KR102287877B1 - Composition for Improving Memory and Cognitive Function Comprising Psyllium husk - Google Patents
Composition for Improving Memory and Cognitive Function Comprising Psyllium husk Download PDFInfo
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- KR102287877B1 KR102287877B1 KR1020140029692A KR20140029692A KR102287877B1 KR 102287877 B1 KR102287877 B1 KR 102287877B1 KR 1020140029692 A KR1020140029692 A KR 1020140029692A KR 20140029692 A KR20140029692 A KR 20140029692A KR 102287877 B1 KR102287877 B1 KR 102287877B1
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Abstract
본 발명은 차전자피(Psyllium husk)를 포함하는 기억력 및 인지기능 증진용 조성물에 관한 것으로, 보다 상세하게는 차전자피를 유효성분으로 포함하는 기억력 개선 또는 인지기능 장애의 예방 또는 치료용 약학 조성물, 및 기억력 개선 또는 인지기능 장애의 예방 또는 개선용 식품 조성물에 관한 것이다. 본 발명의 차전자피를 포함하는 조성물은 기억력 개선 및 치매와 같은 인지기능 장애의 예방, 개선 및 치료 효과를 나타내는바, 기억력 개선 또는 인지기능 장애의 치료를 위한 의약품 및 건강기능식품 등에 유용하게 사용할 수 있다.The present invention relates to a composition for enhancing memory and cognitive function comprising Psyllium husk, and more particularly, to a pharmaceutical composition for improving memory or preventing or treating cognitive dysfunction, and improving memory, comprising psyllium husk as an active ingredient Or it relates to a food composition for preventing or improving cognitive dysfunction. The composition containing the psyllium hull of the present invention exhibits prevention, improvement and treatment effects of memory improvement and cognitive function disorders such as dementia, and thus can be usefully used in medicines and health functional foods for memory improvement or treatment of cognitive dysfunction. .
Description
본 발명은 차전자피(Psyllium husk)를 포함하는 기억력 및 인지기능 증진용 조성물에 관한 것으로, 보다 상세하게는 차전자피를 유효성분으로 포함하는 기억력 개선 또는 인지기능 장애의 예방 또는 치료용 약학 조성물, 및 기억력 개선 또는 인지기능 장애의 예방 또는 개선용 건강기능식품 조성물에 관한 것이다.
The present invention relates to a composition for enhancing memory and cognitive function comprising Psyllium husk, and more particularly, to a pharmaceutical composition for improving memory or preventing or treating cognitive dysfunction, and improving memory, comprising Psyllium husk as an active ingredient Or it relates to a health functional food composition for preventing or improving cognitive dysfunction.
치매는 일반적으로 인간의 인지기능, 지적능력, 감정 및 행동변화 등에서 뚜렷한 손상을 나타내는 복합 임상 증후군으로서, 기억력, 주의력, 언어기능, 시공간 능력 등의 대뇌피질 기능장애가 발생하여 일상, 사회생활을 영위하는데 큰 어려움을 겪게 되는 상태이다. 치매라고 정의할 때는 기억력을 포함하여 다른 인지기능 중 한 가지 이상의 장애가 있는 경우를 말하며, 단순히 기억력만 떨어진 경우는 치매라고 하지 않는다. Dementia is a complex clinical syndrome that generally shows significant impairment in human cognitive function, intellectual ability, emotional and behavioral changes, etc. It is in a state of great difficulty. When defined as dementia, it refers to a case in which one or more of other cognitive functions, including memory, are impaired.
치매의 원인으로는 퇴행성 뇌질환인 알츠하이머병(Alzheimer's Disease)이나 파킨슨병(Parkinson's Disease)에서부터 뇌출혈, 대사성질환인 간성뇌병증, 윌슨병(Wilson's Disease), 감염성 질환인 신경매독, 후천성면역결핍증, 알코올과 같은 약물중독, 뇌외상 등 다양한 병인이 있으며, 어떤 형태로는 중추신경계에 구조적, 기능적 이상을 초래할 수 있는 질환은 치매를 유발할 수가 있다. 그 중에서도 알츠하이머병에 의한 치매가 50 내지 60 %로 가장 많으며, 뇌혈관 질환에 의한 치매가 그 다음이다. The causes of dementia include Alzheimer's disease and Parkinson's disease, which are degenerative brain diseases, cerebral hemorrhage, hepatic encephalopathy, a metabolic disease, Wilson's disease, neurosyphilis, acquired immunodeficiency syndrome, alcohol and other infectious diseases. There are various etiologies such as drug addiction and brain trauma, and diseases that can cause structural and functional abnormalities in the central nervous system in some form can cause dementia. Among them, dementia due to Alzheimer's disease accounts for 50 to 60%, and dementia due to cerebrovascular disease is next.
기억 인지 장애는 알츠하이머 질환자들이 처음으로 겪는 증상이며 또한 가장 흔한 증상이다. 알츠하이머병의 초기에 환자들은 최근의 대화나 일의 내용을 자세하게 기억하지 못하는 최근 기억(recent memory) 장애를 겪게 되는데, 이는 해마의 신경세포가 손상되어 최근 기억을 저장하는 기능이 떨어진 데에서 기인한다. 하지만 이 시기에는 먼 과거에 있었던 사건들에 대한 과거 기억(remote long-term memory)은 상대적으로 잘 유지된다. 그러나 병이 점차 진행됨에 따라 장기기억의 저장과 관련된 대뇌피질이 손상되면서 이러한 과거의 기억도 점차 장애를 보이게 된다. Memory and cognitive impairment is the first and most common symptom experienced by people with Alzheimer's disease. In the early stages of Alzheimer's disease, patients suffer from a recent memory disorder that prevents them from remembering the details of recent conversations or events. . However, during this period, the remote long-term memory of events in the distant past is relatively well maintained. However, as the disease progresses, the cerebral cortex related to the storage of long-term memories is damaged, and these past memories are also gradually impaired.
한편, 동맥경화에 이어 발생한 혈전에 의해 뇌동맥이 막혀 조직이 죽게 되는 지역이 해마(hippocampus)와 같은 중요 지역에서 발생하면 치매로 발전하게 되며, 혈관성치매에서 가장 많은 비율을 차지하는 것은 가는 혈관들이 막히거나 또는 혈액공급이 원활하지 못해 발생하는 겉질밑 허혈성 혈관성 치매(subcortical ischemic vascular dementia, SIVD)(전체 혈관성 치매의 35 내지 67 % 차지)이다(Roman et al., Subcortical ischaemic vascular dementia. Lancet Neurol 2002;1:426-436). 겉질밑 허혈성 혈관성치매(SIVD)에서의 손상은 주로 백색질에서 일어나며 이러한 질환을 닮은 동물모델을 만들기 위해 다양한 방법들이 사용되고 있다(Hainsworth & Markus, Do in vivo experimental models reflect human cerebral small vessel disease? A systematic review. J Cerebral Blood Flow & Metabolism 2008;28:1877-1891). 혈관성 치매에 대해서는 백색질을 이루는 희소돌기아교세포(oligodendrocyte)가 혈관성치매가 일어나는 조건에서 세포자살에 의해 죽는다는 것이 밝혀졌으며, 이를 억제하여 치료를 하기 위한 연구가 진행되고 있다. On the other hand, if the area where the cerebral artery is blocked by a blood clot that occurs following arteriosclerosis and the tissue is killed occurs in an important area such as the hippocampus, it develops into dementia. or subcortical ischemic vascular dementia (SIVD) (35 to 67% of all vascular dementias), which is caused by insufficient blood supply (Roman et al., Subcortical ischemic vascular dementia. Lancet Neurol 2002;1) :426-436). Damage in subcortical ischemic vascular dementia (SIVD) mainly occurs in the white matter, and various methods are used to make animal models resembling these diseases (Hainsworth & Markus, Do in vivo experimental models reflect human cerebral small vessel disease? A systematic review (J Cerebral Blood Flow & Metabolism 2008;28:1877-1891). For vascular dementia, it has been found that oligodendrocytes constituting the white matter die by apoptosis under conditions in which vascular dementia occurs, and research is underway to suppress it and treat it.
현재 우리나라의 알츠하이머병 치료제의 경우 외국계열 회사가 98 %의 점유율을 차지하고 있을 정도로 수입에 의존하는 바가 크다. 더욱이 한 회사가 시장의 80 %를 차지하고 있어 사실상 독점하고 있다고 볼 수 있다(한국과학기술정보연구원. 치매치료제. p.116, 2002). 이는 국가경쟁력 측면에서도 치매 치료분야의 성장이 시급함을 알 수 있다. 따라서 부작용이 적으면서 효과적인 항건망제제 및 기억력 개선제의 개발은 알츠하이머 질환자의 삶의 질 향상과 초기 병증 개선 및 치료에 상당한 도움을 줄 수 있으며, 또한 기억인지력의 장애를 겪는 건망증, 치매환자에게도 도움을 줄 수 있을 것으로 사료된다.Currently, in the case of Alzheimer's disease treatment in Korea, foreign companies are highly dependent on imports, accounting for 98% of the market share. Moreover, as one company occupies 80% of the market, it can be said that it has a de facto monopoly (Korea Institute of Science and Technology Information. Dementia treatment drugs. p.116, 2002). This shows that the growth of the dementia treatment field is urgently needed in terms of national competitiveness as well. Therefore, the development of effective anti-forgetfulness and memory improving agents with fewer side effects can significantly help improve the quality of life of Alzheimer's disease patients and improve and treat early symptoms, and also help patients with forgetfulness and dementia who suffer from memory cognition disorders. is expected to be able to give.
한편, 차전자피는 산업적으로 건강기능식품 기능성 원료로서, 식이섬유를 79 % 이상 함유하고 있어 최근 콜레스테롤 개선 및 배변활동 원활의 건강기능식품으로 주목을 받고 있지만 신경계에 미치는 영향에 대해서는 알려진 바 없다.
Meanwhile, psyllium hull is an industrially functional raw material for health functional food and contains 79% or more of dietary fiber.
이러한 배경 하에서, 상기 차전자피의 기억력 증진 및 인지기능 장애의 예방 및 치료 효능을 밝히기 위하여 예의 노력한 결과, 차전자피가 기억력 손상을 회복시키고 혈관성 치매와 같은 인지기능 장애의 치료에 탁월한 효과가 있음을 확인하여, 본 발명을 완성하였다.
Under this background, as a result of diligent efforts to elucidate the efficacy of the psyllium to improve memory and prevent and treat cognitive dysfunction, it was confirmed that the psyllium has an excellent effect in restoring memory damage and in the treatment of cognitive dysfunction such as vascular dementia, The present invention was completed.
본 발명의 하나의 목적은 차전자피를 유효성분으로 포함하는 기억력 개선 또는 인지기능 장애의 예방 또는 치료용 약학 조성물을 제공하는 것이다.One object of the present invention is to provide a pharmaceutical composition for preventing or treating memory improvement or cognitive dysfunction comprising psyllium psyllium as an active ingredient.
본 발명의 다른 하나의 목적은 차전자피를 유효성분으로 포함하는 기억력 개선 또는 인지기능 장애의 예방 또는 개선용 건강기능식품 조성물을 제공하는 것이다.
Another object of the present invention is to provide a health functional food composition for improving memory or preventing or improving cognitive function comprising psyllium hull as an active ingredient.
상기 과제를 달성하기 위한 하나의 양태로서, 본 발명은 차전자피를 유효성분으로 포함하는 기억력 개선 또는 인지기능 장애의 예방 또는 치료용 약학 조성물을 제공한다.
As one aspect for achieving the above object, the present invention provides a pharmaceutical composition for preventing or treating memory improvement or cognitive dysfunction comprising psyllium psyllium as an active ingredient.
본 발명에서 용어 "차전자피(Psyllium husk)"는, 질경이과(Plantaginaceae)에 속하는 다년생 초본 질경이(Plantago asiatica)의 성숙한 종자인 차전자의 껍질을 당해 업계에 널리 공지된 추출, 분리, 정제방법에 의해 수득되거나, 시판되는 분말형태의 시약을 말한다. In the present invention, the term "Psyllium husk" is obtained by extracting, separating, and purifying the skin of psyllium, which is a mature seed of the perennial herbaceous plantain (Plantaginaceae) belonging to the plant Plantago asiatica, which is well known in the art. or commercially available powdered reagents.
구체적으로 차전자(Psyllium)는 전세계 생산량의 약 80 %를 차지하는 인도가 주산지이며, 1,000 개 차전자의 무게가 2 g 보다 작은 차전자 씨앗의 껍질을 차전자피라고 한다. 보다 구체적으로 차전차피 식이섬유(fiber)는 차전차피의 분말이며, 상기 분말은 차전자의 씨앗을 분쇄하여 전체 씨앗의 약 25 %를 차지하는 껍질을 분리한 다음 제분하여, 가는 입자로 만든 후 체로 걸러 얻을 수 있다. 상기 분말의 섭취방법은 상기 분말 3.5 g을 250 ml 물에 녹여 섭취하거나, 캡슐형태로 섭취되기도 한다.Specifically, Psyllium is mainly produced in India, which accounts for about 80% of the world's production. More specifically, the dietary fiber (fiber) of the psyllium hull is a powder of the psyllium psyllium, and the powder is pulverized seeds of psyllium to separate the husk, which accounts for about 25% of the total seeds, and then milled it to make fine particles and sieved it can be obtained As for the ingestion method of the powder, 3.5 g of the powder is dissolved in 250 ml water, or ingested in the form of a capsule.
한방에서 차전자는 강력한 이뇨제로 신장염, 방광염 및 요도염 등에 널리 사용되어 왔으며, 무기질, 단백질, 비타민류 및 다당류 등이 많이 함유되어 있어, 상기 차전자 성분들은 항염증 작용에 관여하는 것으로 알려져 있다.
In oriental medicine, psyllium has been widely used for nephritis, cystitis, and urethritis as a powerful diuretic, and contains a lot of minerals, proteins, vitamins, and polysaccharides.
본 발명의 차전자피를 유효성분으로 하는 조성물은 기억력 개선 및 인지기능 장애의 예방, 치료 또는 개선 효과가 있다.The composition comprising the psyllium hull of the present invention as an active ingredient has an effect of improving memory and preventing, treating or improving cognitive function.
본 발명에서 용어 "기억" 또는 "기억력"은 주위 환경으로부터 얻은 새로운 정보나 학습된 경험, 지식을 습득하여 뇌의 특정부위에 부호화하여 저장하고 이를 다시 회상할 수 있는 능력을 의미한다. 본 발명의 조성물은 상기와 같은 기억력을 개선시킬 수 있는 효과가 있으며, 이러한 효과에는 정상인의 기억력을 증진시키는 효과 뿐만 아니라 손상된 기억력 또는 기억력 장애를 회복시키는 모든 효과를 포함할 수 있다.In the present invention, the term "memory" or "memory" refers to the ability to acquire new information, learned experiences, or knowledge obtained from the surrounding environment, encode and store it in a specific part of the brain, and recall it again. The composition of the present invention has the effect of improving memory as described above, and these effects may include not only the effect of enhancing the memory of normal people, but also all the effects of restoring damaged memory or memory impairment.
상기 기억력 장애는 외상, 주의력 결핍, 노화, 질병 등의 다양한 원인에 의하여 상기 기억력이 정상인에 비해 낮아진 상태를 의미하며, 건망증, 집중력 장애, 공간지각력 손실, 학습능력의 둔화, 인지력 상실 등을 포함하는 개념이다.The memory impairment refers to a state in which the memory is lower than that of a normal person due to various causes such as trauma, attention deficit, aging, disease, etc. Concept.
본 발명의 일실시예에서는 차전자피의 기억력에 대한 효과를 확인하기 위하여, 스코폴라민으로 기억력 손상(건망증)을 유도한 랫트에서 수동회피실험을 진행한 결과, 차전자피가 스코폴라민에 의한 인지기억력 손상을 회복시키는 효과가 있음을 확인하였다(도 1).
In one embodiment of the present invention, in order to confirm the effect of psyllium on memory, a passive avoidance experiment was conducted in rats induced with memory impairment (forgetfulness) with scopolamine. It was confirmed that there is an effect of restoring the (Fig. 1).
본 발명에서 "인지기능"은 지식과 정보를 효율적으로 조작하는 능력으로서, 본 발명의 목적상 인지기능 장애는 상기와 같은 인지기능이 저하되어 생기는 상태, 그에 따른 질환, 그를 증상으로 하는 모든 질환을 포함할 수 있는 개념으로써, 바람직하게는 뇌 신경세포의 손상으로 발생하는 장애를 의미할 수 있다. 본 발명의 인지기능 장애에는 건망증, 알츠하이머병(Alzheimer's disease), 혈관성 치매, 두부손상에 의한 치매 또는 파킨슨씨병(Parkinson's disease) 등이 포함될 수 있으며, 바람직하게는 혈관성 치매일 수 있다.In the present invention, "cognitive function" is the ability to efficiently manipulate knowledge and information, and for the purpose of the present invention, cognitive dysfunction is a condition caused by a decrease in cognitive function as described above, a disease resulting therefrom, and all diseases having the same symptoms. As a concept that can be included, it may preferably mean a disorder caused by damage to brain neurons. Cognitive dysfunction of the present invention may include forgetfulness, Alzheimer's disease, vascular dementia, dementia or Parkinson's disease caused by head injury, and the like, preferably vascular dementia.
본 발명의 일실시예에서는 차전자피의 혈관성 치매에 대한 효과를 확인하기 위하여, 만성 관류저하 모델을 이용하여 혈관성 치매에 의한 동공대광반사(pupillary light reflex, PLR) 손실 및 백색질 손상에 대한 효과를 확인한 결과, 백색질 중 시각로의 손상으로 인한 PLR 손실이 억제되는 효과를 확인하였으며(표 1), 또한 시각로 부위에서 차전자피에 의해 백색질 손상이 억제되는 효과를 확인하였다(도 2). 따라서, 본 발명의 차전자피가 혈관성 치매를 포함한 인지기능 장애를 개선할 수 있는 효과를 나타냄을 확인하였다.
In one embodiment of the present invention, in order to confirm the effect of psyllium cortex on vascular dementia, the effect on pupillary light reflex (PLR) loss and white matter damage caused by vascular dementia was confirmed using a chronic hypoperfusion model. , the effect of suppressing PLR loss due to damage to the visual tract among white matter was confirmed (Table 1), and also the effect of inhibiting white matter damage by psyllium in the visual tract region was confirmed ( FIG. 2 ). Therefore, it was confirmed that the psyllium skin of the present invention exhibits the effect of improving cognitive dysfunction including vascular dementia.
본 발명에서, 용어 "예방"이란 본 발명에 따른 약학 조성물의 투여에 의해 인지기능 장애의 발생, 확산 및 재발을 억제 또는 지연시키는 모든 행위를 의미하고, "치료"란 상기 약학 조성물의 투여에 의해 인지기능 장애의 의심 및 발병 개체의 증상이 호전되거나 이롭게 변경하는 모든 행위를 의미한다.
In the present invention, the term "prevention" refers to any action that inhibits or delays the occurrence, spread, and recurrence of cognitive dysfunction by administration of the pharmaceutical composition according to the present invention, and "treatment" refers to any action by administration of the pharmaceutical composition. It refers to any action that improves or beneficially changes the symptoms of the suspected or affected individual of cognitive dysfunction.
상기 본 발명의 약학조성물은 약학적으로 허용가능한 담체를 추가로 포함할 수 있다. 본 발명의 용어 "약학적으로 허용가능한"이란 상기 조성물에 노출되는 세포나 인간에게 독성이 없는 특성을 나타내는 것을 의미한다. 상기 담체는 완충제, 보존제, 무통화제, 가용화제, 등장제, 안정화제, 기제, 부형제, 윤활제 등 당업계에 공지된 것이라면 제한없이 사용할 수 있다.The pharmaceutical composition of the present invention may further include a pharmaceutically acceptable carrier. As used herein, the term “pharmaceutically acceptable” means exhibiting non-toxic properties to cells or humans exposed to the composition. The carrier may be used without limitation as long as it is known in the art, such as buffers, preservatives, soothing agents, solubilizers, isotonic agents, stabilizers, bases, excipients, lubricants, and the like.
또한 본 발명의 약학조성물은 각각 통상의 방법에 따라 산제, 과립제, 정제, 캡슐제, 현탁액, 에멀젼, 시럽, 에어로졸 등의 경구형 제형, 외용제, 좌제 및 멸균 주사용액의 형태로 제형화하여 사용될 수 있다. 나아가, 연고제, 로션제, 스프레이제, 패취제, 크림제, 산제, 현탁제, 겔제 또는 젤의 형태의 피부 외용제의 형태로 사용될 수 있다. 본 발명의 조성물에 포함될 수 있는 담체, 부형제 및 희석제로는 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 및 광물유를 들 수 있다. 제제화할 경우에는 보통 사용하는 충진제, 증량제, 결합제, 습윤제, 붕해제, 계면활성제 등의 희석제 또는 부형제를 사용하여 조제된다.In addition, the pharmaceutical composition of the present invention can be used in the form of oral dosage forms such as powders, granules, tablets, capsules, suspensions, emulsions, syrups, aerosols, external preparations, suppositories, and sterile injection solutions, respectively, according to conventional methods. there is. Furthermore, it may be used in the form of an ointment, lotion, spray, patch, cream, powder, suspension, gel, or external preparation for skin in the form of a gel. Carriers, excipients and diluents that may be included in the composition of the present invention 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 and mineral oil. In the case of formulation, it is prepared using diluents or excipients, such as commonly used fillers, extenders, binders, wetting agents, disintegrants, and surfactants.
경구투여를 위한 고형제제에는 정제, 환제, 산제, 과립제, 캡슐제 등이 포함되며, 이러한 고형제제는 상기 트레쿨리아 아프리카나 추출물에 적어도 하나 이상의 부형제 예를 들면, 전분, 칼슘카보네이트 (calcium carbonate), 수크로스(sucrose) 또는 락토오스(lactose), 젤라틴 등을 섞어 조제된다. 또한 단순한 부형제 이외에 마그네슘 스티레이트, 탈크 같은 윤활제들도 사용된다. 경구를 위한 액상 제제로는 현탁제, 내용액제, 유제, 시럽제 등이 해당되는 데 흔히 사용되는 단순희석제인 물, 리퀴드 파라핀 이외에 여러 가지 부형제, 예를 들면 습윤제, 감미제, 방향제, 보존제 등이 포함될 수 있다. Solid preparations for oral administration include tablets, pills, powders, granules, capsules, etc., and these solid preparations include at least one excipient in the Treculia africana extract, for example, starch, calcium carbonate , sucrose or lactose, gelatin, etc. are mixed and prepared. In addition to simple excipients, lubricants such as magnesium stearate and talc are also used. Liquid formulations for oral use include suspensions, solutions, emulsions, syrups, etc., which are commonly used simple diluents such as water and liquid paraffin, and various excipients such as wetting agents, sweeteners, fragrances, and preservatives. there is.
비경구 투여를 위한 제제에는 멸균된 수용액, 비수성용제, 현탁제, 유제, 동결건조 제제, 좌제가 포함된다. 비수성용제, 현탁제로는 프로필렌글리콜 (propylene glycol), 폴리에틸렌 글리콜, 올리브오일과 같은 식물성 기름, 에틸올레이트와 같은 주사 가능한 에스테르 등이 사용될 수 있다. 좌제의 기제로는 위텝솔(witepsol), 마크로골, 트윈 61(tween 61), 카카오지, 라우린지, 글리세로제라틴 등이 사용될 수 있다.
Formulations for parenteral administration include sterile aqueous solutions, non-aqueous solutions, suspensions, emulsions, freeze-dried preparations, and suppositories. Non-aqueous solvents and suspending agents include propylene glycol, polyethylene glycol, vegetable oils such as olive oil, and injectable esters such as ethyl oleate. As the base of the suppository, witepsol, macrogol, tween 61, cacao butter, laurin, glycerogelatin, and the like can be used.
본 발명의 약학조성물은 약학적으로 유효한 양으로 투여한다. 본 발명의 용어 "약학적으로 유효한 양"은 의학적 치료에 적용 가능한 합리적인 수혜/위험 비율로 질환을 치료하기에 충분하며 부작용을 일으키지 않을 정도의 양을 의미하며, 유효용량 수준은 환자의 건강상태, 질환의 종류, 중증도, 약물의 활성, 약물에 대한 민감도, 투여 방법, 투여 시간, 투여 경로 및 배출 비율, 치료기간, 배합 또는 동시 사용되는 약물을 포함한 요소 및 기타 의학 분야에 잘 알려진 요소에 따라 결정될 수 있다. 본 발명의 조성물은 개별 치료제로 투여하거나 다른 치료제와 병용하여 투여될 수 있고, 종래의 치료제와 순차적으로 또는 동시에 투여될 수 있으며, 단일 또는 다중 투여될 수 있다. 상기한 요소들을 모두 고려하여 부작용 없이 최소한의 양으로 최대 효과를 얻을 수 있는 양을 투여하는 것이 중요하며, 이는 당업자에 의해 용이하게 결정될 수 있다.The pharmaceutical composition of the present invention is administered in a pharmaceutically effective amount. As used herein, the term "pharmaceutically effective amount" refers to an amount sufficient to treat a disease at a reasonable benefit/risk ratio applicable to medical treatment and not to cause side effects, and the effective dose level depends on the patient's health condition, disease type, severity, drug activity, sensitivity to drug, administration method, administration time, administration route and excretion rate, treatment period, factors including drugs used in combination or concurrently, and other factors well known in the medical field. can The composition of the present invention may be administered as an individual therapeutic agent or in combination with other therapeutic agents, may be administered sequentially or simultaneously with conventional therapeutic agents, and may be administered singly or multiple times. In consideration of all of the above factors, it is important to administer an amount that can obtain the maximum effect with a minimum amount without side effects, which can be easily determined by those skilled in the art.
본 발명의 조성물은 쥐, 랫트, 생쥐, 가축, 인간 등의 포유동물에 다양한 경로로 투여될 수 있다. 투여의 모든 방식은 예상될 수 있는데, 예를 들면, 경구, 직장 또는 정맥, 근육, 피하, 자궁내 경막 또는 뇌혈관 내(intracerebroventricular) 주사에 의해 투여될 수 있다. 또한, 상기 약학적 조성물 중 유효성분의 투여량은 투여경로, 질병의 정도, 환자의 나이, 성별, 체중 등에 따라 달라질 수 있으며, 일일 1회 내지 수회 투여할 수 있다. 그러나 바람직한 효과를 위해서, 1일 0.01 mg/kg 내지 10 g/kg으로, 바람직하게는 1 mg/kg 내지 1 g/kg으로 투여하는 것이 좋다. 투여는 하루에 한번 투여할 수도 있고, 수회 나누어 투여할 수 있다. 따라서, 상기 투여량은 어떠한 면으로든 본 발명의 범위를 한정하는 것은 아니다.
The composition of the present invention may be administered to mammals such as rats, rats, mice, livestock, and humans by various routes. Any mode of administration can be envisaged, for example, by oral, rectal or intravenous, intramuscular, subcutaneous, intrauterine dural or intracerebroventricular injection. In addition, the dosage of the active ingredient in the pharmaceutical composition may vary depending on the route of administration, the degree of disease, the age, sex, weight, etc. of the patient, and may be administered once to several times a day. However, for the desired effect, it is recommended to be administered at 0.01 mg/kg to 10 g/kg per day, preferably 1 mg/kg to 1 g/kg. Administration may be administered once a day, or may be administered in several divided doses. Accordingly, the above dosage does not limit the scope of the present invention in any way.
다른 하나의 양태로서, 본 발명은 차전자피를 필요로 하는 개체에게 투여하는 단계를 포함하는, 기억력 개선 또는 인지기능 장애의 예방 또는 치료방법을 제공한다.As another aspect, the present invention provides a method for preventing or treating memory improvement or cognitive dysfunction, comprising administering to an individual in need of psyllium.
본 발명의 용어 "개체"란, 상기 기억력 개선이 필요하거나 인지기능 장애가 발병하였거나 발병할 수 있는 인간을 포함한 원숭이, 소, 말, 양, 돼지, 닭, 칠면조, 메추라기, 고양이, 개, 마우스, 쥐, 랫트, 토끼 또는 기니아 피그를 포함한 모든 동물을 의미하고, 본 발명의 약학 조성물을 개체에게 투여함으로써 상기 질환들을 효과적으로 예방 또는 치료할 수 있다. 본 발명의 약학적 조성물은 기존의 치료제와 병행하여 투여될 수 있다.As used herein, the term "individual" means monkey, cow, horse, sheep, pig, chicken, turkey, quail, cat, dog, mouse, rat , refers to all animals, including rats, rabbits, or guinea pigs, and can effectively prevent or treat the above diseases by administering the pharmaceutical composition of the present invention to an individual. The pharmaceutical composition of the present invention may be administered in parallel with a conventional therapeutic agent.
본 발명의 용어 "투여"란, 임의의 적절한 방법으로 환자에게 소정의 물질을 제공하는 것을 의미하며, 본 발명의 조성물의 투여 경로는 목적 조직에 도달할 수 있는 한 어떠한 일반적인 경로를 통하여 투여될 수 있다. 복강 내 투여, 정맥 내 투여, 근육 내 투여, 피하 투여, 피 내 투여, 경구 투여, 국소 투여, 비 내 투여, 폐 내 투여, 직장 내 투여될 수 있으나, 이에 제한되지는 않는다. 또한, 본 발명의 약학적 조성물은 활성 물질이 표적 세포로 이동할 수 있는 임의의 장치에 의해 투여될 수도 있다. 바람직한 투여방식 및 제제는 정맥 주사제, 피하 주사제, 피내 주사제, 근육 주사제, 점적 주사제 등이다. 주사제는 생리식염액, 링겔액 등의 수성 용제, 식물유, 고급 지방산 에스테르(예, 올레인산에칠 등), 알코올 류(예, 에탄올, 벤질알코올, 프로필렌글리콜, 글리세린 등) 등의 비수성 용제 등을 이용하여 제조할 수 있고, 변질 방지를 위한 안정화제(예, 아스코르빈산, 아황산수소나트륨, 피로아황산나트륨, BHA, 토코페롤, EDTA 등), 유화제, pH 조절을 위한 완충제, 미생물 발육을 저지하기 위한 보존제(예, 질산페닐수은, 치메로살, 염화벤잘코늄, 페놀, 크레솔, 벤질알코올 등) 등의 약학적 담체를 포함할 수 있다.
The term "administration" of the present invention means providing a predetermined substance to a patient by any suitable method, and the administration route of the composition of the present invention may be administered through any general route as long as it can reach the target tissue. there is. Intraperitoneal administration, intravenous administration, intramuscular administration, subcutaneous administration, intradermal administration, oral administration, topical administration, intranasal administration, intrapulmonary administration, may be administered intrarectally, but is not limited thereto. In addition, the pharmaceutical composition of the present invention may be administered by any device capable of transporting an active substance to a target cell. Preferred administration methods and formulations are intravenous injections, subcutaneous injections, intradermal injections, intramuscular injections, drip injections, and the like. For injections, aqueous solvents such as physiological saline solution and Ringel's solution, vegetable oil, higher fatty acid esters (eg, ethyl oleate), and non-aqueous solvents such as alcohols (eg, ethanol, benzyl alcohol, propylene glycol, glycerin, etc.) Stabilizers for preventing deterioration (e.g., ascorbic acid, sodium hydrogen sulfite, sodium pyrosulfite, BHA, tocopherol, EDTA, etc.), emulsifiers, buffers for pH control, to inhibit the growth of microorganisms Pharmaceutical carriers such as preservatives (eg, phenylmercuric nitrate, thimerosal, benzalkonium chloride, phenol, cresol, benzyl alcohol, etc.) may be included.
또 다른 하나의 양태로서, 본 발명은 차전자피를 유효성분으로 포함하는 기억력 개선 또는 인지기능 장애의 예방 또는 개선용 식품 조성물을 제공한다.As another aspect, the present invention provides a food composition for preventing or improving memory or cognitive dysfunction, comprising psyllium hull as an active ingredient.
상기 차전자피에 관해서는 상기에서 설명한 바와 같으며, 본 발명의 차전자피는 기억력 개선 및 인지기능 장애의 예방 또는 개선 효과를 가짐으로써 그 목적에 맞게 식품 첨가물로 식품 조성물에 포함시킬 수 있다.The psyllium hull is the same as described above, and the psyllium hull of the present invention has the effect of improving memory and preventing or improving cognitive function, and thus may be included in the food composition as a food additive according to the purpose.
본 발명의 조성물을 식품 조성물로 사용하는 경우, 상기 차전자피를 그대로 첨가하거나 다른 식품 또는 식품 성분과 함께 사용할 수 있고, 통상의 방법에 따라 적절하게 사용할 수 있다. 유효 성분의 혼합양은 사용 목적(예방, 건강 또는 치료적 처치)에 따라 적합하게 결정될 수 있으며, 식품학적으로 허용가능한 식품 보조 첨가제를 추가로 포함할 수 있다. When the composition of the present invention is used as a food composition, the psyllium hull may be added as it is or used together with other foods or food ingredients, and may be appropriately used according to a conventional method. The mixing amount of the active ingredient may be suitably determined according to the purpose of use (prophylactic, health or therapeutic treatment), and may further include a food pharmaceutically acceptable food supplement additive.
본 발명의 식품 조성물은 통상적인 의미의 식품을 모두 포함할 수 있으며, 기능성 식품, 건강기능식품 등 당업계에 알려진 용어와 혼용 가능하다.The food composition of the present invention may include all foods in a conventional sense, and may be used interchangeably with terms known in the art, such as functional food and health functional food.
본 발명의 용어 "기능성 식품"은 건강기능식품에 관한 법률 제6727호에 따른 인체에 유용한 기능성을 가진 원료나 성분을 사용하여 제조 및 가공한 식품을 의미하며, "기능성"이라 함은 인체의 구조 및 기능에 대하여 영양소를 조절하거나 생리학적 작용 등과 같은 보건 용도에 유용한 효과를 얻을 목적으로 섭취하는 것을 의미한다.The term "functional food" as used in the present invention means a food manufactured and processed using raw materials or ingredients useful for the human body according to Health Functional Food Act No. 6727, and "functionality" refers to the structure of the human body. And it refers to ingestion for the purpose of obtaining useful effects for health purposes such as regulating nutrients for function or physiological action.
또한, 본 발명의 용어 "건강기능식품"은 건강보조의 목적으로 특정성분을 원료로 하거나 식품 원료에 들어있는 특정성분을 추출, 농축, 정제, 혼합 등의 방법으로 제조, 가공한 식품을 말하며, 상기 성분에 의해 생체방어, 생체리듬의 조절, 질병의 방지와 회복 등 생체조절기능을 생체에 대하여 충분히 발휘할 수 있도록 설계되고 가공된 식품을 말하는 것으로서, 상기 건강식품용 조성물은 질병의 예방 및 질병의 회복 등과 관련된 기능을 수행할 수 있다.In addition, the term "health functional food" as used herein refers to a food manufactured and processed using a specific ingredient as a raw material for the purpose of health supplementation or by extracting, concentrating, refining, or mixing a specific ingredient contained in the food raw material, It refers to food designed and processed to sufficiently exert biological control functions such as biological defense, regulation of biological rhythm, prevention and recovery of disease, etc., by the above ingredients, and the composition for health food is used for prevention of diseases and prevention of diseases. It can perform functions related to recovery, etc.
본 발명의 조성물이 사용될 수 있는 식품의 종류에는 제한이 없다. 아울러 본 발명의 차전자피를 활성성분으로 포함하는 조성물은 당업자의 선택에 따라 식품에 함유될 수 있는 적절한 기타 보조 성분과 공지의 첨가제를 혼합하여 제조할 수 있다. 첨가할 수 있는 식품의 예로는 육류, 소세지, 빵, 쵸코렛, 캔디류, 스낵류, 과자류, 피자, 라면, 기타 면류, 껌류, 아이스크림 류를 포함한 낙농제품, 각종 스프, 음료수, 차, 드링크제, 알콜 음료 및 비타민 복합제 등이 있으며, 본 발명에 따른 화합물을 주성분으로 하여 제조한 즙, 차, 젤리 및 주스 등에 첨가하여 제조할 수 있다. 또한, 환제, 분말, 과립, 침제, 정제, 캡슐 또는 음료의 형태로 사용할 수 있다.There is no limitation on the kind of food in which the composition of the present invention can be used. In addition, the composition comprising the psyllium hull of the present invention as an active ingredient can be prepared by mixing other suitable auxiliary ingredients that may be contained in food and known additives according to the selection of those skilled in the art. Examples of foods that can be added include meat, sausage, bread, chocolate, candy, snacks, confectionery, pizza, ramen, other noodles, gums, dairy products including ice cream, various soups, beverages, tea, drinks, alcoholic beverages and There are vitamin complexes and the like, and it can be prepared by adding the compound according to the present invention as a main component to juice, tea, jelly, juice, and the like. In addition, it can be used in the form of pills, powders, granules, needles, tablets, capsules or beverages.
본 발명의 건강 음료 조성물은 지시된 비율로 필수 성분으로서 상기 화합물을 함유하는 외에는 액체성분에는 특별한 제한 점은 없으며 통상의 음료와 같이 여러 가지 향미제 또는 천연 탄수화물 등을 추가 성분으로서 함유할 수 있다. 상술한 천연 탄수화물의 예로는 모노사카라이드, 예를 들어, 포도당, 과당 등; 디사카라이드, 예를 들어 말토스, 슈크로스 등; 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, 글리시르히진 등)) 및 합성 향미제(사카린, 아스파르탐 등)를 유리하게 사용할 수 있다. 상기 천연 탄수화물의 비율은 본 발명의 조성물 100 ml 당 일반적으로 약 1 내지 20 g, 바람직하게는 약 5 내지 12 g이다.The health beverage composition of the present invention has no particular limitation on the liquid component except for containing the above compound as an essential component in the indicated ratio, and may contain various flavoring agents or natural carbohydrates as additional components like a conventional beverage. Examples of the above-mentioned natural carbohydrates include monosaccharides such as glucose, fructose and the like; disaccharides such as maltose, sucrose and the like; polysaccharides such as dextrins, cyclodextrins; and sugar alcohols such as xylitol, sorbitol, and erythritol. As flavoring agents other than those described above, natural flavoring agents (taumatin, stevia extract (eg rebaudioside A, glycyrrhizin, etc.)) and synthetic flavoring agents (saccharin, aspartame, etc.) can be advantageously used. there is. The proportion 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.
상기 외에 본 발명의 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, 알콜, 탄산 음료에 사용되는 탄산화제 등을 함유할 수 있다. 그밖에 본 발명의 조성물들은 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 비율은 그렇게 중요하진 않지만 본 발명의 조성물 100 중량부 당 0 내지 약 20 중량부의 범위에서 선택되는 것이 일반적이다.
In addition to the above, the 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 thickening agents (cheese, chocolate, etc.), pectic acid and its salts, alginic acid and its salts. salts, organic acids, protective colloidal thickeners, pH adjusters, stabilizers, preservatives, glycerin, alcohols, carbonating agents used in carbonated beverages, and the like. In addition, the compositions of the present invention may contain natural fruit juice and pulp for the production of fruit juice beverages and vegetable beverages. These components may be used independently or in combination. The proportion of these additives is not critical, but is generally selected in the range of 0 to about 20 parts by weight per 100 parts by weight of the composition of the present invention.
본 발명의 차전자피를 포함하는 조성물은 기억력 개선 및 치매와 같은 인지기능 장애의 예방, 개선 및 치료 효과를 나타내는바, 기억력 개선 또는 인지기능 장애의 치료를 위한 의약품 및 건강기능식품 등에 유용하게 사용할 수 있다.
The composition containing the psyllium hull of the present invention exhibits prevention, improvement and treatment effects of memory improvement and cognitive dysfunction such as dementia, and thus can be usefully used in pharmaceuticals and health functional foods for improving memory or treating cognitive dysfunction. .
도 1은 스코폴라민에 의해 기억력 손상이 유도된 랫트에서 차전자피(Psyllium husk)의 투여에 따른 기억력 증진 효과를 나타내는 수동회피실험 결과이다.(왼쪽: 정상군으로 정상 랫트, 가운데: 대조군으로 스코폴라민만 투여한 랫트, 오른쪽: 차전자피를 투여한 랫트)
도 2는 혈관성 치매가 유도된 랫트의 시각로(optic tract) 지역에서 차전자피의 투여에 따른 백색질의 수초 손상 정도를 관찰한 결과이다.1 is a result of a passive avoidance experiment showing the memory enhancement effect according to the administration of Psyllium husk in rats induced by memory impairment by scopolamine. Rats administered with Minman, right: rats administered with psyllium hull)
2 is a result of observing the degree of myelin damage of white matter according to the administration of psyllium in the optic tract region of a rat induced with vascular dementia.
이하, 실시예를 통하여 본 발명의 구성 및 효과를 더욱 상세히 설명하고자 한다. 이들 실시예는 오로지 본 발명을 예시하기 위한 것일 뿐, 본 발명의 범위가 이들 실시예에 의해 한정되는 것은 아니다.
Hereinafter, the configuration and effects of the present invention will be described in more detail through examples. These examples are only for illustrating the present invention, and the scope of the present invention is not limited by these examples.
실시예 1: 차전자피(Psyllium husk)의 기억력 손상 억제 효과 확인Example 1: Confirmation of the memory impairment inhibitory effect of Psyllium husk
차전자피를 Pharmagen,(USA)으로부터 구입하였다. Psyllium hulls were purchased from Pharmagen, (USA).
실험동물로는 체중 280 내지 300 g 전후의 랫트(Sprague Dawley 8 주령, ㈜샘타코바이오, 오산)를 일주일 동안 실험환경에 적응시켜 사용하였다. 정상군, 대조군 그리고 실험군, 이렇게 3개의 군으로 나누었다. 적응기간(행동실험 전 7일) 및 행동실험기간 동안 500 mg/kg의 농도로 차전자피를 동물사료와 섞어 랫트들이 자유롭게 먹도록 하였으며, 투여 8 일째에 상기 랫트의 복강으로 0.9 mg/kg의 스코폴라민을 행동실험 실시 30 분 전에 주사하여 기억력 상실 동물모델을 확립하였다.As experimental animals, rats (Sprague Dawley, 8 weeks old, Samtaco Bio, Osan) weighing around 280 to 300 g were used after acclimatization to the experimental environment for one week. They were divided into three groups: normal group, control group, and experimental group. During the adaptation period (7 days before the behavioral experiment) and the behavioral experiment period, psyllium hull was mixed with animal feed at a concentration of 500 mg/kg and the rats were allowed to eat freely. An animal model of memory loss was established by injecting min 30 minutes before the behavioral experiment.
실험동물은 대구가톨릭대학교 의과대학 동물사육실 내에서 온도는 21 내지 24 ℃, 습도는 40 내지 60 %로 유지하였고, 낮 12 시간 밤 12 시간 주기로 하였다.
The experimental animals were maintained at a temperature of 21 to 24 °C and a humidity of 40 to 60% in the animal breeding room of the Daegu Catholic University College of Medicine, and the cycle was 12 hours during the day and 12 hours at night.
차전자피의 기억력에 대한 효과를 확인하기 위하여, 아세틸콜린 수용체의 길항제인 스코폴라민으로 기억력 손상을 유도한 랫트에서 수동회피실험(passive avoidance test)을 응용한 하기와 같은 실험을 수행하였다.In order to confirm the effect of psyllium on memory, the following experiment was performed using the passive avoidance test in rats induced with memory impairment with scopolamine, an acetylcholine receptor antagonist.
구체적으로, 동일한 구조의 밝은 구획과 어두운 구획 (가로 26 cm, 세로 28 cm, 높이 15 cm)이 길로틴 문(guillotine door, 가로 9 cm, 세로 10 cm)으로 연결되어 있는 장치에서 수동회피실험을 수행하였다. 밝은 구획은 전구가 설치되어 있으며 어두운 구획은 전기자극을 줄 수 있도록 바닥에 전기 전도성 망(stainless grid)이 깔려져 있다.Specifically, a passive evasion experiment was performed in a device in which the light and dark compartments (26 cm wide, 28 cm long, 15 cm high) of the same structure are connected by a guillotine door (9 cm wide, 10 cm long). did. The light section is equipped with light bulbs and the dark section has an electrically conductive grid on the floor to provide electrical stimulation.
수동회피실험은 총 2 일 동안 진행되었다. 첫째 날에는 밝은 구획에 랫트를 넣고 1분간 적응시키고 조명을 켠 다음 칸막이 문을 열어주었다. 일반적으로 랫트는 조명이 없는 어두운 구획으로 들어가게 되는데, 이때 자동적으로 칸막이 문이 닫히도록 하였고, 불이 꺼진 상태에서 바닥의 망을 통해 0.5 mA의 전류를 5초 동안 흘려주어 foot shock을 받게 하였다. 이러한 훈련은 랫트가 20 초 안에 조명이 없는 방으로 들어갈 때까지 반복하였다. The passive avoidance experiment was conducted for a total of 2 days. On the first day, the rats were placed in a bright compartment, acclimatized for 1 minute, the light was turned on, and the compartment door was opened. In general, the rat is entered into a dark compartment without lighting, at this time, the partition door was automatically closed, and a 0.5 mA current was passed through the mesh on the floor for 5 seconds while the light was turned off to receive a foot shock. This training was repeated until the rat entered an unlit room within 20 seconds.
실험 둘째 날(24 시간 후), 랫트를 밝은 구획에 다시 넣어주면 랫트는 조명이 들어와도 어두운 구획에 들어가기를 꺼려하게 되며, 이때 랫트가 어두운 구획으로 들어갈 때까지의 소요되는 시간 즉 step-through latency를 측정하였다 (retention trial). 한편, 랫트가 어두운 구획으로 들어가지 않는 경우 cut-off 시간을 300 초로 하였다.
On the second day of the experiment (after 24 hours), when the rat is put back into the bright compartment, the rat is reluctant to enter the dark compartment even when the light is on. was measured (retention trial). On the other hand, when the rat does not enter the dark compartment, the cut-off time was set to 300 seconds.
실험 결과, 도 1에 나타낸 바와 같이, step-through latency time은 정상군의 경우에 300.00 ± 0.0 초를 기록하였으며, 스코폴라민을 투여하여 기억력 손상을 유도한 군(대조군)의 경우에는 62.2 ± 34.6 초를 기록하여 237.8 초의 차이를 나타냄으로써, 기억력 손상이 확실하게 유발된 것을 확인할 수 있었다.As a result of the experiment, as shown in FIG. 1, the step-through latency time was 300.00 ± 0.0 seconds in the case of the normal group, and 62.2 ± 34.6 in the group (control group) in which memory impairment was induced by administration of scopolamine. By recording seconds and showing a difference of 237.8 seconds, it was confirmed that memory impairment was clearly induced.
한편, 스코폴라민의 투여와 함께 차전자피 500 mg/kg 을 투여한 실험군에서는 202.4 ± 49.1 초의 step-through latency time을 보임으로써, 차전자피의 투여가 스코폴라민에 의해 유도된 손상된 기억력의 회복에 현저한 효과가 있음을 확인할 수 있었다(도 1).On the other hand, in the experimental group administered with 500 mg/kg of psyllium hull along with the administration of scopolamine, a step-through latency time of 202.4 ± 49.1 seconds was shown, indicating that administration of psyllium had a significant effect on the recovery of damaged memory induced by scopolamine. It could be confirmed that there is (FIG. 1).
이러한 행동실험 결과를 통하여, 차전자피가 기억력을 회복시키고 인지기능을 증진시키는 데 효과적임을 알 수 있었다.
Through these behavioral test results, it was found that psyllium is effective in restoring memory and enhancing cognitive function.
실시예 2: 차전자피의 혈관성 치매에 의한 백색질 손상 억제 효과 확인Example 2: Confirmation of the effect of inhibiting white matter damage due to vascular dementia of psyllium
실시예 2-1.Example 2-1. 동공반응조사에 의한 백색질 손상 억제 효과 확인Confirmation of white matter damage inhibition effect by pupil response investigation
차전자피의 혈관성 치매에 대한 효과를 확인하기 위하여, 혈관성 치매 모델(bileteral common carotid artery occlusion, BCCAO)을 응용하여 흔히 사용되는 만성 관류저하 모델(chronic hypoperfusion model)을 통해 백색질 손상 억제 효과를 확인하였다.In order to confirm the effect of psyllium on vascular dementia, a vascular dementia model (bileteral common carotid artery occlusion, BCCAO) was applied and the effect of inhibiting white matter damage was confirmed through a commonly used chronic hypoperfusion model.
차전자피를 Pharmagen,(USA)으로부터 구입하여, 이를 100, 500 및 2,000 mg/kg/day의 용량으로 사료와 섞어서 총경동맥 결찰 5 일 전부터 랫트들에게 먹이기 시작하여 30 일 동안 지속적으로 공급하였다.Psyllium hulls were purchased from Pharmagen, (USA), mixed with feed at doses of 100, 500 and 2,000 mg/kg/day, and fed to the rats 5 days before common carotid artery ligation and continuously supplied for 30 days.
실험동물로는 체중 280 내지 310 g 전후의 랫트(Sprague Dawley 8 주령, ㈜샘타코바이오, 오산)를 일주일 동안 실험환경에 적응시켜 사용하였다. 정상군, 대조군 그리고 실험군, 이렇게 3개의 군으로 나누었다. 적응기간(행동실험 전 5 일) 및 30 일간의 실험기간 동안 100, 500 및 2,000 mg/kg/day 의 농도로 차전자피를 사료와 섞어 랫트들이 자유롭게 먹도록 하였다. As experimental animals, rats (Sprague Dawley, 8 weeks old, Samtaco Bio, Osan) weighing around 280 to 310 g were used after adapting to the experimental environment for a week. They were divided into three groups: normal group, control group, and experimental group. During the adaptation period (5 days before the behavioral experiment) and 30 days of the experiment, psyllium hulls were mixed with the feed at concentrations of 100, 500 and 2,000 mg/kg/day so that the rats were allowed to eat freely.
실험동물은 대구가톨릭대학교 의과대학 동물사육실 내에서 온도는 21 내지 24 ℃, 습도는 40 내지 60 %로 유지하였고, 낮 12 시간 밤 12 시간 주기로 하였다.
The experimental animals were maintained at a temperature of 21 to 24 °C and a humidity of 40 to 60% in the animal breeding room of the Daegu Catholic University College of Medicine, and the cycle was 12 hours during the day and 12 hours at night.
차전자피의 혈관성 치매에 대한 효과를 확인하기 위하여, 혈관성 치매 모델(bileteral common carotid artery occlusion, BCCAO)을 응용하여 흔히 사용되는 만성 관류저하 모델(chronic hypoperfusion model)을 통해 백색질 손상 억제 효과를 확인하였다.In order to confirm the effect of psyllium on vascular dementia, a vascular dementia model (bileteral common carotid artery occlusion, BCCAO) was applied and the effect of inhibiting white matter damage was confirmed through a commonly used chronic hypoperfusion model.
혈관성 치매모델은 체중 280 내지 310 g의 랫트를 흡입마취기(multiplus)를 이용하여 이소플루란(isoflurane, 하나제약, 대한민국)으로 흡입 마취시킨 후, 두 총경동맥(common carotid artery)을 수술로 노출시켜 봉합실로 묶는 BCCAO(bilateral common carotid artery occlusion) 방법으로, 전체 뇌에 공급되는 혈류량을 4주 동안 감소시켜 확립하였다. In the vascular dementia model, rats weighing 280 to 310 g were inhaled and anesthetized with isoflurane (Hana Pharmaceutical, Korea) using an inhalation anesthetic (multiplus), and then both common carotid arteries were surgically exposed. The BCCAO (lateral common carotid artery occlusion) method was established by reducing the blood flow to the whole brain for 4 weeks.
혈관성치매가 발생하면 백색질 중 시각로(optic tract)의 손상이 가장 먼저 그리고 가장 심각하게 발생한다. 급성이든 만성이든 혈액의 저관류에 의해 발생하는 망막 손상의 지표로 동공 반응이 관련되어 있다. 따라서 차전자피가 총경동맥을 묶어 발생시킨 혈관성 치매 모델에서 동공 반응에 어떠한 영향을 주는지 확인하기 위하여, 눈에 밝은 빛을 비추었을 때 약 10 초 안에 조리개가 줄어드는지 줄어들지 않는지에 의한 동공대광반사(pupillary light reflex, PLR) 손실을 조사하였다(Graefe's Arch Clin Exp Ophthalmol. 2006;244:199-204).When vascular dementia occurs, damage to the optic tract is the first and most severe white matter. Pupillary response has been implicated as an indicator of retinal damage caused by hypoperfusion of blood, whether acute or chronic. Therefore, in order to confirm how the psyllium affects the pupillary response in the vascular dementia model caused by tying the common carotid artery, the pupillary light reflection (pupillary light) by whether the aperture decreases or not within about 10 seconds when a bright light is irradiated to the eye. reflex, PLR) loss was investigated (Graefe's Arch Clin Exp Ophthalmol. 2006;244:199-204).
표 1에 나타낸 바와 같이, 대조군에서 양쪽 눈 모두 PLR 손실이 온 랫트는 57 %, 한쪽 눈에만 PLR 손실이 온 랫트는 29 %, 양쪽 모두 PLR 손실이 없는 랫트는 14 %로 나타난 반면, 차전자피를 100 mg/kg의 농도로 사료에 섞어 먹인 실험군에서는 양쪽 눈 모두 PLR 손실이 온 랫트는 38 %, 한쪽 눈만 PLR 손실이 온 랫트는 38 %, 양쪽 모두 PLR 손실 없이 정상인 랫트는 24 % 로 나타났다. As shown in Table 1, in the control group, 57% of rats with PLR loss in both eyes, 29% of rats with PLR loss in only one eye, and 14% of rats with no PLR loss in both eyes, whereas psyllium was 100%. In the experimental group fed with the feed at a concentration of mg/kg, 38% of rats with PLR loss in both eyes, 38% of rats with PLR loss in only one eye, and 24% of normal rats without PLR loss in both eyes.
또한, 차전자피를 500 mg/kg 및 2000 mg/kg의 농도로 사료에 섞어 먹인 실험군에서는 양쪽 눈에서 모두 PLR 손실이 온 랫트는 전혀 없고, 양쪽 모두 PLR 손실 없이 정상인 랫트는 비율이 훨씬 더 증가하였다.In addition, in the experimental group fed psyllium hulls mixed with feed at concentrations of 500 mg/kg and 2000 mg/kg, there were no rats with PLR loss in both eyes, and the ratio of rats with no PLR loss in both eyes was significantly increased.
따라서, 차전자피를 먹인 실험군이 대조군보다 동공반응이 정상군에 가깝게 유지되고 있음을 확인할 수 있었다.
Therefore, it could be confirmed that the pupillary response of the experimental group fed with psyllium skin was maintained closer to that of the normal group than the control group.
실시예 2-2.Example 2-2. 룩솔 패스트 블루(Luxol fast blue) 염색법에 의한 백색질 손상 억제 효과 확인Confirmation of white matter damage inhibition effect by Luxol fast blue staining method
차전자피의 혈관성 치매에 대한 효과를 확인하기 위하여, 룩솔 패스트 블루염색방법을 통해 백색질 손상 억제 효과를 확인하였다.
In order to confirm the effect of psyllium on vascular dementia, the inhibitory effect of white matter damage was confirmed through the Luxol Fast Blue staining method.
실험동물로는 체중 280 내지 310 g 전후의 랫트(Sprague Dawley 8 주령, ㈜샘타코바이오, 오산)를 일주일 동안 실험환경에 적응시켜 사용하였다. 정상군, 대조군 그리고 실험군, 이렇게 3개의 군으로 나누었다. 적응기간(행동실험 전 5 일) 및 30 일간의 실험기간 동안 10 및 100 mg/kg/day의 농도로 차전자피를 사료와 섞어 랫트들이 자유롭게 먹도록 하였다.
As experimental animals, rats (Sprague Dawley, 8 weeks old, Samtaco Bio, Osan) weighing around 280 to 310 g were used after adapting to the experimental environment for a week. They were divided into three groups: normal group, control group, and experimental group. During the adaptation period (5 days before the behavioral experiment) and 30 days of the experiment, psyllium hulls were mixed with the feed at concentrations of 10 and 100 mg/kg/day and the rats were allowed to eat freely.
만성 관류저하 모델에서는 랫트의 양쪽 총경동맥을 묶으면 척추동맥을 통해 공급된 혈액이 윌리스환(circle of Willis)을 거쳐 뇌에 공급된다. 하지만 공급되는 혈액의 양이 적어 백색질 부분이 선택적으로 죽게 되며 이 지역으로는 뇌들보 (corpus callosum), 속섬유막 (internal capsule) 및 시각로 (optic tract)가 있다(Farkas et al., Permanent, bilateral common carotid artery occlusion in the rat: a model for chronic cerebral hypoperfusion-related neurodegenrative diseases. Brain Res Rev 2007;54:162-180). 뇌에는 세포체(cell body)와 축삭(axon) 등으로 구성된 신경세포(neuron) 외에도 신경세포에 영양분을 공급하고 과잉의 신경전달물질을 제거하는 별아교세포(astrocyte)와 신경세포를 구성하는 축삭(axon)을 통해 전기신호전달을 원활하게 하기 위해 필요한 수초(말이집)(myelin)를 생성하는 희소돌기아교세포(oligodendrocyte) 및 신경세포가 죽거나 감염되었을 때 죽은 세포를 제거하는 역할을 하는 미세아교세포(microglia)로 구성되어 있으며(Allen & Barres, Neuroscience:than just brain glue. Nature 2009 Feb 5;457(7230):675-7), 세포외기질로는 주로 다당류인 히알유로난(hyaluronan)으로 구성되어 있다(Rauch, Extracellular matrix components associated with remodeling processes in brain. Cell Mol Life Sci 2004;61:2031-2045). 이 중에서 혈관성 치매에 관여하는 백색질에는 신경세포의 축삭이 주를 이루고 있기 때문에 조직을 백색질 위주로 관찰하며 이들 손상을 확인하기 위하여 룩솔 패스트 블루(Luxol fast blue) 염색법을 실시하였다.In the chronic hypoperfusion model, when both common carotid arteries in rats are tied, blood supplied through the vertebral arteries is supplied to the brain through the circle of Willis. However, due to the small amount of blood supplied, the white matter part is selectively killed, and these regions include the corpus callosum, the internal capsule, and the optic tract (Farkas et al., Permanent, bilateral). common carotid artery occlusion in the rat: a model for chronic cerebral hypoperfusion-related neurodegenrative diseases. Brain Res Rev 2007;54:162-180). In the brain, in addition to neurons composed of a cell body and axon, astrocytes that supply nutrients to neurons and remove excess neurotransmitters, and axons that make up neurons ), oligodendrocytes that produce myelin, which are necessary for smooth electrical signal transmission, and microglia ( microglia) (Allen & Barres, Neuroscience: than just brain glue. Nature 2009 Feb 5;457(7230):675-7), and the extracellular matrix is mainly composed of polysaccharide hyaluronan. (Rauch, Extracellular matrix components associated with remodeling processes in brain. Cell Mol Life Sci 2004;61:2031-2045). Among these, white matter involved in vascular dementia mainly consists of axons of nerve cells, so tissue was mainly observed in white matter and Luxol fast blue staining was performed to confirm these damages.
구체적으로, 혈관(capillary)에 혈액이 공급되지 않으면 에너지 소모는 많고 활성산소종의 발생이 높은 희소돌기아교세포(oligodendrocyte)가 세포자살 등에 의해 먼저 죽게 될 뿐만 아니라 (McTigue & Tripathi, 2008), 활성화된 기질 금속단백분해효소(matrix metalloproteinase)에 의해 수초를 구성하는 단백질인 MBP (myelin-basic protein) 등이 분해되면서 수초가 손상된다(Arai & Lo, 2009 ; Mctigue & Tripathi, 2008). 이에 따른 수초의 손상은 조직 슬라이드를 백색질이 존재하는 위치인 브레그마(bregma point)로부터 -2.64 내지 -3.12 mm 위치를 획득하여 룩솔 패스트 블루 용액과 탄산 리튬(lithium carbonate) 용액을 이용하여 염색을 실시하고, 수초의 상태에 따라 점수를 매겨 수초의 손상 정도를 판단하였다(Pistorio et al., A modified technique for high-resolution staining of myelin. J Neurosci Methods 2006;153:135-146). 각각의 환산된 점수는 하기 표 2에 나타낸 바와 같으며, 손상이 잘 일어나는 지역 가운데 대표적인 시각로 지역을 중심으로 관찰하였다.Specifically, if blood is not supplied to the capillary, oligodendrocytes with high energy consumption and high generation of reactive oxygen species not only die first by apoptosis, etc. (McTigue & Tripathi, 2008), but also activate Myelin-basic protein (MBP), a protein constituting myelin, is degraded by matrix metalloproteinase, which damages myelin (Arai & Lo, 2009; Mctigue & Tripathi, 2008). As a result, the myelin sheath was damaged by obtaining a position of -2.64 to -3.12 mm from the bregma point, where the white matter exists, and staining the tissue slide using Luxol Fast Blue solution and lithium carbonate solution. The degree of damage to the myelin was determined by scoring according to the condition of the myelin (Pistorio et al., A modified technique for high-resolution staining of myelin. J Neurosci Methods 2006;153:135-146). Each converted score is as shown in Table 2 below, and was observed centered on the region with a representative view among the regions where damage occurs well.
상기 실험결과, 도 2에 나타낸 바와 같이, 혈관성 치매를 유도하지 않은 정상군에 비하여 혈관성 치매를 유도한 대조군에서 손상점수가 매우 높게 나타나는 것을 확인할 수 있었으며, 반면 차전자피를 100 mg/kg 의 농도로 투여한 군(0.66 ± 0.25, p<0.05)에서는 대조군(1.57 ± 0.28, p<0.05)에 비하여 손상점수가 현저하게 감소하는 것을 확인할 수 있었다. As a result of the above experiment, as shown in FIG. 2 , it was confirmed that the damage score was very high in the control group induced with vascular dementia compared to the normal group that did not induce vascular dementia, whereas psyllium was administered at a concentration of 100 mg/kg. In one group (0.66 ± 0.25, p<0.05), it was confirmed that the damage score was significantly reduced compared to the control group (1.57 ± 0.28, p < 0.05).
이와 같은 실험결과를 통하여, 차전자피의 투여가 혈관성 치매 발생시 생기는 백색질의 손상을 억제한다는 것을 확인할 수 있었으며, 그에 따라 차전자피가 혈관성 치매의 개선에 효과가 있음을 알 수 있었다.
Through these experimental results, it could be confirmed that the administration of psyllium hull inhibited the damage to white matter that occurred during the occurrence of vascular dementia, and thus it was found that psyllium was effective in improving vascular dementia.
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 실시 예들은 모든 면에서 예시적인 것이며 한정적인 것이 아닌 것으로서 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 claims described below and their equivalents.
Claims (5)
A pharmaceutical composition for preventing or treating vascular dementia, comprising Psyllium husk as an active ingredient.
The pharmaceutical composition according to claim 1, wherein the psyllium hull is in the form of a powder.
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| KR20230121659A (en) | 2022-02-11 | 2023-08-21 | 주식회사 네이처센스 | Composition for improving mental health comprising natural extract |
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| KR20150107938A (en) | 2015-09-24 |
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