day after the last CORT injection. The rotarod apparatus (Ugo Basile, Comerio Varese, Italy) consisted of a rotating spindle with a diameter of 3 cm and five individual compartments that allowed testing five mice simultaneously. After administration, the subjects were trained at a rotation speed of 4 rpm on the first day and 20 rpm on the second day. Then, on the third day, the experiment was performed at 25 rpm, and the falling time was measured. The practice was conducted twice at 5-minute intervals with a time limit of 300 seconds each, and the main experiment was conducted three times at 5-minute intervals and the average value was used.
도 4는 정상군, 대조군, IMI군, 실시예 1군 및 비교예 1군이 로타로드 레일에 머무는 시간을 측정한 그래프이다. Figure 4 is a graph measuring the time the normal group, control group, IMI group, Example 1 group, and Comparative Example 1 group stayed on the rotarod rail.
실험동물의 우울증 유사 행동이 나타나게 되면 마우스가 로타로드 레일에 머무는 시간의 유의적으로 감소하며, 이는 우울증 유사 행동에 따라 나타나는 운동능력저하를 의미한다.When an experimental animal exhibits depression-like behavior, the time the mouse stays on the rotarod rail is significantly reduced, which means a decrease in exercise capacity that occurs due to depression-like behavior.
도 4에 도시된 바와 같이, 실시예 1군은 대조군 및 비교예 1군에 비하여 로타로드 레일에 머무는 시간이 유의적으로 증가한 것을 확인하였으며, 이는 IMI군에 비해서도 유의적으로 증가한 것을 확인하였다.As shown in Figure 4, it was confirmed that the time spent on the rotarod rail in Example 1 group was significantly increased compared to the control group and Comparative Example 1 group, which was also confirmed to be significantly increased compared to the IMI group.
이는, 실시예 1의 추출물이 항우울에 효능이 있다는 것을 의미한다.This means that the extract of Example 1 has antidepressant efficacy.
하기에 본 발명의 분말을 함유하는 조성물의 제제예를 설명하나, 본 발명은 이를 한정하고자 함이 아닌 단지 구체적으로 설명하고자 함이다.Below, a formulation example of a composition containing the powder of the present invention is described, but the present invention is not intended to be limited, but merely explained in detail.
제제예 1. 산제의 제조Formulation Example 1. Preparation of powder
실시예 1에서 얻은 추출물 분말 500 mg500 mg of extract powder obtained in Example 1
유당 100 mg100 mg lactose
탈크 10 mgTalc 10 mg
상기의 성분들을 혼합하고 기밀포에 충진하여 산제를 제조한다.The above ingredients are mixed and filled into an airtight bubble to prepare a powder.
제제예 2. 정제의 제조Formulation Example 2. Preparation of tablets
실시예 1에서 얻은 추출물 분말 300 mg300 mg of extract powder obtained in Example 1
옥수수전분 100 mgCorn starch 100 mg
유당 100 mg100 mg lactose
스테아린산 마그네슘 2 mgMagnesium stearate 2 mg
상기의 성분들을 혼합한 후 통상의 정제의 제조방법에 따라서 타정하여 정제를 제조한다.After mixing the above ingredients, tablets are manufactured by compressing them according to a typical tablet manufacturing method.
제제예 3. 캅셀제의 제조Formulation Example 3. Preparation of capsules
실시예 1에서 얻은 추출물 분말 200 mg200 mg of extract powder obtained in Example 1
결정성 셀룰로오스 3 mg3 mg crystalline cellulose
락토오스 14.8 mgLactose 14.8 mg
마그네슘 스테아레이트 0.2 mgMagnesium stearate 0.2 mg
통상의 캡슐제 제조방법에 따라 상기의 성분을 혼합하고 젤라틴 캡슐에 충전하여 캡슐제를 제조한다.Capsules are prepared by mixing the above ingredients and filling them into gelatin capsules according to a typical capsule manufacturing method.
제제예 4. 주사제의 제조Formulation Example 4. Preparation of injection
실시예 1에서 얻은 추출물 분말 600 mg600 mg of extract powder obtained in Example 1
만니톨 180 mgMannitol 180 mg
주사용 멸균 증류수 2974 mgSterile distilled water for injection 2974 mg
Na2HPO4,12H2O 26 mgNa 2 HPO 4, 12H 2 O 26 mg
통상의 주사제의 제조방법에 따라 1 앰플 당 상기의 성분 함량으로 제조한다.It is prepared with the above ingredients per ampoule according to the usual manufacturing method for injections.
제제예 5. 액제의 제조Formulation Example 5. Preparation of liquid formulation
실시예 1에서 얻은 추출물 분말 4 g4 g of extract powder obtained in Example 1
이성화당 10 g10 g isomerized sugar
만니톨 5 g5 g mannitol
정제수 적량Proper amount of purified water
통상의 액제의 제조방법에 따라 정제수에 각각의 성분을 가하여 용해시키고 레몬향을 적량 가한 다음 상기의 성분을 혼합한 다음 정제수를 가하여 전체를 정제수를 가하여 전체 100g으로 조절한 후 갈색병에 충진하여 멸균시켜 액제를 제조한다.According to the usual liquid preparation method, add and dissolve each ingredient in purified water, add an appropriate amount of lemon flavor, mix the above ingredients, add purified water, adjust the total to 100g by adding purified water, and then fill it in a brown bottle and sterilize it. to produce a liquid.
제제예 6. 과립제의 제조Formulation Example 6. Preparation of granules
실시예 1에서 얻은 추출물 분말 1,000 mg1,000 mg of extract powder obtained in Example 1
비타민 혼합물 적량Vitamin mixture dosage
비타민 A 아세테이트 70 ㎍Vitamin A acetate 70 μg
비타민 E 1.0 mgVitamin E 1.0 mg
비타민 B1 0.13 mgVitamin B1 0.13 mg
비타민 B2 0.15 mgVitamin B2 0.15 mg
비타민 B6 0.5 mgVitamin B6 0.5 mg
비타민 B12 0.2 ㎍Vitamin B12 0.2 ㎍
비타민 C 10 mgVitamin C 10 mg
비오틴 10 ㎍Biotin 10 μg
니코틴산아미드 1.7 mgNicotinamide 1.7 mg
엽산 50 ㎍Folic acid 50 μg
판토텐산 칼슘 0.5 mgCalcium pantothenate 0.5 mg
무기질 혼합물 적량Mineral mixture appropriate amount
황산제1철 1.75 mgFerrous sulfate 1.75 mg
산화아연 0.82 mgZinc oxide 0.82 mg
탄산마그네슘 25.3 mgMagnesium carbonate 25.3 mg
제1인산칼륨 15 mgMonobasic Potassium Phosphate 15 mg
제2인산칼슘 55 mgDibasic calcium phosphate 55 mg
구연산칼륨 90 mgPotassium citrate 90 mg
탄산칼슘 100 mgCalcium carbonate 100 mg
염화마그네슘 24.8 mgMagnesium chloride 24.8 mg
상기의 비타민 및 미네랄 혼합물의 조성비는 비교적 과립제에 적합한 성분을 바람직한 실시예로 혼합 조성하였지만, 그 배합비를 임의로 변형 실시하여도 무방하며, 통상의 과립제 제조방법에 따라 상기의 성분을 혼합한 다음, 과립을 제조하고, 통상의 방법에 따라 건강기능식품 조성물 제조에 사용할 수 있다.The composition ratio of the above vitamin and mineral mixture is a mixture of components relatively suitable for granules in a preferred embodiment, but the mixing ratio may be modified arbitrarily. The above components are mixed according to a typical granule manufacturing method, and then the granules are mixed. It can be prepared and used to manufacture a health functional food composition according to a conventional method.
제제예 7. 기능성 음료의 제조Formulation Example 7. Preparation of functional beverage
실시예 1에서 얻은 추출물 분말 1,000 mg 1,000 mg of extract powder obtained in Example 1
구연산 1,000 mg1,000 mg citric acid
올리고당 100 g100 g oligosaccharides
매실농축액 2 g2 g plum concentrate
타우린 1 g1 g taurine
정제수를 가하여 전체 900 mLAdd purified water to make a total of 900 mL.
통상의 건강음료 제조방법에 따라 상기의 성분을 혼합한 다음, 약 1 시간 동안 85 ℃에서 교반 가열한 후, 만들어진 용액을 여과하여 멸균된 2 L 용기에 취득하여 밀봉 멸균한 뒤 냉장 보관한 다음 본 발명의 기능성 음료 조성물 제조에 사용한다. After mixing the above ingredients according to a typical health drink manufacturing method, stirring and heating at 85°C for about 1 hour, the resulting solution was filtered, placed in a sterilized 2 L container, sealed, sterilized, stored in the refrigerator, and then refrigerated. Used for manufacturing the functional beverage composition of the invention.
상기 조성비는 비교적 기호음료에 적합한 성분을 바람직한 실시예로 혼합 조성하였지만, 수요계층, 수요국가, 사용용도 등 지역적, 민족적 기호도에 따라서 그 배합비를 임의로 변형 실시하여도 무방하다.The composition ratio is a preferred embodiment of mixing ingredients relatively suitable for beverages of preference, but the mixing ratio may be arbitrarily modified according to regional and ethnic preferences such as demand class, country of demand, and intended use.
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