KR20190057782A - Composition for improving sleep disorder containing lettuce and Scutellariae extract as an active ingredient - Google Patents
Composition for improving sleep disorder containing lettuce and Scutellariae extract as an active ingredient Download PDFInfo
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- KR20190057782A KR20190057782A KR1020170155122A KR20170155122A KR20190057782A KR 20190057782 A KR20190057782 A KR 20190057782A KR 1020170155122 A KR1020170155122 A KR 1020170155122A KR 20170155122 A KR20170155122 A KR 20170155122A KR 20190057782 A KR20190057782 A KR 20190057782A
- Authority
- KR
- South Korea
- Prior art keywords
- extract
- sleep disorder
- lettuce
- sleep
- extract powder
- Prior art date
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- A—HUMAN NECESSITIES
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Abstract
Description
본 발명은 상추 및 황금 추출물을 유효성분으로 함유하는 수면 장애 개선용 조성물에 관한 것으로, 보다 구체적으로 상추 및 황금 추출물을 유효성분으로 함유하는 수면 질환 또는 수면 장애 예방 또는 치료용 약학적 조성물, 또는 수면 질 개선, 일주기 리듬 변화를 위한 조성물, 또는 건강식품에 관한 것이다.
The present invention relates to a composition for improving sleep disorder comprising an extract of lettuce and a gold extract as an active ingredient, and more particularly to a composition for preventing or treating sleep disorder or sleep disorder containing an extract of lettuce and gold extract as an active ingredient, Quality improvement, composition for circadian rhythm change, or health food.
잠을 자면서 보내는 시간이 우리 일생의 1/3을 차지할 정도로 수면은 우리 모두에게 중요하다. 수면이란 눈이 감긴 채 의식 활동이 쉬는 상태를 말하며 사람이 낮 동안 활동하면서 사용한 에너지를 보충하고 신체활동으로 인해 쌓인 피로를 회복하는 중요한 과정이다. 수면은 에너지와 피로 회복을 하는 시간일 뿐만 아니라 인간의 성장에 꼭 필요한 성장호르몬이 가장 많이 분비되는 시간이다. 우리 몸에서 뇌는 생명 유지를 위한 모든 생리적 기능을 총괄하는 곳으로 이 뇌가 적절한 활동의 균형을 유지하기 위해 반드시 휴식이 필요하며, 이러한 휴식은 대부분 수면 시간에 이루어진다.Sleep is important to all of us, as sleeping time is one third of our life. Sleep refers to the state of conscious activity in which the eyes are closed, and it is an important process to recover the fatigue accumulated by physical activity by supplementing the energy used by people during daytime activities. Sleep is not only time to recover energy and fatigue, but also the most secretion of growth hormone essential for human growth. The brain in our body is responsible for all of the physiological functions for maintaining life. This brain needs to be rested in order to maintain proper balance of activity, and most of these rests occur during sleeping time.
그러나 현대인들은 업무과다, 스트레스 증가, 노령화, 교통의 발달(수면주기변화), 생활환경 및 질환 등의 다양한 원인으로 성인 중 10% 이상이 수면 장애를 호소하며 성인의 1/3 정도는 일생 동안 어떤 형태로든 수면 장애를 경험한다고 한다. 수면 장애는 흔히 신경정신질환의 초기 증상으로 나타나며 일부 정신질환은 수면생리의 특징적인 변화를 동반한다. '국민건강보험공단'의 분석 결과에 따르면, 2006~2015년 국내 수면장애 환자는 약 15만명(2006년)에서 약 46만명(2015년)으로 10년 사이 209%나 증가하였고, 10대 및 20대의 경우에도 10년 사이 수면 장애를 겪고 있는 환자가 2배 가량 늘어난 것으로 나타났다.
However, modern people are affected by various causes such as overwork, stress, aging, development of traffic (change of sleep cycle), living environment and disease, and more than 10% of adults complain of sleeping disorder. It is said to experience sleep disorder in form. Sleep disturbances are often the early symptoms of neuropsychiatric disorders, and some mental illnesses are accompanied by a characteristic change in sleep physiology. According to the analysis of National Health Insurance Corporation, the number of patients with domestic sleep disorder in 2006 ~ 2015 increased by 209% from about 150,000 (2006) to about 460,000 (2015) in 10 years, The number of patients suffering from sleep disturbance for the past 10 years has doubled.
현재 상용되는 대표적 항불안제는 벤조디아제핀(benzodiazepine), 디아제팜(diazepam), 옥사제팜(oxazepam), 프라제팜(prazepam), 로라제팜(lorazepam), 알프라졸람(alprazolam), 헬라제팜(helazepam), 클로나제팜(clonazepam) 등이 있으며, 이들 약물들은 주로 진정 및 수면유도의 목적으로도 사용된다. 이중 벤조디아제핀은 가장 흔히 사용하는 항불안제로, 효과가 즉각 나타나지만 습관성과 중독성이 단점으로 전문의의 치료에 따라 약을 사용하지 않으면 증상이 재발하거나 금단증상이 나타나며, 다른 부작용으로 졸음, 운동실조, 기립성 저혈압, 호흡 억제, 두통, 만성수면장애, 간질환 등이 나타난다고 보고되고 있다. 이처럼 현재 신경안정을 위하여 불안과 수면장애 치료를 위해 많이 사용되고 있는 약물들은 장기 복용에 의해 내성과 의존성이 생기며, 기억 감퇴, 감각기능의 마비, 호흡기능의 억제와 같은 부작용을 동반하는 것으로 알려져 있고, 민간요법의 경우, 그 효능 검증의 기준이 적절하게 마련되어 있지 않아 객관적인 효능 평가가 어려운 단점이 있다. 따라서, 이런 불안증과 수면장애 개선할 수 있는 신경안정제를 대체하기 위하여 생약을 이용한 천연의약품에 대한 필요성이 대두되고 있다.
Representative anxiolytics commonly used today include benzodiazepine, diazepam, oxazepam, prazepam, lorazepam, alprazolam, helazepam, clonazepam, and clonazepam. These drugs are mainly used for calming and inducing sleep. Doubly administered benzodiazepines are the most commonly used anxiolytic drugs, but their effects are immediate, but they are addictive and addictive. Due to the specialist's treatment, symptoms may recur or withdrawal symptoms and other side effects may include drowsiness, ataxia, orthostatic hypotension , Respiratory depression, headache, chronic sleep disorder, and liver disease. These drugs, which are currently used for the treatment of anxiety and sleep disorders, are known to cause tolerance and dependence by long-term use, accompanied by side effects such as memory decline, paralysis of sensory function, and suppression of respiratory function, In the case of folk remedies, there is a disadvantage that objective efficacy evaluation is difficult because the criteria for verifying efficacy is not adequately prepared. Therefore, there is a need for natural medicines using herbal medicines to replace such anxiety and nervous stabilizers that can improve sleeping disorders.
이에 본 발명자들은 천연물 유래 수면 장애 치료제를 개발하기 위해 노력한 결과, 상추(Lactuca sativa) 및 황금(Scutellaria baicalensis) 복합 추출물을 분말 과립으로 제조 시 용해도가 우수하고, 용해하여 음용 시 쓴맛이 거의 없으며 추출물 특유의 향을 마스킹하고 우수한 수면 증진 효과가 있음을 확인함으로써, 상기 상추 및 황금 복합 추출물을 수면 장애 예방 또는 치료용 조성물, 또는 수면 질 개선, 및 일주기 리듬 변화를 위한 조성물, 또는 건강식품으로 사용할 수 있음을 밝힘으로써, 본 발명을 완성하였다.
Accordingly, the present inventors have made efforts to develop a therapeutic agent for sleep disorder caused by natural products, and found that Lactuca sativa and Golden ( Scutellaria baicalensis ) powder as a powder granule and has excellent solubility in dissolving, and has little bitter taste when consumed. By masking the fragrance of the extract and having an excellent sleep enhancement effect, the extract of lettuce and golden complex Or a composition for treatment, or a composition for improving sleep quality and a change in circadian rhythm, or as a health food.
본 발명의 목적은 상추(Lactuca sativa) 및 황금(Scutellaria baicalensis) 복합 추출물을 유효성분으로 함유하는 수면 질환 또는 수면 장애 예방 또는 치료용 약학적 조성물을 제공하기 위한 것이다.It is an object of the present invention to provide a method for producing Lactuca sativa and gold ( Scutellaria) The present invention also provides a pharmaceutical composition for preventing or treating sleep disorder or sleep disorder, which comprises the extract of Baikalensis as an active ingredient.
본 발명의 다른 목적은 상추 및 황금 복합 추출물을 유효성분으로 함유하는 수면 질환 또는 수면 장애 예방 또는 개선용 건강식품을 제공하기 위한 것이다.
Another object of the present invention is to provide a health food for preventing or ameliorating sleep disorder or sleep disorder, which comprises an extract of lettuce and a golden compound as an active ingredient.
상기 목적을 달성하기 위하여, 본 발명은 상추(Lactuca sativa) 및 황금(Scutellaria baicalensis) 복합 추출물을 유효성분으로 함유하는 수면 질환 또는 수면 장애 예방 또는 치료용 약학적 조성물을 제공한다.In order to achieve the above object, the present invention relates to a method for producing Lactuca sativa and golden ( Scutellaria) The present invention also provides a pharmaceutical composition for preventing or treating sleep disorder or sleep disorder, which comprises a compound of the present invention as an active ingredient.
또한, 본 발명은 상추 및 황금 복합 추출물을 유효성분으로 함유하는 수면 질환 또는 수면 장애 예방 또는 개선용 식품, 건강식품을 제공한다.The present invention also provides a food or health food for preventing or ameliorating sleep disorder or sleep disorder, which comprises extract of lettuce and a golden compound as an active ingredient.
또한, 본 발명은 상추 및 황금 복합 추출물을 유효성분으로 함유하는 수면 질 개선용, 일주기 리듬 변화용 식품, 건강식품을 제공한다. The present invention also provides a composition for improving sleep quality, a dietary cycle-changing food, and a health food containing an extract of lettuce and a golden compound as an active ingredient.
아울러, 본 발명은 In addition,
1) 상추 추출물 분말 및 황금 추출물 분말을 혼합하여 복합 추출물 분말을 제조하는 단계;1) preparing a complex extract powder by mixing a lettuce extract powder and a gold extract powder;
2) 단계 1)의 복합 추출물 분말 및 당류를 혼합하여 시드(seed)를 제조하는 단계; 및2) preparing a seed by mixing the complex extract powder of step 1) and saccharides; And
3) 단계 2)의 시드를 유동층 과립기의 내부에 첨가하여 유동화하고, 물을 분사하여 당류가 코팅된 복합 추출물 분말 과립을 수득하는 단계를 포함하는, 상추 및 황금 복합 추출물 분말 과립의 제조방법 및 상기 방법으로 제조된 상추 및 황금 복합 추출물 분말 과립을 제공한다.
3) a method for producing the extract granules of lettuce and golden complex extract, comprising the steps of adding the seed of step 2) to the inside of the fluidized bed granulator to fluidize and spraying water to obtain a saccharide-coated complex extract powder granule; The extract of lettuce and golden complex extract prepared by the above method is provided.
본 발명의 상추(Lactuca sativa) 및 황금(Scutellaria baicalensis) 복합 추출물은 분말 과립으로 제조 시 용해도가 우수하고, 용해하여 음용 시 쓴맛이 거의 없으며 추출물 특유의 향을 마스킹하고 우수한 수면 증진 효과를 나타내므로, 불면증, 기면증, 수면 중 이상행동, 과수면증 등을 포함하는 수면 질환 또는 수면 장애 예방 또는 치료용 조성물, 또는 수면 질 개선, 일주기 리듬 변화를 위한 조성물, 또는 건강식품으로 유용하게 사용될 수 있다.
The inventive lettuce ( Lactuca sativa ) and golden ( Scutellaria baicalensis ) is a powdery granule which has excellent solubility in manufacturing and has little bitter taste when it is dissolved and has an excellent masking effect on the extract and exhibits excellent sleeping effect. Therefore, insomnia, narcolepsy, abnormal behavior during sleep, And the like, or a composition for improving sleep quality, a composition for changing circadian rhythm, or a health food.
이하 본 발명을 상세히 설명한다.
Hereinafter, the present invention will be described in detail.
본 발명은 상추(Lactuca sativa) 및 황금(Scutellaria baicalensis) 복합 추출물을 유효성분으로 함유하는 수면 질환 또는 수면 장애 예방 또는 치료용 약학적 조성물을 제공한다.The present invention relates to an extract of Lactuca sativa and golden ( Scutellaria) The present invention also provides a pharmaceutical composition for preventing or treating sleep disorder or sleep disorder, which comprises a compound of the present invention as an active ingredient.
상기 복합 추출물은 하기의 단계들을 포함하는 방법에 의해 제조되는 것이 바람직하나, 이에 한정되지 않는다: The complex extract is preferably, but not limited to, prepared by a method comprising the steps of:
a) 상추 및 황금 각각에 추출용매를 가하여 추출하는 단계;a) extracting lettuce and gold with an extraction solvent;
b) 단계 a)의 추출물 각각을 여과하는 단계;b) filtering each of the extracts of step a);
c) 단계 b)의 여과물 각각을 감압 농축하는 단계; 및c) concentrating the filtrate of step b) under reduced pressure; And
d) 단계 c)의 농축물 각각을 건조하고 혼합하는 단계.d) drying and mixing each of the concentrates of step c).
본 발명의 제조방법에 있어서, 단계 a)의 상추 및 황금은 재배한 것 또는 시판되는 것을 제한 없이 사용할 수 있다.In the production process of the present invention, lettuce and gold of step a) may be cultivated or commercially available without any limitation.
본 발명의 제조방법에 있어서, 상기 단계 a)의 추출용매는 물, 알코올 또는 이의 혼합물을 사용하는 것이 바람직하다. 상기 알코올로는 C1 내지 C2의 저급 알코올 이용하는 것이 바람직하며, 저급 알코올로는 에탄올 또는 메탄올을 이용하는 것이 바람직하다. 추출방법으로는 진탕추출, Soxhelt 추출 또는 환류 추출을 이용하는 것이 바람직하나, 이에 한정하지 않는다. 상기 추출용매를 건조된 상추 또는 황금 분량의 6 내지 12배 첨가하여 추출하는 것이 바람직하며, 8 내지 10배 첨가하여 추출하는 것이 더욱 바람직하다. 추출 온도는 20℃ 내지 100℃인 것이 바람직하며, 80℃ 내지 90℃인 것이 가장 바람직하나, 이에 한정하지 않는다. 또한, 추출시간은 1 내지 24시간이 바람직하며, 2 내지 10시간이 더욱 바람직하고, 3 내지 5시간이 가장 바람직하나, 이에 한정하지 않는다. 아울러 추출 횟수는 1 내지 3회인 것이 바람직하나, 이에 한정되는 것은 아니다. In the production method of the present invention, it is preferable to use water, an alcohol or a mixture thereof in the step (a). As the alcohol, C 1 to C 2 lower alcohols are preferably used, and as the lower alcohol, ethanol or methanol is preferably used. As the extraction method, it is preferable to use shaking extraction, Soxhelt extraction or reflux extraction, but not limited thereto. It is preferable that the extraction solvent is added by 6 to 12 times of dried lettuce or golden extract, more preferably by 8 to 10 times of extraction. The extraction temperature is preferably 20 ° C to 100 ° C, and most preferably 80 ° C to 90 ° C, but is not limited thereto. The extraction time is preferably 1 to 24 hours, more preferably 2 to 10 hours, and most preferably 3 to 5 hours, but is not limited thereto. The number of extraction times is preferably 1 to 3 times, but is not limited thereto.
본 발명의 제조방법에 있어서, 단계 c)의 감압농축은 진공 감압 농축기 또는 진공회전증발기를 이용하는 것이 바람직하나 이에 한정하지 않는다. In the production method of the present invention, it is preferable to use a vacuum decompression concentrator or a vacuum rotary evaporator for the decompression concentration in step c), but it is not limited thereto.
본 발명의 제조방법에 있어서, 단계 d)의 건조는 감압건조, 진공건조, 비등건조, 분무건조 또는 동결건조하는 것이 바람직하고, 분무건조하는 것이 더욱 바람직하나, 이에 한정하지 않는다. 건조 온도는 100 내지 200℃인 것이 바람직하고, 160 내지 180℃인 것이 더욱 바람직하나, 이에 한정하지 않는다. 또한, 상추 및 황금 건조물 각각을 1 : 0.5 내지 2의 중량비로 배합하는 것이 바람직하나, 이에 한정되는 것은 아니다.In the production process of the present invention, drying in step d) is preferably carried out under reduced pressure, vacuum drying, boiling, spray drying or freeze drying, more preferably spray drying, but not always limited thereto. The drying temperature is preferably 100 to 200 ° C, more preferably 160 to 180 ° C, but is not limited thereto. In addition, it is preferable to mix each of lettuce and golden dried material at a weight ratio of 1: 0.5 to 2, but not limited thereto.
상기 상추 및 황금 복합 추출물은 과립화된 분말 과립으로 제형화될 수 있다. 상기 분말 과립은 용해도가 우수하고, 용해하여 음용 시 쓴맛이 거의 없으며 추출물 특유의 향을 마스킹하여 기호도가 우수하다.The lettuce and golden composite extract may be formulated into granulated powder granules. The powder granules are excellent in solubility, dissolve, have little bitter taste when consumed, and are excellent in preference because they mask the unique fragrance of the extract.
상기 분말 과립은 하기의 단계들을 포함하는 방법에 의해 과립화될 수 있으나, 이에 제한되지 않는다:The powder granules may be granulated by a method including, but not limited to, the following steps:
1) 상추 추출물 분말 및 황금 추출물 분말을 혼합하여 복합 추출물 분말을 제조하는 단계;1) preparing a complex extract powder by mixing a lettuce extract powder and a gold extract powder;
2) 단계 1)의 복합 추출물 분말 및 당류를 혼합하여 시드(seed)를 제조하는 단계; 및2) preparing a seed by mixing the complex extract powder of step 1) and saccharides; And
3) 단계 2)의 시드를 유동층 과립기의 내부에 첨가하여 유동화하고, 물을 분사하여 당류가 코팅된 복합 추출물 분말 과립을 수득하는 단계.3) adding the seed of step 2) to the inside of the fluidized bed granulator to fluidize, and spraying water to obtain a saccharide-coated complex extract powder granule.
본 발명의 제조방법에 있어서, 상기 단계 1)에서 상추 추출물 분말 및 황금 추출물 분말을 1 : 0.5 내지 2의 중량비로 혼합하는 것이 바람직하나, 이에 한정하지 않는다.In the preparation method of the present invention, it is preferable to mix the lettuce extract powder and the gold extract powder at a weight ratio of 1: 0.5 to 2 in the step 1), but the present invention is not limited thereto.
본 발명의 제조방법에 있어서, 상기 단계 2)에서 복합 추출물 분말 및 당류를 1 : 1.0 내지 3.5의 중량비로 혼합하는 것이 바람직하고, 1 : 1.5 내지 3.0의 중량비로 혼합하는 것이 보다 바람직하나, 이에 한정하지 않는다. 또한, 상기 복합 추출물 분말을 15 내지 25 중량부, 당류를 15 내지 75 중량부로 혼합할 수 있다. 상기 당류는 예를 들어 무수결정포도당, 함수결정포도당, 과당, 말토스, 슈크로스, 올리고당, 덱스트린, 사이클로덱스트린, 자이리톨, 소르비톨, 에리스리톨, 팔라티노스, 트레할로스, 스테비오사이드, 수크랄로스, 아스파탐 또는 아세파탐 칼륨일 수 있고, 구체적으로 과당일 수 있으나, 이에 제한하지 않는다. 상기 복합 추출물 분말 및 당류를 혼합하고 입자크기를 균일화하기 위해 당업계에 공지된 다양한 믹서기 및 분쇄기를 이용할 수 있다.In the preparation method of the present invention, the complex extract powder and saccharide are preferably mixed in a weight ratio of 1: 1.0 to 3.5 in the step 2), more preferably 1: 1.5 to 3.0, I never do that. The complex extract powder may be mixed in an amount of 15 to 25 parts by weight and the saccharide may be mixed in an amount of 15 to 75 parts by weight. The saccharides may be selected from, for example, anhydrous crystalline glucose, water soluble glucose, fructose, maltose, sucrose, oligosaccharide, dextrin, cyclodextrin, xylitol, sorbitol, erythritol, palatinose, trehalose, stevioside, sucralose, aspartame, Potassium, and may be specifically fructose, but is not limited thereto. Various blenders and mills known in the art can be used to mix the combined extract powder and saccharides and to uniformize the particle size.
본 발명의 제조방법에 있어서, 상기 단계 3)은 유동층 과립기의 흡입공기온도 50 내지 80℃의 조건, 배기온도 30 내지 40℃의 조건에서 실시될 수 있다.In the production method of the present invention, the step 3) may be carried out under the conditions of an inlet air temperature of the fluidized bed granulator of 50 to 80 캜 and an exhaust temperature of 30 to 40 캜.
상기 수면 질환 또는 수면 장애는 불면증, 기면증, 수면 중 이상행동 또는 과수면증일 수 있으나, 수면과 관련된 질환이면 이에 제한되지는 않는다.The sleep disorder or sleep disorder may be insomnia, narcolepsy, abnormal behavior during sleep, or sleep deprivation, but is not limited to a disease related to sleep.
본 발명에서 상기 "불면증"은 가장 대표적인 수면 장애 증상으로, 잠자리에 누워도 잠들기 어려운 입면 장애, 하룻밤 동안 잠을 깨는 횟수가 5회 이상인 수면유지 장애, 일찍 잠을 깨서 다시 잠들지 못하는 조기각성 장애로 구별될 수 있다.In the present invention, the term " insomnia " is the most typical symptom of sleeping disorder. The sleeping disorder is a sleeping disorder that is difficult to fall asleep even when lying on a bed, a sleep maintenance disorder in which the sleeping number is five times or more per night, and a premature arousal disorder .
본 발명에서 상기 "기면증"은 렘(REM) 수면의 비정상적인 발현으로 인한 수면 장애 질환으로, 주된 증상인 주간 과다 졸림증(excessive daytime sleepness) 외에, 크게 웃거나 화를 내는 등 감정의 자극이 있을 때 몸의 힘이 갑자기 빠지는 허탈발작(cataplexy), 잠에 들거나 깰 때 머리는 깨어 있으나 몸을 움직일 수 없는 수면 마비(sleep paralysis), 잠에 들거나 잠에서 깰 때 꿈이 현실로 이행되어 보이는 입면환각(hypnagogic hallucination) 등이 동반되어 나타난다.In the present invention, the term " narcolepsy " is a sleep disorder disorder caused by abnormal expression of REM sleep. In addition to excessive daytime sleepiness, which is the main symptom, when there is stimulation of emotion such as laughing or anger, A sleep paralysis that can not move the body when it wakes up or wakes up when it wakes up or sleeps; a hypnagogic (a sleeping hallucination) in which dreams seem to be shifted to reality when awakening or falling asleep; hallucination).
본 발명에서 상기 "수면 중 이상행동"은 하지불안증후군, 가위눌림, 악몽, 렘수면 장애, 수면 보행증(몽유병), 야경증 등과 같이 정상적인 경우 수면 중에 나타나지 않는 움직임이나 행동이 나타나는 증상으로, 특히 하지불안증후군은 다리에 나타나는 스멀거림이나 저림증 같은 불쾌한 감각으로 인해 다리를 움직이고 싶은 충동을 느끼며 때로는 충동을 참을 수 없어 수면 중에 다리를 떨거나 꿈틀거려야만 하는 증상이다.In the present invention, the term " abnormal behavior during sleep " is a symptom in which a motion or behavior that does not occur during normal sleep, such as restless leg syndrome, scissors depression, nightmare, REM sleep disorder, sleeping wake (sleepwalking) Syndrome is an unpleasant sensation, such as numbness or numbness on the legs, which makes you feel an urge to move your legs. Sometimes you can not stand urge and you have to shake or twist your legs while you sleep.
본 발명에서 상기 "과수면증"은 렘(REM) 수면의 비정상적인 발현과는 상관없이, 밤 중 깊은 잠에 들지 못해 충분한 수면 시간을 취했음에도 낮에 계속 졸음이 몰려와 일상생활에 지장을 받을 정도의 상태를 일컫는 수면 장애이다. 기면증과 달리 잠에 빠지는 것을 본인이 인지하지 못하고 갑자기 잠이 드는 '수면발작' 증상은 나타나지 않는다.
In the present invention, the term " sleeping symptom " refers to a symptom of sleeping in the daytime and a hindrance to daily life, even though the user has not taken a deep sleep at night and has a sufficient sleep time regardless of the abnormal expression of REM sleep Is a sleep disorder that refers to the state of Unlike narcolepsy, you do not notice a 'sleeping' symptom that you do not notice when you fall asleep and suddenly fall asleep.
본 발명의 구체적인 실시예에서, 본 발명자들은 상추 및 황금 복합 추출물을 제조한 후, 이의 용해도를 높이기 위해 유동층 과립 공정을 통해 복합 추출물 분말 과립을 제조하였다. 또한, 상기 분말 과립 제조 공정에서 복합 추출물 분말 및 결정과당을 1 : 1.5 내지 3.0의 중량비로 혼합할 경우 제조된 복합 추출물 분말 과립의 용해도가 현저히 우수함을 확인하였다. 아울러, 상기 용해도가 우수한 복합 추출물 분말 과립을 이용하여 관능평가를 수행한 결과, 음용 시 쓴맛이 거의 없고, 향의 거부감이 없으며, 이에 종합적 기호도가 우수함을 확인하였다.In a specific embodiment of the present invention, the present inventors prepared a composite extract powder granule by a fluidized bed granulation process to prepare an extract of lettuce and a gold complex, and then increase the solubility thereof. In addition, it was confirmed that when the complex extract powder and the crystalline fructose were mixed at a weight ratio of 1: 1.5 to 3.0 in the powder granule production process, the solubility of the composite extract powder granules prepared was remarkably excellent. As a result of sensory evaluation using the powdery granules of the extract having excellent solubility, it was confirmed that there was almost no bitter taste at the time of drinking, no irritation to the fragrance, and excellent overall acceptability.
또한, 상기 용해도가 우수한 복합 추출물 분말 과립을 이용하여 수면의 질을 평가한 결과, 상기 복합 추출물 분말 과립을 용해하여 복용한 피험자의 수면의 질이 개선되는 것을 확인하였다.Further, as a result of evaluating the quality of the water using the granules of the complex extract powder having excellent solubility, it was confirmed that the quality of sleep of the subjects who took the granules of the complex extract powder dissolved was improved.
따라서, 본 발명의 상추 및 황금 복합 추출물의 분말 과립은 용해도 우수하고, 섭취의 거부감이 없으며, 수면 증진 효능이 우수하므로, 상기 상추 및 황금 복합 추출물을 수면 질환 또는 수면 장애 예방 또는 치료용 조성물의 유효성분으로 유용하게 이용할 수 있다.
Therefore, the powder granules of the lettuce and the golden complex extract of the present invention are excellent in solubility, have no irritation to ingestion, and have excellent sleep improving effect, so that the extract of lettuce and the golden complex is effective for the prevention or treatment of sleep disorders or sleep disorders It can be usefully used as a component.
본 발명의 조성물은 경구 또는 비경구 투여(예를 들어, 도포 또는 정맥 내, 피하, 복강 내 주사)할 수 있으나 경구 투여가 바람직하다. 비경구 투여를 위한 제제로는 각각 통상의 방법에 따라 산제, 과립제, 정제, 캡슐제, 멸균된 수용액, 액제, 비수성용제, 현탁제, 에멀젼, 시럽, 좌제, 에어로졸 등의 외용제 및 멸균 주사제제의 형태로 제형화하여 사용될 수 있으며, 바람직하게는 크림, 젤, 패취, 분무제, 연고제, 경고제, 로션제, 리니멘트제, 파스타제 또는 카타플 라스마제의 피부 외용 약학적 조성물을 제조하여 사용할 수 있으나, 이에 한정하는 것은 아니다. 국소 투여의 조성물은 임상적 처방에 따라 무수형 또는 수성형일 수 있다. 비수성용제, 현탁제로는 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. 경구 투여를 위한 고형제제에는 산제, 과립제, 정제, 캡슐제, 연질캅셀제, 환 등이 포함된다. 경구를 위한 액상 제제로는 현탁제, 내용액제, 유제, 시럽제, 에어로졸 등이 해당되는데 흔히 사용되는 단순희석제인 물, 리퀴드 파라핀 이외에 여러 가지 부형제, 예를 들면 습윤제, 감미제, 방향제, 보존제 등이 포함될 수 있다.The composition of the present invention can be administered orally or parenterally (e.g., applied or intravenously, subcutaneously, intraperitoneally), but oral administration is preferred. As the agent for parenteral administration, the external preparation such as powders, granules, tablets, capsules, sterilized aqueous solutions, liquid preparations, non-aqueous solutions, suspensions, emulsions, syrups, suppositories and aerosols, The composition may be formulated in the form of a cream, a gel, a patch, a spray, an ointment, a warning agent, a lotion, a liniment, a pasta or a cataplasm. However, the present invention is not limited thereto. The composition for topical administration may be anhydrous or water-based, depending on the clinical formulation. Examples of the suspending agent include propylene glycol, polyethylene glycol, vegetable oil such as olive oil, injectable ester such as ethyl oleate, and the like. Examples of the suppository base include witepsol, macrogol, tween 61, cacao butter, laurin, glycerogelatin and the like. Solid form preparations for oral administration include powders, granules, tablets, capsules, soft capsules, and the like. Examples of liquid formulations for oral use include suspensions, solutions, emulsions, syrups and aerosols. In addition to water and liquid paraffin, which are commonly used simple diluents, various excipients such as wetting agents, sweeteners, fragrances and preservatives .
상기 조성물은 투여를 위해서 상추 및 황금 복합 추출물 유효성분 이외에 추가로 약제학적으로 허용 가능한 담체를 1종 이상 포함하여 제조할 수 있다. 약제학적으로 허용 가능한 담체는 식염수, 멸균수, 링거액, 완충 식염수, 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 등으로 제제화할 수 있다.The composition may be prepared by adding at least one pharmaceutically acceptable carrier in addition to the active ingredient of lettuce and the golden complex extract for administration. The pharmaceutically acceptable carrier may be a mixture of saline, sterilized water, Ringer's solution, buffered saline, dextrose solution, maltodextrin solution, glycerol, ethanol and one or more of these components. If necessary, an antioxidant, , And other conventional additives such as a bacteriostatic agent may be added. In addition, a diluent, a dispersant, a surfactant, a binder, and a lubricant may be additionally added to formulate the composition for injectable use such as an aqueous solution, a suspension or an emulsion.
본 발명에 따른 약제학적으로 허용가능한 첨가제는 상기 조성물에 대해 0.1~90 중량부 포함되는 것이 바람직하다.The pharmaceutically acceptable additives according to the present invention are preferably contained in an amount of 0.1 to 90 parts by weight based on the composition.
본 발명의 조성물의 바람직한 투여량은 체내에서 활성성분의 흡수도, 환자의 연령, 성별 및 비만의 정도에 따라 다르지만, 당업자에 의해 적절하게 선택될 수 있다. 그러나 바람직한 효과를 위해서, 경구 투여제의 경우 일반적으로 성인에게 1일에 체중 1㎏당 본 발명의 조성물을 1일 0.0001 내지 100 ㎎/㎏으로, 바람직하게는 0.001 내지 100 ㎎/㎏으로 투여하는 것이 좋다. 투여는 하루에 한번 투여할 수도 있고, 수회 나누어 투여할 수도 있다. 상기 투여량은 어떠한 면으로든 본 발명의 범위를 한정하는 것은 아니다.The preferred dosage of the composition of the present invention varies depending on the degree of absorption of the active ingredient in the body, the age of the patient, the sex, and the degree of obesity, but can be appropriately selected by those skilled in the art. However, in order to obtain the desired effect, in the case of an oral administration agent, it is generally practiced to administer the composition of the present invention to an adult at a dose of 0.0001 to 100 mg / kg per day, preferably 0.001 to 100 mg / kg per kilogram of body weight per day good. The administration may be carried out once a day or divided into several times. The dose is not intended to limit the scope of the invention in any way.
본 발명의 조성물은 상추 및 황금 복합 추출물에 추가로 동일 또는 유사한 기능을 나타내는 유효성분을 1종 이상 함유할 수 있다.
The composition of the present invention may contain at least one active ingredient which exhibits the same or similar functions in addition to the lettuce and the golden compound extract.
본 발명은 상추 및 황금 복합 추출물을 유효성분으로 함유하는, 수면 질환 또는 수면 장애 예방 또는 개선용 식품, 건강식품을 제공한다.The present invention provides a food for preventing or improving sleep disorder or sleep disorder, and a health food containing the extract of lettuce and the golden compound as an active ingredient.
또한, 본 발명은 상추 및 황금 복합 추출물을 유효성분으로 함유하는, 수면 질 개선용, 일주기 리듬 변화용 식품, 건강식품을 제공한다.The present invention also provides a composition for improving sleep quality, a dietary cycle-changing food, and a health food containing an extract of lettuce and a golden compound as an active ingredient.
상기 상추 및 황금 복합 추출물은 상기 수면 질환 또는 수면 장애 예방 또는 치료용 조성물에 대한 설명과 동일한 바, 구체적인 설명은 상기 내용을 원용하고, 이하에서는 식품 또는 건강식품에 특유한 구성에 대해서만 설명하도록 한다.The extracts of lettuce and golden complex are the same as those for the composition for the prevention or treatment of sleep disorder or sleep disorder. The detailed description is based on the above description, and only the composition specific to food or health food will be described below.
한편, 약학적 조성물과 마찬가지로, 본 발명의 상추 및 황금 복합 추출물의 분말 과립은 용해도 우수하고, 섭취의 거부감이 없으며, 수면 증진 효능이 우수하므로, 상기 상추 및 황금 복합 추출물을 수면 질환 또는 수면 장애 예방 또는 개선, 수면 질 개선, 일주기 리듬 변화용 식품, 건강식품의 유효성분으로 유용하게 사용될 수 있다.
As in the case of the pharmaceutical composition, the powder granules of the lettuce and golden complex extract of the present invention have excellent solubility, no irritation to ingestion, and excellent sleep improving effect, so that the extract of lettuce and golden complex Or improvement, improvement of sleep quality, change of circadian rhythm, and health food.
본 발명의 상추 및 황금 복합 추출물을 식품 또는 음료 첨가물로 사용할 경우, 상기 상추 및 황금 복합 추출물을 그대로 첨가하거나 다른 식품 또는 식품 성분과 함께 사용되고, 통상적인 방법에 따라 적절하게 사용될 수 있다. 상기 상추 및 황금 복합 추출물의 혼합양은 그의 사용목적(예방, 건강 또는 치료적 처치)에 따라 적합하게 결정될 수 있다. 건강 및 위생을 목적으로 하거나 또는 건강조절을 목적으로 하는 장기간의 섭취의 경우, 상기 상추 및 황금 복합 추출물은 안전성 면에서 아무런 문제가 없기 때문에, 장기간 복용이 가능하다. 상기 식품의 종류에는 특별한 제한은 없다. 상기 물질을 첨가할 수 있는 식품의 예로는 육류, 소세지, 빵, 초콜릿류, 캔디류, 스넥류, 과자류, 피자, 라면, 기타 면류, 껌류, 아이스크림류를 포함한 낙농제품, 각종 스프, 음료수, 차, 드링크제, 알코올 음료 및 비타민 복합제 등이 있다. 음료수로 제형화할 경우에 상추 및 황금 복합 추출물 이외에 첨가되는 액체 성분으로는 이제 한정되지는 않으나, 통상의 음료와 같이 여러 가지 향미제 또는 천연 탄수화물 등을 추가 성분으로서 함유할 수 있다. 상술한 천연 탄수화물의 예는 모노사카라이드(예, 포도당, 과당 등), 디사카라이드(예, 말토오스, 수크로오스 등) 및 폴리사카라이드(예, 덱스트린, 시클로덱스트린 등과 같은 통상적인 당), 및 자일리톨, 소르비톨, 에리스리톨 등의 당 알코올이다. 상기 천연 탄수화물의 비율은 본 발명의 조성물 100 ㎖ 당 일반적으로 약 1 내지 20 g, 바람직하게는 약 5 내지 12 g이다. 상술한 것 이외의 향미제로서 천연 향미제[타우마린, 스테비아 추출물(예, 레바우디오시드 A, 글리시르히진 등)] 및 합성 향미제(예, 사카린, 아스파르탐 등)를 사용할 수 있다.
When the lettuce and the golden compound extract of the present invention is used as a food or beverage additive, the lettuce and the golden compound extract may be added directly or used together with other food or food ingredients, and suitably used according to a conventional method. The amount of the mixture of the lettuce and the golden compound extract can be suitably determined according to the purpose of use (prevention, health or therapeutic treatment). In the case of long-term intake for the purpose of health and hygiene or for the purpose of controlling health, the lettuce and the golden compound extract have no problem in terms of safety and can be taken for a long time. There is no particular limitation on the kind of the food. Examples of foods to which the above substances can be added include dairy products including meat, sausage, bread, chocolate, candy, snack, confectionery, pizza, ramen, other noodles, gums, ice cream, soups, drinks, tea, , Alcoholic beverages and vitamin complexes. When formulated as a beverage, the liquid component to be added in addition to the lettuce and the golden complex extract is not limited to any one, but may include various flavors or natural carbohydrates as an additional ingredient such as ordinary beverages. Examples of such natural carbohydrates include monosaccharides such as glucose and fructose, disaccharides such as maltose and sucrose and polysaccharides such as those commonly used in dextrin and cyclodextrins, , Sorbitol, and erythritol. The ratio of the natural carbohydrate is generally about 1 to 20 g, preferably about 5 to 12 g per 100 ml of the composition of the present invention. Natural flavors such as taumarin and stevia extract (e.g., rebaudioside A and glycyrrhizin) and synthetic flavorings (e.g., saccharin, aspartame, etc.) can be used as flavors other than those described above .
또한, 본 발명의 식품 조성물은 여러 가지 영양제, 비타민, 광물(전해질), 합성 풍미제 및 천연 풍미제 등의 풍미제, 착색제 및 증진제(치즈, 초콜릿 등), 펙트산 및 그의 염, 유기산, 보호성 콜로이드 증점제, pH 조절제, 안정화제, 방부제, 글리세린, 알코올, 탄산음료에 사용되는 탄산화제 등을 함유할 수 있다. 또한 본 발명의 식품 조성물은 과일 및 야채 음료의 제조를 위한 과육을 함유할 수 있다. 이러한 성분은 단독으로 또는 조합으로 사용될 수 있으며, 이러한 첨가제의 비율은 조성물 전체 중량당 0.001 내지 50 중량부의 범위에서 선택되는 것이 일반적이다.
In addition, the food composition of the present invention can be used as a flavoring agent such as various nutrients, vitamins, minerals (electrolytes), synthetic flavors and natural flavors, colorants and enhancers (cheese, chocolate, etc.), pectic acid and its salts, Colloidal thickeners, pH adjusting agents, stabilizers, preservatives, glycerin, alcohols, carbonating agents used in carbonated drinks, and the like. The food composition of the present invention may also contain pulp for the production of fruit and vegetable drinks. These components may be used singly or in combination, and the proportion of such additives is generally selected in the range of 0.001 to 50 parts by weight based on the total weight of the composition.
이하 본 발명의 실시예, 실험예 및 제조예에 의해 상세히 설명한다.Hereinafter, the present invention will be described in detail with reference to Examples, Experimental Examples and Preparation Examples.
단, 하기 실시예, 실험예 및 제조예는 본 발명을 예시하는 것일 뿐, 본 발명의 내용이 하기 실시예, 실험예 및 제조예에 한정되는 것은 아니다.
However, the following Examples, Experimental Examples and Preparation Examples are merely illustrative of the present invention, and the content of the present invention is not limited to the following Examples, Experimental Examples and Production Examples.
<< 실시예Example 1> 상추 추출물 및 황금 추출물의 제조 1> Preparation of lettuce extract and gold extract
90% 이상의 수분함량을 갖는 상추(Lactuca sativa)의 수분함량을 5% 이하가 되도록 17시간 동안 건조한 후 분쇄하였다. 분쇄한 상추 건조물에 9배수의 70% 에탄올을 넣고 85℃에서 4시간 동안 2회 분할 추출 및 여과한 후, 30 내지 35 brix로 감압농축하고 170℃에서 분무건조 하여 70% 에탄올 추출물 분말을 얻었다.The water content of lettuce ( Lactuca sativa ) having a water content of 90% or more was dried for 17 hours to be less than 5% and then pulverized. To the dried tossed crushed product, 9 times of 70% ethanol was added, followed by extraction and filtration twice at 85 ° C for 4 hours, followed by concentration under reduced pressure of 30 to 35 brix and spray drying at 170 ° C to obtain a 70% ethanol extract powder.
또한, 시판되는 황금(Scutellaria baicalensis) 건조물을 절각하고, 절각한 황금 건조물에 9배수의 70% 에탄올을 넣고 85℃에서 4시간 동안 2회 분할 추출 및 여과한 후, 30 내지 35 brix로 감압농축하고 170℃에서 분무건조 하여 70% 에탄올 추출물 분말을 얻었다.
In addition, commercially available gold ( Scutellaria baicalensis) to jeolgak the dry product, and insert a 70% ethanol 9 drain at a jeolgak golden dry product was concentrated under reduced pressure to from 85 ℃ for 4 hours two parts extracted and filtered, and 30 to 35 brix, and spray dried at 170 ℃ 70 % Ethanol extract powder.
<< 실시예Example 2> 상추 및 황금 복합 추출물 분말 과립의 제조 2> Preparation of lettuce and golden compound extract powder granules
에탄올 추출물은 물에 잘 용해되지 않고 서로 뭉치는 단점이 있다. 이러한 단점을 개선하기 위해 상추 및 황금 복합 추출물 분말을 결정과당으로 코팅하고 과립화 하였다. Ethanol extracts are not well soluble in water and have a disadvantage of aggregation. To overcome these drawbacks, lettuce and gold complex extract powder was coated with crystalline fructose and granulated.
구체적으로, 상기 <실시예 1>에서 제조한 상추 에탄올 추출물 분말 및 황금 에탄올 추출물을 1 : 1 비율로 혼합하여 상추 및 황금 복합 추출물 분말을 제조하였다. 그 다음, 제조한 상추 및 황금 복합 추출물 분말 18 중량%와 결정과당 36 중량%를 혼합하고, 이를 흡입공기온도가 50 내지 80℃이고, 배기온도가 30 내지 40℃인 배치타입(batch type) 유동층 과립기로 옮겨서 유동층 과립기 내부에서 상기 혼합물을 유동화시키면서 정제수를 총 3회 분사기를 통해 유동화에 분사시켰다. 이에 따라 결정과당이 상추 및 황금 복합 추출물 분말에 코팅된 상추 및 황금 복합 추출물 분말 과립을 수득하였다.
Specifically, the lettuce ethanol extract powder and the golden ethanol extract prepared in Example 1 were mixed at a ratio of 1: 1 to prepare an extract of lettuce and a golden composite extract. Then, 18 wt% of the prepared lettuce and golden composite extract powder and 36 wt% of fructose were mixed, and this was mixed with a batch type fluidized bed having an intake air temperature of 50 to 80 캜 and an exhaust temperature of 30 to 40 캜 Purified water was injected into the fluidization through the injector three times in total while transferring to the granulator and fluidizing the mixture inside the fluidized bed granulator. Thus, the lettuce and the golden composite extract powder granules coated with the crystalline fructose-coated lettuce and the golden composite extract powder were obtained.
<< 실험예Experimental Example 1> 상추 및 황금 복합 추출물 분말 과립의 용해도 확인 1> Determination of Solubility of Lettuce and Golden Composite Extract Powder Granules
과립 제조 시 상추 및 황금 복합 추출물 분말과 결정과당의 혼합 비율에 달리하여 제조한 본 발명의 복합 추출물 분말 과립의 용해도를 확인하기 위하여, 분산성 및 침전성을 분석하였다.In order to confirm the solubility of the granules of the complex extract of the present invention prepared by varying the mixing ratio of the lettuce and the golden complex extract powder and the crystalline fructose in the granule production, the dispersibility and the sedimentation property were analyzed.
구체적으로, 상기 <실시예 2>에 기재된 방법과 동일한 방법으로 진행하되, 상추 및 황금 복합 추출물 분말 18 중량%에 결정과당을 1 : 1 (#1), 1 : 1.5 (#2), 1 : 2 (#3), 1 : 2.5 (#4) 및 1 : 3 (#5)의 중량% 비율로 혼합하여 상추 및 황금 복합 추출물 분말 과립을 제조하였다.(# 1), 1: 1.5 (# 2), and 1: 1 (# 2) were added to 18% by weight of the lettuce and the golden composite extract powder, respectively, in the same manner as described in Example 2, (# 3), 1: 2.5 (# 4) and 1: 3 (# 5) by weight to prepare an extract of lettuce and a golden composite powder.
그 다음, 분산성을 분석하기 위하여, 상기 복합 추출물 분말 과립 각각을 마시는 물 100 ㎖에 10 g씩 첨가하고 섞은 다음 실온에서 10분 동안 방치한 후 스펙트로포토미터(spectrophotometer)로 450 mn에서 흡광도를 측정하고, 하기 [수학식 1]을 이용하여 투광도(T%)를 계산하였다. 이 때 투광도는 시료의 농도와 무관하기 때문에 배합 비율에 따른 농도 편차 오류를 배제할 수 있다. 또한, 투광도가 10인 경우 90%의 빛이 시료를 통과하지 못함을 의미한다.Next, to analyze the dispersibility, 10 g of each of the above-mentioned extract powder granules was added to 100 ml of drinking water, and the mixture was allowed to stand at room temperature for 10 minutes. Then, the absorbance was measured at 450 mn by a spectrophotometer , And the transmittance (T%) was calculated using the following formula (1). In this case, since the transmittance is independent of the concentration of the sample, the concentration deviation error due to the mixing ratio can be excluded. Also, when the transmittance is 10, it means that 90% of the light can not pass through the sample.
* A= 450 nm 흡광도값* A = absorbance value at 450 nm
또한, 침전성을 분석하기 위하여, 분말 간 응집력에 의해 발생한 침전물의 양 및 침전물 낸 공극률 증가로 높아진 침전물의 높이를 측정하였다. 상기 복합 추출물 분말 과립 각각을 마시는 물 100 ㎖가 포함된 단위면적 15.7 cm2 유리병에 10 g씩 첨가하고 섞은 다음 실온에서 7일 동안 방치한 후 상층액을 제거하였다. 그 다음, 유리병 단위면적당 침전된 침전물의 높이를 측정하고, 침전물을 70℃에서 6 시간 동안 건조한 후 침전물의 양을 측정한 다음, 하기 [수학식 2]를 이용하여 침전율(%)을 계산하였다.In order to analyze the sedimentation property, the height of precipitate increased by the amount of precipitate generated by the cohesive force between powders and the porosity of the precipitate was measured. 10 g of each of the combined extract powder granules was added to a 15.7 cm 2 glass bottle containing 100 ml of drinking water, and the mixture was allowed to stand at room temperature for 7 days, and then the supernatant was removed. Then, the height of the precipitate per unit area of the glass bottle was measured, and the precipitate was dried at 70 DEG C for 6 hours, and the amount of the precipitate was measured. Then, the sedimentation rate (%) was calculated using the following formula .
대조군으로 상기 <실시예 1>에서 제조한 상추 추출물 분말 및 황금 추출물 분말을 1 : 1의 혼합비율로 혼합한 복합 추출물 분말을 이용하였다.As a control, the complex extract powder obtained by mixing the lettuce extract powder and the gold extract powder prepared in Example 1 at a mixing ratio of 1: 1 was used.
그 결과, 표 1에 나타낸 바와 같이, 코팅 공정을 거치지 않은 대조군의 경우 투광도가 9.036%, 침전율이 18.9%로 나타나 용해도가 좋지 않은 반면, 코팅 공정을 거친 복합 추출물 분말 과립의 용해도가 우수함을 확인하였다. 특히, 복합 추출물 분말과 결정과당의 혼합 비율이 1 : 1.5 내지 3일 때 용해도가 현저히 우수함을 확인하였다.
As a result, as shown in Table 1, in the control group not subjected to the coating process, the transparency was 9.036% and the precipitation rate was 18.9%, indicating that the solubility of the composite extract powder granules after the coating process was excellent . Particularly, it was confirmed that the solubility was remarkably excellent when the mixing ratio of the combined extract powder and fructose was 1: 1.5 to 3.
<< 실험예Experimental Example 2> 상추 및 황금 복합 추출물 분말 과립에 대한 관능 평가 2> Sensory Evaluation of Powder Granules of Lettuce and Gold Composite Extracts
본 발명의 상추 및 황금 복합 추출물 분말 과립의 향, 맛 및 종합적 기호도를 알아보기 위하여, 상기 <실험예 1>에서 용해도가 우수한 복합 추출물 분말 과립을 이용하여 관능평가를 수행하였다. In order to examine the flavor, taste and overall acceptability of the lettuce and golden composite extract powder granules of the present invention, the sensory evaluation was carried out by using the powdery granules of the extract having excellent solubility in the <Experimental Example 1>.
구체적으로, 관능평가는 향, 맛 및 전체적인 기호도 등이 충분히 훈련된 전문관능시험요원 20명에게 상기 <실험예 1>에서 상추 및 황금 복합 추출물 분말에 결정과당을 1 : 2.5의 중량% 비율로 혼합한 복합 추출물 분말 과립 10 g을 용해한 음용수 100 ㎖를 섭취하게 하고, 7점 척도법으로, 즉, 매우 좋음(7), 좋음(6), 약간 좋음(5), 보통(4), 약간 싫음(3), 싫음(2), 매우 싫음(1)으로 평가한 후, 그 평균점으로 판정하였다.Specifically, the sensory evaluation was carried out by mixing 20 fructose-fructose extract powders of lettuce and gold complex extract powder with a weight ratio of 1: 2.5 in Experimental Example 1, (7), good (6), slightly better (5), moderate (4), slightly favorable (3) ), Liked (2), and very disliked (1).
판정기준은 다음과 같다.The criteria are as follows.
매우 좋음 : 7.0 점;Very good: 7.0 points;
좋음 : 6.0 점;Good: 6.0 points;
약간 좋음 : 5.0 점;Slightly better: 5.0 points;
보통 : 4.0 점;Average: 4.0 points;
약간 싫음 : 3.0 점;Some likes: 3.0 points;
싫음 : 2.0 점; 및Liking: 2.0 points; And
매우 싫음 : 1.0 점.Very liked: 1.0 points.
그 결과, 하기 표 2에 나타낸 바와 같이, 본 발명의 상추 및 황금 복합 추출물 분말 과립의 쓴맛이 거의 느껴지지 않고 단맛 및 목넘김이 음용하기에 양호하며, 종합적 기호도가 우수함을 확인하였다.
As a result, as shown in the following Table 2, it was confirmed that the bitter taste of the lettuce and golden composite extract powder granules of the present invention was hardly felt, and the sweetness and throat were good for drinking, and the overall acceptability was excellent.
<< 실험예Experimental Example 3> 상추 및 황금 복합 추출물 분말 과립에 의한 수면 증진 확인 3> Confirmation of sleep enhancement by powdered granules of lettuce and golden compound extract
본 발명의 상추 및 황금 복합 추출물 분말 과립에 의한 수면 증진 효능을 확인하기 위하여, 상기 <실험예 1>에서 용해도가 우수한 복합 추출물 분말 과립을 이용하여 수면의 질을 분석하였다.In order to confirm the sleep enhancement efficacy of the lettuce and golden composite extract powder granules according to the present invention, the quality of the sleep surface was analyzed by using the granules of the extract having excellent solubility in the <Experimental Example 1>.
구체적으로, 피험자 40명을 대상으로 실험군 20명 및 대조군 20명으로 나누고, 실험군 20명에게 상기 <실험예 1>에서 상추 및 황금 복합 추출물 분말에 결정과당을 1 : 2.5의 중량% 비율로 혼합한 복합 추출물 분말 과립 10 g을 용해한 음용수 100 ㎖를 1일 1회 복용하게 하였다. 대조군 20명에게는 위약을 1일 1회 복용하게 하였다.Specifically, the test subjects were divided into 20 experimental groups and 20 control groups. Twenty experimental groups were mixed with the lettuce and golden composite extract powder in the ratio of 1: 2.5 by weight in the <Experimental Example 1> 100 ml of drinking water in which 10 g of the complex extract granules were dissolved was taken once a day. Twenty patients in the control group received placebo once a day.
그 다음, PSQI(Pittsburgh Sleep Quality Index)를 이용하여 수면의 질을 평가하였다. PSQI의 평가항목은 하기 [표 3]에 나타내었다. 이 때, 유효성은 실험군과 대조군에 대하여 독립 표본 t-test를 사용하였다(p<0.05). 실험 전 수면의 질을 평가하여 하기 [표 4]와 같이 각 그룹 간 유의미한 차이가 없음을 확인하였다.Next, the quality of sleep was assessed using the Pittsburgh Sleep Quality Index (PSQI). The evaluation items of PSQI are shown in Table 3 below. At this time, the efficacy was tested by independent t-test for the experimental group and the control group (p <0.05). The quality of sleep before the experiment was evaluated and it was confirmed that there was no significant difference between the groups as shown in Table 4 below.
이 후, 7일간 수면의 질을 평가하였다. 설문지 작성은 1인당 2회 작성하며, 시료를 복용하기 전에 작성하고 7일간 시료를 복용한 후 동일한 설문지를 다시 작성하였다.After this, the quality of sleep was evaluated for 7 days. The questionnaires were written twice per person, before the sample was taken, and after taking the sample for 7 days, the same questionnaire was rewritten.
각각의 항목에서 0점은 아무런 어려움 없다는 것을 나타내며, 3점은 심각한 어려움을 나타낸다. 7가지 컴포넌트(component) 점수들를 합산하여 하나의 전체적 점수를 산출하였고, 0~21의 점수 범위를 가진다. 0점은 아무런 어려움이 없다는 것을 나타내며, 21점은 전 방면에 걸쳐 심각한 어려움을 가지는 것을 나타낸다.
In each item, 0 indicates no difficulty, and 3 indicates serious difficulty. Seven component scores are summed to produce a total score, ranging from 0 to 21. A score of 0 indicates that there is no difficulty, and a score of 21 indicates that there is a serious difficulty across the front.
그 결과, 표 5에 나타낸 바와 같이, 대조군에 비해 본 발명의 상추 및 황금 복합 추출물 분말 과립을 복용한 실험군의 수면 유도 효능이 보다 우수하며, 이를 통해 상추 및 황금 복합 추출물에 의해 수면의 질이 개선됨을 확인하였다.
As a result, as shown in Table 5, the test group taking the lettuce and golden compound extract powder granules according to the present invention had better sleep inducing effect than the control group, thereby improving the quality of sleep by the lettuce and golden compound extract Respectively.
Control group
1.08
1.05
3.225
0.004
Experimental group
2.26
1.87
6.112
0.000
Claims (14)
Lettuce ( Lactuca sativa ) and golden ( Scutellaria The present invention relates to a pharmaceutical composition for preventing or treating sleep disorder or sleep disorder,
The method of claim 1, wherein the combined extract comprises water, C 1 To C 2 lower alcohol, or a mixed solvent thereof.
The pharmaceutical composition according to claim 2, wherein the lower alcohol is ethanol or methanol.
The pharmaceutical composition for preventing or treating sleep disorder or sleep disorder according to claim 1, wherein the complex extract is formulated in a weight ratio of 1: 0.5 to 2 of lettuce and gold.
The pharmaceutical composition for preventing or treating sleep disorder or sleep disorder according to claim 1, wherein the complex extract is formulated into granulated powder granules.
1) 상추 추출물 분말 및 황금 추출물 분말을 혼합하여 복합 추출물 분말을 제조하는 단계;
2) 단계 1)의 복합 추출물 분말 및 당류를 혼합하여 시드(seed)를 제조하는 단계; 및
3) 단계 2)의 시드를 유동층 과립기의 내부에 첨가하여 유동화하고, 물을 분사하여 당류가 코팅된 복합 추출물 분말 과립을 수득하는 단계.
The pharmaceutical composition for preventing or treating sleep disorder or sleep disorder according to claim 5, wherein the powder granules are produced through the following steps:
1) preparing a complex extract powder by mixing a lettuce extract powder and a gold extract powder;
2) preparing a seed by mixing the complex extract powder of step 1) and saccharides; And
3) adding the seed of step 2) to the inside of the fluidized bed granulator to fluidize, and spraying water to obtain a saccharide-coated complex extract powder granule.
The pharmaceutical composition according to claim 1, wherein the sleep disorder or sleep disorder is selected from the group consisting of insomnia, narcolepsy, abnormal sleep behavior, and sleepiness.
Lettuce and a golden compound extract as an active ingredient for preventing or ameliorating sleep disorder or sleep disorder; For improving the quality of sleep; Or health food for diurnal rhythm change.
2) 단계 1)의 복합 추출물 분말 및 당류를 혼합하여 시드를 제조하는 단계; 및
3) 단계 2)의 시드를 유동층 과립기의 내부에 첨가하여 유동화하고, 물을 분사하여 당류가 코팅된 복합 추출물 분말 과립을 수득하는 단계를 포함하는, 상추 및 황금 복합 추출물 분말 과립의 제조방법.
1) preparing a complex extract powder by mixing a lettuce extract powder and a gold extract powder;
2) preparing a seed by mixing the complex extract powder and saccharides of step 1); And
3) adding the seed of step 2) to the inside of the fluidized bed granulator to fluidize, and spraying water to obtain a saccharide-coated complex extract powder granule.
[Claim 11] The method according to claim 9, wherein the extract of lettuce extract and the powder of gold extract are mixed at a weight ratio of 1: 0.5 to 2 in the step 1).
[Claim 9] The method according to claim 9, wherein the complex extract powder and saccharide are mixed at a weight ratio of 1: 1.0 to 3.5 in step 2).
The method according to claim 9, wherein 15 to 25 parts by weight of the complex extract powder and 15 to 75 parts by weight of the saccharide are mixed in step 2).
The method according to claim 9, wherein the saccharide is selected from the group consisting of anhydrous crystalline glucose, hydrolyzed glucose, fructose, maltose, sucrose, oligosaccharide, dextrin, cyclodextrin, xylitol, sorbitol, erythritol, palatinose, trehalose, stevioside, Wherein the extract is selected from the group consisting of sucralose, aspartame, and acacetam potassium.
13. The extract granules of lettuce and golden complex extract according to any one of claims 9 to 13.
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| CN1334016A (en) * | 2001-08-01 | 2002-02-06 | 宋连春 | scutellaria tea and its preparing process |
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| KR20140064280A (en) * | 2012-11-20 | 2014-05-28 | 노태진 | Somniferous composition comprising the extracts, fractions or isolated compounds of lettuce and process for preparation thereof |
| KR20160010159A (en) * | 2014-07-18 | 2016-01-27 | 노태진 | Grain syrup based on lettuce those flower stalk came up |
| KR101779536B1 (en) | 2017-05-11 | 2017-09-18 | 주식회사농심 | Composition for treating sleep disorder and enhacning sleeping time containing polygonatum extract |
| KR20170123534A (en) * | 2016-04-29 | 2017-11-08 | 주식회사 벤스랩 | Composition for improving sleep disturbance and sleep inducing |
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