KR102158598B1 - Composition for preventing or treating behcet's diseases or herpes simplex virus infection containing lactobacillus animalis - Google Patents
Composition for preventing or treating behcet's diseases or herpes simplex virus infection containing lactobacillus animalis Download PDFInfo
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- KR102158598B1 KR102158598B1 KR1020180119069A KR20180119069A KR102158598B1 KR 102158598 B1 KR102158598 B1 KR 102158598B1 KR 1020180119069 A KR1020180119069 A KR 1020180119069A KR 20180119069 A KR20180119069 A KR 20180119069A KR 102158598 B1 KR102158598 B1 KR 102158598B1
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- disease
- behcet
- lactobacillus animalis
- composition
- prevention
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Abstract
본 발명은 락토바실러스 애니멀리스(Lactobacillus animalis), 이의 배양물, 또는 이의 파쇄물을 포함하는 베체트병의 예방 또는 치료용 약학 조성물 및 건강기능식품 조성물을 제공한다. 또한, 락토바실러스 애니멀리스, 이의 배양물, 또는 이의 파쇄물을 포함하는 헤르페스 바이러스 감염증의 예방 또는 치료용 약학 조성물 및 건강기능식품 조성물을 제공한다. 상기 조성물은 프리바이오틱 화합물을 더 포함할 수 있다. 상기 락토바실러스 애니멀리스는 락테이트를 생산하고, 상기 락테이트는 체내에서 부티레이트와 같은 짧은 사슬 지방산으로 전환될 수 있으며, 수지상 세포의 활성화 분자의 발현을 조절할 수 있어 효과적으로 베체트병 또는 헤르페스 바이러스 감염증을 예방하고 치료할 수 있다. The present invention provides a pharmaceutical composition and a health functional food composition for the prevention or treatment of Behcet's disease, including Lactobacillus animalis , a culture thereof, or a lysate thereof. In addition, it provides a pharmaceutical composition and a health functional food composition for the prevention or treatment of herpes virus infection, including Lactobacillus animalis, a culture thereof, or a lysate thereof. The composition may further include a prebiotic compound. The Lactobacillus animalis produces lactate, and the lactate can be converted into short-chain fatty acids such as butyrate in the body, and can control the expression of activating molecules in dendritic cells, effectively preventing Behcet's disease or herpes virus infection. And cure.
Description
본 발명은 락토바실러스 애니멀리스(Lactobacillus animalis)를 포함하는 베체트병 또는 헤르페스 바이러스 감염증의 예방 또는 치료용 조성물에 관한 것이다.The present invention relates to a composition for the prevention or treatment of Behcet's disease or herpes virus infection, including Lactobacillus animalis .
베체트병(Behcet's disease)은 희귀난치성 염증성 질환으로 구강 및/또는 생식기의 반복적인 아프타성 궤양, 포도막염(uveitis) 및 피부 병변을 증상으로 한다. 임상 증상은 피부궤양뿐만 아니라 관절, 중추신경계(central nervous system), 위장, 신장, 비뇨생식기, 폐, 심혈관, 장출혈, 장천공 등의 소화기계 관련, 상하대 정맥 증후군, 대동맥 역류 등의 증상이 동반된 심각한 만성적 염증이 다면적으로 나타난다. 이러한 증상은 전신성의 혈관염과 관련된 것으로, 베체트병의 중심적인 병리 생리학적 특징이다.Behcet's disease is a rare and refractory inflammatory disease characterized by recurrent aphthous ulcers, uveitis and skin lesions of the oral and/or genital organs. Clinical symptoms include not only skin ulcers, but also joints, central nervous system, gastrointestinal, kidney, genitourinary, lung, cardiovascular, intestinal bleeding, and digestive system related symptoms such as intestinal perforation, upper and lower venous syndrome, and aortic reflux. Chronic inflammation appears multifaceted. These symptoms are associated with systemic vasculitis and are a central pathophysiological feature of Behçet's disease.
헤르페스 바이러스 감염증(Herpes simplex virus infection)은 단순 포진바이러스(Herpes virus hominis)에 의한 감염증인데, 그 증상이 베체트병과 유사하다. 단순성 포진, 헤르페스성 습진, 외상성 포진 등의 피부질환; 아프타성 구내염(aphthous stomatitis), 재발성 구내염, 급성 헤르페스성 비염, 음부 헤르페스 등의 점막 질환; 및 결막염, 각격막염, 각막궤양 등의 안구 질환이 나타난다.Herpes simplex virus infection is an infection caused by Herpes virus hominis, and its symptoms are similar to Behcet's disease. Skin diseases such as herpes simplex, herpes eczema, and traumatic herpes; Mucosal diseases such as aphthous stomatitis, recurrent stomatitis, acute herpetic rhinitis, and genital herpes; And eye diseases such as conjunctivitis, keratitis, and corneal ulcer.
베체트병의 정확한 발병 원인은 밝혀지지 않았지만, 헤르페스 바이러스 감염이 촉발한 자가면역(autoimmune)과 자가 염증성(autoinflammatory) 반응과 관련이 있다. 헤르페스 바이러스를 마우스 귀이개에 감염시켜 베체트병 증상을 유발하여, 베체트병 동물 모델로 사용하기도 한다. The exact cause of Behçet's disease has not been identified, but it is associated with autoimmune and autoinflammatory reactions triggered by herpes virus infection. It is also used as an animal model for Behcet's disease by infecting the herpes virus into the ear canal of a mouse, causing symptoms of Behçet disease.
베체트병에서 세포의 침입형태는 대식세포(macrophage)와 수지상세포(dendritic cell)를 비롯하여, CD4+ T 세포, CD8+ T 세포, NK 세포, 호중구(neutrophil) 등이 관여한다. 또한, 사이토카인(cytokine) 생산의 증가와도 관련이 있다. 베체트병 환자에서 마이크로비옴(microbiome) 표현이 정상인과 다른 것으로 나타나는 것으로 보아, 일부 바이러스와 세균에 대한 면역 반응이 베체트병의 염증 반응과 관련이 있을 가능성이 있다. In Behcet's disease, the invasive form of cells involves macrophages and dendritic cells, CD4+ T cells, CD8+ T cells, NK cells, and neutrophils. It is also associated with an increase in cytokine production. As the expression of microbiome in Behcet's disease patients appears to be different from that of normal people, it is possible that the immune response to some viruses and bacteria is related to the inflammatory response of Behcet's disease.
베체트병은 피부 점막 염증이나 관절염 등 가벼운 증상만 보이는 경우도 있으나, 심한 포도막염이나 뇌, 폐, 심장, 신장 등 주요 장기를 침범하여 심각한 후유증을 동반할 수 있다. 헤르페스 바이러스 감염증 또한, 뇌, 눈 등에 나타나는 합병증에 의한 장애가 발생할 수 있는 문제가 있다.Behcet's disease may show only mild symptoms such as skin mucosal inflammation or arthritis, but severe uveitis or invasion of major organs such as the brain, lungs, heart, and kidneys may accompany serious sequelae. Herpes virus infection also has a problem that may cause disorders due to complications that appear in the brain and eyes.
상기와 같은 문제점을 해결하기 위해, 본 발명은 락토바실러스 애니멀리스를 포함하는 베체트병 또는 헤르페스 바이러스 감염증의 예방 또는 치료용 약학 조성물을 제공한다.In order to solve the above problems, the present invention provides a pharmaceutical composition for the prevention or treatment of Behcet's disease or herpes virus infection, including Lactobacillus animalis.
본 발명은 락토바실러스 애니멀리스를 포함하는 베체트병 또는 헤르페스 바이러스 감염증의 예방 또는 개선용 건강기능식품 조성물을 제공한다.The present invention provides a health functional food composition for preventing or improving Behcet's disease or herpes virus infection, including Lactobacillus animalis.
본 발명에 따른 베체트병의 예방 또는 치료용 약학 조성물은 락토바실러스 애니멀리스(Lactobacillus animalis), 이의 배양물, 또는 이의 파쇄물을 포함할 수 있다.The pharmaceutical composition for the prophylaxis or treatment of Behcet's disease according to the present invention may include Lactobacillus animalis , a culture thereof, or a lysate thereof.
본 발명에 따른 베체트병의 예방 또는 개선용 건강기능식품 조성물은 락토바실러스 애니멀리스, 이의 배양물, 또는 이의 파쇄물을 포함할 수 있다.The health functional food composition for preventing or improving Behcet's disease according to the present invention may include Lactobacillus animalis, a culture thereof, or a lysate thereof.
본 발명에 따른 헤르페스 바이러스 감염증의 예방 또는 치료용 약학 조성물은 락토바실러스 애니멀리스, 이의 배양물, 또는 이의 파쇄물을 포함할 수 있다.The pharmaceutical composition for preventing or treating a herpes virus infection according to the present invention may include Lactobacillus animalis, a culture thereof, or a lysate thereof.
본 발명에 따른 헤르페스 바이러스 감염증의 예방 또는 개선용 건강기능식품 조성물은 락토바실러스 애니멀리스, 이의 배양물, 또는 이의 파쇄물을 포함할 수 있다.The health functional food composition for preventing or improving herpes virus infection according to the present invention may include Lactobacillus animalis, a culture thereof, or a lysate thereof.
본 발명에 따른 베체트병 또는 헤르페스 바이러스 감염증의 예방 또는 치료용 약학 조성물을 이용함으로써, 희귀난치성 베체트병 또는 헤르페스 바이러스 감염증을 예방할 수 있고, 발병된 경우 효과적으로 치료할 수 있다. 상기 약학 조성물을 베체트병, 베체트병에 의해 유발된 염증성 질환, 헤르페스 바이러스 감염증 등에 기존 치료제와 병행하여 사용함으로써 치료 효과를 더욱 증대시킬 수 있다.By using the pharmaceutical composition for the prevention or treatment of Behcet's disease or herpes virus infection according to the present invention, it is possible to prevent rare and intractable Behcet's disease or herpes virus infection, and effectively treat an outbreak. The therapeutic effect may be further increased by using the pharmaceutical composition in combination with existing therapeutic agents for Behcet's disease, inflammatory diseases caused by Behcet's disease, and herpes virus infection.
또한, 본 발명에 따른 베체트병 또는 헤르페스 바이러스 감염증의 예방 또는 개선용 건강기능식품 조성물을 함유하는 다양한 식품을 통해 안전하게 베체트병 또는 헤르페스 바이러스 감염증을 예방하고 개선할 수 있다.In addition, it is possible to safely prevent and improve Behcet's disease or herpes virus infection through various foods containing a health functional food composition for preventing or improving Behcet's disease or herpes virus infection according to the present invention.
도 1은 본 발명의 일 실험예에 따른 결과를 나타낸다.1 shows the results according to an experimental example of the present invention.
이하, 본 발명을 상세하게 설명하기로 한다. Hereinafter, the present invention will be described in detail.
본 발명은 락토바실러스 애니멀리스(Lactobacillus animalis), 이의 배양물, 또는 이의 파쇄물을 포함하는 베체트병의 예방 또는 치료용 약학 조성물, 또는 헤르페스 바이러스 감염증의 예방 또는 치료용 약학 조성물을 제공한다. The present invention provides a pharmaceutical composition for the prevention or treatment of Behcet's disease, comprising Lactobacillus animalis , a culture thereof, or a lysate thereof, or a pharmaceutical composition for the prevention or treatment of a herpes virus infection.
또한, 본 발명은 락토바실러스 애니멀리스(Lactobacillus animalis), 이의 배양물, 또는 이의 파쇄물을 포함하는 베체트병의 예방 또는 개선용 건강기능식품 조성물, 또는 헤르페스 바이러스 감염증의 예방 또는 개선용 건강기능식품 조성물을 제공한다. In addition, the present invention provides a health functional food composition for the prevention or improvement of Behcet's disease, including Lactobacillus animalis , a culture thereof, or a lysate thereof, or a health functional food composition for preventing or improving herpes virus infection. to provide.
본 명세서에서 "예방"이란, 본 발명에 따른 약학 조성물 또는 건강기능식품 조성물의 투여에 의해 베체트병, 헤르페스 바이러스 감염증, 또는 이들의 적어도 하나 이상의 증상의 발생을 억제시키거나 발병을 지연시키는 모든 행위를 의미한다. 또한, 재발을 예방하거나 방지하기 위해 상기 질병에 차도가 있는 대상의 치료를 포함한다.In the present specification, "prevention" refers to any action of inhibiting or delaying the onset of Behcet's disease, herpes virus infection, or at least one or more symptoms thereof by administration of the pharmaceutical composition or health functional food composition according to the present invention. it means. In addition, it includes treatment of a subject with remission of the disease to prevent or prevent recurrence.
본 명세서에서 "치료"란, 본 발명에 따른 약학 조성물의 투여에 의해 베체트병, 헤르페스 바이러스 감염증, 또는 이들의 적어도 하나 이상의 증상을 완화, 감소, 또는 소멸시키는 등 그 증세를 호전시키거나 이롭게 변경하는 모든 행위를 의미한다.In the present specification, "treatment" means alleviating, reducing, or eliminating at least one symptom of Behcet's disease, herpes virus infection, or at least one of them by administration of the pharmaceutical composition according to the present invention. It means all actions.
본 명세서에서 "개선"이란, 본 발명에 따른 건강기능식품 조성물의 섭취에 의해 베체트병, 헤르페스 바이러스 감염증, 또는 이들의 적어도 하나 이상의 증상이 완화, 감소, 또는 소멸시키는 등 그 증세를 호전시키거나 이롭게 변경하는 모든 행위를 의미한다.In the present specification, the term "improvement" means that the symptoms of Behcet's disease, herpes virus infection, or at least one or more symptoms thereof are alleviated, reduced, or eliminated by ingestion of the health functional food composition according to the present invention. It means any act that changes.
본 명세서에서 "약학 조성물"이란, 특정한 목적을 위해 투여되는 조성물로, 본 발명의 목적상 베체트병, 헤르페스 바이러스 감염증, 또는 이들의 적어도 하나 이상의 증상을 예방하거나 또는 치료하기 위해 투여되는 것을 의미한다.As used herein, the term "pharmaceutical composition" means a composition administered for a specific purpose, and for the purposes of the present invention, it is meant to be administered to prevent or treat Behcet's disease, herpes virus infection, or at least one symptom thereof.
본 명세서에서 "건강기능식품"이란, 특정보건용식품(food for specified health use, FoSHU)과 유사한 뜻으로, 영양 공급 외에도 생체 조절 기능이 효율적으로 나타나도록 가공된 의학, 의료 효과가 높은 식품을 의미한다.In the present specification, the term "health functional food" has a meaning similar to food for specified health use (FoSHU), and refers to foods with high medical and medical effects processed so that the biological regulation function is effectively displayed in addition to nutritional supply. do.
본 발명에 따른 베체트병 또는 헤르페스 바이러스 감염증의 예방 또는 치료용 약학 조성물 및 건강기능식품 조성물은 락토바실러스 애니멀리스(Lactobacillus animalis)를 포함할 수 있다. The pharmaceutical composition and health functional food composition for the prevention or treatment of Behcet's disease or herpes virus infection according to the present invention may include Lactobacillus animalis .
본 발명에서 "락토바실러스 애니멀리스"는 한국 전통 음식인 김치 제조 과정에서 가장 많이 발생하는 젖산균(Lactic acid bacteria) 중 하나이다. 젖산균은 물질대사에 의해 글루코오스 등의 당류를 젖산으로 분해시키는 후벽균류 세균의 총칭으로, 유산균이라고도 한다. 젖산균은 창자 등의 소화기관(장내세균)이나 질 안에서 병원균 및 유해세균의 생육을 저지하여 다른 병원 미생물로부터 몸을 지키고 항상성 유지를 돕는다. 젖산균에는 락토바실러스속(Lactobacillus)과 스트렙토코쿠스속 (Streptococcus)의 여러 종류가 있고, 상기 락토바실러스 애니멀리스는 상기 락토바실러스속의 한 종(species)이다.In the present invention, "Lactic acid bacteria" is one of the lactic acid bacteria that occur most in the process of manufacturing kimchi, a traditional Korean food. Lactic acid bacteria is a generic term for a bacterium of the posterior wall fungus that decomposes sugars such as glucose into lactic acid by metabolism, and is also called lactic acid bacteria. Lactic acid bacteria protect the body from other pathogenic microorganisms and help maintain homeostasis by blocking the growth of pathogens and harmful bacteria in the digestive system (intestinal bacteria) such as the intestine or in the vagina. There are several types of lactobacillus genus (Lactobacillus) and Streptococcus (Streptococcus) , and the Lactobacillus animalis is a species of the genus Lactobacillus.
락토바실러스속(Lactobacillus)은 당류를 발효하여 에너지를 획득하고 다량의 젖산(유산)을 생성하는 그람 양성(Gram-positive)의 통성 혐기성(facultative anaerobe) 또는 미호기성(microaerophilic) 세균으로, 형태적으로는 막대 모양의 무포자 간균으로 다형성을 나타낸다. 락토바실러스속의 크기는 0.5~0.9×1~11μm로 단간균에서 장간균의 여러 형태를 나타내며, 대부분은 운동성이 없고, 산소가 적은 환경에서 즐겨 발육하며 각종의 당에서 젖산을 생성한다. 젖산균에 의한 젖산발효(유산발효)에는 젖산만을 생성하는 정상 발효(homo fermentative)와 동시에 알코올, 이산화탄소, 아세트산 등 다른 물질을 생성하는 혼합발효(hetero fermentative)가 있다.Lactobacillus genus (Lactobacillus) is a facultative anaerobic (facultative anaerobe) or non-aerobic (microaerophilic) bacteria of Gram-positive (Gram-positive), to the fermentation of sugars obtained energy and generates a large amount of lactic acid (lactic acid), a morphological Is a rod-shaped, spore-free bacilli, indicating polymorphism. The size of the genus Lactobacillus is 0.5~0.9×1~11μm, representing various types of enterobacteriaceae from monobacterial bacillus, most of them are non-motile, enjoy development in an environment with little oxygen, and produce lactic acid from various sugars. Lactic acid fermentation (lactic acid fermentation) by lactic acid bacteria includes homo fermentative, which produces only lactic acid, and hetero fermentative, which produces other substances such as alcohol, carbon dioxide, and acetic acid.
락토바실러스속에는 생육온도역, 당류발효 양상, 생성유산의 광학이성체 등의 성질에 따라 60종 이상의 종(species)이 있다. 예를 들어, 락토바실러스 불가리쿠스(L. bulgarcus)는 가장 오래 전부터 알려진 젖산균으로, 면역물질과 항균물질을 형성하고, 변비와 설사에 도움을 준다. 주로 요구르트의 제조에 사용되며 생육 최적온도는 40℃이다. 상기 종은 순수 배양한 균을 치즈나 발효 버터 제조시의 스타터로 사용한다. 락토바실러스 아시도필루스(L. acidophilus)는 사람 및 모든 포유류와 그 밖의 동물의 장에 존재하는 호기성 젖산균으로, 과산화수소수 및 천연항상물질을 형성하여 포도상구균, 살모넬라균과 같은 유해균을 억제한다. 버터, 우유의 제조나 장내 자가중독의 치료에 사용된다. 락토바실러스 카제이(L. casei)는 면역조절 능력을 가지고, 유해균 억제에 도움을 주며, 장내세균의 구성 변화와 대사작용에 효과적이다. 치즈 제조 및 우유나 유청(乳淸)을 원료로 하는 젖산 제조에 사용되고, 생육 최적온도는 30℃이다. 락토바실러스 플란타룸(L. plantarum)은 식물에서 추출된 유산균으로 항균 물질 락토린을 형성하여 포진 바이러스 억제 효과를 가진다. 상기 종은 D-젖산과 L-젖산을 생성하고 김치, 엔실리지 등에 항상 존재하며, 또 치즈의 풍미를 내는 데 작용을 한다. 락토바실러스 브레비스(L.brevis)는 항염작용을 통해 헬리코박터로 인한 위 염증의 감소, 잇몸병 등에 효과적이다. In the genus Lactobacillus, there are more than 60 species according to the properties of the growth temperature range, saccharide fermentation pattern, and optical isomers of produced abortions. For example, L. bulgarcus is the oldest known lactic acid bacteria, forming immune and antibacterial substances, and helping with constipation and diarrhea. It is mainly used for the manufacture of yogurt, and the optimum temperature for growth is 40℃. This species is used as a starter in the production of cheese or fermented butter using pure cultured bacteria. Lactobacillus acidophilus (L. acidophilus) is an aerobic lactic acid bacteria present in the intestine of humans, all mammals and other animals, and forms hydrogen peroxide and natural anti-inflammatory substances to inhibit harmful bacteria such as Staphylococcus aureus and Salmonella. It is used in the manufacture of butter and milk or in the treatment of intestinal addiction. Lactobacillus casei (L. casei) has immunomodulatory ability, helps to suppress harmful bacteria, and is effective in changing the composition and metabolism of intestinal bacteria. It is used for manufacturing cheese and lactic acid using milk or whey as a raw material, and the optimum growth temperature is 30℃. Lactobacillus plantarum (L. plantarum) is a lactic acid bacterium extracted from a plant and forms the antibacterial substance lactorin, which has the effect of inhibiting the herpes virus. These species produce D-lactic acid and L-lactic acid, are always present in kimchi, ensilience, etc., and also act to bring out the flavor of cheese. Lactobacillus brevis (L. brevis ) is effective in reducing gastric inflammation caused by Helicobacter through anti-inflammatory properties, and for gum disease.
락토바실러스속에는 이처럼 다양한 종이 있고, 이들은 유사하지만 조금씩 서로 다른 기능으로 쓰이고 있다. 락토바실러스 애니멀리스 역시 이들과 유사한 점이 있으나, 본 발명에 따른 락토바실러스 애니멀리스는 베체트병의 예방 또는 치료용 조성물로 이용될 수 있다. There are such a variety of species in the genus Lactobacillus, and they are similar but are used with slightly different functions. Lactobacillus animalis is also similar to these, but the Lactobacillus animalis according to the present invention can be used as a composition for preventing or treating Behcet's disease.
본 발명에 따른 조성물은 상기 락토바실러스 애니멀리스 단일종 만을 포함할 수 있다. 상기 조성물은 상기 락토바실러스 애니멀리스 외의 임의의 다른 박테리아 속 또는 종을 포함하지 않을 수 있다. 상기 조성물이 상기 락토바실러스 애니멀리스 외 하나 이상의 다른 박테리아 속 또는 종을 포함하는 경우, 상기 다른 박테리아 속 또는 종은 최소한, 또는 생물학적으로 무관한 양만을 포함할 수 있다.The composition according to the present invention may contain only a single species of Lactobacillus animalis. The composition may not contain any other bacterial genera or species other than the Lactobacillus animalis. The composition is the Lactobacillus animalis When one or more other bacterial genera or species are included, the other bacterial genera or species may contain only a minimal or biologically irrelevant amount.
본 발명에 따른 조성물은 상기 락토바실러스 애니멀리스 외 다른 물질을 더 포함할 수 있다. 상기 조성물은 하나 이상의 다른 박테리아 속 또는 종을 포함할 수 있다. 상기 조성물은 상기 락토바실러스 애니멀리스와 생체 내에서 공생적으로 살 수 있는 하나 이상의 다른 박테리아 속 또는 종을 포함할 수 있다.The composition according to the present invention may further include a material other than the Lactobacillus animalis. The composition may comprise one or more other bacterial genera or species. The composition may comprise the Lactobacillus animalis and one or more other bacterial genera or species capable of living symbiotically in vivo.
본 발명에 따른 조성물은 락토바실러스 애니멀리스의 배양물, 또는 이의 파쇄물을 포함할 수 있다. 상기 배양물은 배지에서 배양한 배양액 자체, 상기 배양액을 여과 또는 원심분리하여 균주를 제거한 여액 등 배양액 자체로부터 파생되는 가공물을 포함할 수 있다. 상기 파쇄물은 균주를 파쇄한 파쇄물 및 상기 파쇄물을 원심분리하여 얻어진 상등액 등을 포함할 수 있다. 또한, 상기 조성물은 살아있는, 즉, 활성의 락토바실러스 애니멀리스 및 사멸된 락토바실러스 애니멀리스의 혼합물을 포함할 수도 있다. The composition according to the present invention may include a culture of Lactobacillus animalis, or a lysate thereof. The culture may include a processed product derived from the culture solution itself, such as a culture solution cultured in a medium itself, a filtrate obtained by filtering or centrifuging the culture solution to remove a strain. The lysate may include a lysate obtained by crushing the strain and a supernatant obtained by centrifuging the lysate. In addition, the composition is a living, that is, active Lactobacillus animalis And a mixture of killed Lactobacillus animalis.
본 발명에 따른 조성물은 베체트병의 예방 또는 치료의 용도로 사용할 수 있다. 베체트병(Behcet's disease, BD)은 구강 궤양, 음부 궤양, 안구 염증 외에도 피부, 혈관, 위장관, 중추신경계, 심장 및 폐 등 여러 장기를 침범할 수 있는 희귀난치성 만성 염증성 질환으로, 본 발명이 예방, 개선, 또는 치료하려는 표적이 베체트병에 한정되는 것은 아니다. 베체트병과 관련되거나 베체트병에 의해 유발된 다른 염증 질환도 포함될 수 있다.The composition according to the present invention can be used for prevention or treatment of Behcet's disease. Behcet's disease (BD) is a rare and intractable chronic inflammatory disease that can invade various organs such as skin, blood vessels, gastrointestinal tract, central nervous system, heart and lungs, as well as oral ulcers, genital ulcers, and eye inflammation. The target to be improved or treated is not limited to Behcet's disease. Other inflammatory diseases associated with or caused by Behçet's disease may also be included.
또한, 본 발명에 따른 조성물은 헤르페스 바이러스 감염증 또는 그에 의한 염증 질환들의 예방 또는 치료의 용도로 사용할 수 있다. 헤르페스 바이러스 감염증(Herpes simplex virus infection)은 단순 헤르페스 바이러스(Herpes simplex virus)에 감염되어 발생하는 바이러스성 질환으로, 단순 헤르페스 바이러스는 단순 포진 바이러스라고도 하며, 이에 감염되면 피부 점막에 생기는 물집과 같은 가벼운 증상에서부터 뇌염과 같은 중증의 질환까지 다양한 증상이 나타난다. 단순 포진 바이러스는 대상포진 바이러스와 마찬가지로 한 번 감염되면 평생 동안 사람의 몸속에 존재하는데, 평소에는 잠복상태로 있기 때문에 증상이 나타나지 않지만 자극에 의해 바이러스가 다시 활성화되면 증상이 재발할 수 있다.In addition, the composition according to the present invention can be used for prevention or treatment of herpes virus infection or inflammatory diseases caused by it. Herpes simplex virus infection is a viral disease caused by infection with the Herpes simplex virus, and herpes simplex virus is also called a herpes simplex virus, and when infected with it, mild symptoms such as blisters that form on the skin mucosa Symptoms range from severe diseases such as encephalitis. Like the shingles virus, once infected, the herpes simplex virus exists in the human body for a lifetime. Since it is usually dormant, symptoms do not appear, but symptoms may recur when the virus is reactivated by stimulation.
베체트병의 원인은 아직 명확하게 알려져 있지 않지만, 오래전부터 유전적인 소인이 있는 환자에서 헤르페스 바이러스 감염과 같은 환경적인 요인이 더해지면서 면역 반응이 활성화되고, 그 결과 여러 가지 증상이 나타난다고 알려져 있다. 따라서 과도한 면역 반응을 억제함과 동시에 염증 반응을 감소시킬 경우, 베체트병 또는 헤르페스 바이러스 감염증의 증상을 예방, 개선, 또는 치료할 수 있다.The cause of Behçet's disease is not yet clearly known, but it has been known for a long time that in patients with a genetic predisposition, the immune response is activated by the addition of environmental factors such as herpes virus infection, and as a result, various symptoms appear. Therefore, when suppressing the excessive immune response and simultaneously reducing the inflammatory response, symptoms of Behcet's disease or herpes virus infection can be prevented, ameliorated, or treated.
본 발명에 따른 조성물에 있어서, 상기 락토바실러스 애니멀리스는 락테이트(lactate)를 생산할 수 있고, 상기 락테이트는 체내에서 장내 미생물에 의해 아세테이트, 부티레이트 등의 짧은 사슬 지방산(short-chain fatty acids; SCFAs)으로 전환될 수 있다. 즉, 상기 락토바실러스 애니멀리스가 생산한 상기 락테이트는 부티레이트(butyrate)의 합성을 위한 전구체가 될 수 있다.In the composition according to the present invention, the Lactobacillus animalis can produce lactate, and the lactate is short-chain fatty acids such as acetate and butyrate by intestinal microorganisms in the body (SCFAs). ) Can be converted. That is, the lactate produced by the Lactobacillus animalis may be a precursor for the synthesis of butyrate.
인체에 자연적으로 존재하는 모든 미생물 군의 집합체를 인간 마이크로비옴(human microbiome)이라 하고, 인간의 장내 미생물 군집이 지니는 유전자 집합체를 장내 마이크로비옴(intestinal microbiome)이라 한다. 인간의 장내 미생물은 태어날 때부터 유전, 식습관, 생활 습관 등에 따라 개인별로 다양한 군집 구조를 갖는다.The aggregate of all microbial groups that naturally exist in the human body is called the human microbiome, and the gene collection of the human intestinal microbiome is called the intestinal microbiome. From birth, human gut microbes have a diverse cluster structure for each individual according to heredity, diet, and lifestyle.
상기 장내 마이크로비옴을 통해 베체트병 환자와 건강한 일반인의 장내 미생물 구조 및 짧은 사슬 지방산(SCFAs) 생성에 대해 비교하였을 때, 장내 미생물 군집의 차이를 발견할 수 있다. 상기 베체트병 환자는 상기 건강한 일반인에 비해 로세브리아(Roseburia)와 숩도리그라눌룸(Subdoligranulum)이 상대적으로 상당히 감소된 것으로 나타났다. 일반적으로 건강한 사람들은 로세브리아와 숩도리그라눌룸 등의 프로바이오틱스(유익균)들을 많이 가지고 있으나, 상기 베체트병 환자는 특유의 장내 미생물 불균형이 존재하였다. 그로 인해 상기 베체트병 환자의 부티레이트(butyrate, 낙산염)와 같은 짧은 사슬 지방산의 생산이 현저히 감소되었음을 확인할 수 있었다. When comparing the intestinal microbial structure and the production of short-chain fatty acids (SCFAs) between Behcet's disease patients and healthy ordinary people through the intestinal microbiome, differences in the intestinal microbial community can be found. The Behcet's disease patients showed relatively significantly reduced levels of Roseburia and Subdoligranulum compared to the healthy general population. In general, healthy people have a lot of probiotics (beneficial bacteria) such as Rosebria and Sudori Granulum, but Behcet's disease patients have a unique intestinal microbial imbalance. As a result, it was confirmed that the production of short chain fatty acids such as butyrate (butyrate) in the Behcet's disease patient was significantly reduced.
인간의 장내 환경, 특히 대장은 1011cfu/g에 이르는 혐기성 미생물이 사는 생물 반응기로, 식물 유래의 펙틴, 셀룰로오즈, 헤미셀룰로오즈 그리고 효소 저항성 전분(resistant starch) 등 인간 스스로 소화하기 어려운 다당류가 상기 미생물에 의해 분해될 수 있다. 이 과정에서 발효에 의한 락테이트(lactate)와 아세테이트, 부티레이트와 같은 짧은 사슬 지방산들이 생성된다. Human intestinal environment, especially the large intestine, is a bioreactor where anaerobic microorganisms up to 10 11 cfu/g live, and polysaccharides that are difficult to digest by humans such as plant-derived pectin, cellulose, hemicellulose and enzyme-resistant starch are the microorganisms. Can be decomposed by In this process, short-chain fatty acids such as lactate, acetate and butyrate are produced by fermentation.
그 중 부티레이트는 혐기성 박테리아에 의해서만 수행되는 발효 공정의 최종 생성물로, 상기 부티레이트의 생성량에 비례해 장 운동성을 높이고, 장 상피세포의 중요한 에너지원이 되어 세포의 물질 대사 활성 및 증식을 조절할 수 있다. 또한, 상기 부티레이트는 암 발생 억제, 면역계의 강화, 염증 저감화, 산화 스트레스 억제 등 건강에 유익한 기능을 한다. 예를 들어, 상기 부티레이트는 전사 인자 NF-κB의 활성화를 억제하여 전염증성 사이토카인(proinflammatory cytokines)의 생성을 감소시켜, 결과적으로 항염증 효과를 나타낼 수 있다. 뿐만 아니라, 상기 부티레이트의 농도에 따라, 세포 성장을 억제하거나 분화를 촉진할 수 있어, 종양 세포에서 세포 사멸을 유도할 수 있고, 손상되지 않은 조직의 세포를 위한 영양 인자로도 작용할 수 있다.Among them, butyrate is the final product of the fermentation process carried out only by anaerobic bacteria, increases intestinal motility in proportion to the amount of butyrate produced, becomes an important energy source for intestinal epithelial cells, and can regulate metabolic activity and proliferation of cells. In addition, the butyrate has beneficial functions for health such as suppressing the occurrence of cancer, strengthening the immune system, reducing inflammation, and suppressing oxidative stress. For example, the butyrate inhibits the activation of the transcription factor NF-κB to reduce the production of proinflammatory cytokines, resulting in an anti-inflammatory effect. In addition, depending on the concentration of the butyrate, it is possible to inhibit cell growth or promote differentiation, thereby inducing apoptosis in tumor cells, and acting as a nutrient factor for cells of intact tissue.
또한, 상기 부티레이트는 조절 T 세포의 분화를 촉진할 수 있는데, 상기 조절 T 세포(Regulatory T cell: Treg)는 생체 내에서 자연성(natural) 조절 T 세포와 적응성(adaptive) 조절 T 세포를 모두 포함하는 것으로, 상기 부티레이트는 조절 T 세포가 가지는 모든 기작이 촉진 또는 증진되어 생체 내의 면역 반응이 정상 상태를 유지하도록 면역 조절 작용을 한다. 즉, 면역 억제 반응이 촉진 또는 증진되는 것을 의미한다.In addition, the butyrate may promote the differentiation of regulatory T cells, and the regulatory T cells (Treg) include both natural and adaptive regulatory T cells in vivo. As such, the butyrate promotes or enhances all mechanisms of regulatory T cells, and thus acts as an immune modulator so that the immune response in vivo maintains a normal state. That is, it means that the immune suppression response is promoted or enhanced.
베체트병 환자의 경우, 상기 로세브리아, 숩도리그라눌룸 등의 장내 세균의 감소로 인한 상기 부티레이트 생산의 결함으로 조절 T 세포 반응이 감소되고 면역-병리학적 작용 T 세포 반응의 활성화가 유도될 수 있다. 이에 따라, 베체트병과 같은 자가면역 질병 등이 발생할 수 있다. 상기 부티레이트를 생산하는 미생물에는 상기 로세브리아 외에도 루미노코커스 알부스(Ruminococcus albus), 유박테리움 렉탈레(Eubacterium rectale) 등이 있다.In the case of Behcet's disease patients, regulatory T cell responses may be reduced due to defects in the production of butyrate due to a decrease in intestinal bacteria such as Rosebria and Sudori granulum, and activation of immune-pathological T cell responses may be induced. . Accordingly, autoimmune diseases such as Behcet's disease may occur. Microorganisms that produce the butyrate include Ruminococcus albus, Eubacterium rectale, and the like in addition to the rosebria .
본 발명에 따른 조성물에 있어서, 상기 락토바실러스 애니멀리스는 수지상 세포의 활성화 분자의 발현을 조절할 수 있다. In the composition according to the present invention, the Lactobacillus animalis can regulate the expression of an activating molecule in dendritic cells.
수지상 세포(Dendritic cell, DC)는 피부(랑게르한스 세포라는 특화된 형태의 수지상 세포)와 코, 폐 및 장 내부의 경계면과 같은 외부 환경과 접촉해 있는 조직에 존재한다. 상기 수지상 세포는 포유류의 면역계를 구성하는 면역세포로, 전문적 항원제시세포(professional antigen presenting cell)로 작용할 수 있다. 이들의 주 기능은 항원 물질을 처리하고 이를 세포 표면에 발현하여 T 세포에게 제시한다. 이로써 이들은 선천성 면역계와 적응성 면역계를 연결해 주는 전달자로서 역할을 한다.Dendritic cells (DC) exist in tissues that are in contact with the skin (a specialized form of dendritic cells called Langerhans cells) and the external environment, such as the interface inside the nose, lungs and intestines. The dendritic cells are immune cells constituting the immune system of mammals, and can function as professional antigen presenting cells. Their main function is to process antigenic substances and express them on the cell surface to present them to T cells. As a result, they act as messengers that connect the innate and adaptive immune systems.
선천적 면역은 외래 물질에 대한 반응에서 비-특이적 면역 활성화의 주된 동인이다. 미성숙한 수지상 세포는 항원의 내재화를 특수화하고 지속적인 항원 감시를 허용하는 주변 조직을 통해 분배되고, 감염성 물질 및 외래 물질로부터의 여러 가지 신호에 의해 조정되며, 상기 신호는 수지상 세포의 분화 및 성숙을 촉발한다. Innate immunity is a major driver of non-specific immune activation in response to foreign agents. Immature dendritic cells are distributed through surrounding tissues that specialize in antigen internalization and allow continuous antigen monitoring, and are regulated by various signals from infectious and foreign substances, which trigger the differentiation and maturation of dendritic cells. do.
수지상 세포 분화 및 활성화시 발현되기 시작하는 분자는 선천적 면역과 후천적 면역을 연결하는 것을 보조한다. 예를 들어, 성숙한 수지상 세포는 림프구와의 증가된 상호작용을 위해 림프절로 수지상 세포 이동을 촉진하는 케모카인 수용체 및 부착 분자, CD54의 발현을 상향-조절한다. 공동자극 분자, CD80 및 CD86의 발현은 T 세포 활성화 및 항원-특이적 면역반응의 개시에 필요한 공동자극 신호를 제공한다. CD40의 결찰은 공동-자극 분자의 발현을 증진시키고 IL-12의 방출을 유도하여 T 세포 활성화를 촉진한다. 이후 분화된 T 세포는 후천적 면역 반응의 복합 상호작용을 편성한다. Molecules that begin to be expressed upon dendritic cell differentiation and activation help link innate and acquired immunity. For example, mature dendritic cells up-regulate the expression of CD54, a chemokine receptor and adhesion molecule that promotes dendritic cell migration to the lymph nodes for increased interaction with lymphocytes. Expression of the co-stimulatory molecules, CD80 and CD86, provides the co-stimulatory signals necessary for T cell activation and initiation of an antigen-specific immune response. Ligation of CD40 promotes T cell activation by enhancing the expression of co-stimulatory molecules and inducing the release of IL-12. The differentiated T cells then organize a complex interaction of acquired immune responses.
또한, 수지상 세포는 활성화 T 세포의 기능을 억제할 수 있는 조절 T 세포로의 분화를 유도하여 자가 면역과 이식 조직의 거부 반응(transplant rejection) 방지 및 자가 항원에 대한 면역 관용 기작(self tolerance)의 유도에 있어 중요한 역할을 한다. 그러나 자기 관용을 유도하거나 계속 유지하는데 있어서 문제가 생기게 되면 자기 항원에 대하여 면역 반응이 일어나게 되고, 이로 인하여 자신의 조직을 공격하는 현상이 발생하는데 이러한 과정에 의해 발생되는 질환을 자가 면역 질환이라고 한다. 상기 베체트병이 상기 자가 면역 질환의 한 예가 될 수 있고, 그 외에도 류마티스 관절염, 1형 당뇨병(인슐린 의존성), 전신성 루푸스, 크론병, 건선 등이 있다.In addition, dendritic cells induce differentiation into regulatory T cells that can inhibit the function of activated T cells, thereby preventing autoimmunity and transplant rejection, and of immune tolerance to autoantigens. It plays an important role in judo. However, when there is a problem in inducing or maintaining self-tolerance, an immune response to the self-antigen occurs, and thus, a phenomenon of attacking the own tissue occurs. A disease caused by this process is called an autoimmune disease. The Behcet's disease may be an example of the autoimmune disease, and in addition, there are rheumatoid arthritis, type 1 diabetes (insulin dependent), systemic lupus, Crohn's disease, and psoriasis.
본 발명에 따른 조성물에 있어서, 상기 약학 조성물은 각각 통상의 방법에 따라 다양한 형태로 제형화하여 사용될 수 있다. 상기 약학 조성물이 체내로 신속적으로 또는 지속적으로 제공될 수 있도록 제형화될 수 있다. 예를 들어, 캡슐제, 정제, 과립제, 분말제, 현탁액, 또는 시럽의 경구형 제형으로 제형화할 수 있다. 또한, 상기 락토바실러스 애니멀리스는 동결 건조, 분무 건조, 또는 생존가능한 형태로 상기 약학 조성물로 제공될 수 있다. In the composition according to the present invention, each of the pharmaceutical compositions may be formulated and used in various forms according to conventional methods. The pharmaceutical composition may be formulated so that it can be rapidly or continuously provided to the body. For example, it can be formulated as an oral dosage form of capsules, tablets, granules, powders, suspensions, or syrups. In addition, the Lactobacillus animalis may be provided as the pharmaceutical composition in a freeze-dried, spray-dried, or viable form.
상기 경구형 제형은 장용성 제형을 포함할 수 있다. 상기 장용성 제형은 장용 코팅물을 포함하여 위 저항성을 가져 상기 약학 조성물을 장으로 적합하게 전달할 수 있다. 예를 들어, 본 발명에 의한 약학 조성물이 약 6.8 초과의 pH를 갖는 장의 위치에 도달할 때 그의 내용물을 방출하도록 설계될 수 있다. 또한, 상기 경구형 제형은 상기 장용 코팅물 없이 본질적으로 장용성 제형으로 형성될 수 있다.The oral dosage form may include an enteric dosage form. The enteric formulation has gastric resistance, including an enteric coating, so that the pharmaceutical composition can be suitably delivered to the intestine. For example, a pharmaceutical composition according to the present invention can be designed to release its contents when it reaches the location of the intestine having a pH greater than about 6.8. In addition, the oral dosage form can be essentially formed into an enteric dosage form without the enteric coating.
상기 캡슐제는 연질 캡슐을 포함할 수 있다. 상기 연질 캡슐은 캡슐 외피에 존재하는 연화제, 예를 들어, 글리세롤, 소르비톨, 말티톨 및 폴리에틸렌 글리콜의 첨가 때문에, 특정 탄력성 및 유연도를 가질 수 있다. 상기 연질 캡슐은 젤라틴 또는 전분에 기초하여 형성될 수 있고, 다양한 형상, 예를 들어, 원통형, 타원형, 직사각형 또는 어뢰형을 가질 수 있다.The capsule agent may include a soft capsule. The soft capsule may have a certain elasticity and flexibility due to the addition of an emollient present in the capsule shell, such as glycerol, sorbitol, maltitol and polyethylene glycol. The soft capsule may be formed based on gelatin or starch, and may have various shapes, for example, cylindrical, oval, rectangular or torpedo-shaped.
본 발명에 따른 약학 조성물은 비경구 투여형으로 제형화하여 사용될 수 있다. 상기 비경구 투여형은 멸균 주사용액, 좌제가 포함될 수 있다. The pharmaceutical composition according to the present invention can be formulated and used in a parenteral dosage form. The parenteral dosage form may include sterile injectable solutions and suppositories.
본 발명에 따른 약학 조성물은 상기 제형에 따라 약학적으로 허용가능한 담체, 부형제, 또는 희석제를 추가로 포함하여 제조할 수 있다. 상기 "약학적으로 허용가능한"이란, 상기 약학 조성물에 노출되는 세포나 인간에게 독성이 없는 특성을 나타내는 것을 의미한다.The pharmaceutical composition according to the present invention can be prepared by additionally including a pharmaceutically acceptable carrier, excipient, or diluent according to the formulation. The "pharmaceutically acceptable" means exhibiting properties that are not toxic to cells or humans exposed to the pharmaceutical composition.
본 발명에서 사용가능한 담체, 부형제 또는 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 또는 광물유 등을 들 수 있다.Carriers, excipients or diluents that can be used in the present invention include lactose, dextrose, sucrose, sorbitol, mannitol, xylitol, erythritol, maltitol, starch, gum acacia, alginate, gelatin, calcium phosphate, calcium silicate, cellulose, Methyl cellulose, microcrystalline cellulose, polyvinyl pyrrolidone, water, methylhydroxybenzoate, propylhydroxybenzoate, talc, magnesium stearate, or mineral oil.
본 발명에 따른 약학 조성물을 상기 형태로 제제화할 경우에는 보통 사용하는 충진제, 증량제, 결합제, 습윤제, 붕해제, 계면활성제 등의 희석제 또는 부형제를 사용하여 조제될 수 있다. 예를 들어, 본 발명에 따른 락토바실러스 애니멀리스가 단일 박테리아로 상기 약학 조성물에 포함되는 경우, 상기 박테리아의 안정성을 유지하기 위해 하나 이상의 다른 박테리아 균주 및 충진제를 포함하도록 제제화할 수 있다.When the pharmaceutical composition according to the present invention is formulated in the above form, it can be prepared using diluents or excipients such as commonly used fillers, extenders, binders, wetting agents, disintegrants, and surfactants. For example, when the Lactobacillus animalis according to the present invention is included in the pharmaceutical composition as a single bacterium, it may be formulated to contain one or more other bacterial strains and fillers to maintain the stability of the bacterium.
경구투여를 위한 고형제제에는 정제, 환제, 산제, 과립제, 캡슐제 등이 포함되며, 이러한 고형제제는 상기 화합물은 적어도 하나 이상의 부형제, 예를 들면, 전분, 칼슘카보네이트(calciumcarbonate), 수크로스(sucrose) 또는 락토오스(lactose), 젤라틴 등을 섞어 조제할 수 있다.Solid preparations for oral administration include tablets, pills, powders, granules, capsules, and the like. These solid preparations contain at least one excipient, such as starch, calcium carbonate, and sucrose. ) Or lactose (lactose), gelatin, etc. can be mixed to prepare.
또한 단순한 부형제 이외에 마그네슘 스테아레이트, 탈크 같은 윤활제들도 사용될 수 있다. 경구를 위한 액상 제제로는 현탁제, 내용액제, 유제, 시럽제 등이 해당되는데 흔히 사용되는 단순희석제인 물, 리퀴드 파라핀 이외에 여러 가지 부형제, 예를 들면 습윤제, 감미제, 방향제, 보존제 등이 포함될 수 있다. In addition, in addition to simple excipients, lubricants such as magnesium stearate and talc may also be used. Liquid preparations for oral use include suspensions, liquid solutions, emulsions, syrups, etc. In addition to water and liquid paraffin, which are commonly used simple diluents, various excipients such as wetting agents, sweetening agents, fragrances, and preservatives may be included. .
본 발명에 따른 약학 조성물은 추가의 치료제와 조합하여 사용될 때 특히 효과적일 수 있다. 상기 약학 조성물은 베체트병 또는 헤르페스 바이러스 감염증의 치료에 일반적으로 사용되는 화합물, 예를 들면 항생제, 항염증제, 마취제, 진통제 등을 추가로 포함할 수 있다. 이는, 각각의 제형에 따라 약간씩 변화될 수 있고, 이에 제한되지 않는다.The pharmaceutical composition according to the invention can be particularly effective when used in combination with an additional therapeutic agent. The pharmaceutical composition may further include a compound generally used for the treatment of Behcet's disease or herpes virus infection, for example, antibiotics, anti-inflammatory agents, anesthetics, analgesics, and the like. This may vary slightly depending on each formulation, but is not limited thereto.
본 발명에 따른 조성물은 하나 이상의 적합한 프리바이오틱(prebiotic) 화합물을 더 포함하여 배합될 수 있다. The composition according to the invention may further comprise one or more suitable prebiotic compounds.
본 발명에서 "프리바이오틱(prebiotic) 화합물"은 위장관 내 특정 미생물의 성장을 증가시키는 비 소화성 성분으로, 프로바이오틱스(Probiotics; 유익균)의 영양원이 되어 프로바이오틱스를 활성화시키거나 균주의 수를 증가시킬 수 있다. 상기 프리바이오틱 화합물은 포유류의 위산 등의 효소에 의한 가수 분해와 소화 흡수에 내성이 있고, 상기 프로바이오틱스의 작용에 의해 발효되며, 상기 프로바이오틱스의 증식 및 활성을 선택적으로 자극하는 물질이 될 수 있다. In the present invention, the "prebiotic compound" is a non-digestible component that increases the growth of specific microorganisms in the gastrointestinal tract, and becomes a nutrient source of probiotics (beneficial bacteria) to activate probiotics or increase the number of strains. . The prebiotic compound is resistant to hydrolysis and digestion and absorption by enzymes such as gastric acid in mammals, is fermented by the action of the probiotics, and can be a substance that selectively stimulates the proliferation and activity of the probiotics.
상기 프리바이오틱 화합물은 일반적으로 올리고-, 폴리사카라이드, 또는 당 알코올과 같은 비-소화성 탄수화물로, 프룩토-올리고사카라이드(Fructo-Oligosaccharide; FOS), 이소말토-올리고사카라이드(Isomalto-Oligosaccharide; IMO), 자일로-올리고사카라이드(Xylo-Oligosaccharide; XOS), 키토-올리고사카라이드(Chito-Oligosaccharide; COS), 펙틴(Pectin), 이눌린(Inulin), 베타-글루칸(β-glucan), 폴리덱스트로스(Polydextrose), D-타가토스(D-tagatose), 및 아카시아 섬유로 이루어진 군에서 선택된 하나 이상일 수 있다. 상기 프리바이오틱 화합물은 상기 프로바이오틱스의 종류, 유형, 조합 등에 따라 포함되는 양과 그 활성 특징이 달라질 수 있다. 예를 들어, 상기 조성물은 총 중량 조성물에 대해 약 1 내지 약 30 중량%, 바람직하게는 5 내지 20 중량%의 양으로 상기 프리바이오틱 화합물을 포함할 수 있고, 상기 프리바이오틱 화합물에 의해 상기 락토바실러스 애니멀리스의 활성이 달라질 수 있으며, 최종적으로 생성되는 부티레이트의 양 또한 달라질 수 있다.The prebiotic compounds are generally oligo-, polysaccharides, or non-digestible carbohydrates such as sugar alcohols, fructo-oligosaccharides (FOS), isomalto-oligosaccharides (Isomalto-Oligosaccharides). ; IMO), Xylo-Oligosaccharide (XOS), Chito-Oligosaccharide (COS), Pectin, Inulin, Beta-glucan, Polydextrose (Polydextrose), D- tagatose (D-tagatose), and may be at least one selected from the group consisting of acacia fibers. The amount of the prebiotic compound and its activity characteristics may vary depending on the type, type, and combination of the probiotics. For example, the composition may comprise the prebiotic compound in an amount of about 1 to about 30% by weight, preferably 5 to 20% by weight, based on the total weight of the composition, and the prebiotic compound The activity of Lactobacillus animalis may vary, and the amount of butyrate finally produced may also vary.
본 발명에 따른 조성물에 있어서, 상기 약학 조성물은 약학적으로 유효한 양으로 투여될 수 있다. 상기 "약학적으로 유효한 양"이란, 의학적 치료에 적용 가능한 합리적인 수혜/위험 비율로 질환을 치료하기에 충분하며 부작용을 일으키지 않을 정도의 양을 의미하며, 유효 용량 수준은 환자의 건강상태, 궤양의 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.In the composition according to the present invention, the pharmaceutical composition may be administered in a pharmaceutically effective amount. The "pharmaceutically effective amount" means an amount sufficient to treat a disease at a reasonable benefit/risk ratio applicable to medical treatment and does not cause side effects, and the effective dose level is the patient's health condition, The type, severity, activity of the drug, sensitivity to the drug, method of administration, time of administration, route and rate of excretion, duration of treatment, factors including drugs used in combination or concurrently, and other factors well known in the medical field. .
예를 들어, 성인 인간에 대한 박테리아의 적합한 일일 투여량은 약 1 x 103 내지 약 1 x 1011 CFU(콜로니 형성 단위)일 수 있고, 예를 들어, 약 1 x 107 내지 약 1 x 1010CFU, 다른 예에서는 약 1 x 106 내지 약 1 x 1010CFU 일 수 있다.For example, a suitable daily dose of bacteria for an adult human may be about 1 x 10 3 to about 1 x 10 11 CFU (colony forming unit), for example about 1 x 10 7 to about 1 x 10 10 CFU, in another example, may be about 1 x 10 6 to about 1 x 10 10 CFU.
본 발명에 따른 조성물은 상기 조성물의 중량에 대하여 약 1 x 106 내지 약 1 x 1011 CFU/g의 양으로 박테리아 균주를 함유할 수 있다. 예를 들어, 약 1 x 107 내지 약 1 x 1010 CFU/g이다. 투여량은 예를 들어, 1g, 3g, 5g 및 10g 일 수 있다.The composition according to the present invention may contain a bacterial strain in an amount of about 1 x 10 6 to about 1 x 10 11 CFU/g based on the weight of the composition. For example, about 1 x 10 7 to about 1 x 10 10 CFU/g. The dosage can be, for example, 1g, 3g, 5g and 10g.
본 발명에 따른 약학 조성물은 개별적으로 투여되거나 다른 치료제와 병용하여 투여될 수 있으며, 종래의 치료제와 순차적 또는 동시에 투여될 수 있다. 또한, 단일 또는 다중 투여될 수 있다. 상기 요소를 모두 고려하여 부작용 없이 최소한의 양으로 최대 효과를 얻을 수 있는 양을 투여하는 것이 중요하다.The pharmaceutical composition according to the present invention may be administered individually or in combination with other therapeutic agents, and may be administered sequentially or simultaneously with conventional therapeutic agents. It can also be administered single or multiple. It is important to take into account all of the above factors and administer an amount capable of obtaining the maximum effect in a minimum amount without side effects.
본 발명에 따른 조성물에 있어서, 상기 건강기능식품 조성물 또한, 캡슐제, 정제, 과립제, 분말제, 현탁액, 또는 시럽 등 다양한 형태로 제조될 수 있다.In the composition according to the present invention, the health functional food composition may also be prepared in various forms such as capsules, tablets, granules, powders, suspensions, or syrups.
상기 건강기능식품은 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, pH조절제, 안정화제, 방부제, 글리세린, 알코올, 탄산 음료에 사용되는 탄산화제 등을 함유할 수 있다. 또한, 천연 과일쥬스, 과일 쥬스 음료 및 야채 음료의 제조를 위한 과육을 함유할 수 있다. 이러한 성분들은 독립적으로 또는 조합하여 사용할 수 있다. The health functional foods include various nutrients, vitamins, minerals (electrolytes), flavoring agents such as synthetic flavoring agents and natural flavoring agents, coloring agents and thickeners (cheese, chocolate, etc.), pectic acid and salts thereof, alginic acid and salts thereof, It may contain organic acids, protective colloidal thickeners, pH adjusters, stabilizers, preservatives, glycerin, alcohols, carbonates used in carbonated beverages, and the like. In addition, it may contain flesh for the manufacture of natural fruit juice, fruit juice beverage and vegetable beverage. These components may be used independently or in combination.
상기 건강기능식품은 유제품, 빵, 과자류, 아이스크림류, 음료수, 차, 기능수, 및 비타민 복합제 중 어느 하나의 형태일 수 있다.The health functional food may be in the form of any one of dairy products, bread, confectionery, ice cream, beverage, tea, functional water, and vitamin complex.
상기 건강기능식품은 식품첨가물을 추가로 포함할 수 있으며, "식품첨가물"로서의 적합여부는 다른 규정이 없는 한 식품의약품안정청에 승인된 식품첨가물공전의 총칙 및 일반시험법 등에 따라 해당 품목에 관한 규격 및 기준에 의하여 판정한다.The above health functional food may additionally contain food additives, and, unless otherwise specified, compliance with the "food additive" is the standard for the relevant item in accordance with the General Regulations of the Food Additives Code approved by the Food and Drug Administration and the General Test Act, etc. And the criteria.
상기 "식품첨가물공전"에 수재된 품목으로 예를 들어, 케톤류, 글리신, 구연산칼륨, 니코틴산, 계피산 등의 화학적 합성품, 감색소, 감초추출물, 결정셀룰로오스, 고랭색소, 구아검 등의 천연첨가물, L-글루타민산나트륨제제, 면류첨가알칼리제, 보존료제제, 타르색소제제 등의 혼합 제제류들을 들 수 있다.Items listed in the "Food Additives Code", for example, chemical synthetic products such as ketones, glycine, potassium citrate, nicotinic acid, and cinnamic acid, natural additives such as reduced pigment, licorice extract, crystalline cellulose, high cooling pigment, guar gum, L -Mixed preparations such as sodium glutamate preparation, noodle additive alkali preparation, preservative preparation, and tar color preparation are mentioned.
이때, 건강기능식품을 제조하는 과정에서 음료를 포함한 식품에 첨가되는 조성물은 필요에 따라 그 함량을 적절히 가감할 수 있으며, 구체적으로는 식품 100 중량%에 1 내지 15 중량%가 포함되도록 첨가할 수 있다.At this time, the composition added to food including beverages in the process of manufacturing health functional foods can be appropriately added or subtracted as needed, and specifically, it can be added to include 1 to 15% by weight to 100% by weight of food. have.
상기 건강기능식품은 영양 보충제와 같이 본 발명의 치료 효과이외에 영양적인 이득을 제공할 수 있다. 또한 상기 건강기능식품은 본 발명에 따른 상기 약학 조성물 및 상기 건강기능식품 조성물의 맛을 증강시키거나 또는 상기 약학 조성물보다는 일반적인 식품 품목에 보다 유사하여 소비하기에 더 매력적이도록 제형화될 수 있다. The health functional food may provide nutritional benefits in addition to the therapeutic effect of the present invention, such as a nutritional supplement. In addition, the health functional food may be formulated to enhance the taste of the pharmaceutical composition and the health functional food composition according to the present invention, or to be more attractive for consumption because it is more similar to a general food item than the pharmaceutical composition.
이하, 실시예를 들어 본 발명을 보다 상세하게 설명하기로 한다. 다만 하기의 실시예는 당업계에서 평균적인 지식을 가진 자에게 본 발명을 보다 완전하게 설명하기 위해 제공되는 것이며 본 발명의 내용을 예시하는 것일 뿐이므로 본 발명의 범위가 하기 실시예에 한정되는 것은 아니다.Hereinafter, the present invention will be described in more detail with reference to examples. However, the following examples are provided to more fully describe the present invention to those with average knowledge in the art, and are only illustrative of the contents of the present invention, so that the scope of the present invention is limited to the following examples. no.
[실시예][Example]
베체트병 유사 마우스 모델Behcet's disease-like mouse model
ICR strain 5주령 마우스에 헤르페스 바이러스(Herpes simplex virus) 1형을 상처낸 귀이개에 접종하였다. 상기 마우스 중 피부 궤양, 홍반 등의 염증 증상을 동반하여 베체트병 특징을 보이는 마우스를 베체트병 유사 마우스 모델로 선정하여 본 실험에 사용하였다.ICR strain 5-week-old mice were inoculated with Herpes simplex virus type 1 onto a wound ear canal. Among the above mice, mice exhibiting Behcet's disease characteristics accompanied by inflammatory symptoms such as skin ulcers and erythema were selected as a Behcet's disease-like mouse model and used in this experiment.
투여방법Method of administration
2×108개의 락토바실러스 애니멀리스를 매일 1회씩, 10일간 베체트병 유사 마우스 모델에 경구 투여 후 증상을 확인하였다. 본 실시예에 사용된 락토바실러스 애니멀리스는 KCTC(#3501)로부터 분양받았다.Symptoms were confirmed after oral administration of 2×10 8 Lactobacillus animals once daily to a Behcet's disease-like mouse model for 10 days. The Lactobacillus animalis used in this example was pre-sale from KCTC (#3501).
실험결과Experiment result
도 1은 본 발명의 일 실험예에 따른 결과를 나타낸다.1 shows the results according to an experimental example of the present invention.
도 1을 참조하면, 베체트병 유사 마우스 모델에서 락토바실러스 애니멀리스 경구 투여 전, 투여 10일의 증상을 촬영하여 호전 여부를 비교하였다. Referring to Figure 1, Lactobacillus animalis in a Behcet's disease-like mouse model Before oral administration, symptoms on the 10th day of administration were photographed to compare whether or not they improved.
락토바실러스 애니멀리스 투여 10일 후에 피부 궤양 증상 및 홍반 증상이 호전되는 양상을 보였다.After 10 days of Lactobacillus animalis administration, symptoms of skin ulcer and erythema were improved.
이제까지 본 발명에 대한 구체적인 실시예들을 살펴보았다. 본 발명이 속하는 기술 분야에서 통상의 지식을 가진 자는 본 발명이 본 발명의 본질적인 특성에서 벗어나지 않는 범위에서 변형된 형태로 구현될 수 있음을 이해할 수 있을 것이다. 그러므로 개시된 실시예들은 한정적인 관점이 아니라 설명적인 관점에서 고려되어야 한다. 본 발명의 범위는 전술한 설명이 아니라 특허청구범위에 나타나 있으며, 그와 동등한 범위 내에 있는 모든 차이점은 본 발명에 포함된 것으로 해석되어야 할 것이다.So far, specific examples of the present invention have been described. Those of ordinary skill in the art to which the present invention pertains will be able to understand that the present invention can be implemented in a modified form without departing from the essential characteristics of the present invention. Therefore, the disclosed embodiments should be considered from an illustrative point of view rather than a limiting point of view. The scope of the present invention is shown in the claims rather than the above description, and all differences within the scope equivalent thereto should be construed as being included in the present invention.
Claims (10)
상기 락토바실러스 애니멀리스는 락테이트(lactate)를 생성하고, 상기 락테이트는 체내에서 부티레이트(butyrate)로 전환되는 것을 특징으로 하는, 베체트병의 예방 또는 치료용 약학 조성물.The method of claim 1,
The lactobacillus animalis produces lactate, and the lactate is converted into butyrate in the body. A pharmaceutical composition for the prevention or treatment of Behcet's disease.
상기 락토바실러스 애니멀리스는 수지상 세포의 활성화 분자의 발현을 조절하는 것을 특징으로 하는, 베체트병의 예방 또는 치료용 약학 조성물.The method of claim 1,
The Lactobacillus animalis is a pharmaceutical composition for the prevention or treatment of Behcet's disease, characterized in that it regulates the expression of an activating molecule of dendritic cells.
상기 조성물은 프리바이오틱(prebiotic) 화합물을 더 포함하고,
상기 프리바이오틱 화합물은 프룩토-올리고사카라이드(Fructo-Oligosaccharide; FOS), 이소말토-올리고사카라이드(Isomalto-Oligosaccharide; IMO), 자일로-올리고사카라이드(Xylo-Oligosaccharide; XOS), 키토-올리고사카라이드(Chito-Oligosaccharide; COS), 펙틴(Pectin), 이눌린(Inulin), 베타-글루칸(β-glucan), 폴리덱스트로스(Polydextrose), D-타가토스(D-tagatose), 및 아카시아 섬유로 이루어진 군에서 선택되는 하나 이상인 것을 특징으로 하는, 베체트병의 예방 또는 치료용 약학 조성물.The method of claim 1,
The composition further comprises a prebiotic compound,
The prebiotic compounds are fructo-oligosaccharide (FOS), isomalto-oligosaccharide (IMO), xylo-oligosaccharide (XOS), chito- Composed of oligosaccharides (Chito-Oligosaccharide; COS), pectin, inulin, beta-glucan, polydextrose, D-tagatose, and acacia fiber A pharmaceutical composition for the prevention or treatment of Behcet's disease, characterized in that at least one selected from the group.
상기 락토바실러스 애니멀리스는 락테이트(lactate)를 생성하고, 상기 락테이트는 체내에서 부티레이트(butyrate)로 전환되는 것을 특징으로 하는, 베체트병의 예방 또는 개선용 건강기능식품 조성물.The method of claim 5,
The Lactobacillus animalis produces lactate, and the lactate is converted into butyrate in the body. A health functional food composition for preventing or improving Behcet's disease.
상기 락토바실러스 애니멀리스는 수지상 세포의 활성화 분자의 발현을 조절하는 것을 특징으로 하는, 베체트병의 예방 또는 개선용 건강기능식품 조성물.The method of claim 5,
The Lactobacillus animalis is a health functional food composition for preventing or improving Behcet's disease, characterized in that it regulates the expression of the activation molecule of dendritic cells.
상기 조성물은 프리바이오틱(prebiotic) 화합물을 더 포함하고,
상기 프리바이오틱 화합물은 프룩토-올리고사카라이드(Fructo-Oligosaccharide; FOS), 이소말토-올리고사카라이드(Isomalto-Oligosaccharide; IMO), 자일로-올리고사카라이드(Xylo-Oligosaccharide; XOS), 키토-올리고사카라이드(Chito-Oligosaccharide; COS), 펙틴(Pectin), 이눌린(Inulin), 베타-글루칸(β-glucan), 폴리덱스트로스(Polydextrose), D-타가토스(D-tagatose), 및 아카시아 섬유로 이루어진 군에서 선택되는 하나 이상인 것을 특징으로 하는, 베체트병의 예방 또는 개선용 건강기능식품 조성물.The method of claim 5,
The composition further comprises a prebiotic compound,
The prebiotic compounds are fructo-oligosaccharide (FOS), isomalto-oligosaccharide (IMO), xylo-oligosaccharide (XOS), chito- Composed of oligosaccharides (Chito-Oligosaccharide; COS), pectin, inulin, beta-glucan, polydextrose, D-tagatose, and acacia fiber A health functional food composition for preventing or improving Behcet's disease, characterized in that at least one selected from the group.
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