KR102338347B1 - Composition for preventing or treating tic disorders comprising an extract of Rehmannia glutinosa as an active ingredient - Google Patents
Composition for preventing or treating tic disorders comprising an extract of Rehmannia glutinosa as an active ingredient Download PDFInfo
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- KR102338347B1 KR102338347B1 KR1020200009819A KR20200009819A KR102338347B1 KR 102338347 B1 KR102338347 B1 KR 102338347B1 KR 1020200009819 A KR1020200009819 A KR 1020200009819A KR 20200009819 A KR20200009819 A KR 20200009819A KR 102338347 B1 KR102338347 B1 KR 102338347B1
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- South Korea
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- extract
- present
- composition
- tic
- rehmannia
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Abstract
본 발명은 지황(Rehmannia glutinosa) 추출물 또는 이의 분획물을 유효성분으로 포함하는, 틱 장애의 예방 또는 치료용 약학적 조성물, 의약외품 조성물, 식품 조성물 및 상기 조성물을 인간을 제외한 개체에게 투여하는 단계를 포함하는, 틱 장애의 예방 또는 치료 방법에 관한 것이다.
본 발명의 지황 추출물 또는 이의 분획물은 눈 깜박임을 비롯한 틱 장애의 증상을 효과적으로 억제시킬 수 있는바, 지황 추출물을 유효성분으로 포함하는 본 발명의 조성물은 틱 장애 또는 투렛 증후군의 예방 또는 치료를 목적으로 유용하게 사용될 수 있다.The present invention comprises the step of administering to Rehmannia (Rehmannia glutinosa) extract or a fraction of the active ingredient, the prevention or treatment a pharmaceutical composition of the tic disorder comprising thereof, quasi compositions, food compositions, and objects except the composition of human , to a method for preventing or treating a tic disorder.
The Rehmannia Extract or a fraction thereof of the present invention can effectively suppress symptoms of tic disorders including blinking. It can be usefully used.
Description
본 발명은 지황(Rehmannia glutinosa) 추출물 또는 이의 분획물을 유효성분으로 포함하는, 틱 장애의 예방 또는 치료용 약학적 조성물, 의약외품 조성물, 식품 조성물 및 상기 조성물을 인간을 제외한 개체에게 투여하는 단계를 포함하는, 틱 장애의 예방 또는 치료 방법에 관한 것이다.The present invention comprises the step of administering to Rehmannia (Rehmannia glutinosa) extract or a fraction of the active ingredient, the prevention or treatment a pharmaceutical composition of the tic disorder comprising thereof, quasi compositions, food compositions, and objects except the composition of human , to a method for preventing or treating a tic disorder.
틱 장애(tic disorder)는 갑자기 반복적이고 불수의적이며 불규칙한 상동적 근육운동 또는 음성이 특징적으로 나타나는 소아기 신경질환이다. 틱은 단순틱과 복합틱으로 나눌 수 있고, 또한 근육틱과 음성틱으로도 나눌 수 있다. 1년 이상 지속적으로 근육틱 또는 음성틱이 나타날 경우 투렛 증후군(Tourette syndrome)으로 진행할 수 있다. 투렛 증후군은 만성적인 예후를 나타내며, 적당한 시기에 치료를 받지 않을 경우 평생 동안 지속되기도 한다. 해외 연구 결과에 따르면 틱 장애의 유병률은 약 6-12% 정도로 보고되고 있으며, 투렛 증후군은 약 0.3 내지 1%로 보고되고 있다. 국내의 경우 건강보험심사평가원 자료에 의하면, 진단받은 환자수는 연평균 약 5%씩 증가하여 2015년 기준 약 1만 6천 명이 진료를 받았으며, 연령별로는 10대가 42.5%, 10세 미만이 37.9%로 대부분 10대 이하에서 발생하였다. 증상은 얼굴과 목 등 신체 상부에서 시작하여 다리 쪽으로 진행하는 경향이 있으며, 사춘기 초기까지 증상이 가장 심했다가 후반부터 점차 호전되어 성인기에는 환자의 25%에서만 증상이 나타난다. 한편, 이러한 틱 장애는 유전적 요소 또는 환경적 요소의 상호작용으로 발생할 수 있다. 구체적으로, 도파민 계통의 이상이나 뇌의 피질-선조체-시상-피질 회로의 이상 등 신경생물학적 원인이 있을 수 있으며, 부모가 어릴 때 틱 증상을 보인 유전적 원인이 있을 수 있다.Tic disorder is a childhood neurological disorder characterized by sudden, repetitive, involuntary, and irregular stereotyped muscle movements or voices. Tics can be divided into simple tics and complex tics, and also into muscular tics and vocal tics. If muscular or vocal tics continue for more than 1 year, it may progress to Tourette Syndrome. Tourette's syndrome has a chronic prognosis and may persist for life if not treated in a timely manner. According to the results of overseas studies, the prevalence of tic disorders is reported to be about 6-12%, and Tourette's syndrome is reported to be about 0.3 to 1%. In Korea, according to data from the Health Insurance Review and Assessment Service, the number of diagnosed patients increased by an average of 5% per year, with approximately 16,000 people receiving treatment as of 2015. Most of them occurred under the age of 10. Symptoms tend to start in the upper part of the body, such as the face and neck, and progress toward the legs. Symptoms are the most severe until early puberty, and then gradually improve from the latter part of puberty, and symptoms appear in only 25% of patients in adulthood. On the other hand, these tic disorders may occur due to the interaction of genetic factors or environmental factors. Specifically, there may be neurobiological causes such as abnormalities in the dopamine system or abnormalities in the cortical-striatal-thalamus-cortical circuit in the brain, and there may be genetic causes in which parents showed tic symptoms when they were young.
틱 장애의 치료는 크게 행동치료와 약물치료로 나눌 수 있는데, 특히 약물 치료에서는 도파민계 작용약물인 할로페리돌(haloperidol), 피모지드(pimozide), 리스페리돈(risperidone) 등이 사용되며, 이 경우 약 70-80% 또는 틱 장애 또는 투렛 증후군 환자들의 증상이 호전된다. 다만, 그 부작용으로는 진전 증상, 정좌불능증, 추체외로증상, 체중증가 및 지연성 운동부전증 등이 알려져 있다. 그밖에 비정형 항정신병 약물인 올란자핀(olanzapine), 노르에피네프린계 작용 약물인 클로니딘(clonidine), GABA계 작용 약물인 바클로펜(baclofen), 세로토닌계 작용 약물인 플루옥세틴(fluoxetine) 등이 알려져 있으나, 이 역시 추체외로증상, 불면증 및 피로감 등 부작용이 많은 것으로 보고되었다.Treatment of tic disorders can be broadly divided into behavioral therapy and drug therapy. In particular, dopaminergic drugs such as haloperidol, pimozide, and risperidone are used in drug treatment, and in this case, about 70- Symptoms improve in 80% or in patients with tic disorder or Tourette's syndrome. However, as side effects, tremor symptoms, akathisia, extrapyramidal symptoms, weight gain, and tardive dyskinesia are known. Other known atypical antipsychotic drugs, such as olanzapine, norepinephrine, clonidine, GABA, baclofen, and serotonin, fluoxetine, are also known. Many side effects such as extrapyramidal symptoms, insomnia and fatigue have been reported.
한편, 지황(Rehmannia glutinosa)은 현삼과에 속하는 여러해살이 초본식물로, 중국산 식물로 전체에 짧은 털이 있으며 뿌리는 굵고 옆으로 뻗으며 감색을 나타낸다. 지황의 뿌리는 한방에서 약재로 사용하는데, 그대로 사용하는 것은 생지황, 건조시켜 쓰는 것은 건지황, 술을 넣고 쪄서 만든 것은 숙지황으로 알려져 있다. 지황의 추출물은 혈액응고를 촉진하거나 이뇨 작용 및 해열 등의 효과가 있는 것으로 알려져 있으나, 지황 추출물 단독으로 틱 장애 또는 또는 투렛 증후군에 대한 치료 효과 등은 전혀 알려진 바가 없었다.On the other hand, Rehmannia glutinosa is a herbaceous perennial plant belonging to the family Hyonsengaceae, a Chinese plant, has short hairs, thick roots, and a dark blue color. Rehmannia root is used as a medicinal herb in oriental medicine, and it is known as raw jihwang when used as it is, dried jihuang for use, and steamed with alcohol as sukjihwang. It is known that the extracts of rehuhuang promote blood coagulation or have diuretic and antipyretic effects, but the therapeutic effect of rehmannia extract alone on tic disorders or Tourette's syndrome has not been known at all.
이러한 배경하에 본 발명의 발명자들은 틱 장애의 증상 완화 효과가 있으면서도 부작용이 없는 소재를 개발하고자 예의 노력한 결과, 지황 추출물 또는 이의 분획물이 암페타민 또는 2,5-Dimethoxy-4-iodoamphetamine(DOI)로 유도된 눈 깜박임, 머리 흔들기 등 틱 장애의 증상을 감소시킬 수 있는바, 이를 틱 장애 또는 투렛 증후군의 예방 또는 치료를 위한 조성물로 사용할 수 있음을 확인하여 본 발명을 완성하였다.Under this background, the inventors of the present invention made diligent efforts to develop a material that has no side effects while having an effect of alleviating the symptoms of tic disorders. As a result, the extract or a fraction thereof was induced with amphetamine or 2,5-Dimethoxy-4-iodoamphetamine (DOI). The present invention was completed by confirming that it can be used as a composition for preventing or treating tic disorders or Tourette's syndrome since it can reduce symptoms of tic disorders such as blinking eyes and shaking the head.
본 발명의 하나의 목적은 지황(Rehmannia glutinosa) 추출물 또는 이의 분획물을 유효성분으로 포함하는, 틱 장애의 예방 또는 치료용 약학적 조성물을 제공하는 것이다.One object of the invention to provide a pharmaceutical composition for preventing or treating, tic disorders, including Rehmannia (Rehmannia glutinosa) extract or fractions thereof as an active ingredient.
본 발명의 다른 하나의 목적은 지황 추출물 또는 이의 분획물을 유효성분으로 포함하는, 틱 장애의 예방 또는 개선용 의약외품 조성물을 제공한다.Another object of the present invention is to provide a quasi-drug composition for the prevention or improvement of tic disorders, comprising a Rehmannia glutinosa extract or a fraction thereof as an active ingredient.
본 발명의 또 다른 하나의 목적은 지황 추출물 또는 이의 분획물을 유효성분으로 포함하는, 틱 장애의 예방 또는 개선용 식품 조성물을 제공한다.Another object of the present invention is to provide a food composition for preventing or improving tic disorders, comprising a Rehmannia glutinosa extract or a fraction thereof as an active ingredient.
본 발명의 또 다른 하나의 목적은 상기 조성물을 인간을 제외한 개체에게 투여하는 단계를 포함하는, 틱 장애의 예방 또는 치료 방법을 제공하는 것이다.Another object of the present invention is to provide a method for preventing or treating tic disorders, comprising administering the composition to a subject other than humans.
이를 구체적으로 설명하면 다음과 같다. 한편, 본 출원에서 개시된 각각의 설명 및 실시형태는 각각의 다른 설명 및 실시 형태에도 적용될 수 있다. 즉, 본 출원에서 개시된 다양한 요소들의 모든 조합이 본 출원의 범주에 속한다. 또한, 하기 기술된 구체적인 서술에 의하여 본 출원의 범주가 제한된다고 볼 수 없다.This will be described in detail as follows. Meanwhile, each description and embodiment disclosed in the present application may be applied to each other description and embodiment. That is, all combinations of the various elements disclosed in the present application fall within the scope of the present application. In addition, it cannot be seen that the scope of the present application is limited by the detailed description described below.
상기 목적을 달성하기 위한 본 발명의 하나의 양태는 지황(Rehmannia glutinosa) 추출물 또는 이의 분획물을 유효성분으로 포함하는, 틱 장애의 예방 또는 치료용 약학적 조성물을 제공한다.One aspect of the present invention for achieving the above object provides a pharmaceutical composition for preventing or treating tic disorders, comprising a Rehmannia glutinosa extract or a fraction thereof as an active ingredient.
본 발명 지황 추출물 또는 이의 분획물을 개체에 투여할 경우, 암페타민 또는 2,5-Dimethoxy-4-iodoamphetamine(DOI)로 유도된 틱 반응(눈 깜박임, 머리 흔들기)을 비롯한 틱 장애의 증상을 감소시킬 수 있는바, 이는 지황 추출물 또는 이의 분획물을 유효성분으로 포함하는 조성물이 틱 장애 또는 투렛 증후군의 예방 또는 치료 효과가 있음을 나타내는 것이며, 이러한 효과는 본 발명의 발명자들에 의해 최초로 규명된 점에서 그 의의가 매우 크다.When the extract of the present invention or a fraction thereof is administered to a subject, symptoms of tic disorders including amphetamine or 2,5-Dimethoxy-4-iodoamphetamine (DOI)-induced tic reactions (blinking eyes, head shaking) can be reduced. As a result, this indicates that the composition comprising the extract or a fraction thereof as an active ingredient has a preventive or therapeutic effect on tic disorders or Tourette's syndrome, and this effect is significant in that it was first identified by the inventors of the present invention. is very large
본 발명에서 용어 "지황(Rehmannia glutinosa)"은 현삼과에 속하는 여러해살이 초본식물로, 중국산 식물로 전체에 짧은 털이 있으며 뿌리는 굵고 옆으로 뻗으며 감색을 나타낸다. 지황의 뿌리는 한방에서 약재로 사용하는데, 그대로 사용하는 것은 생지황, 건조시켜 쓰는 것은 건지황, 술을 넣고 쪄서 만든 것은 숙지황으로 알려져 있다. 지황의 추출물은 혈액응고를 촉진하거나 이뇨 작용 및 해열 등의 효과가 있는 것으로 알려져 있으나, 지황 추출물 단독의 틱 장애 또는 또는 투렛 증후군에 대한 치료 효과는 전혀 알려진 바가 없다.In the present invention, the term " Rehmannia glutinosa " is a perennial herbaceous plant belonging to the Hyeonsamaceae family, a Chinese plant, with short hairs throughout, and a thick root extending sideways and showing a dark blue color. Rehmannia root is used as a medicinal herb in oriental medicine, and it is known as raw jihwang when used as it is, dried jihuang for use, and steamed with alcohol as sukjihwang. It is known that the extract of rehuhuang promotes blood coagulation or has effects such as diuretic action and antipyretic effect, but the therapeutic effect of rehmannia extract alone on tic disorders or Tourette's syndrome is not known at all.
본 발명의 "추출물"은 목적하는 물질을 용매에 침지한 후 상온 또는 가온 상태에서 일정시간 동안 추출하여 수득한 액상성분, 상기 액상성분으로부터 용매를 제거하여 수득한 고형분 등의 결과물을 의미할 수 있다. 뿐만 아니라, 상기 결과물에 이외에 상기 결과물의 희석액, 이들의 농축액, 이들의 조정제물, 정제물 등을 모두 포함하는 것으로 포괄적으로 해석될 수 있다. 구체적으로, 본 발명에서 추출물은 지황 추출물을 의미하며, 보다 구체적으로는 지황 뿌리의 추출물을 의미할 수 있다. 상기 지황은 상업적으로 판매되는 것을 구입하여 사용하거나, 자연에서 채취 또는 재배된 것을 사용할 수 있으며, 이에 제한되는 것은 아니다.The "extract" of the present invention refers to a result such as a liquid component obtained by immersing a target substance in a solvent and then extracting it at room temperature or in a warm state for a certain time, a solid obtained by removing the solvent from the liquid component, etc. . In addition, in addition to the result, it can be comprehensively interpreted as including all of the dilutions of the results, their concentrates, their preparations, and their purified products. Specifically, in the present invention, the extract refers to an extract of Rehmannia Root, and more specifically, may refer to an extract of Rehmannia Root. The Rehmannia may be purchased and used commercially, or may be collected or grown in nature, but is not limited thereto.
상기 지황 추출물을 추출하는 방법은 특별히 제한되지 않으며, 당해 기술 분야에서 통상적으로 사용하는 방법에 따라 추출할 수 있다. 상기 추출 방법의 비제한적인 예로는, 열수 추출법, 초음파 추출법, 여과법, 환류 추출법 등을 들 수 있으며, 이들은 단독으로 수행되거나 2종 이상의 방법을 병용하여 수행될 수 있다. 또한, 상기 지황 추출물의 추출에 사용되는 추출용매의 종류는 특별히 제한되지 않으며, 당해 기술 분야에서 공지된 임의의 용매를 사용할 수 있다. 구체적으로, 상기 추출용매는 물, 탄소수 1 내지 4의 알코올 및 이들의 혼합 용매로 이루어진 군에서 선택된 하나 이상일 수 있다. 본 발명의 일 실시예에서는 지황 뿌리에 10배 부피의 물을 넣고, 전체 부피가 절반으로 줄어들 때까지 가열하여 추출액을 제조하였다.The method of extracting the Rehmannia Root extract is not particularly limited, and may be extracted according to a method commonly used in the art. Non-limiting examples of the extraction method include hot water extraction, ultrasonic extraction, filtration, and reflux extraction, and these may be performed alone or in combination of two or more methods. In addition, the type of the extraction solvent used for the extraction of the Rehmannia Root extract is not particularly limited, and any solvent known in the art may be used. Specifically, the extraction solvent may be one or more selected from the group consisting of water, an alcohol having 1 to 4 carbon atoms, and a mixed solvent thereof. In one embodiment of the present invention, 10 times the volume of water was added to the root of the rehullah root, and the extract was prepared by heating until the total volume was reduced to half.
본 발명에서 용어 "분획물"은 여러 다양한 구성 성분들을 포함하는 혼합물로부터 특정 성분 또는 특정 성분 그룹을 분리하기 위하여 분획을 수행하여 얻어진 결과물을 의미한다.In the present invention, the term "fraction" refers to a result obtained by performing fractionation in order to separate a specific component or a specific component group from a mixture including various components.
본 발명에서 상기 분획물을 얻는 분획 방법은 특별히 제한되지 아니하며, 당해 기술 분야에서 통상적으로 사용하는 방법에 따라 수행될 수 있다. 다양한 용매를 처리하여 수행하는 용매 분획법, 일정한 분자량 컷-오프 값을 갖는 한외 여과막을 통과시켜 수행하는 한외여과 분획법, 크로마토그래피 분획법 및 이의 조합 등이 될 수 있다. 또한, 본 발명에서 상기 분획물을 얻는 데에 사용되는 용매의 종류는 특별히 제한되지 아니하며, 당해 기술 분야에서 공지된 임의의 용매를 사용할 수 있다. 상기 분획 용매의 비제한적인 예로는 물, 유기용매 또는 이들의 혼합용매 등을 사용할 수 있으며, 상기 유기용매는 탄소수 1 내지 4의 알코올이나, 에틸아세테이트 또는 아세톤 등의 극성용매, 헥산 또는 디크로로메탄의 비극성용매 또는 이들의 혼합용매를 사용할 수 있다. 또한, 구체적으로 물, 탄소수 1 내지 4의 알코올 또는 이들의 혼합용매를 사용할 수 있다.In the present invention, the fractionation method for obtaining the fraction is not particularly limited, and may be performed according to a method commonly used in the art. It may be a solvent fractionation method performed by treating various solvents, an ultrafiltration fractionation method performed by passing through an ultrafiltration membrane having a constant molecular weight cut-off value, a chromatographic fractionation method, and a combination thereof. In addition, in the present invention, the type of solvent used to obtain the fraction is not particularly limited, and any solvent known in the art may be used. Non-limiting examples of the fractionation solvent include water, an organic solvent, or a mixed solvent thereof, and the organic solvent is an alcohol having 1 to 4 carbon atoms, a polar solvent such as ethyl acetate or acetone, hexane or dichloro. A non-polar solvent of methane or a mixed solvent thereof may be used. In addition, specifically, water, an alcohol having 1 to 4 carbon atoms, or a mixed solvent thereof may be used.
본 발명에서 용어 "틱 장애(tic disorder)"는 갑자기 반복적이고 불수의적이며 불규칙한 상동적 근육운동 또는 음성이 특징적으로 나타나는 신경질환을 의미한다. 틱(틱 장애)은 단순틱과 복합틱으로 나뉘며, 또한 근육틱(운동틱)과 음성틱으로 나뉜다. 단순 근육틱은 순간적인 눈 깜박임, 머리 흔들기, 목 경련 등 근육의 경련, 얼굴 찡그림이나 어깨 으쓱임 등의 증상이 있으며, 음성틱은 헛기침, 킁킁거리는 소리, 코웃음 치기와 동물이 짖는 소리 또는 단어, 구 혹은 문맥을 벗어나는 문장, 외설증(Coprolalia) 등의 증상이 있다. 또한, 이러한 근육틱 또는 음성틱이 1년 이상 지속적으로 나타날 경우 "투렛 증후군(Tourette syndrome)"이라 한다. 그 밖에 틱 장애는 "만성 운동 또는 만성 음성틱 장애" 및 "일과성 틱 장애" 등으로 분류될 수 있으며, 이에 특별히 제한되지 않는다. 이러한 틱 장애는 유전적 요소 또는 환경적 요소의 상호작용으로 발생할 수 있으며, 구체적으로 도파민 계통의 이상이나 뇌의 피질-선조체-시상-피질 회로의 이상 등 신경생물학적 원인 또는 부모가 어릴 때 틱 증상을 보인 유전적 원인이 있을 수 있다.As used herein, the term “tic disorder” refers to a neurological disease characterized by sudden, repetitive, involuntary, and irregular stereotyped muscle movements or voices. Tics (tic disorders) are divided into simple tics and complex tics, and also into muscular tics (motor tics) and vocal tics. Simple muscle tics have symptoms such as momentary blinking of the eyes, shaking head, neck cramps, etc., facial grimacing or shrugging. There are symptoms such as phrases or sentences out of context, and coprolalia. In addition, if these muscular or vocal tics continue to appear for more than one year, it is called "Tourette Syndrome". In addition, tic disorders may be classified into "chronic motor or chronic vocal tic disorders" and "transient tic disorders", but is not particularly limited thereto. These tic disorders can be caused by the interaction of genetic factors or environmental factors. Specifically, neurobiological causes, such as abnormalities in the dopamine system or abnormalities in the cortical-striatal-thalamus-cortical circuit in the brain, or when parents develop tic symptoms when they are young There may be a genetic cause shown.
본 발명의 일 실시예에서는 이러한 틱 장애의 증상을 유발하고자 개체(마우스)에 암페타민 또는 2,5-Dimethoxy-4-iodoamphetamine(DOI)을 복강투여하여 대표적인 틱 장애 증상인 눈 깜박임을 유발한 후 상기 지황 추출물 투여에 따른 효과를 확인하였다.In one embodiment of the present invention, amphetamine or 2,5-Dimethoxy-4-iodoamphetamine (DOI) is intraperitoneally administered to an individual (mouse) to induce symptoms of tic disorders to induce blinking, which is a typical symptom of tic disorder, and then The effect of the administration of rehmannia extract was confirmed.
본 발명에서 용어 "예방"은 본 발명 조성물의 투여로 틱 장애 및/또는 투렛 증후군 관련 증상을 억제 또는 지연시키는 모든 행위를 의미하며, 본 발명에서 용어 "치료"는 본 발명 조성물의 투여로 틱 장애 및/또는 투렛 증후군의 증상이 호전되거나 이롭게 변경되는 모든 행위를 의미한다.In the present invention, the term "prevention" refers to any act of suppressing or delaying symptoms related to tic disorders and/or Tourette's syndrome by administration of the composition of the present invention, and the term "treatment" in the present invention refers to tic disorders by administration of the composition of the present invention. and/or all actions in which the symptoms of Tourette's syndrome are improved or beneficially changed.
본 발명의 약학적 조성물은 상기 지황 추출물 이외에 약학적 조성물의 제조에 통상적으로 사용하는 약학적으로 허용가능한 담체, 부형제 또는 희석제를 추가로 포함할 수 있다. 상기 담체, 부형제 및 희석제의 구체적인 예로는 락토즈, 덱스트로즈, 수크로스, 솔비톨, 만니톨, 자일리톨, 에리스리톨, 말티톨, 전분, 아카시아 고무, 알지네이트, 젤라틴, 칼슘 포스페이트, 칼슘 실리케이트, 셀룰로즈, 메틸 셀룰로즈, 미정질 셀룰로스, 폴리비닐 피롤리돈, 물, 메틸히드록시벤조에이트, 프로필히드록시벤조에이트, 탈크, 마그네슘 스테아레이트 또는 광물유 등이 사용될 수 있으나, 이에 제한되지 않는다.The pharmaceutical composition of the present invention may further include a pharmaceutically acceptable carrier, excipient or diluent commonly used in the preparation of pharmaceutical compositions in addition to the extract of Rehmannia glutinosa. Specific examples of the carrier, excipient and diluent include lactose, dextrose, sucrose, sorbitol, mannitol, xylitol, erythritol, maltitol, starch, acacia gum, alginate, gelatin, calcium phosphate, calcium silicate, cellulose, methyl cellulose, Microcrystalline cellulose, polyvinyl pyrrolidone, water, methylhydroxybenzoate, propylhydroxybenzoate, talc, magnesium stearate or mineral oil may be used, but is not limited thereto.
또한, 본 발명의 약학적 조성물은 각각 통상의 방법에 따라 정제, 환제, 산제, 과립제, 캡슐제, 현탁제, 내용액제, 유제, 시럽제, 멸균된 수용액, 비수성용제, 현탁제, 유제 및 동결 건조제로 이루어진 군으로부터 선택되는 어느 하나의 제형을 가질 수 있으며, 상기 제형은 경구 또는 비경구의 여러 가지 형태일 수 있다. 제제화할 경우에는 통상적으로 사용하는 충진제, 증량제, 결합제, 습윤제, 붕해제, 계면활성제 등의 희석제 또는 부형제를 사용하여 조제될 수 있으나, 이에 제한되지 않는다. 구체적으로, 경구투여를 위한 고형제제에는 정제, 환제, 산제, 과립제, 캡슐제 등이 사용될 수 있으며, 상기 고형제제는 적어도 하나 이상의 부형제 예를 들면 전분, 탄산칼슘, 수크로오스(sucrose) 또는 락토오스(lactose), 젤라틴 등이 사용될 수 있다. 또한, 단순한 부형제 이외에 스테아린산 마그네슘, 탈크 등과 같은 윤활제 등이 사용될 수 있으나, 이에 제한되지 않는다. 또한, 경구투여를 위한 액상제제로는 현탁제, 내용액제, 유제, 시럽제 등이 사용될 수 있으며, 통상적으로 사용되는 단순 희석제인 물, 리퀴드 파라핀 이외에 여러 가지 부형제, 예를 들면 습윤제, 감미제, 방향제, 보존제 등이 사용될 수 있다. 비경구투여를 위한 제제에는 멸균된 수용액, 비수성용제, 현탁제, 유제, 동결건조 제제 또는 좌제 등이 사용될 수 있다. 상기 비수성용제, 현탁제로는 프로필렌글리콜(propylene glycol), 폴리에틸렌 글리콜, 올리브 오일과 같은 식물성 기름, 에틸올레이트와 같은 주사 가능한 에스테로 등이 사용될 수 있으나, 이에 제한되지 않는다.In addition, the pharmaceutical composition of the present invention can be prepared according to a conventional method for tablets, pills, powders, granules, capsules, suspensions, internal solutions, emulsions, syrups, sterilized aqueous solutions, non-aqueous solvents, suspensions, emulsions and freeze-drying agents, respectively. It may have any one dosage form selected from the group consisting of, and the dosage form may be oral or parenteral in various forms. In the case of formulation, it may be prepared using commonly used diluents or excipients such as fillers, extenders, binders, wetting agents, disintegrants, and surfactants, but is not limited thereto. Specifically, tablets, pills, powders, granules, capsules, etc. may be used in the solid preparation for oral administration, and the solid preparation may include at least one excipient, for example, starch, calcium carbonate, sucrose or lactose. ), gelatin, etc. may be used. In addition, lubricants such as magnesium stearate and talc may be used in addition to simple excipients, but the present invention is not limited thereto. In addition, as liquid formulations for oral administration, suspensions, internal solutions, emulsions, syrups, etc. may be used, and various excipients, for example, wetting agents, sweeteners, fragrances, in addition to commonly used simple diluents such as water and liquid paraffin, Preservatives and the like may be used. A sterile aqueous solution, a non-aqueous solution, a suspension, an emulsion, a freeze-dried formulation, or a suppository may be used as a formulation for parenteral administration. Examples of the non-aqueous solvent and suspending agent include, but are not limited to, propylene glycol, polyethylene glycol, vegetable oils such as olive oil, and injectable esters such as ethyl oleate.
본 발명 약학적 조성물의 개별적인 투약의 최적량 및 투약 간격은 치료되고 있는 병의 성질 및 정도, 투여 제형, 경로 및 부위, 그리고 개체의 나이와 건강상태에 의해 결정될 것이고, 의사가 궁극적으로 사용될 적절한 투약을 결정할 것이라는 것은 당해 분야의 당업자가 알 수 있을 것이다. 이러한 투약은 적절할 정도로 자주 반복될 수 있다. 부작용이 생긴다면, 보통의 임상 진료에 따라서 투여량 및 빈도를 변경하거나 또는 감소시킬 수 있다. 또한, 본 발명 조성물의 투여 경로는 본 발명의 목적을 달성할 수 있는 한 어떠한 일반적인 경로를 통하여 투여될 수 있다. 예를 들어 본 발명의 약학적 조성물은 복강내 투여, 정맥내 투여, 피하 투여, 피내 투여, 경구 투여될 수 있으나, 이에 제한되지는 않는다.The optimal amount and dosing interval of individual administration of the pharmaceutical composition of the present invention will be determined by the nature and extent of the disease being treated, the dosage form, route and site, and the age and health condition of the individual, and the doctor will ultimately use the appropriate dosage to be used. will be determined by one of ordinary skill in the art. Such dosing may be repeated as often as appropriate. If side effects occur, the dosage and frequency may be changed or reduced according to normal clinical practice. In addition, the administration route of the composition of the present invention may be administered through any general route as long as it can achieve the object of the present invention. For example, the pharmaceutical composition of the present invention may be administered intraperitoneally, intravenously, subcutaneously, intradermally, orally, but is not limited thereto.
상기 목적을 달성하기 위한 본 발명의 다른 하나의 양태는 지황 추출물 또는 이의 분획물을 유효성분으로 포함하는, 틱 장애의 예방 또는 개선용 의약외품 조성물을 제공한다. 상기 지황, 추출물, 틱 장애 및 예방은 전술한 바와 같다. 본 발명에서 용어 "개선"은 본 발명의 지황 추출물을 포함하는 의약외품 조성물을 적용하여, 틱 장애 및/또는 투렛 증후군 관련 증상을 완화시키는 효과를 나타내는 것을 의미한다.Another aspect of the present invention for achieving the above object provides a quasi-drug composition for the prevention or improvement of tic disorders, comprising a Rehmannia glutinosa extract or a fraction thereof as an active ingredient. The rehmannia glutinosa extract, tic disorders and prevention are the same as described above. In the present invention, the term "improvement" means that the quasi-drug composition containing the extract of the present invention is applied to show the effect of alleviating symptoms related to tic disorders and/or Tourette's syndrome.
또한, 본 발명의 의약외품 조성물에는 지황 추출물 이외에 필요에 따라 약학적으로 허용 가능한 담체, 부형제 또는 희석제를 더욱 포함할 수 있다. 상기 약학적으로 허용 가능한 담체, 부형제 또는 희석제는 본 발명의 효과를 해하지 않는 한 제한되지 않으며, 예를 들어 충진제, 증량제, 결합제, 습윤제, 붕해제, 계면활성제, 윤활제, 감미제, 방향제, 보존제 등을 포함할 수 있다. 본 발명의 약학적으로 허용 가능한 담체, 부형제 또는 희석제의 대표적인 예로는, 락토즈, 덱스트로스, 슈크로스, 솔비톨, 만니톨, 자일리톨, 말티톨, 전분, 젤라틴, 글리세린, 아카시아 고무, 알지네이트, 칼슘포스페이트, 칼슘카보네이트, 칼슘실리케이트, 셀룰로즈, 메틸 셀룰로즈, 미정질 셀룰로즈, 폴리비닐 피롤리돈, 물, 메틸히드록시벤조에이트, 프로필히드록시벤조에이트, 탈크, 마그네슘 스테아레이트, 광물유, 프로필렌글리콜, 폴리에틸렌글리콜, 식물성 오일, 주사가능한 에스테르, 위텝솔, 마크로골, 트윈 61, 카카오지, 라우리지 등을 들 수 있다. 또한, 본 발명의 지황 추출물을 유효성분으로 포함하는 조성물을 의약외품으로 사용하는 경우 추가로 동일 또는 유사한 기능을 나타내는 성분을 1종 이상 함유할 수 있으며, 본 발명의 목적을 달성할 수 있는 한 성분의 종류는 특별히 제한되지 않는다.In addition, the quasi-drug composition of the present invention may further include a pharmaceutically acceptable carrier, excipient or diluent, if necessary, in addition to the extract of Rehmannia. The pharmaceutically acceptable carrier, excipient or diluent is not limited as long as it does not impair the effects of the present invention, and includes, for example, fillers, extenders, binders, wetting agents, disintegrants, surfactants, lubricants, sweeteners, fragrances, preservatives, etc. may include Representative examples of the pharmaceutically acceptable carrier, excipient or diluent of the present invention include lactose, dextrose, sucrose, sorbitol, mannitol, xylitol, maltitol, starch, gelatin, glycerin, acacia gum, alginate, calcium phosphate, calcium Carbonate, calcium silicate, cellulose, methyl cellulose, microcrystalline cellulose, polyvinyl pyrrolidone, water, methylhydroxybenzoate, propylhydroxybenzoate, talc, magnesium stearate, mineral oil, propylene glycol, polyethylene glycol, vegetable oil , injectable esters, Witepsol, Macrogol, Tween 61, cacao butter, laurage, and the like. In addition, when the composition containing the extract of the present invention as an active ingredient is used as a quasi-drug, it may contain one or more ingredients exhibiting the same or similar function, and one ingredient that can achieve the object of the present invention. The type is not particularly limited.
상기 목적을 달성하기 위한 본 발명의 다른 하나의 양태는 지황 추출물 또는 이의 분획물을 유효성분으로 포함하는, 틱 장애의 예방 또는 개선용 식품 조성물을 제공한다. 상기 지황, 추출물, 틱 장애, 예방 및 개선은 전술한 바와 같다.Another aspect of the present invention for achieving the above object provides a food composition for preventing or improving tic disorders, comprising a Rehmannia glutinosa extract or a fraction thereof as an active ingredient. The rehmannia glutinosa extract, tic disorder, prevention and improvement are the same as described above.
본 발명에서 용어 "식품"은 육류, 소시지, 빵, 초콜릿, 캔디류, 스낵류, 과자류, 피자, 라면, 기타 면류, 껌류, 아이스크림류를 포함한 낙농제품, 각종 스프, 음료수, 차, 드링크제, 알코올음료, 비타민 복합제, 건강 기능(성) 식품 및 건강 식품 등이 있으며, 통상적인 의미에서의 식품을 모두 포함한다.In the present invention, the term "food" refers to meat, sausage, bread, chocolate, candy, snacks, confectionery, pizza, ramen, other noodles, gum, dairy products including ice cream, various soups, beverages, tea, drinks, alcoholic beverages, There are vitamin complexes, health function (sex) food , and health food , and it includes all foods in a normal sense.
상기 "건강 기능(성) 식품(functional food)"이란, 영양 공급 외에도 생체조절기능이 효율적으로 나타나도록 가공된 의학, 의료효과가 높은 식품을 의미한다. 여기서 "기능(성)"이라 함은 인체의 구조 및 기능에 대하여 영양소를 조절하거나 생리학적 작용 등과 같은 보건용도에 유용한 효과를 얻는 것을 의미한다. 본 발명의 식품 조성물은 당 업계에서 통상적으로 사용되는 방법에 의하여 제조 가능하며, 제조시에는 당 업계에서 통상적으로 첨가하는 원료 및 성분을 첨가하여 제조할 수 있다. 또한 상기 식품의 제형 또한 식품으로 인정되는 제형이면 제한없이 제조될 수 있다. 본 발명의 식품 조성물은 다양한 형태의 제형으로 제조될 수 있으며, 일반 약품과는 달리 식품을 원료로 하여 약품의 장기 복용 시 발생할 수 있는 부작용 등이 없는 장점이 있고, 휴대성이 뛰어나, 본 발명의 식품은 틱 장애의 증상을 예방, 개선시키기 위한 보조제로 섭취가 가능하다.The "healthy functional (sex) food (functional food)" means a food with high medical and medical effects processed to efficiently exhibit bioregulatory functions in addition to nutritional supply. Here, "function (sex)" means to obtain a useful effect for health purposes such as regulating nutrients or physiological action with respect to the structure and function of the human body. The food composition of the present invention can be prepared by a method commonly used in the art, and at the time of manufacture, it can be prepared by adding raw materials and components commonly added in the art. In addition, if the formulation of the above food is also a formulation that is recognized as a food, it can be manufactured without limitation. The food composition of the present invention can be prepared in various forms, and unlike general drugs, has the advantage that there are no side effects that may occur during long-term administration of the drug using food as a raw material, and has excellent portability, Food can be consumed as a supplement to prevent and improve symptoms of tic disorders.
상기 "건강 식품(health food)"은 일반식품에 비해 적극적인 건강유지나 증진 효과를 가지는 식품을 의미하고, 건강보조식품(health supplement food)은 건강보조 목적의 식품을 의미한다. 본 명세서 내에서 건강 기능 식품, 건강식품, 건강보조식품의 용어는 혼용될 수 있다. 구체적으로, 상기 건강 기능 식품은 본 발명의 추출물 또는 분획물을 음료, 차류, 향신료, 껌, 과자류 등의 식품 소재에 첨가하거나, 캡슐화, 분말화, 현탁액 등으로 제조한 식품으로, 이를 섭취할 경우 건강상 특정한 효과를 가져 오는 것을 의미하나, 일반 약품과는 달리 식품을 원료로 하여 약품의 장기 복용 시 발생할 수 있는 부작용이 없는 장점이 있다. 본 발명의 식품 조성물은 일상적으로 섭취하는 것이 가능하기 때문에 틱 장애의 예방 또는 개선에 대하여 높은 효과를 기대할 수 있으므로, 매우 유용하게 사용될 수 있다.The "health food" means a food having an active health maintenance or promotion effect compared to general food, and health supplement food means a food for the purpose of health supplementation. In this specification, the terms health functional food, health food, and health supplement may be used interchangeably. Specifically, the health functional food is a food prepared by adding the extract or fraction of the present invention to food materials such as beverages, teas, spices, gum, and confectionery, or manufactured by encapsulation, powdering, suspension, etc. This means that it has a specific effect, but unlike general drugs, it has the advantage of not having side effects that may occur when taking the drug for a long time because it uses food as a raw material. Since the food composition of the present invention can be ingested on a daily basis, a high effect can be expected for the prevention or improvement of tic disorders, so it can be very usefully used.
또한, 본 발명의 식품 조성물은 생리학적으로 허용 가능한 담체를 추가로 포함할 수 있는데, 담체의 종류는 특별히 제한되지 않으며 당해 기술 분야에서 통상적으로 사용되는 담체라면 어느 것이든 사용할 수 있다. 또한, 상기 식품 조성물은 식품 조성물에 통상 사용되어 냄새, 맛, 시각 등을 향상시킬 수 있는 추가 성분을 포함할 수 있다. 예들 들어, 비타민 A, C, D, E, B1, B2, B6, B12, 니아신(niacin), 비오틴(biotin), 폴레이트(folate), 판토텐산(panthotenic acid) 등을 포함할 수 있다. 또한, 아연(Zn), 철(Fe), 칼슘(Ca), 크롬(Cr), 마그네슘(Mg), 망간(Mn), 구리(Cu), 크륨(Cr) 등의 미네랄을 포함할 수 있다. 또한, 라이신, 트립토판, 시스테인, 발린 등의 아미노산을 포함할 수 있다. 또한, 상기 식품 조성물은 방부제(소르빈산 칼륨, 벤조산나트륨, 살리실산, 데히드로초산나트륨 등), 살균제(표백분과 고도 표백분, 차아염소산나트륨 등), 산화방지제(부틸히드록시아니졸(BHA), 부틸히드록시톨류엔(BHT) 등), 착색제(타르색소 등), 발색제(아질산 나트륨, 아초산 나트륨 등), 표백제(아황산나트륨), 조미료(MSG 글루타민산나트륨 등), 감미료(둘신, 사이클레메이트, 사카린, 나트륨 등), 향료(바닐린, 락톤류 등), 팽창제(명반, D-주석산수소칼륨 등), 강화제, 유화제, 증점제(호료), 피막제, 검기초제, 거품억제제, 용제, 개량제 등의 식품 첨가물(food additives)을 포함할 수 있다. 상기 첨가물은 식품의 종류에 따라 선별되고 적절한 양으로 사용될 수 있다. 본 발명의 추출물 또는 분획물은 그대로 첨가되거나 다른 식품 또는 식품 성분과 함께 사용될 수 있고, 통상적인 방법에 따라 적절하게 사용될 수 있다.In addition, the food composition of the present invention may further include a physiologically acceptable carrier, the type of carrier is not particularly limited and any carrier commonly used in the art may be used. In addition, the food composition may include additional ingredients that are commonly used in the food composition to improve odor, taste, vision, and the like. For example, vitamins A, C, D, E, B1, B2, B6, B12, niacin, biotin, folate, pantothenic acid, and the like may be included. In addition, it may include minerals such as zinc (Zn), iron (Fe), calcium (Ca), chromium (Cr), magnesium (Mg), manganese (Mn), copper (Cu), and chromium (Cr). In addition, it may include amino acids such as lysine, tryptophan, cysteine, and valine. In addition, the above food composition contains preservatives (potassium sorbate, sodium benzoate, salicylic acid, sodium dehydroacetate, etc.), disinfectants (bleaching powder, high bleaching powder, sodium hypochlorite, etc.), antioxidants (butylhydroxyanisole (BHA), butyl hydrochloride, etc.) Loxytoluene (BHT), etc.), coloring agents (tar pigments, etc.), coloring agents (sodium nitrite, sodium nitrite, etc.), bleach (sodium sulfite), seasonings (MSG sodium glutamate, etc.), sweeteners (dulcin, cyclemate, saccharin, etc.) , sodium, etc.), flavorings (vanillin, lactones, etc.), swelling agents (alum, D-potassium hydrogen tartrate, etc.), strengthening agents, emulsifiers, thickeners (flavors), filming agents, gum base agents, foam inhibitors, solvents, improving agents, etc. It may contain food additives. The additive may be selected according to the type of food and used in an appropriate amount. The extract or fraction of the present invention may be added as it is or may be used together with other food or food ingredients, and may be appropriately used according to a conventional method.
상기 목적을 달성하기 위한 본 발명의 또 다른 하나의 양태는 지황 추출물 또는 이의 분획물을 유효성분으로 포함하는 조성물을 인간을 제외한 개체에게 투여하는 단계를 포함하는, 틱 장애의 예방 또는 치료 방법을 제공한다. 상기 지황, 추출물, 틱 장애, 예방 및 치료는 전술한 바와 같다.Another aspect of the present invention for achieving the above object provides a method for preventing or treating tic disorders, comprising administering to an individual other than humans a composition comprising a rehmannia glutinosa extract or a fraction thereof as an active ingredient. . The rehmannia glutinosa extract, tic disorder, prevention and treatment are the same as described above.
본 발명에서 용어, "개체"는 틱 장애 및/또는 투렛 증후군이 이미 발병하였거나 발병할 수 있는 인간을 포함한 모든 동물을 의미하고, 본 발명의 지황 추출물을 유효성분으로 포함하는 조성물을 개체에게 투여함으로써 상기 틱 장애 및/또는 투렛 증후군과 관련 증상을 효과적으로 예방 및 치료할 수 있다. 상기 개체는 개, 소, 말, 토끼, 마우스, 랫트, 닭 또는 인간을 포함하는 포유류 전체를 의미하나, 이에 특별히 제한되지 않는다. 본 발명의 일 실시예에서는, 암페타민 또는 2,5-Dimethoxy-4-iodoamphetamine(DOI)로 틱 반응(눈 깜박임, 머리 흔들기)을 유발시킨 개체(마우스)에 지황 추출물을 처리한 결과 양성 대조군 아리피프라졸과 유사한 수준으로 눈 깜박임을 감소시켰음을 확인하였다.As used herein, the term "individual" refers to all animals, including humans, that have already or may develop tic disorders and/or Tourette's syndrome. It is possible to effectively prevent and treat the tic disorder and/or Tourette's syndrome and related symptoms. The subject refers to all mammals including dogs, cattle, horses, rabbits, mice, rats, chickens, or humans, but is not particularly limited thereto. In one embodiment of the present invention, as a result of treatment with a rehmannia extract in a subject (mouse) that induced a tic reaction (blinking eyes, shaking head) with amphetamine or 2,5-Dimethoxy-4-iodoamphetamine (DOI), the positive control aripiprazole and It was confirmed that blinking was reduced to a similar level.
본 발명의 지황 추출물 또는 이의 분획물은 눈 깜박임을 비롯한 틱 장애의 증상을 효과적으로 억제시킬 수 있는바, 지황 추출물 또는 이의 분획물을 유효성분으로 포함하는 본 발명의 조성물은 틱 장애 또는 투렛 증후군의 예방 또는 치료를 목적으로 유용하게 사용될 수 있다.Rehmannia glutinosa extract or a fraction thereof of the present invention can effectively suppress symptoms of tic disorders including blinking. can be usefully used for the purpose of
도 1은 암페타민에 의해 유도된 틱 반응(눈 깜박임)에 대한 지황 추출물의 효과를 비교, 분석한 것이다.
도 2는 2,5-Dimethoxy-4-iodoamphetamine(DOI)에 의해 유도된 틱 반응(머리 흔들기)에 대한 지황 추출물의 효과를 비교, 분석한 것이다.1 is a comparison and analysis of the effect of a rehmannia extract on the tic response (blinking eyes) induced by amphetamines.
Figure 2 is a comparison and analysis of the effect of rehubar extract on the tic reaction (head shaking) induced by 2,5-Dimethoxy-4-iodoamphetamine (DOI).
이하, 본 발명을 하기 실시예를 통하여 보다 상세하게 설명한다. 그러나 이들 실시예는 본 발명을 예시적으로 설명하기 위한 것으로 본 발명의 범위가 이들 실시예만으로 한정되는 것은 아니다.Hereinafter, the present invention will be described in more detail through the following examples. However, these examples are for illustrative purposes only, and the scope of the present invention is not limited to these examples only.
실시예 1: 지황 추출물의 제조Example 1: Preparation of Rehmannia Extract
지황(Rehmannia glutinosa)의 뿌리에 10배 부피의 물을 넣고, 전체 부피가 절반으로 줄어들 때까지 가열하여 추출액을 제조하였다. 이후 추출액을 Whatman No.1 필터에 거른 후 감압하에 수조에서 농축하고 동결건조(Elela, model FD-5N)하여 이 건조물을 시료로 사용하였다. 10 times the volume of water was added to the root of Rehmannia glutinosa and heated until the total volume was reduced to half to prepare an extract. Thereafter, the extract was filtered through Whatman No. 1 filter, concentrated in a water bath under reduced pressure, and freeze-dried (Elela, model FD-5N), and the dried product was used as a sample.
실시예 2: 암페타민에 의해 유도된 틱 반응(눈 깜박임)에 대한 지황 추출물의 효과Example 2: Effect of Rehmannia Extract on Tic Response (Blinking) Induced by Amphetamines
ICR 웅성 마우스 5주령을 구입하고 1주일 간 안정화하여 실험에 사용하였다. 그룹 당 사용 동물은 vehicle 투여군 5마리, 그 외 약물 투여군은 4마리로 하였다. 시험물질로는 지황 추출물 각 100, 200 mg/kg을 경구 투여 하였고, 양성대조군으로 아리피프라졸(aripiprazole) 1 mg/kg을 복강 투여하여 사용하였다. 구체적으로, 마우스에 각 시험물질(또는 vehicle)을 농도별로 투여하고, 투여 30분 후에 암페타민(amphetamine) 10 mg/kg을 복강투여하여 틱 반응(눈 깜박임)을 유발하였다. 이후 10분 뒤 암페타민을 복강투여한 동물을 각각 관찰케이지에 넣고 2분 간 적응 시간 후 30분 간 행동을 관찰하였다. 행동 관찰은 비디오 카메라로 촬영 후 눈 깜박임(eye blinking) 행동을 분석하였다.ICR male mice 5 weeks old were purchased and used in the experiment after stabilization for 1 week. The animals used per group were 5 animals in the vehicle-administered group, and 4 animals in the other drug-administered groups. As a test substance, 100 and 200 mg/kg of each rehmannia extract were orally administered, and as a positive control, 1 mg/kg of aripiprazole was intraperitoneally administered and used. Specifically, each test substance (or vehicle) was administered to mice by concentration, and 10 mg/kg of amphetamine was administered intraperitoneally 30 minutes after administration to induce a tic reaction (blink). After 10 minutes, the animals administered intraperitoneally with amphetamines were placed in observation cages, respectively, and the behavior was observed for 30 minutes after an adaptation time for 2 minutes. Behavioral observation was analyzed with a video camera and then eye blinking behavior.
그 결과, 본 발명의 지황 추출물을 처리한 경우 암페타민으로 유도된 눈 깜박임을 감소시켰으며, 특히 200 mg/kg에서 대조군 대비 유의한 효과가 있음을 확인하였다(도 1). 또한, 이는 양성대조군인 아리피프라졸 1 mg/kg을 처리한 것과 유사한 결과를 나타내었다.As a result, it was confirmed that the treatment with the extract of the present invention reduced amphetamine-induced blinking, and in particular, it was confirmed that there was a significant effect compared to the control at 200 mg/kg (FIG. 1). In addition, it exhibited similar results to those treated with 1 mg/kg of aripiprazole, a positive control.
실시예 3: 2,5-Dimethoxy-4-iodoamphetamine(DOI)에 의해 유도된 틱 반응(머리 흔들기)에 대한 지황 추출물의 효과Example 3: Effect of Rehmannia Extract on Tick Response (Head Shaking) induced by 2,5-Dimethoxy-4-iodoamphetamine (DOI)
ICR 웅성 마우스 5주령을 구입하고 1주일 간 안정화하여 실험에 사용하였다. 그룹 당 사용 동물은 vehicle 투여군 6마리, 그 외 약물 투여군은 8마리로 하였다. 시험물질로는 지황 추출물 각 100, 200 mg/kg을 경구 투여 하였고, 양성대조군으로 아리피프라졸(aripiprazole) 1 mg/kg을 복강 투여하여 사용하였다. 구체적으로, 마우스에 각 시험물질(또는 vehicle)을 농도별로 투여하고, 투여 30분 후에 2,5-Dimethoxy-4-iodoamphetamine(DOI) 1 mg/kg을 복강투여하여 틱 반응(머리 흔들기)을 유발하였다. 이후 10분 뒤 DOI를 복강투여한 동물을 각각 관찰케이지에 넣고 2분 간 적응 시간 후 30분 간 행동을 관찰하였다. 행동 관찰은 비디오 카메라로 촬영 후 머리 흔들기(head twitch) 행동을 분석하였다.ICR male mice 5 weeks old were purchased and used in the experiment after stabilization for 1 week. The animals used per group were 6 animals in the vehicle-administered group, and 8 animals in the other drug-administered groups. As a test substance, 100 and 200 mg/kg of each rehmannia extract were orally administered, and as a positive control, 1 mg/kg of aripiprazole was intraperitoneally administered and used. Specifically, each test substance (or vehicle) was administered to mice by concentration, and 30 minutes after administration, 1 mg/kg of 2,5-Dimethoxy-4-iodoamphetamine (DOI) was intraperitoneally administered to induce a tic reaction (head shaking). did After 10 minutes, the animals to which the DOI was administered intraperitoneally were placed in observation cages, respectively, and the behavior was observed for 30 minutes after an adaptation time for 2 minutes. Behavioral observation was analyzed with head twitch behavior after filming with a video camera.
그 결과, 본 발명의 지황 추출물을 처리한 경우 100 mg/kg 농도에서도 DOI로 유도된 머리 흔들기를 유의한 수준으로 감소시켰으며, 특히 200 mg/kg에서는 양성대조군인 아리피프라졸과도 유사한 효과가 있음을 확인하였다(도 2).As a result, it was found that the treatment with the extract of the present invention reduced the DOI-induced head shaking to a significant level even at a concentration of 100 mg/kg, and in particular, at 200 mg/kg, it had a similar effect to aripiprazole, a positive control. was confirmed (FIG. 2).
이상의 설명으로부터, 본 발명이 속하는 기술분야의 당업자는 본 발명이 그 기술적 사상이나 필수적 특징을 변경하지 않고서 다른 구체적인 형태로 실시될 수 있다는 것을 이해할 수 있을 것이다. 이와 관련하여, 이상에서 기술한 실시예들은 모든 면에서 예시적인 것이며 한정적인 것이 아닌 것으로 이해해야만 한다. 본 발명의 범위는 상기 상세한 설명보다는 후술하는 특허 청구범위의 의미 및 범위 그리고 그 등가 개념으로부터 도출되는 모든 변경 또는 변형된 형태가 본 발명의 범위에 포함되는 것으로 해석되어야 한다.From the above description, those skilled in the art to which the present invention pertains will understand that the present invention may be embodied in other specific forms without changing the technical spirit or essential characteristics thereof. In this regard, it should be understood that the embodiments described above are illustrative in all respects and not restrictive. The scope of the present invention should be construed as being included in the scope of the present invention, rather than the above detailed description, all changes or modifications derived from the meaning and scope of the following claims and their equivalents.
Claims (7)
Rehmannia glutinosa ( Rehmannia glutinosa ) A pharmaceutical composition for preventing or treating tic disorders, comprising a hot water extract as an active ingredient.
The pharmaceutical composition according to claim 1, wherein the composition inhibits muscle and/or vocal tics among symptoms of tic disorders.
The pharmaceutical composition according to claim 1, wherein the tic disorder is Tourette syndrome.
A quasi-drug composition for preventing or improving tic disorders, comprising the hot water extract of Rehmannia glutinosa as an active ingredient.
A food composition for the prevention or improvement of tic disorders, comprising the hot water extract of Rehmannia glutinosa as an active ingredient.
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CN103169871A (en) * | 2013-04-11 | 2013-06-26 | 太仓市胜舟生物技术有限公司 | Medicament for treating tic disorder disease |
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CN103169874A (en) | 2013-04-11 | 2013-06-26 | 太仓市胜舟生物技术有限公司 | Use of traditional Chinese medicine composition containing cortex albiziae |
CN103169871A (en) * | 2013-04-11 | 2013-06-26 | 太仓市胜舟生物技术有限公司 | Medicament for treating tic disorder disease |
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