KR102141737B1 - Composition for treating depression and anxiety comprising mixture of creatine and taurine - Google Patents
Composition for treating depression and anxiety comprising mixture of creatine and taurine Download PDFInfo
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- KR102141737B1 KR102141737B1 KR1020180126942A KR20180126942A KR102141737B1 KR 102141737 B1 KR102141737 B1 KR 102141737B1 KR 1020180126942 A KR1020180126942 A KR 1020180126942A KR 20180126942 A KR20180126942 A KR 20180126942A KR 102141737 B1 KR102141737 B1 KR 102141737B1
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- South Korea
- Prior art keywords
- creatine
- taurine
- anxiety
- mixture
- present
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Abstract
본 발명은 크레아틴 및 타우린의 혼합물을 유효성분으로 함유하는, 우울장애 및 불안장애 치료용 약학적 조성물 및 긴장 완화용 건강기능식품 조성물에 관한 것이다.The present invention relates to a pharmaceutical composition for treating depressive disorder and anxiety disorder and a health functional food composition for relaxing tension, which contains a mixture of creatine and taurine as an active ingredient.
Description
본 발명은 크레아틴 및 타우린의 혼합물을 함유하는 우울장애 및 불안장애의 치료용 약학적 조성물에 관한 것으로, 구체적으로는 크레아틴이 타우린과 같거나 더 많은 양으로 존재하는 혼합물을 함유하는 우울장애 및 불안장애의 치료용 약학적 조성물에 관한 것이다.The present invention relates to a pharmaceutical composition for the treatment of depressive disorder and anxiety disorder, which contains a mixture of creatine and taurine, specifically, depressive disorder and anxiety disorder, which contains a mixture in which creatine is present in an amount equal to or greater than taurine. It relates to a pharmaceutical composition for the treatment of.
현대 사회는 급격히 발전되고 다변화됨에 따라 현대인들에게 여러 가지 역할을 요구하며, 이에 따라 각종 스트레스로 인한 우울 및 불안 장애를 호소하는 사람들이 증가하고 있다. 질병관리본부에서 수행한 2008 - 2016년 지역사회건강조사 결과에 따르면 평소 일상 생활 중 스트레스를 "대단히 많이" 또는 "많이" 느끼는 사람의 스트레스 인지율은 평균 28.3%로 보고 하고 있으며, 이는 지난 8년간 변동 없는 추세를 보고하고 있다. 스트레스로 인한 긴장은 일시적으로 우울 증상 및 불안 증상(초조, 걱정, 근심) 유발하며, 오래 지속되는 경우 적응장애, 수면장애, 불안장애 등의 원인이 되므로 조기에 적극적으로 증상을 개선하기 위한 개입이 중요하다 (질병관리본부 지역사회건강조사 2016-2008, https://chs.cdc.go.kr).As the modern society is rapidly developed and diversified, various roles are demanded by modern people, and accordingly, people who complain of depression and anxiety disorders due to various stresses are increasing. According to the 2008-2016 Community Health Survey conducted by the Korea Centers for Disease Control and Prevention, the average stress perception rate of people who feel "very much" or "high" during daily life is reported to be 28.3% on average, which has changed over the past 8 years. It is reporting a missing trend. Tension caused by stress temporarily causes depressive symptoms and anxiety symptoms (anxiety, anxiety, anxiety), and if it lasts long, it can cause adaptive disorder, sleep disorder, anxiety disorder, etc. It is important (Community Health Research Center for Disease Control and Prevention 2016-2008, https://chs.cdc.go.kr).
현재 임상에서 우울증상이나 불안증상에 대한 약물치료는 주로 diazepam, lorazepam, clonazepam, alprazolam 등의 benzodiazepine 계통의 항불안 약물 혹은 azapirone계의 buspirone 그리고, zolpidem과 같은 imidazopyridine계통의 약물도 불안증으로 인한 단기 불면증 치료에 사용되고 있다.In current clinical trials, medications for depression or anxiety symptoms are mainly for the treatment of short-term insomnia caused by anxiety by anti-anxiety drugs such as diazepam, lorazepam, clonazepam, alprazolam, or benzodiazepine-based anti-anxiety drugs, or azapirone-based buspirone, and imidazopyridine-based drugs such as zolpidem. Is being used.
그러나, 이러한 약물들은 항정신성 의약품으로 분류되는 약물이며, 심리적, 신체적으로 의존하게 만들어 약물 남용이 우려되는 등의 위험성을 내포하고 있다. However, these drugs are classified as antipsychotic drugs, and have risks such as fear of drug abuse by making them psychologically and physically dependent.
이에, 천연물을 이용하여 의존성이 낮으면서도 효과적으로 불안장애, 우울장애 등의 긴장을 완화 내지 치료할 수 있는 물질의 개발이 요구되는 실정이다.Accordingly, there is a need to develop a substance that can effectively relieve or treat tensions such as anxiety disorders and depressive disorders while having low dependence using natural products.
이러한 배경 하에, 본 발명자들은 우울, 불안 등의 긴장완화 효과를 나타내는 천연물을 발굴하고자 노력하였다. 그 결과, 크레아틴 및 타우린의 혼합물이 크레아틴 또는 타우린 단일물에 비해 뛰어난 긴장완화 효과를 나타낼 수 있음을 발견하여 본 발명을 완성하였다. Under these backgrounds, the present inventors tried to find natural products that exhibit a tension-relieving effect such as depression and anxiety. As a result, the present invention was completed by discovering that a mixture of creatine and taurine can exhibit superior tension-releasing effects compared to creatine or taurine monoliths.
본 발명의 목적은 크레아틴 및 타우린의 혼합물을 유효성분으로 함유하는 우울장애 및 불안장애 치료용 약학적 조성물을 제공하는 것이다.An object of the present invention is to provide a pharmaceutical composition for the treatment of depressive disorder and anxiety disorder containing a mixture of creatine and taurine as an active ingredient.
본 발명의 다른 목적은 크레아틴 및 타우린의 혼합물을 유효성분으로 함유하는 긴장 완화용 건강기능식품을 제공하는 것이다. Another object of the present invention is to provide a health functional food for relaxation of tension containing a mixture of creatine and taurine as an active ingredient.
그러나, 본 발명이 해결하고자 하는 과제는 이상에서 언급한 과제로 제한되지 않으며, 언급되지 않은 또 다른 과제들은 아래의 기재로부터 해당 기술분야의 통상의 지식을 가진 자에게 명확하게 이해될 수 있을 것이다.However, the problems to be solved by the present invention are not limited to the problems mentioned above, and other problems not mentioned will be clearly understood by those having ordinary knowledge in the art from the following description.
본 발명의 일 실시예에 따르면, 크레아틴 및 타우린의 혼합물을 유효성분으로 함유하는, 우울장애 및 불안장애 치료용 약학적 조성물이 제공된다.According to an embodiment of the present invention, there is provided a pharmaceutical composition for treating depressive disorder and anxiety disorder, which contains a mixture of creatine and taurine as an active ingredient.
일 측에 따르면, 크레아틴은 타우린과 같거나 더 많은 양으로 존재할 수 있다.According to one side, creatine may be present in the same amount as or greater than taurine.
일 측에 따르면, 크레아틴 및 타우린의 비율은 1:1 내지 3:1일 수 있다.According to one side, the ratio of creatine and taurine may be 1:1 to 3:1.
일 측에 따르면, 감미제, 착향제, 보존제, 용해보조제, 유화제, pH 조절제, 항산화제 및 착색제로 이루어지는 군으로부터 선택되는 하나 이상의 약학적으로 허용가능한 첨가제를 더 포함할 수 있다.According to one side, it may further include one or more pharmaceutically acceptable additives selected from the group consisting of sweeteners, flavoring agents, preservatives, solubilizers, emulsifiers, pH adjusting agents, antioxidants and colorants.
본 발명의 다른 일 실시예에 따르면, 크레아틴 및 타우린의 혼합물을 유효성분으로 함유하는, 긴장 완화용 건강기능식품 조성물이 제공된다.According to another embodiment of the present invention, a health functional food composition for relaxation of tension is provided, which contains a mixture of creatine and taurine as an active ingredient.
일 측에 따르면, 크레아틴은 타우린과 같거나 더 많은 양으로 존재할 수 있다.According to one side, creatine may be present in the same amount as or greater than taurine.
일 측에 따르면, 크레아틴 및 타우린의 비율은 1:1 내지 3:1일 수 있다.According to one side, the ratio of creatine and taurine may be 1:1 to 3:1.
본 발명의 크레아틴 및 타우린의 혼합물을 유효성분으로 함유하는 우울장애 및 불안장애 치료용 약학적 조성물은 오랜 기간동안 인류가 섭취해 온 천연물을 유효성분으로 함유하므로 안전성이 높다. The pharmaceutical composition for the treatment of depressive disorder and anxiety disorder, which contains the mixture of creatine and taurine of the present invention as an active ingredient, has high safety because it contains natural substances that humans have ingested for a long time as an active ingredient.
또한, 본 발명의 조성물에 함유된 크레아틴 및 타우린의 혼합물은 크레아틴 또는 타우린 단일물에 비해 뛰어난 긴장완화 효과를 나타낼 수 있다. In addition, the mixture of creatine and taurine contained in the composition of the present invention may exhibit superior relaxation effect compared to creatine or taurine monohydrate.
본 발명의 효과는 상기한 효과로 한정되는 것은 아니며, 본 발명의 상세한 설명 또는 청구범위에 기재된 발명의 구성으로부터 추론 가능한 모든 효과를 포함하는 것으로 이해되어야 한다.It should be understood that the effects of the present invention are not limited to the above-described effects, and include all effects that can be deduced from the configuration of the invention described in the detailed description or claims of the present invention.
도 1은 우울/불안 장애 초파리 모델에 크레아틴, 타우린 및 크레아틴과 타우린의 혼합물을 투여한 후 등반 활동도(Climbing activity)를 측정하여 나타낸 것이다.
도 2a 내지 도 2e는 각각 우울/불안 장애 초파리 모델에 크레아틴, 타우린 및 크레아틴과 타우린의 혼합물을 투여한 후 비디오 추적을 통해 움직인 거리(Distance moved), 속도(velocity), 움직인 시간(Moving), 움직이지 않은 시간(Not moving) 및 이동도(mobility)를 관측하여 나타낸 것이다.
도 3는 우울/불안 장애 초파리 모델에 크레아틴, 타우린 및 크레아틴과 타우린의 혼합물을 투여한 후 초파리 활동 모니터링 시스템(Drosophila activity monitoring system, DAM)을 측정한 결과를 actogram으로 나타낸 것이다.
도 4은 우울/불안 장애 초파리 모델에 크레아틴(B), 타우린(C) 및 크레아틴과 타우린의 혼합물(A)을 투여한 경우의 생존률을 비교한 것이다.
도 5는 우울/불안 장애 마우스 모델에 크레아틴과 타우린을 1:1 및 3:1 비율로 혼합한 혼합물을 투여한 후 오픈 필드 테스트에서 관측된 움직인 거리, 움직인 시간, 움직이지 않은 시간, 중앙(center zone)에 머무르는 시간과 빈도를 측정하여 나타낸 것이다.
도 6는 우울/불안 장애 마우스 모델에 크레아틴과 타우린을 1:1 및 3:1 비율로 혼합한 혼합물을 투여하여 꼬리 매달기 실험(Tail suspension test)을 진행한 경우의 이동도, 움직임 및 움직이지 않은 정도를 측정하여 나타낸 것이다. FIG. 1 shows the measurement of climbing activity after administration of creatine, taurine, and a mixture of creatine and taurine to a Drosophila model of depressive/anxiety disorder.
2A to 2E show the distance moved, velocity, and moving time through video tracking after administering creatine, taurine, and a mixture of creatine and taurine to a depressed/anxiety disorder Drosophila model, respectively. , It is shown by observing not moving time and mobility.
FIG. 3 is an actogram showing the results of measuring a Drosophila activity monitoring system (DAM) after administering creatine, taurine, and a mixture of creatine and taurine to a Drosophila/anxiety disorder Drosophila model.
4 is a comparison of survival rates when creatine (B), taurine (C), and a mixture of creatine and taurine (A) are administered to a depressive/anxiety disorder Drosophila model.
Figure 5 is a depressed / anxiety disorder mouse model after administering a mixture of creatine and taurine in a ratio of 1:1 and 3:1, the observed distance, movement time, movement time, median observed in the open field test It shows the time and frequency of staying in the (center zone).
FIG. 6 shows the mobility, movement, and motion of a mouse model of depressive/anxiety disorder in a tail suspension test by administering a mixture of creatine and taurine in a 1:1 and 3:1 ratio. It was measured and measured.
이하에서, 첨부된 도면을 참조하여 실시예들을 상세하게 설명한다. 그러나, 실시예들에는 다양한 변경이 가해질 수 있어서 특허출원의 권리 범위가 이러한 실시예들에 의해 제한되거나 한정되는 것은 아니다. 실시예들에 대한 모든 변경, 균등물 내지 대체물이 권리 범위에 포함되는 것으로 이해되어야 한다.Hereinafter, embodiments will be described in detail with reference to the accompanying drawings. However, various changes may be made to the embodiments, and the scope of the patent application right is not limited or limited by these embodiments. It should be understood that all modifications, equivalents, or substitutes for the embodiments are included in the scope of rights.
실시예에서 사용한 용어는 단지 설명을 목적으로 사용된 것으로, 한정하려는 의도로 해석되어서는 안된다. 단수의 표현은 문맥상 명백하게 다르게 뜻하지 않는 한, 복수의 표현을 포함한다. 본 명세서에서, "포함하다" 또는 "가지다" 등의 용어는 명세서 상에 기재된 특징, 숫자, 단계, 동작, 구성요소, 부품 또는 이들을 조합한 것이 존재함을 지정하려는 것이지, 하나 또는 그 이상의 다른 특징들이나 숫자, 단계, 동작, 구성요소, 부품 또는 이들을 조합한 것들의 존재 또는 부가 가능성을 미리 배제하지 않는 것으로 이해되어야 한다.The terms used in the examples are used for illustrative purposes only and should not be construed as limiting. Singular expressions include plural expressions unless the context clearly indicates otherwise. In this specification, terms such as “include” or “have” are intended to indicate that a feature, number, step, operation, component, part, or combination thereof described on the specification exists, and that one or more other features are present. It should be understood that the existence or addition possibilities of fields or numbers, steps, operations, components, parts or combinations thereof are not excluded in advance.
다르게 정의되지 않는 한, 기술적이거나 과학적인 용어를 포함해서 여기서 사용되는 모든 용어들은 실시예가 속하는 기술 분야에서 통상의 지식을 가진 자에 의해 일반적으로 이해되는 것과 동일한 의미를 가지고 있다. 일반적으로 사용되는 사전에 정의되어 있는 것과 같은 용어들은 관련 기술의 문맥 상 가지는 의미와 일치하는 의미를 가지는 것으로 해석되어야 하며, 본 출원에서 명백하게 정의하지 않는 한, 이상적이거나 과도하게 형식적인 의미로 해석되지 않는다.Unless otherwise defined, all terms used herein, including technical or scientific terms, have the same meaning as commonly understood by a person skilled in the art to which the embodiment belongs. Terms, such as those defined in a commonly used dictionary, should be interpreted as having meanings consistent with meanings in the context of related technologies, and should not be interpreted as ideal or excessively formal meanings unless explicitly defined in the present application. Does not.
또한, 첨부 도면을 참조하여 설명함에 있어, 도면 부호에 관계없이 동일한 구성 요소는 동일한 참조부호를 부여하고 이에 대한 중복되는 설명은 생략하기로 한다. 실시예를 설명함에 있어서 관련된 공지 기술에 대한 구체적인 설명이 실시예의 요지를 불필요하게 흐릴 수 있다고 판단되는 경우 그 상세한 설명을 생략한다.In addition, in the description with reference to the accompanying drawings, the same reference numerals are assigned to the same components regardless of reference numerals, and redundant descriptions thereof will be omitted. In describing the embodiments, when it is determined that detailed descriptions of related known technologies may unnecessarily obscure the subject matter of the embodiments, the detailed descriptions will be omitted.
본 명세서에서 사용된 용어 "크레아틴(creatine)"은 질소를 포함하고 있는 유기산의 일종으로서, 생체 내에서 합성되며 척추동물 근육의 에너지 공급에 중요한 역할을 하는 물질을 의미한다. The term "creatine" as used herein refers to a substance that is synthesized in vivo and plays an important role in the energy supply of vertebrate muscle as a kind of organic acid containing nitrogen.
본 명세서에서 사용된 용어 "타우린(taurine, 2-aminoethanesulfonic acid)"은 유기산의 일종으로서, 근골격계를 만들고 심혈관계가 기능을 유지하는데 필수적이며, 뇌혈관장벽(blood brain barrier, BBB)을 통과할 수 있어서 신경전달물질을 막고, 해마의 기능을 강화시키는 등 중추신경계의 기능을 조절할 수도 있다고 알려진 물질을 의미한다.The term "taurine (2-aminoethanesulfonic acid)" as used herein is a type of organic acid, it is necessary to make the musculoskeletal system and maintain the cardiovascular system, and can pass through the blood brain barrier (BBB). It means a substance known to be able to control the functions of the central nervous system, such as blocking neurotransmitters and enhancing the function of the hippocampus.
본 명세서에서 사용되는 용어, "치료"란 본 발명의 조성물의 투여에 의해 우울장애 또는 불안장애에 의한 증세가 호전되거나 이롭게 변경되는 모든 행위를 의미한다.As used herein, the term "treatment" refers to all actions in which symptoms of depression or anxiety disorder are improved or beneficially changed by administration of the composition of the present invention.
본 발명자 들은 종래에 다양한 용도로 사용되어 왔던 크레아틴 및 타우린의 혼합물이 크레아틴 또는 타우린의 단일물에 비해 현저히 뛰어난 우울/불안 증세를 완화하는 긴장 완화효과가 있음을 발견하여 본 발명을 완성하였다.The present inventors have completed the present invention by discovering that the mixture of creatine and taurine, which has been used for various purposes, has a tension-relieving effect to alleviate significantly depressive/anxiety symptoms compared to creatine or taurine single substances.
따라서, 본 발명의 일 실시예에 따르면, 크레아틴 및 타우린의 혼합물을 유효성분으로 함유하는, 우울장애 및 불안장애 치료용 약학적 조성물이 제공된다.Accordingly, according to an embodiment of the present invention, there is provided a pharmaceutical composition for treating depression and anxiety disorder, which contains a mixture of creatine and taurine as an active ingredient.
특히, 상기 혼합물에서는 크레아틴이 타우린과 같거나 더 많은 양으로 존재하는 것이 바람직하다. 구체적으로, 크레아틴과 타우린의 비율은 1:1 내지 5:1일 수 있으며, 보다 바람직하게는 1:1 내지 3:1이다. 한편, 크레아틴과 타우린의 비율이 상기 범위를 벗어나는 경우 긴장 완화 효과가 저하되며, 특히 크레아틴의 양이 타우린 보다 적은 양으로 존재하게 되는 경우에는 크레아틴 및 타우린의 단독물을 이용하는 경우보다 긴장 완화 효과가 떨어지게 된다.In particular, it is preferred that creatine is present in the mixture in an amount equal to or greater than taurine. Specifically, the ratio of creatine and taurine may be 1:1 to 5:1, and more preferably 1:1 to 3:1. On the other hand, if the ratio of creatine and taurine is out of the above range, the effect of reducing tension is lowered. In particular, when the amount of creatine is present in a smaller amount than taurine, the effect of relaxing the tension is lower than when using the creatine and taurine alone. do.
본 발명의 약학적 조성물은 약제로 이용되기 위해서 약제학적 분야에서 공지된 방법에 의해 제조될 수 있으며, 약학적으로 허용되는 담체, 부형제, 희석제, 안정화제, 방부제 등과 혼합하여 분말, 과립, 정제, 캡슐제, 또는 주사제 등의 제형으로 제조되어 사용될 수 있다. The pharmaceutical composition of the present invention may be prepared by a method known in the pharmaceutical field for use as a pharmaceutical, and is mixed with a pharmaceutically acceptable carrier, excipient, diluent, stabilizer, preservative, etc. to form powders, granules, tablets, It can be prepared and used as a formulation such as capsules or injections.
상기 희석제로는 프로필렌 글리콜, 폴리에틸렌 글리콜, 올리브유, 땅콩유와 같은 식물성유 등의 비수성 용매나 염수(바람직하게는 0.8%의 염수), 완충 매질을 포함한 물(바람직하게는 0.05M의 인산염 완충액) 등의 수성 용매 등을 들 수 있으나, 이에 한정되는 것은 아니다.As the diluent, non-aqueous solvents such as propylene glycol, polyethylene glycol, olive oil, and vegetable oils such as peanut oil, brine (preferably 0.8% brine), and water containing a buffering medium (preferably 0.05M phosphate buffer) And an aqueous solvent such as, but is not limited thereto.
상기 부형제로는 전분, 글루코스, 락토스, 수크로스, 젤라틴, 맥아, 쌀, 밀가루, 백악, 실리카 겔, 나트륨 스테아레이트, 글리세롤 모노스테아레이트, 활석, 나트륨 클로라이드, 무수 탈지유, 글리세롤, 프로필렌, 글리콜, 물, 에탄올 등을 들 수 있으나, 이에 한정되는 것은 아니다.The excipients include starch, glucose, lactose, sucrose, gelatin, malt, rice, wheat flour, chalk, silica gel, sodium stearate, glycerol monostearate, talc, sodium chloride, skimmed anhydride, glycerol, propylene, glycol, water , Ethanol and the like, but is not limited thereto.
상기 안정화제로는 소르비톨, 만니톨, 전분, 수크로스, 덱스트란, 글루타메이트, 글루코스 등의 탄수화물이나 분유, 혈청 알부민, 카제인 등의 동물성, 식물성 또는 미생물성 단백질 등의 단백질을 들 수 있으나, 이에 한정되는 것은 아니다.Examples of the stabilizing agent include sorbitol, mannitol, starch, sucrose, dextran, glutamate, glucose, and other carbohydrates or powdered milk, proteins such as animal, vegetable or microbial proteins such as serum albumin and casein. no.
상기 방부제로는 티메로살, 메르티올레이트, 젠타마이신, 네오마이신, 니스타틴, 암포테리신 B, 테트라사이클린, 페니실린, 스트렙토마이신, 폴리믹신 B 등을 들 수 있으나, 이에 한정되는 것은 아니다.The preservative may include thimerosal, merthiolate, gentamicin, neomycin, nistatin, amphotericin B, tetracycline, penicillin, streptomycin, polymyxin B, and the like, but is not limited thereto.
상기 약학적 조성물은 개별 치료제로 투여되거나 다른 치료제와 병용하여 투여될 수 있고 종래의 치료제와 순차로 또는 동시에 투여될 수 있다. 그리고 단일 또는 다중 투여될 수 있다. 상기 요소를 모두 고려하여 부작용없이 최소한의 양으로 최대 효과를 얻을 수 있는 양을 투여하는 것이 중요하며, 이는 당업자에 의해 용이하게 결정될 수 있다.The pharmaceutical composition may be administered as an individual therapeutic agent or in combination with other therapeutic agents, and may be administered sequentially or simultaneously with a conventional therapeutic agent. And it can be administered single or multiple. Considering all of the above factors, it is important to administer an amount that can achieve the maximum effect in a minimal amount without side effects, which can be easily determined by those skilled in the art.
또한, 이들은 비경구 투여(예컨대, 정맥 내, 피하, 복강 내 또는 국소에 적용)하거나 경구 투여될 수 있다. 비경구 투여는 정맥내, 근육내, 복강내, 흉골내, 경피 및 동맥내 주사 및 주입을 포함하는 투여 방식을 의미한다. 상기 조성물의 비경구 투여는 바람직한 순도 하에 약제학적으로 허용 가능한 담체, 즉 사용되는 농도와 투여량에서 수용체에 비독성이고 다른 제제 성분과 혼화 될 수 있는 것을 혼합하여 단위 투여량의 제형으로 조제하는 것이 바람직할 수 있다.In addition, they can be administered parenterally (eg, applied intravenously, subcutaneously, intraperitoneally or topically) or orally. Parenteral administration means a mode of administration including intravenous, intramuscular, intraperitoneal, intrasternal, transdermal and intraarterial injections and infusions. Parenteral administration of the composition is to prepare a unit dosage form by mixing a pharmaceutically acceptable carrier under a desired purity, that is, non-toxic to the receptor at the concentration and dosage used and miscible with other formulation ingredients. It may be desirable.
본 발명의 약학적 조성물은 치료학적으로 유효한 양으로 투여한다. 상기 치료학적으로 유효한 양(therapeutically effective amount)은 의학적 치료에 적용 가능한 합리적인 수혜/위험 비율로 질환을 치료하기에 충분한 양을 의미하며, 환자의 연령, 성별, 체중, 건강상태, 질병의 증상, 투여시간, 투여방법에 따라 적적히 선택될 수 있으며, 바람직하게는 성인기준 1일 0.001 ~ 100 mg이 투여될 수 있다.The pharmaceutical composition of the present invention is administered in a therapeutically effective amount. The therapeutically effective amount means an amount sufficient to treat the disease at a reasonable benefit/risk ratio applicable to medical treatment, and the patient's age, gender, weight, health condition, symptoms of the disease, and administration It may be appropriately selected according to the time and the administration method, and preferably, 0.001 to 100 mg per day based on an adult may be administered.
본 발명의 다른 일 실시예에 따르면, 크레아틴 및 타우린의 혼합물을 유효성분으로 함유하는, 긴장 완화용 건강기능식품 조성물이 제공된다. According to another embodiment of the present invention, a health functional food composition for relaxation of tension is provided, which contains a mixture of creatine and taurine as an active ingredient.
본 명세서에서 사용되는 용어 "개선"이란 치료되는 상태와 관련된 파라미터, 예를 들면 증상의 정도를 적어도 감소시키는 모든 행위를 의미한다.As used herein, the term "improvement" refers to any action that at least reduces the severity of the parameters associated with the condition being treated, such as symptoms.
본 발명에 따른 건강기능식품 조성물은 우울/불안 등의 긴장을 완화시키는 효과를 가지므로, 우울/불안 증세를 보이지만 우울장애 또는 불안장애를 갖는 것은 아닌 사람들의 증상을 개선 또는 완화할 목적으로 식품, 음료 등의 건강보조 식품에 첨가할 수 있다.The health functional food composition according to the present invention has an effect of alleviating tension such as depression/anxiety, and thus food for the purpose of improving or alleviating symptoms of people who show symptoms of depression/anxiety but who do not have depression or anxiety disorder, It can be added to health supplements such as drinks.
본 발명의 우울장애 및 불안장애 치료용 약학적 조성물과 마찬가지로 상기 혼합물에서는 크레아틴이 타우린 보다 많은 양으로 존재하는 것이 바람직하다. 구체적으로, 크레아틴과 타우린의 비율은 1:1 내지 5:1일 수 있으며, 보다 바람직하게는 1:1 내지 3:1이다.Like the pharmaceutical composition for the treatment of depressive disorder and anxiety disorder of the present invention, it is preferable that creatine is present in a larger amount than taurine in the mixture. Specifically, the ratio of creatine and taurine may be 1:1 to 5:1, and more preferably 1:1 to 3:1.
상기 식품의 종류에는 특별한 제한은 없다. 상기 물질을 첨가할 수 있는 식품의 예로는 드링크제, 육류, 소시지, 빵, 비스킷, 떡, 초콜릿, 캔디류, 스낵류, 과자류, 피자, 라면, 기타 면류, 껌류, 아이스크림류를 포함한 낙농제품, 각종 스프, 음료수, 알코올 음료 및 비타민 복합제, 유제품 및 유가공 제품 등이 있으며, 통상적인 의미에서의 건강기능식품을 모두 포함한다.There are no particular restrictions on the type of food. Examples of foods to which the above substances can be added are drinks, meat, sausage, bread, biscuits, rice cake, chocolate, candy, snacks, confectionery, pizza, ramen, other noodles, gums, dairy products including ice cream, various soups, Beverages, alcoholic beverages and vitamin complexes, dairy products and dairy products, etc., and include all functional foods in the ordinary sense.
본 발명의 건강기능식품 조성물은 식품에 그대로 첨가하거나 다른 식품 또는 식품 성분과 함께 사용될 수 있고, 통상적인 방법에 따라 적절하게 사용될 수 있다. 유효 성분의 혼합량은 그의 사용 목적(예방 또는 개선용)에 따라 적합하게 결정될 수 있다. 일반적으로, 식품 또는 음료의 제조시에 본 발명의 조성물은 원료에 대하여 15 중량% 이하, 바람직하게는 10 중량% 이하의 양으로 첨가된다. 그러나 건강 및 위생을 목적으로 하거나 또는 건강 조절을 목적으로 하는 장기간의 섭취의 경우에는 상기 양은 상기 범위 이하일 수 있다.The health functional food composition of the present invention may be added as it is to foods or used with other foods or food ingredients, and may be suitably used according to conventional methods. The mixing amount of the active ingredient can be appropriately determined according to its purpose of use (for prevention or improvement). Generally, the composition of the present invention is added in an amount of 15% by weight or less, preferably 10% by weight or less, with respect to the raw materials in the manufacture of a food or beverage. However, in the case of long-term intake for health and hygiene purposes or for health control purposes, the amount may be below the above range.
본 발명의 건강기능식품 조성물은 지시된 비율로 필수 성분으로서 상기 화합물을 함유하는 외에는 다른 성분에는 특별한 제한이 없으며 통상의 음료와 같이 여러 가지 향미제 또는 천연 탄수화물 등을 추가 성분으로서 함유할 수 있다. 상술한 천연 탄수화물의 예는 모노사카라이드, 예를 들어, 포도당, 과당 등; 디사카라이드, 예를 들어 말토스, 슈크로스 등; 및 폴리사카라이드, 예를 들어 덱스트린, 시클로덱스트린 등과 같은 통상적인 당, 및 자일리톨, 소르비톨, 에리트리톨 등의 당알콜이다. 상술한 것 이외의 향미제로서 천연 향미제(타우마틴, 스테비아 추출물(예를 들어 레바우디오시드 A, 글리시르히진등) 및 합성 향미제(사카린, 아스파르탐 등)를 유리하게 사용할 수 있다. 상기 천연 탄수화물의 비율은 당업자의 선택에 의해 적절하게 결정될 수 있다.The health functional food composition of the present invention has no particular limitation on other ingredients except for containing the compound as an essential ingredient in the indicated proportions, and may contain various flavoring agents or natural carbohydrates, etc., as additional ingredients, such as ordinary drinks. Examples of the natural carbohydrates described above include monosaccharides, such as glucose, fructose, and the like; Disaccharides such as maltose, sucrose, etc.; And polysaccharides, for example, conventional sugars such as dextrin, cyclodextrin, and sugar alcohols such as xylitol, sorbitol, and erythritol. As flavoring agents other than those described above, natural flavoring agents (taumatine, stevia extract (for example, rebaudioside A, glycyrrhizine, etc.) and synthetic flavoring agents (saccharin, aspartame, etc.) can be advantageously used. The proportion of the natural carbohydrate can be appropriately determined by the choice of those skilled in the art.
그 밖에 본 발명의 건강기능식품 조성물은 여러 가지 영양제, 비타민, 광물(전해질), 합성 풍미제 및 천연 풍미제 등의 풍미제, 착색제 및 중진제(치즈, 초콜릿 등), 펙트산 및 그의 염, 알긴산 및 그의 염, 유기산, 보호성 콜로이드 증점제, pH 조절제, 안정화제, 방부제, 글리세린, 알코올, 탄산음료에 사용되는 탄산화제 등을 함유할 수 있다. 그 밖에 본 발명의 조성물은 천연 과일 쥬스 및 과일 쥬스 음료 및 야채 음료의 제조를 위한 과육을 함유할 수 있다. 이러한 성분은 독립적으로 또는 조합하여 사용할 수 있다. 이러한 첨가제의 비율 또한 당업자에 의해 적절히 선택될 수 있다In addition, the health functional food composition of the present invention includes various nutrients, vitamins, minerals (electrolytes), flavoring agents such as synthetic flavoring agents and natural flavoring agents, coloring agents and neutralizing agents (cheese, chocolate, etc.), pectic acid and salts thereof, Alginic acid and salts thereof, organic acids, protective colloidal thickeners, pH adjusting agents, stabilizers, preservatives, glycerin, alcohols, carbonic acid used in carbonated beverages, and the like. In addition, the composition of the present invention may contain natural fruit juice and pulp for the production of fruit juice beverages and vegetable beverages. These ingredients can be used independently or in combination. The proportion of these additives can also be appropriately selected by those skilled in the art
이하, 실시예를 통하여 본 발명을 보다 상세히 설명하기로 한다. 하기 실시예는 본 발명을 예시하기 위한 목적으로 기술된 것으로서, 본 발명의 범위가 이에 한정되는 것은 아니다.Hereinafter, the present invention will be described in more detail through examples. The following examples are described for the purpose of illustrating the present invention, and the scope of the present invention is not limited thereto.
<실시예 1: 우울/불안 장애 동물모델의 제조>< Example 1: Preparation of animal model for depressive/anxiety disorder >
1-1. 초파리 동물모델의 제조1-1. Preparation of Drosophila animal models
초파리를 DAM vial에 한 마리씩 넣고, shaker를 이용해 300 Hz 진동을 20초간 주고 10초 휴식하는 것을 15분간 반복 후 30분간 다시 휴식하는 전체 cycle을 하루에 12번 수행함으로써 초파리에게 스트레스를 부여하여 우울/불안 장애 초파리 동물모델을 제조하였다.Drosophila is stressed and depressed by putting Drosophila one on a DAM vial, applying 300 Hz vibration for 20 seconds using a shaker, and repeating 10 seconds of rest for 15 minutes and then performing a full cycle of rest for 30 minutes 12 times a day. An anxiety disorder Drosophila animal model was prepared.
1-2. 마우스 동물모델의 제조1-2. Preparation of mouse animal models
마우스를 구속 홀더에 넣어 4시간동안 구속 스트레스를 주는 것을 통해 우울/불안 장애 마우스 동물모델을 제조하였다. A mouse animal model of depressive/anxiety disorder was prepared by placing the mouse in a restraint holder and applying restraint stress for 4 hours.
<실시예 2: 크레아틴 및 타우린 혼합물의 항 우울 /불안 효과 평가 - 초파리 동물모델>< Example 2: Evaluation of anti-depressive /anxiety effect of creatine and taurine mixture -Drosophila animal model >
2-1 초파리 등반 2-1 Drosophila climbing 활동도(Climbing activity) 를Climbing activity 이용한 Used 항 우울Anti-depression /불안 효과 및 안전성 평가/Anxiety effect and safety evaluation
상기 실시예 1-1의 방법으로 제조한 초파리 동물 모델에 크레아틴, 타우린의 단일물을 각각 0.05%, 0.1%, 0.15%, 0.2% 농도로 포함하는 시약과 크레아틴 및 타우린의 혼합물(크레아틴과 타우린의 비율 1:1, 3:1, 1:2) 시약을 투여하였다. A mixture of creatine and taurine (a ratio of creatine and taurine) with a reagent containing creatine and taurine in a concentration of 0.05%, 0.1%, 0.15%, and 0.2%, respectively, in the Drosophila animal model prepared by the method of Example 1-1. 1:1, 3:1, 1:2) Reagent was administered.
그 다음, 원형플라스틱 vial에 20마리씩 넣고 vial을 바닥에 살살 내려쳐 초파리를 바닥에 떨어트린 뒤, 15초 후 초파리가 얼마나 위로 올라가는지 측정하였다. Next, 20 animals were placed in a circular plastic vial, and the vial was gently lowered to the bottom to drop the fruit fly to the floor, and after 15 seconds, the fruit fly climbed up.
그 결과, 도 1에 나타난 바와 같이 우울/불안 초파리에서 감소되었던 등반 활동도(Climbing activity)가 크레아틴이 타우린보다 더 많은 혼합물인 3:1에서 크레아틴 및 타우린의 단일물 또는 2:1,1:1 크레아틴 및 타우린 혼합물에 비해 정상 초파리 수준(normal line)까지 증가하며 항우울/불안 효과를 보였다. As a result, as shown in FIG. 1, the reduced climbing activity in depressed/anxiety Drosophila is a mixture of creatine and taurine in a 3:1 mixture with more creatine than taurine, or a 2:1,1:1 creatine. And compared to the taurine mixture, it increased to the normal Drosophila level (normal line) and showed antidepressant/anxiety effect.
2-2 초파리 Video tracking을 이용한 2-2 Using Drosophila Video Tracking 항 우울Anti-depression /불안 효과 및 안전성 평가/Anxiety effect and safety evaluation
상기 실시예 1-1의 방법으로 3일간 스트레스를 부여하여 제조한 초파리 동물 모델에 크레아틴, 타우린의 단일물을 각각 0.05%, 0.1%, 0.15%, 0.2% 농도로 포함하는 시약과 크레아틴 및 타우린의 혼합물(크레아틴과 타우린의 비율 1:1, 3:1, 1:2) 시약을 투여하였다. 그 다음, 지름 8cm인 원형 arena에 초파리를 한마리씩 넣고 5분간 초파리의 움직임을 촬영 후 분석하였다. 초파리의 행동은 움직인 거리(distance moved), 속도(velocity), 움직임(moving), 움직이지 않은 정도(not moving), 이동도(mobility)지표로 측정하였다. Creatine and a mixture of creatine and taurine, each containing 0.05%, 0.1%, 0.15%, and 0.2% concentrations of creatine and taurine in a Drosophila animal model prepared by applying stress for 3 days in the method of Example 1-1. (Creatine to taurine ratio 1:1, 3:1, 1:2) Reagent was administered. Then, each of the fruit flies was placed in a circular arena having a diameter of 8 cm, and the movement of the fruit flies was analyzed for 5 minutes. Drosophila behavior was measured by distance moved, velocity, moving, not moving, and mobility indicators.
그 결과, 도 2a 내지 도 2e에 나타난 바와 같이 우울/불안 초파리에서 크레아틴 및 타우린의 혼합물을 투여한 군이 크레아틴과 타우린을 단일 투여한 군에 비해 감소되었던 움직인 거리(distance moved), 속도(velocity), 움직임(moving), 이동도(mobility)이 정상 초파리 수준(normal line)만큼 증가하였고, 증가되었던 움직이지 않은 정도(not moving)가 정상 초파리 수준(normal line)만큼 감소하는 항우울/불안 효과가 관찰되었다.As a result, as shown in Figs. 2A to 2E, the group administered with a mixture of creatine and taurine in depressed/anxiety Drosophila decreased distance and velocity compared to the creatine and taurine single group. ), antidepressant/anxiety effect that the movement and mobility increased by the normal Drosophila level, and the increased not moving decreased by the Normal Drosophila level. Was observed.
2-3. 초파리 활동 2-3. Fruit fly activity 모니터링monitoring 시스템( system( DrosophilaDrosophila activity monitoring system, DAM)을 이용한 activity monitoring system (DAM) 항 우울Anti-depression /불안 효과 및 안전성 평가/Anxiety effect and safety evaluation
상기 실시예 1-1에서 제조한 초파리 동물 모델에 크레아틴, 타우린의 단일물을 각각 0.05%, 0.1%, 0.15%, 0.2% 농도로 포함하는 시약과 크레아틴 및 타우린의 혼합물(크레아틴과 타우린의 비율 1:1, 3:1, 1:2) 시약을 투여하였다.A mixture of creatine and taurine (a ratio of creatine and taurine 1: 1) and a reagent comprising creatine and taurine in 0.05%, 0.1%, 0.15%, and 0.2% concentrations, respectively, in the Drosophila animal model prepared in Example 1-1. 1, 3:1, 1:2) Reagent was administered.
그 다음, 시약을 투여한 초파리를 직경 0.5 cm에 길이 7 cm인 투명한 DAM vial 안에 한 마리씩 넣고, DAM vial의 한쪽 끝에는 초파리 밥을 넣은 뒤 반대쪽을 솜으로 막았다. DAM vial의 중앙에 센서가 위치하도록 조절한 뒤 초파리의 움직임을 측정했다. DAM은 3일간 초파리를 암흑에 적응시킨 뒤 빛의 유무와는 관계없이 일주기 리듬(circadian rhythm)이 잘 잡혔는지 확인 후 암흑 속에서 실험을 진행했다. 실험은 하루 스트레스를 주고, 다음날 측정하는 방식으로 총 3번 반복했으며, DAM 으로 총 움직임(total movement) actogram 측정과 동시에 초파리의 생존률(survival rate)을 함께 확인했다.Then, each of the Drosophila to which the reagent was administered was placed in a transparent DAM vial 0.5 cm in diameter and 7 cm in length, Drosophila rice was placed at one end of the DAM vial, and the other side was blocked with cotton. After adjusting the sensor to be located in the center of the DAM vial, the movement of the fruit fly was measured. DAM adapted Drosophila to darkness for 3 days, and then conducted experiments in the dark after confirming that the circadian rhythm was well caught with or without light. The experiment was repeated a total of three times by stressing the day and measuring the next day, and the survival rate of Drosophila was confirmed simultaneously with the measurement of the total movement actogram with DAM.
그 결과, 도 3에 나타낸 바와 같이, 크레아틴 및 타우린의 혼합물을 투여한 경우, 우울/불안 초파리에서 관찰되었던 일주기리듬 패턴의 교란이 정상 초파리군 패턴과 비슷하게 회복되며 항우울/불안 효과가 관찰되었다. 특히 크레아틴:타우린 3:1 혼합물이 정상 초파리군과 가장 비슷한 패턴을 보였다.As a result, as shown in FIG. 3, when a mixture of creatine and taurine was administered, disturbance of the circadian rhythm pattern observed in depressed/anxiety Drosophila recovered similar to that of the normal Drosophila group pattern, and antidepressive/anxiety effect was observed. . In particular, the creatine:taurine 3:1 mixture showed the most similar pattern to the normal fruit fly group.
생존률은 도 4에 나타낸 바와 같이, 크레아틴과 타우린의 비율이 1:2인 경우를 제외하고는 크레아틴 및 타우린 단일물의 투여에 비해 혼합물의 생존률이 정상 수준보다 더 높은 것을 확인할 수 있었다.As shown in FIG. 4, it was confirmed that the survival rate of the mixture was higher than the normal level compared to the administration of the creatine and taurine single agents, except that the ratio of creatine and taurine was 1:2.
<실시예 3: 크레아틴 및 타우린 혼합물의 항 우울 /불안 효과 평가 - 마우스 동물모델>< Example 3: Evaluation of anti-depressive /anxiety effect of creatine and taurine mixture -mouse animal model >
상기 실시예 1-2에서 제조한 마우스 동물모델에 크레아틴과 타우린의 비율을 각각10:0, 1:1, 1:3, 3:1, 0:10으로 혼합한 혼합물 시약을 투여하여 다음의 실험에 이용하였으며, 대조군으로는 정상 마우스 및 상기 실시예 1-2에서 제조한 마우스 동물모델에 플루옥세틴(fluoxetine)을 투여한 마우스를 이용하였다.In the mouse animal model prepared in Example 1-2, the mixture of creatine and taurine in a ratio of 10:0, 1:1, 1:3, 3:1, and 0:10 was administered to each of the following experiments. As a control, a normal mouse and a mouse to which fluoxetine was administered to the mouse animal model prepared in Example 1-2 were used.
3-1. 오픈 필드 테스트3-1. Open field test
마우스를 가로 세로 40 cm의 검은 상자에 넣고, 자유롭게 움직이는 것을 비디오로 촬영한 후 Ethovision으로 분석했다. 마우스의 총 이동거리와 움직이는 시간, 그리고 상자 중심부의 15*15 cm의 center zone에 들어간 횟수, 머무른 시간을 측정하여 도 5에 나타냈다.The mouse was placed in a black box with a width of 40 cm, and free-moving motion pictures were recorded and analyzed with Ethovision. The total moving distance and the moving time of the mouse, the number of times in the center zone of 15*15 cm in the center of the box, and the residence time are measured and shown in FIG. 5.
그 결과, 도 5에 나타낸 바와 같이, 오픈 필드 테스트를 통해 관측할 수 있는 총 이동거리, 움직인 시간, 머무른 시간, 중앙(center zone)에 머무른 시간과 빈도에 있어 크레아틴과 타우린을 3:1 및 1:1로 투여한 우울/불안 마우스는 정상 마우스 및 플루옥세틴을 투여한 마우스와 유사한 수치를 나타내 항우울/불안 효과를 보인 반면, 크레아틴 또는 타우린의 단일물(10:0, 0:10)이나, 크레아틴을 타우린보다 적은 양으로 투여한 경우(1:3) 우울/불안 마우스에는 정상범위(normal line)를 넘거나, 이에 미치지 못하는 결과를 보여 항우울/불안 효과가 관찰되지 않았다. As a result, as shown in FIG. 5, the creatine and taurine were 3:1 and 3 in terms of total travel distance, travel time, stay time, and time and frequency of stay in the center zone, which can be observed through the open field test. Depressed/anxiety mice administered at 1:1 showed similar levels to normal mice and mice administered fluoxetine, showing antidepressant/anxiety effects, whereas creatine or taurine singles (10:0, 0:10) or creatine When administered in an amount less than taurine (1:3), depressed/anxiety mice showed results that exceeded or did not reach the normal line, and no antidepressant/anxiety effect was observed.
3-2. 꼬리 매달기 실험(Tail suspension test)3-2. Tail suspension test
각 칸 마다 칸막이를 설치하여 마우스들 간의 영향을 방지하고, 칸의 위쪽에 mouse의 꼬리를 매달았다. 5분 동안 마우스가 발버둥 치며 위로 올라가려는 행동을 video 촬영하고, Ethovision으로 분석하여 그 결과를 도 6에 나타냈다.A divider was installed in each compartment to prevent the influence between the mice, and the tail of the mouse was hung on the top of the compartment. For 5 minutes, a video of a mouse struggling to climb upward was taken, and analyzed by Ethovision, and the results are shown in FIG. 6.
도 6에 나타낸 바와 같이, 이동도(mobility), 움직임(moving) 및 움직이지 않은 정도(not moving)에 있어 크레아틴과 타우린을 3:1 및 1:1로 투여한 우울/불안 마우스는 정상 마우스 및 플루옥세틴을 투여한 마우스와 유사한 수치를 나타내 항우울/불안 효과를 보인 반면, 크레아틴 또는 타우린의 단일물(10:0, 0:10)이나, 크레아틴을 타우린보다 적은 양으로 투여한 경우(1:3)에는 정상범위에 미치지 못하여 항우울/불안 효과가 관찰되지 않았다As shown in FIG. 6, depressed/anxiety mice administered with creatine and taurine at 3:1 and 1:1 in normal mobility and mobility, mobility and not moving were normal mice and It showed similar anti-depressive/anxiety effects to mice that received fluoxetine, whereas creatine or taurine single substance (10:0, 0:10) or creatine was administered in smaller amounts than taurine (1:3). The antidepressant/anxiety effect was not observed because it did not reach the normal range.
이상과 같이 실시예들이 비록 한정된 도면에 의해 설명되었으나, 해당 기술분야에서 통상의 지식을 가진 자라면 상기를 기초로 다양한 기술적 수정 및 변형을 적용할 수 있다. 예를 들어, 설명된 기술들이 설명된 방법과 다른 순서로 수행되거나, 및/또는 설명된 구성요소들이 설명된 방법과 다른 형태로 결합 또는 조합되거나, 다른 구성요소 또는 균등물에 의하여 대치되거나 치환되더라도 적절한 결과가 달성될 수 있다.As described above, although the embodiments have been described by the limited drawings, those skilled in the art can apply various technical modifications and variations based on the above. For example, even if the described techniques are performed in a different order than the described method, and/or the described components are combined or combined in a different form from the described method, or replaced or replaced by another component or equivalent Appropriate results can be achieved.
그러므로, 다른 구현들, 다른 실시예들 및 특허청구범위와 균등한 것들도 후술하는 청구범위의 범위에 속한다.Therefore, other implementations, other embodiments, and equivalents to the claims are also within the scope of the following claims.
Claims (7)
A pharmaceutical composition for treating depressive disorder or anxiety disorder, which contains a mixture of creatine and taurine as an active ingredient, and wherein creatine is present in a greater amount than the taurine.
크레아틴 및 타우린의 질량비는 1:1 초과 3:1 이하인, 우울장애 또는 불안장애 치료용 약학적 조성물.
According to claim 1,
The pharmaceutical composition for treating depressive disorder or anxiety disorder, wherein the mass ratio of creatine and taurine is greater than 1:1 and less than 3:1.
감미제, 착향제, 보존제, 용해보조제, 유화제, pH 조절제, 항산화제 및 착색제로 이루어지는 군으로부터 선택되는 하나 이상의 약학적으로 허용가능한 첨가제를 더 포함하는, 우울장애 또는 불안장애 치료용 약학적 조성물.
According to claim 1,
A pharmaceutical composition for treating depressive disorder or anxiety disorder, further comprising at least one pharmaceutically acceptable additive selected from the group consisting of sweeteners, flavoring agents, preservatives, solubilizers, emulsifiers, pH adjusting agents, antioxidants, and colorants.
A composition containing creatine and taurine as an active ingredient, and the creatine is present in a larger amount than the taurine, a health functional food composition for relaxation of tension.
크레아틴 및 타우린의 질량비는 1:1 초과 3:1 이하인, 긴장 완화용 건강기능식품 조성물.
The method of claim 5,
The mass ratio of creatine and taurine is greater than 1:1 and 3:1 or less, a health functional food composition for relaxation of tension.
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