KR20200131739A - Microorganism strain having activity of improving liver function and use thereof - Google Patents
Microorganism strain having activity of improving liver function and use thereof Download PDFInfo
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- KR20200131739A KR20200131739A KR1020200042863A KR20200042863A KR20200131739A KR 20200131739 A KR20200131739 A KR 20200131739A KR 1020200042863 A KR1020200042863 A KR 1020200042863A KR 20200042863 A KR20200042863 A KR 20200042863A KR 20200131739 A KR20200131739 A KR 20200131739A
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Classifications
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- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
- A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
- A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
- A23L33/135—Bacteria or derivatives thereof, e.g. probiotics
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- A—HUMAN NECESSITIES
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
- A61K35/66—Microorganisms or materials therefrom
- A61K35/74—Bacteria
- A61K35/741—Probiotics
- A61K35/744—Lactic acid bacteria, e.g. enterococci, pediococci, lactococci, streptococci or leuconostocs
- A61K35/747—Lactobacilli, e.g. L. acidophilus or L. brevis
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- A—HUMAN NECESSITIES
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- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
- A61P1/16—Drugs for disorders of the alimentary tract or the digestive system for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
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- C—CHEMISTRY; METALLURGY
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- C12N1/00—Microorganisms, e.g. protozoa; Compositions thereof; Processes of propagating, maintaining or preserving microorganisms or compositions thereof; Processes of preparing or isolating a composition containing a microorganism; Culture media therefor
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- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23V—INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
- A23V2002/00—Food compositions, function of food ingredients or processes for food or foodstuffs
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- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23V—INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
- A23V2200/00—Function of food ingredients
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- A23V2200/3262—Foods, ingredients or supplements having a functional effect on health having an effect on blood cholesterol
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- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
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- C—CHEMISTRY; METALLURGY
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- C12R—INDEXING SCHEME ASSOCIATED WITH SUBCLASSES C12C - C12Q, RELATING TO MICROORGANISMS
- C12R2001/00—Microorganisms ; Processes using microorganisms
- C12R2001/01—Bacteria or Actinomycetales ; using bacteria or Actinomycetales
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Abstract
Description
본 발명은 간 기능 개선 활성을 갖는 균주 및 이의 용도로서, 구체적으로 본 발명은 락토바실러스 펜토서스 KF8(수탁번호 KCCM11997P) 균주, 바실러스 서브틸리스 KF11(수탁번호 KCCM11981P) 균주 또는 락토코쿠스 락티스 KF140(수탁번호 KCCM11673P) 균주를 이용한 간 기능 개선용 건강식품 조성물 및 약학적 조성물에 관한 것이다.The present invention is a strain having liver function improving activity and uses thereof, specifically, the present invention is a Lactobacillus pentosus KF8 (accession number KCCM11997P) strain, Bacillus subtilis KF11 (accession number KCCM11981P) strain or Lactococcus lactis KF140 (Accession No. KCCM11673P) It relates to a health food composition and a pharmaceutical composition for improving liver function using the strain.
간은 인체에서 혈액 저장 및 순환, 혈액량 조절과 방어해독작용을 하며 정신적 활동과 밀접하게 관련되어 있다고 알려져 있다. 산업화에 따른 공해물질, 유독물질에 우리의 몸은 항상 노출되어 있어 우리의 간은 끊임없이 해독작용에 시달리고 있다.The liver is known to have blood storage and circulation, blood volume control and defense detoxification in the human body, and is closely related to mental activity. Our body is always exposed to pollutants and toxic substances caused by industrialization, so our liver is constantly suffering from detoxification.
또한, 간은 완충능력이 큰 기관으로 질환의 초기단계에서는 잘 나타나지 않고 상당히 악화되어서야 발견된다. 간경화, 간암 등은 각종 간질환이 만성적으로 진행될 경우 공통적으로 이르는 마지막 단계이다. 그 원인으로는 알코올, 약물, 화학약품, 바이러스성 간염, 담도질환, 혈색소증(hematochromatosis)과 같은 대사성 질환, 자가 면역성질환 등이 있으나 원인을 알 수 없는 경우도 많아 간은 초기의 건강관리가 매우 중요한 기관이다.In addition, the liver is an organ with a large buffering capacity, and does not appear well in the early stages of the disease, and is found only when it is significantly worsened. Liver cirrhosis and liver cancer are common last steps when various liver diseases develop chronically. The causes include alcohol, drugs, chemicals, viral hepatitis, biliary tract disease, metabolic diseases such as hematochromatosis, and autoimmune diseases, but the cause of the liver is often unknown. It is an institution.
최근 한국인의 건강수준에서 간암에 의한 사망률은 10만 명당 23.4명으로 세계 1위이고 만성 간질환의 경우도 28.8명으로 3번째로 조사되었다. 또한 최근 통계청에서 우리나라 40대의 경우 인구 10만 명당 56.1명이 간질환으로 가장 높은 사망원인으로 발표하여 간질환이 중요한 사회적 문제로 대두되고 있으며, 최근에는 정신적인 스트레스로 인한 간 손상도 발병수가 증가하고 있어 간 기능 개선을 위한 연구에 더욱 집중이 되고 있다.In terms of the recent health level of Koreans, the mortality rate from liver cancer was 23.4 per 100,000 people, the world's No. 1, and chronic liver disease was also the third with 28.8 people. In addition, the National Statistical Office recently announced that 56.1 people per 100,000 people in Korea in their 40s are the highest cause of death due to liver disease, and liver disease is emerging as an important social problem, and recently, the number of liver damage caused by mental stress is increasing. Research is being focused on improving liver function.
한편, 프로바이오틱스는 오랫동안 우리 식생활에서 이용되어 왔으며, 특히 정장 작용, 항암효과 및 면역증강 효과 등의 유익한 효과가 보고되어 왔다.On the other hand, probiotics have been used in our diet for a long time, and in particular, beneficial effects such as intestinal action, anticancer effect, and immune enhancing effect have been reported.
이에 본 발명자들은 프로바이오틱스, 특히 본 발명자들이 이전 연구를 통해 신균주로 분리 및 동정한 균주인 락토바실러스 펜토서스 KF8(수탁번호 KCCM11997P) 균주, 바실러스 서브틸리스 KF11(수탁번호 KCCM11981P) 균주 및 락토코쿠스 락티스 KF140(수탁번호 KCCM11673P) 균주에 대한 새로운 생리활성을 연구하던 중, 상기 세균들이 간 기능을 효과적으로 개선할 수 있음을 확인함으로써 본 발명을 완성하였다.Accordingly, the inventors of the present invention are probiotics, in particular, Lactobacillus pentosus KF8 (accession number KCCM11997P) strain, a strain that the inventors have isolated and identified as a new strain through previous studies, Bacillus subtilis KF11 (accession number KCCM11981P) strain, and Lactococcus While studying new physiological activity for the lactis KF140 (accession number KCCM11673P) strain, the present invention was completed by confirming that the above bacteria can effectively improve liver function.
따라서 본 발명의 목적은 락토바실러스 펜토서스 KF8(수탁번호 KCCM11997P) 균주, 바실러스 서브틸리스 KF11(수탁번호 KCCM11981P) 균주 및 락토코쿠스 락티스 KF140(수탁번호 KCCM11673P) 균주로 이루어진 군 중에서 선택되는 하나 이상의 균주, 이의 파쇄물 또는 이의 배양물을 유효성분으로 포함하는 간 기능 개선용 건강식품 조성물을 제공하는 것이다.Therefore, an object of the present invention is one or more selected from the group consisting of Lactobacillus pentosus KF8 (accession number KCCM11997P) strain, Bacillus subtilis KF11 (accession number KCCM11981P) strain, and Lactococcus lactis KF140 (accession number KCCM11673P) strain. It is to provide a health food composition for improving liver function comprising a strain, its lysate or its culture as an active ingredient.
또한 본 발명의 다른 목적은 락토바실러스 펜토서스 KF8(수탁번호 KCCM11997P) 균주, 바실러스 서브틸리스 KF11(수탁번호 KCCM11981P) 균주 및 락토코쿠스 락티스 KF140(수탁번호 KCCM11673P) 균주로 이루어진 군 중에서 선택되는 하나 이상의 균주, 이의 파쇄물 또는 이의 배양물을 유효성분으로 포함하는 간 기능 개선용 약학적 조성물을 제공하는 것이다.In addition, another object of the present invention is one selected from the group consisting of Lactobacillus pentosus KF8 (accession number KCCM11997P) strain, Bacillus subtilis KF11 (accession number KCCM11981P) strain, and Lactococcus lactis KF140 (accession number KCCM11673P) strain It is to provide a pharmaceutical composition for improving liver function comprising the above strain, its lysate or its culture as an active ingredient.
상기와 같은 본 발명의 목적을 달성하기 위해서, 본 발명은 락토바실러스 펜토서스 KF8(수탁번호 KCCM11997P) 균주, 바실러스 서브틸리스 KF11(수탁번호 KCCM11981P) 균주 및 락토코쿠스 락티스 KF140(수탁번호 KCCM11673P) 균주로 이루어진 군 중에서 선택되는 하나 이상의 균주, 이의 파쇄물 또는 이의 배양물을 유효성분으로 포함하는, 간 기능 개선용 건강식품 조성물을 제공한다. In order to achieve the object of the present invention as described above, the present invention is Lactobacillus pentosus KF8 (accession number KCCM11997P) strain, Bacillus subtilis KF11 (accession number KCCM11981P) strain and Lactococcus lactis KF140 (accession number KCCM11673P) It provides a health food composition for improving liver function, comprising one or more strains selected from the group consisting of strains, lysates or cultures thereof as an active ingredient.
본 발명의 일실시예에 있어서, 상기 조성물은 ALT(Alanine Aminotransferase) 또는 AST(Aspartate Aminotransferase) 활성을 억제시키고, 간 내 총 콜레스테롤 또는 중성지방의 농도 증가를 억제시키고, 또는 간 내 지방 축적을 억제할 수 있다. In one embodiment of the present invention, the composition inhibits ALT (Alanine Aminotransferase) or AST (Aspartate Aminotransferase) activity, inhibits an increase in the concentration of total cholesterol or triglyceride in the liver, or inhibits fat accumulation in the liver. I can.
본 발명의 일실시예에 있어서, 상기 건강식품 조성물은 분말, 과립, 환, 정제, 캡슐, 캔디, 시럽 및 음료 중에서 선택된 어느 하나의 제형일 수 있다.In one embodiment of the present invention, the health food composition may be any one formulation selected from powder, granule, pill, tablet, capsule, candy, syrup, and beverage.
또한 본 발명은 락토바실러스 펜토서스 KF8(수탁번호 KCCM11997P) 균주, 바실러스 서브틸리스 KF11(수탁번호 KCCM11981P) 균주 및 락토코쿠스 락티스 KF140(수탁번호 KCCM11673P) 균주로 이루어진 군 중에서 선택되는 하나 이상의 균주, 이의 파쇄물 또는 이의 배양물을 유효성분으로 포함하는, 간 기능 개선용 약학적 조성물을 제공한다.In addition, the present invention is one or more strains selected from the group consisting of Lactobacillus pentosus KF8 (accession number KCCM11997P) strain, Bacillus subtilis KF11 (accession number KCCM11981P) strain, and Lactococcus lactis KF140 (accession number KCCM11673P) strain, It provides a pharmaceutical composition for improving liver function, comprising the lysate or a culture thereof as an active ingredient.
본 발명의 일실시예에 있어서, 상기 조성물은, ALT(Alanine Aminotransferase) 또는 AST(Aspartate Aminotransferase) 활성을 억제시키고, 간 내 총 콜레스테롤 또는 중성지방의 농도 증가를 억제시키고, 또는 간 내 지방 축적을 억제할 수 있다. In one embodiment of the present invention, the composition inhibits ALT (Alanine Aminotransferase) or AST (Aspartate Aminotransferase) activity, inhibits an increase in the concentration of total cholesterol or triglyceride in the liver, or inhibits fat accumulation in the liver. can do.
본 발명은 락토바실러스 펜토서스 KF8(수탁번호 KCCM11997P) 균주, 바실러스 서브틸리스 KF11(수탁번호 KCCM11981P) 균주 및 락토코쿠스 락티스 KF140(수탁번호 KCCM11673P) 균주로 이루어진 군 중에서 선택되는 하나 이상의 균주, 이의 파쇄물 또는 이의 배양물을 유효성분으로 포함하는 간 기능 개선용 건강식품 조성물 및 간 기능 개선용 약학적 조성물에 관한 것으로, 본 발명의 상기 균주는 ALT(Alanine Aminotransferase) 또는 AST(Aspartate Aminotransferase) 활성을 억제시키고, 간 내 총 콜레스테롤 또는 중성지방의 농도 증가를 억제시키며 간 내 지방 축적을 억제하는 활성이 우수하여, 간 기능 개선을 위한 식품조성물 및 약학적 조성물의 제조에 유용하게 사용될 수 있다. The present invention is one or more strains selected from the group consisting of Lactobacillus pentosus KF8 (accession number KCCM11997P) strain, Bacillus subtilis KF11 (accession number KCCM11981P) strain, and Lactococcus lactis KF140 (accession number KCCM11673P) strain, its It relates to a health food composition for improving liver function and a pharmaceutical composition for improving liver function comprising a lysate or a culture thereof as an active ingredient, wherein the strain of the present invention inhibits ALT (Alanine Aminotransferase) or AST (Aspartate Aminotransferase) activity And, it suppresses the increase in the concentration of total cholesterol or triglyceride in the liver, and has excellent activity of inhibiting fat accumulation in the liver, and can be usefully used in the manufacture of food compositions and pharmaceutical compositions for improving liver function.
도 1은 본 발명의 일실시예에서 락토바실러스 펜토서스 KF8(수탁번호 KCCM11997P) 균주, 바실러스 서브틸리스 KF11(수탁번호 KCCM11981P) 균주 및 락토코쿠스 락티스 KF140(수탁번호 KCCM11673P) 균주를 이용하여 제조된 간 기능 개선용 건강식품의 형태를 사진으로 나타낸 것이다.1 is prepared using a Lactobacillus pentosus KF8 (accession number KCCM11997P) strain, Bacillus subtilis KF11 (accession number KCCM11981P) strain and Lactococcus lactis KF140 (accession number KCCM11673P) strain in an embodiment of the present invention This is a photograph showing the form of health food for improving liver function.
본 발명은 간 기능 개선 활성을 갖는 균주의 신규 용도에 관한 것으로, 상기 간 기능 개선 활성을 갖는 균주는 본 발명의 발명자가 이전에 최초로 분리 및 동정하여 공개된 락토바실러스 펜토서스 KF8(수탁번호 KCCM11997P) 균주, 바실러스 서브틸리스 KF11(수탁번호 KCCM11981P) 균주 및 락토코쿠스 락티스 KF140(수탁번호 KCCM11673P) 균주이다.The present invention relates to a novel use of a strain having liver function improving activity, wherein the strain having liver function improving activity is Lactobacillus pentosus KF8 (accession number KCCM11997P) published by the inventor of the present invention for the first time isolated and identified. Strain, Bacillus subtilis KF11 (accession number KCCM11981P) strain and Lactococcus lactis KF140 (accession number KCCM11673P) strain.
본 발명자들은 상기 본 발명의 균주가 간 기능을 개선할 수 있고 간을 보호하는 활성이 있는지 확인하기 위한 실험을 수행하였는데, 그 결과, 상기 균주를 분말화하여 제조된 식품 형태를 간 손상 동물 모델에 투여한 결과, 간 세포를 보호하고 간 손상 지표인 ALT 및 AST 활성을 억제하는 효과가 우수한 것을 확인하였다.The present inventors conducted an experiment to confirm whether the strain of the present invention can improve liver function and has an activity to protect the liver. As a result, the food form prepared by powdering the strain was applied to a liver injury animal model. As a result of administration, it was confirmed that the effect of protecting liver cells and inhibiting ALT and AST activities, which are indicators of liver damage, was excellent.
상기 ALT(Aspartate Aminotransferase) 대표적인 간 손상 지표로 간, 신장, 심장, 근육 등에 있는 효소로 간에 가장 많은 양이 존재하며, 간세포 손상 시 예민하게 반응하여 그 수치가 증가하기 때문에 간질환의 지표로 사용된다. 주로 간이 다양한 이유로 손상될 경우, 혈중으로 방출되어 혈중 수치가 상승한다.The ALT (Aspartate Aminotransferase) is an enzyme found in liver, kidney, heart, muscle, etc., as a representative indicator of liver damage.It is used as an indicator of liver disease because it reacts sensitively and increases the level of the liver. . Mainly when the liver is damaged for various reasons, it is released into the blood and the blood level rises.
또한, 다른 간 손상 지표인 AST(alanine aminotransferase) 역시 간 손상 시 혈중으로 방출되어 정상 상태인 경우에 비해 혈중 수치가 상승하므로, 이러한 지표들의 함량 측정을 통해 간 손상 정도를 확인할 수 있다.In addition, since AST (alanine aminotransferase), which is another indicator of liver damage, is also released into the blood during liver damage and increases in blood levels compared to a normal state, the extent of liver damage can be determined by measuring the content of these indicators.
한편, 본 발명의 균주인 락토바실러스 펜토서스 KF8(수탁번호 KCCM11997P) 균주, 바실러스 서브틸리스 KF11(수탁번호 KCCM11981P) 균주 또는 락토코쿠스 락티스 KF140(수탁번호 KCCM11673P) 균주를 간 손상이 유발된 마우스 군에 투여한 결과, 혈중 증가된 ALT 및 AST 수치가 2배 이상으로 감소되는 효과가 있음을 확인하였다.On the other hand, Lactobacillus pentosus KF8 (accession number KCCM11997P) strain, Bacillus subtilis KF11 (accession number KCCM11981P) strain or Lactococcus lactis KF140 (accession number KCCM11673P) strain, which is the strain of the present invention, was used as a mouse with liver damage. As a result of administration to the group, it was confirmed that the increased ALT and AST levels in blood were reduced by more than two times.
또한 본 발명의 일실시예에서는 지방간 발병에 따른 간 내 증가된 총콜레스테롤과 중성지방의 함량을 본 발명의 균주 투여 시 감소시킬 수 있는지를 분석하였는데, 본 발명의 균주를 지방간 동물모델에 투여한 결과, 간 내 총콜레스테롤과 중성지방의 함량이 효과적으로 억제되는 것을 확인할 수 있었고, 간 내 지방 축적이 억제되는 것을 확인할 수 있었다.In addition, in an embodiment of the present invention, it was analyzed whether the content of increased total cholesterol and triglycerides in the liver due to the onset of fatty liver can be reduced when the strain of the present invention is administered. As a result of administering the strain of the present invention to an animal model of fatty liver , It was confirmed that the content of total cholesterol and triglyceride in the liver was effectively suppressed, and it was confirmed that fat accumulation in the liver was suppressed.
지방간은 간장에서의 지질 단백질 형성 및 방출의 저해 또는 중성지방(triglyceride) 합성의 항진에 의해 발병된다고 알려져 있다. 에티오닌(Ethionine)은 RNA와 단백질의 합성을 억제하여 간에서 ATP의 생성을 감소시키고 이로 인해 중성지방의 혈장으로의 배출을 저해하며, 또한 지질단백질의 합성도 저해하여 이차적으로 간으로부터 지질의 방출을 억제하므로 에티오닌 투여시 간조직 내 중성지방이 축적되고 혈중 중성지방 및 총 콜레스테롤양은 급격히 저하되어 미세수포 지방증 (microvasicular steatosis)을 일으킨다. 따라서 에티오닌으로 유발되는 지방간 모델에서는 간조직 내 중성지방 함량 및 혈청 내 총 콜레스테롤 함량이 모델의 지표로 이용된다.Fatty liver is known to be caused by inhibition of the formation and release of lipoproteins in the liver or by enhancement of triglyceride synthesis. Ethionine inhibits the synthesis of RNA and protein, thereby reducing the production of ATP in the liver, thereby inhibiting the excretion of triglycerides into the plasma, and also inhibiting the synthesis of lipoproteins, secondary to lipids from the liver. Since it inhibits the release, triglycerides are accumulated in liver tissue when ethionine is administered, and the amount of triglycerides and total cholesterol in the blood decreases rapidly, causing microvasicular steatosis. Therefore, in the ethionine-induced fatty liver model, the triglyceride content in liver tissue and the total cholesterol content in serum are used as indicators of the model.
이러한 점에서 본 발명의 균주는 간 조직 내 중성지방 및 총 콜레스테롤을 감소시킬 수 있는 효과가 있음을 확인하였기에 지방간의 개선 및 치료에 유용함을 알 수 있다.In this respect, it can be seen that the strain of the present invention has an effect of reducing triglycerides and total cholesterol in liver tissue, and thus is useful for improving and treating fatty liver.
나아가 본 발명의 다른 일실시예에서는 임상시험심사위원회(IRB)의 규정에 따라 진행된 자원된 사람들을 대상으로 임상시험을 수행한 결과, 본 발명의 균주를 이용하여 제조된 건강식품을 섭취한 군의 경우, 이를 섭취하지 않은 군에 비해 혈중 ALT 및 AST의 활성이 억제되어 간 기능을 개선하는 효과가 있는 것을 알 수 있었으며, 총 콜레스테롤 및 LDL 콜레스테롤의 함량도 본 발명의 균주 섭취에 의해 감소되는 것을 확인할 수 있었다.Further, in another embodiment of the present invention, as a result of conducting a clinical trial on volunteers conducted in accordance with the regulations of the Institutional Review Board (IRB), the group who ingested health food prepared using the strain of the present invention In the case, it was found that the activity of ALT and AST in the blood was suppressed compared to the group not ingested, thereby improving liver function, and it was confirmed that the content of total cholesterol and LDL cholesterol was also reduced by intake of the strain of the present invention. Could
따라서 이러한 결과를 통해 본 발명자들은 본 발명자들에 의해 최초로 분리 및 동정한 균주인 락토바실러스 펜토서스 KF8(수탁번호 KCCM11997P) 균주, 바실러스 서브틸리스 KF11(수탁번호 KCCM11981P) 균주 또는 락토코쿠스 락티스 KF140(수탁번호 KCCM11673P) 균주를 간 기능 개선을 위한 용도로 사용할 수 있음을 알 수 있었다.Therefore, through these results, the present inventors are the first strain isolated and identified by the present inventors, Lactobacillus pentosus KF8 (accession number KCCM11997P) strain, Bacillus subtilis KF11 (accession number KCCM11981P) strain or Lactococcus lactis KF140 (Accession No. KCCM11673P) it was found that the strain can be used for improving liver function.
그러므로 본 발명은 락토바실러스 펜토서스 KF8(수탁번호 KCCM11997P) 균주, 바실러스 서브틸리스 KF11(수탁번호 KCCM11981P) 균주 및 락토코쿠스 락티스 KF140(수탁번호 KCCM11673P) 균주로 이루어진 군 중에서 선택되는 하나 이상의 균주, 이의 파쇄물 또는 이의 배양물을 유효성분으로 포함하는, 간 기능 개선용 건강식품 조성물을 제공할 수 있다.Therefore, the present invention is one or more strains selected from the group consisting of Lactobacillus pentosus KF8 (accession number KCCM11997P) strain, Bacillus subtilis KF11 (accession number KCCM11981P) strain, and Lactococcus lactis KF140 (accession number KCCM11673P) strain, It is possible to provide a health food composition for improving liver function, including the lysate or a culture thereof as an active ingredient.
본 발명의 상기 간 기능 개선용 건강식품 조성물에 함유될 수 있는 상기 균주의 수는 1.0×105 CFU/g~ 2.0×1015 CFU/g일 수 있으며, 본 발명의 건강식품 조성물에는 상기 균주 중, 1 종류의 균주를 포함할 수 있으며, 또는 1 종류 이상의 혼합 균주를 포함할 수 있으며, 가장 바람직하게는 상기 3종류의 균주를 모두 혼합한 혼합균주로 포함할 수 있다.The number of strains that may be contained in the health food composition for improving liver function of the present invention may be 1.0×10 5 CFU/g to 2.0×10 15 CFU/g, and the health food composition of the present invention includes , It may include one type of strain, or may include one or more types of mixed strains, and most preferably, may be included as a mixed strain obtained by mixing all three types of strains.
본 발명의 실험에서 규명한 상기 락토바실러스 펜토서스 KF8(수탁번호 KCCM11997P) 균주, 바실러스 서브틸리스 KF11(수탁번호 KCCM11981P) 균주 또는 락토코쿠스 락티스 KF140(수탁번호 KCCM11673P) 균주의 간 기능 개선 효과, 즉 혈중 ALT 및 AST 활성 억제, 간 조직 내 총 콜레스테롤 및 중성지방 억제, 간 내 지방축적 억제 효과는 상기 단독 균주 처리에 의해서도 유도될 수 있으며, 상기 균주를 2종 이상 혼합한 경우, 더 우수한 효과를 나타낼 수 있으며, 3가지 균주를 모두 혼합한 경우 가장 우수한 효과를 나타낼 수 있다. 본 발명에서 상기 식품 조성물은 기능성 식품(functional food), 영양 보조제(nutritional supplement), 건강식품(health food) 및 식품 첨가제(food additives) 등의 모든 형태를 포함한다. 상기 유형의 식품 조성물은 당 업계에 공지된 통상적인 방법에 따라 다양한 형태로 제조할 수 있다. 예를 들면, 건강식품으로는 본 발명의 균주 균주 자체, 이의 파쇄물 및 상기 균주 배양물 군 중 하나 이상을 차, 쥬스 및 드링크의 형태로 제조하여 음용하도록 하거나, 과립화, 캡슐화 및 분말화 하여 섭취할 수 있다. 또한, 본 발명의 균주, 이의 파쇄물 및 배양물 군 중 하나 이상을 간 기능 개선 효과가 있다고 알려진 공지의 물질 또는 활성 성분과 함께 혼합하여 조성물의 형태로 제조할 수 있다. 또한, 기능성 식품으로는 음료(알콜성 음료 포함), 과실 및 그의 가공식품(예: 과일통조림, 병조림, 잼, 마아말 레이드 등), 어류, 육류 및 그 가공식품(예: 햄, 소시지콘비이프 등), 빵류 및 면류(예: 우동, 메밀국수, 라면, 스파게티, 마카로니 등), 과즙, 각종 드링크, 쿠키, 엿, 유제품(예: 버터, 치이즈 등), 식용식물유지, 마아가린, 식물성 단백질, 레토르트 식품, 냉동식품, 각종 조미료(예: 된장, 간장, 소스 등) 등에 본 발명의 균주, 이의 파쇄물 및 배양물 군 중 하나 이상을 를 첨가하여 제조할 수 있다. The effect of improving liver function of the Lactobacillus pentosus KF8 (accession number KCCM11997P) strain, Bacillus subtilis KF11 (accession number KCCM11981P) strain or Lactococcus lactis KF140 (accession number KCCM11673P) strain identified in the experiment of the present invention, In other words, inhibition of blood ALT and AST activity, inhibition of total cholesterol and triglyceride in liver tissue, and inhibition of fat accumulation in liver can be induced by the treatment of the single strain, and when two or more strains are mixed, a better effect is obtained. It can be shown, and when all three strains are mixed, the best effect can be exhibited. In the present invention, the food composition includes all forms such as functional food, nutritional supplement, health food, and food additives. Food compositions of this type can be prepared in various forms according to conventional methods known in the art. For example, as a health food, the strain of the present invention itself, its lysates, and one or more of the strain culture groups are prepared in the form of tea, juice, and drink to be consumed, or granulated, encapsulated and powdered to be consumed. can do. In addition, it can be prepared in the form of a composition by mixing at least one of the strain, its lysate and culture group of the present invention together with known substances or active ingredients known to have an effect of improving liver function. In addition, functional foods include beverages (including alcoholic beverages), fruits and processed foods thereof (eg, canned fruit, bottled, jam, marmalade, etc.), fish, meat and processed foods thereof (eg, ham, sausage corn beef). Etc.), bread and noodles (e.g. udon, soba, ramen, spaghetti, macaroni, etc.), fruit juice, various drinks, cookies, syrup, dairy products (e.g. butter, cheese, etc.), edible vegetable oil, margarine, vegetable protein , Retort foods, frozen foods, various seasonings (eg, miso, soy sauce, sauce, etc.), and the like, can be prepared by adding at least one of the strains of the present invention, lysate and culture groups thereof.
본 발명의 식품 조성물 중 상기 본 발명의 균주, 이의 파쇄물 및 배양물 등의 바람직한 함유량으로는 이에 한정되지 않지만 바람직하게는 최종적으로 제조된 식품 중 0.01 내지 50 중량%이다. 또한, 본 발명의 균주, 이의 파쇄물 또는 이의 배양물은 유효성분으로서 식품 첨가제의 형태로 사용하기 위해서는 분말 또는 농축액 형태로 제조하여 사용할 수 있다.In the food composition of the present invention, the preferred content of the strain of the present invention, its lysate and culture, etc. is not limited thereto, but is preferably 0.01 to 50% by weight of the finally prepared food. In addition, the strain of the present invention, its lysate or its culture may be prepared in the form of a powder or a concentrate for use in the form of a food additive as an active ingredient.
또한 본 발명은 락토바실러스 펜토서스 KF8(수탁번호 KCCM11997P) 균주, 바실러스 서브틸리스 KF11(수탁번호 KCCM11981P) 균주 및 락토코쿠스 락티스 KF140(수탁번호 KCCM11673P) 균주로 이루어진 군 중에서 선택되는 하나 이상의 균주, 이의 파쇄물 또는 이의 배양물을 유효성분으로 포함하는 간 기능 개선용 약학적 조성물을 제공할 수 있다.In addition, the present invention is one or more strains selected from the group consisting of Lactobacillus pentosus KF8 (accession number KCCM11997P) strain, Bacillus subtilis KF11 (accession number KCCM11981P) strain, and Lactococcus lactis KF140 (accession number KCCM11673P) strain, It is possible to provide a pharmaceutical composition for improving liver function comprising the lysate or a culture thereof as an active ingredient.
상기 약학적 조성물에는 약학적으로 허용 가능한 염을 단독으로 함유하거나 또는 하나 이상의 약학적으로 허용되는 담체, 부형제 또는 희석제를 추가로 함유할 수 있다. 약학적으로 허용되는 담체로는 예컨대, 경구 투여용 담체 또는 비경구 투여용 담체를 추가로 포함할 수 있다. 경구 투여용 담체는 락토스, 전분, 셀룰로스 유도체, 마그네슘 스테아레이트, 스테아르산 등을 포함할 수 있다. 또한, 비경구 투여용 담체는 물, 적합한 오일, 식염수, 수성 글루코스 및 글리콜 등을 포함할 수 있으며, 안정화제 및 보존제를 추가로 포함할 수 있다. 적합한 안정화제로는 아황산수소나트륨, 아황산나트륨 또는 아스코르브산과 같은 항산화제가 있다. 적합한 보존제로는 벤즈알코늄 클로라이드, 메틸- 또는 프로필-파라벤 및 클로로부탄올이 있다. 그 밖의 약학적으로 허용되는 담체로는 다음의 문헌에 기재되어 있는 것을 참고로 할 수 있다(Remington's Pharmaceutical Sciences, 19th ed., Mack Publishing Company, Easton, PA, 1995). The pharmaceutical composition may contain a pharmaceutically acceptable salt alone, or may further contain one or more pharmaceutically acceptable carriers, excipients, or diluents. The pharmaceutically acceptable carrier may further include, for example, a carrier for oral administration or a carrier for parenteral administration. Carriers for oral administration may include lactose, starch, cellulose derivatives, magnesium stearate, stearic acid, and the like. In addition, the carrier for parenteral administration may include water, suitable oils, saline, aqueous glucose and glycol, and the like, and may further include stabilizers and preservatives. Suitable stabilizers include antioxidants such as sodium hydrogen sulfite, sodium sulfite or ascorbic acid. Suitable preservatives are benzalkonium chloride, methyl- or propyl-paraben and chlorobutanol. Other pharmaceutically acceptable carriers may be referred to as those described in the following literature (Remington's Pharmaceutical Sciences, 19th ed., Mack Publishing Company, Easton, PA, 1995).
본 발명의 약학적 조성물은 인간을 비롯한 포유동물에 어떠한 방법으로도 투여할 수 있다. 예를 들면, 경구 또는 비경구적으로 투여할 수 있다. 비경구적인 투여방법으로는 이에 한정되지는 않으나, 정맥내, 근육내, 동맥내, 골수내, 경막내, 심장내, 경피, 피하, 복강내, 비강내, 장관, 국소, 설하 또는 직장내 투여일 수 있다. 바람직하게는 본 발명의 약학적 조성물은 경구 또는 경피 투여될 수 있다.The pharmaceutical composition of the present invention can be administered to mammals including humans by any method. For example, it can be administered orally or parenterally. Parenteral administration methods include, but are not limited to, intravenous, intramuscular, intraarterial, intramedullary, intrathecal, intracardiac, transdermal, subcutaneous, intraperitoneal, intranasal, intestinal, topical, sublingual or rectal administration Can be Preferably, the pharmaceutical composition of the present invention can be administered orally or transdermally.
본 발명의 약학적 조성물은 상술한 바와 같은 투여 경로에 따라 경구 투여용 또는 비경구 투여용 제제로 제형화 할 수 있다. The pharmaceutical composition of the present invention can be formulated into a formulation for oral administration or parenteral administration according to the route of administration as described above.
경구 투여용 제제의 경우에 본 발명의 조성물은 분말, 과립, 정제, 환제, 당의정제, 캡슐제, 액제, 겔제, 시럽제, 슬러리제, 현탁액 등으로 당업계에 공지된 방법을 이용하여 제형화될 수 있다. 예를 들어, 경구용 제제는 활성성분을 고체 부형제와 배합한 다음 이를 분쇄하고 적합한 보조제를 첨가한 후 과립 혼합물로 가공함으로써 정제 또는 당의정제를 수득할 수 있다. 적합한 부형제의 예로는 락토즈, 덱스트로즈, 수크로즈, 솔비톨, 만니톨, 자일리톨, 에리스리톨 및 말티톨 등을 포함하는 당류와 옥수수 전분, 밀 전분, 쌀 전분 및 감자 전분 등을 포함하는 전분류, 셀룰로즈, 메틸 셀룰로즈, 나트륨 카르복시메틸셀룰로오즈 및 하이드록시프로필메틸-셀룰로즈 등을 포함하는 셀룰로즈류, 젤라틴, 폴리비닐피롤리돈 등과 같은 충전제가 포함될 수 있다. 또한, 경우에 따라 가교결합 폴리비닐피롤리돈, 한천, 알긴산 또는 나트륨 알기네이트 등을 붕해제로 첨가할 수 있다. 나아가, 본 발명의 약학적 조성물은 항응집제, 윤활제, 습윤제, 향료, 유화제 및 방부제 등을 추가로 포함할 수 있다. In the case of a formulation for oral administration, the composition of the present invention may be formulated using a method known in the art as a powder, granule, tablet, pill, dragee, capsule, liquid, gel, syrup, slurry, suspension, etc. I can. For example, in oral preparations, tablets or dragees can be obtained by mixing the active ingredient with a solid excipient, pulverizing it, adding a suitable auxiliary, and processing into a granule mixture. Examples of suitable excipients include sugars including lactose, dextrose, sucrose, sorbitol, mannitol, xylitol, erythritol and maltitol, and starches including corn starch, wheat starch, rice starch and potato starch, cellulose, Fillers such as celluloses including methyl cellulose, sodium carboxymethylcellulose and hydroxypropylmethyl-cellulose, gelatin, and polyvinylpyrrolidone may be included. In addition, in some cases, cross-linked polyvinylpyrrolidone, agar, alginic acid or sodium alginate may be added as a disintegrant. Furthermore, the pharmaceutical composition of the present invention may further include an anti-aggregating agent, a lubricant, a wetting agent, a flavoring agent, an emulsifying agent and a preservative.
비경구 투여용 제제의 경우에는 주사제, 크림제, 로션제, 외용연고제, 오일제, 보습제, 겔제, 에어로졸 및 비강 흡입제의 형태로 당업계에 공지된 방법으로 제형화할 수 있다. 이들 제형은 모든 제약 화학에 일반적으로 공지된 처방서인 문헌(Remington's Pharmaceutical Science, 15th Edition, 1975. Mack Publishing Company, Easton, Pennsylvania 18042, Chapter 87: Blaug, Seymour)에 기재되어 있다. In the case of a formulation for parenteral administration, it can be formulated in the form of injections, creams, lotions, ointments for external use, oils, moisturizers, gels, aerosols, and nasal inhalants by methods known in the art. These formulations are described in Remington's Pharmaceutical Science, 15th Edition, 1975. Mack Publishing Company, Easton, Pennsylvania 18042, Chapter 87: Blaug, Seymour, a formula generally known for all pharmaceutical chemistry.
본 발명의 균주 자체, 이의 파쇄물 및 상기 균주 배양물 등의 총 유효량은 단일 투여량(single dose)으로 환자에게 투여될 수 있으며, 다중 투여량(multiple dose)으로 장기간 투여되는 분할 치료 방법(fractionated treatment protocol)에 의해 투여될 수 있다. 본 발명의 약학적 조성물은 질환의 정도에 따라 유효성분의 함량을 달리할 수 있다. 바람직하게는 본 발명의 균주, 이의 파쇄물 및 배양물의 바람직한 전체 용량은 1일당 환자 체중 1 ㎏ 당 약 0.01ug 내지 1,000 mg, 가장 바람직하게는 0.1 ug 내지 100 mg일 수 있다. 그러나 상기 본 발명의 균주 자체, 이의 파쇄물 및 상기 균주 배양물 등의 용량은 약학적 조성물의 투여 경로 및 치료 횟수뿐만 아니라 환자의 연령, 체중, 건강 상태, 성별, 질환의 중증도, 식이 및 배설율 등 다양한 요인들을 고려하여 환자에 대한 유효 투여량이 결정되는 것이므로, 이러한 점을 고려할 때 당 분야의 통상적인 지식을 가진 자라면 상기 본 발명의 균주, 이의 파쇄물 및 배양물을 면역기능 증진제로서의 특정한 용도에 따른 적절한 유효 투여량을 결정할 수 있을 것이다. 본 발명에 따른 약학적 조성물은 본 발명의 효과를 보이는 한 그 제형, 투여 경로 및 투여 방법에 특별히 제한되지 아니한다.The total effective amount of the strain itself, its lysate, and the strain culture of the present invention may be administered to a patient in a single dose, and a fractionated treatment method administered for a long period of time in multiple doses. protocol). The pharmaceutical composition of the present invention may vary the content of the active ingredient according to the severity of the disease. Preferably, the preferred total dose of the strain, its lysates and cultures of the present invention may be about 0.01 ug to 1,000 mg, most preferably 0.1 ug to 100 mg per 1 kg of patient body weight per day. However, the dose of the strain itself, its lysate, and the strain culture of the present invention is not only the administration route and the number of treatments of the pharmaceutical composition, but also the age, weight, health condition, sex, severity of the disease, diet and excretion rate, etc. Since the effective dosage for the patient is determined in consideration of various factors, those of ordinary skill in the art when considering these points, use the strain of the present invention, its lysate, and the culture according to the specific use as an immune function enhancer. It will be possible to determine an appropriate effective dosage. The pharmaceutical composition according to the present invention is not particularly limited in its formulation, route of administration, and method of administration as long as it exhibits the effects of the present invention.
나아가 본 발명에서 간 기능 개선이란, 간 손상에 의한 증상의 치료, 경감, 예방을 포함하는 의미로서, 간 가능, 간 상태, 간 질환, 간 질병이 치료, 경감 또는 예방되는 것을 말한다. Furthermore, in the present invention, the term "improving liver function" refers to treatment, alleviation, and prevention of symptoms caused by liver damage, and refers to the treatment, reduction or prevention of liver possible, liver conditions, liver diseases, and liver diseases.
본 발명에서 간 손상에 의해 유발될 수 있는 간 질환은 이에 제한되지는 않으나, 자가면역성 간질환, 약물 유인성 간질환, 알코올성 간질환, 감염성 간질환, 선천성 대사성 간질환, 급성 간질환, 간염, 담즙 울체, 지방간 및 만성 간질환을 포함할 수 있다.Liver diseases that may be caused by liver damage in the present invention are not limited thereto, but autoimmune liver disease, drug-induced liver disease, alcoholic liver disease, infectious liver disease, congenital metabolic liver disease, acute liver disease, hepatitis, bile Congestion, fatty liver and chronic liver disease.
이하, 실시예를 통하여 본 발명을 보다 상세히 설명하고자 한다. 이들 실시예는 본 발명을 보다 구체적으로 설명하기 위한 것으로, 본 발명의 범위가 이들 실시예에 한정되는 것은 아니다.Hereinafter, the present invention will be described in more detail through examples. These examples are for explaining the present invention more specifically, and the scope of the present invention is not limited to these examples.
<준비예><Preparation example>
<1> 본 발명의 균주를 함유한 시험용 식품제조<1> Preparation of food for testing containing the strain of the present invention
본 발명자들은 이전에 새로운 신균주로 분리 및 동정한 3개의 균주를 균주 기탁기관에 의뢰하여 기탁번호를 부여받았고, 기탁한 총 3개의 균주(락토바실러스 펜토서스 KF8, 바실러스 서브틸리스 KF11, 락토코쿠스 락티스(Lactococcus lactis) KF140)을 ㈜ 메디오젠에 의뢰하여 시험용 식품을 제조하였다.The present inventors requested the three strains previously isolated and identified as new strains to the strain depositing agency to receive the deposit number, and a total of three strains deposited (Lactobacillus pentosus KF8, Bacillus subtilis KF11, Lactoko Lactococcus lactis KF140) was commissioned to Mediogen Co., Ltd. to prepare a test food.
본 발명에서 사용한 총 3개의 균주는 다음과 같다.A total of three strains used in the present invention are as follows.
-락토바실러스 펜토서스 KF8 : 국제미생물기탁기관인 한국미생물보존센터(KCCM)에 2017년 03월 24일자로 기탁하여 기탁번호 KCCM 11997P를 부여받은 균주를 이용하였다.-Lactobacillus pentosus KF8: A strain deposited on March 24, 2017 with the Korea Microbial Conservation Center (KCCM), an international microbial deposit organization, and given the accession number KCCM 11997P was used.
-바실러스 서브틸리스 KF11 : 국제미생물기탁기관인 한국미생물보존센터(KCCM)에 2017년 2월 24일자로 기탁하였으며, 기탁번호 KCCM 11981P를 부여받은 균주를 이용하였다.-Bacillus subtilis KF11: The strain was deposited on February 24, 2017 with the Korea Microorganism Conservation Center (KCCM), an international microbial deposit organization, and was given the accession number KCCM 11981P.
-락토코쿠스 락티스(Lactococcus lactis) KF140 : 국제미생물기탁기관인 한국미생물보존센터(KCCM)에 기탁하였으며, 기탁번호 KCCM 11673P를 부여받은 균주를 이용하였다. -Lactococcus lactis KF140: It was deposited with the Korea Microbial Conservation Center (KCCM), an international microbial deposit organization, and a strain given with the accession number KCCM 11673P was used.
이들 균주를 이용한 시험용 식품의 제조는 ㈜ 메디오젠에 의뢰하여 종래 균주 형태의 제품을 제조하는 방법에 따라 제조하였고, 주요 원료는 말토덱스트린, 무수결정포도당 및 본 발명의 균주 3종 각각(2.0×109 CFU/g)을 포함하여, 1포 당 1.5g 단위로 포장하였으며 시험에 사용하지 전까지 냉장 보관하였다.Preparation of test foods using these strains was commissioned by Mediogen Co., Ltd. and manufactured according to the method of manufacturing a conventional strain-type product, and the main raw materials were maltodextrin, anhydrous crystalline glucose, and each of the three strains of the present invention (2.0×10 Including 9 CFU/g), it was packaged in units of 1.5g per package and stored refrigerated until it was not used for testing.
이때 상기 시험용 식품의 제조를 위해 사용한 상기 각 균주는 배양배지에서 배양하여 균주를 수득한 후, 이를 동결건조하여 분말화시킨 분말 형태의 균주를 사용하였다At this time, each strain used for the preparation of the test food was cultured in a culture medium to obtain a strain, and then freeze-dried and powdered strains were used.
상기 본 발명에서 사용하기 위해 제조한 시험용 식품의 사진은 도 1에 나타내었다. A photograph of the test food prepared for use in the present invention is shown in FIG. 1.
<2> 시험 대상자<2> Test subjects
본 발명의 3가지 균주에 대한 간기능 개선 효과를 확인하기 위해 다음과 같은 시험 대상자들을 선별하였다.The following test subjects were selected to confirm the effect of improving liver function on the three strains of the present invention.
대상자는 아래의 기준에 적합한 자로 선정하였으며, 이들은 인체적용시험 대상자 모집에 자원하여 선정 기준을 통과한 자에 한하여 하기 실험을 진행하였다. 대상자는, 대구경북 지역에 거주하는 만 25세 이상 45세 이하의 성인으로 총 44명을 대상으로 선정검사를 진행하였고, 선정기준에 적합하고 제외기준에 해당되지 않는 36명이 대상자로 선정되었다.The subjects were selected as those who met the following criteria, and they volunteered to recruit human subjects and conducted the following experiment only for those who passed the selection criteria. Subjects, 44 adults aged 25 to 45 years old living in the Daegu-Gyeongbuk area were selected as subjects, and 36 subjects who met the selection criteria but did not meet the exclusion criteria were selected as subjects.
대상자 선정 기준은, 시험기간 동안 추적관찰이 가능한 자, 연구의 목적, 내용 등에 관하여 충분히 설명을 듣고 자발적으로 시험동의서에 서명한 자에 한하여 선정하였다.The criteria for selection of subjects were selected only for those who were able to follow-up during the test period, and those who voluntarily signed the test consent after having sufficiently explained the purpose and contents of the study.
한편, 다음과 같은 사항에 해당하는 자는 제외시켰다.Meanwhile, those who fall under the following matters were excluded.
- 균주 제품 섭취시 과민반응 경험이 있는 자 -Those who have experienced hypersensitivity reactions when ingesting strain products
- 최근 1개월 이내에 처방 약물, 일반의약품, 건강기능식품 또는 프로바이오틱스 제품을 섭취한 자 -Those who have consumed prescription drugs, over-the-counter drugs, health functional foods, or probiotic products within the last 1 month
- 시험참가 1개월 이내에 항생제를 섭취한 자 -Those who took antibiotics within 1 month of participation in the test
- 시험참가 1개월 이내에 위장 또는 대장 내시경 검사를 한 자 -Those who have undergone gastrointestinal or colonoscopy within 1 month of participation in the test
- BMI 20 미만 또는 35 초과인 자 -Those with a BMI less than 20 or more than 35
- 고혈압(수축기 혈압 160 mmHg 이거나 확장기 혈압 100 mmHg 이상)인 자 -Those with high blood pressure (systolic blood pressure of 160 mmHg or diastolic blood pressure of 100 mmHg or more)
- 공복 혈당 농도 110 초과인 자 -Those with a fasting blood sugar concentration exceeding 110
- ALT 또는 AST가 정상 상한의 2배를 초과하는 자 -Those whose ALT or AST exceeds twice the normal upper limit
- 임신 또는 수유중인 여성 -Pregnant or lactating women
- 시험기간 동안 의학적으로 증명된 방법(예 : 콘돔, 루프, 페미돔 등)을 사용하는 피임에 동의하지 않는 가임기 여성 -Women of childbearing age who disagree with contraception using medically proven methods (eg condoms, loops, femdoms, etc.) during the test period
- 거식증, 우울증, 조울증, 정신과 질환 등으로 지속적인 치료가 필요한 자 -Those who need continuous treatment for anorexia, depression, bipolar disorder, psychiatric disorders, etc.
- 면역관련 질환, 중증의 간 또는 신부전, 악성종양, 폐질환, 교원질증, 다발성 경화증, 알레르기성 피부질환 및 기타 자가면역질환 등의 전신질환이 이행되고 있는 자 -Persons with systemic diseases such as immune-related diseases, severe liver or kidney failure, malignant tumors, lung diseases, collagenosis, multiple sclerosis, allergic skin diseases and other autoimmune diseases
- 시험식품의 흡수에 영향을 줄 수 있는 위장관계 질환 또는 위장관계 수술(단순 맹장수술 또는 탈장수술 제외)의 과거력이 있는 자 -Those who have a history of gastrointestinal diseases or gastrointestinal surgery (excluding simple appendectomy or hernia surgery) that may affect the absorption of the test food
- 시험참가 3개월 이내에 다른 인체적용시험 또는 임상시험에 참여하여 시험용 제품을 섭취한 자(화장품 인체적용시험 제외) -Those who participated in other human application tests or clinical trials within 3 months of participating in the test and ingested the test product (except for the human body application test of cosmetics)
- 위의 사항들 외에 연구자의 판단으로 시험수행이 곤란하다고 판단되는 자 -Those who are judged to be difficult to perform the test by the judgment of the researcher other than the above
또한 입원 당일 문진으로 다음에 해당하는 대상자는 본 시험에서 제외하였다.In addition, the following subjects were excluded from this test due to an interview on the day of admission.
- 입원 전 2주일 이내에 1회당 알코올 50g (소주 1병 이상 또는 맥주 2병 이상) 상당량 이상을 섭취하는 음주를 한 자 -A person who has consumed a significant amount of alcohol 50g or more per serving (more than 1 bottle of soju or 2 bottles of beer) within 2 weeks before hospitalization
- 입원 전 1주일 이내에 1일 소주 1잔 또는 맥주 1잔을 초과하는 음주를 한 자 -Those who drink more than 1 glass of soju or 1 beer per day within 1 week before hospitalization
- 입원 전 1주일 이내에 유제품, 햄버거, 피자 등 패스트푸드, 인스턴트 식품, 튀김류, 구이류 등의 섭취를 한 자 -Those who have consumed dairy products, hamburgers, pizza, and other fast foods, instant foods, fried foods, and grilled foods within one week before hospitalization
- 이전 방문일 이후에 항생제를 섭취한 자 -Those who took antibiotics after the previous visit
- 이전 방문일 이후에 위장 또는 대장 내시경 검사를 한 자 -Those who have undergone gastrointestinal or colonoscopy after the previous visit
- 이전 방문일 이후에 처방 약품, 일반의약품 또는 건강기능식품을 복용한 자 -Those who have taken prescription drugs, over-the-counter drugs or health functional foods since the previous visit
이러한 조건으로 선정된 대상자는, 최소 유효성분석 가능 대상자수로 실험군당 각 10명이 되도록 하였다. Subjects selected under these conditions were each 10 subjects per experimental group with the minimum number of subjects that could be analyzed for efficacy.
선정된 대상자들의 임상시험은 임상시험심사위원회(IRB)의 규정에 따라 진행하였다. The clinical trials of the selected subjects were conducted according to the regulations of the Institutional Review Board (IRB).
<실시예 1><Example 1>
본 발명의 균주 섭취에 따른 간기능 개선 효과 분석Analysis of the effect of improving liver function by ingestion of the strain of the present invention
상기 시험 대상자를 대상으로 26일간 각각의 균주를 섭취 전과 후 채취된 혈액을 이용하여 혈액 내 AST, ALT, 총 콜레스테롤, 중성지방(Triglyceride), LDL 콜레스테롤, HDL 콜레스테롤의 변화를 측정하였다.Changes in AST, ALT, total cholesterol, triglyceride, LDL cholesterol, and HDL cholesterol in the blood were measured using blood collected before and after ingestion of each strain for 26 days.
분석 결과, 상기 표 1에 나타낸 바와 같이, 본 발명의 균주인 락토바실러스 펜토서스 KF8, 바실러스 서브틸리스 KF11 및 락토코쿠스 락티스(Lactococcus lactis) KF140을 각각 섭취시킨 군에서는 간 기능 지표인 ALT(Alanine Aminotransferase) 및 AST(Aspartate Aminotransferase)의 수치가 상기 균주를 섭취하기 이전 보다 효과적으로 억제되어 있는 것으로 나타났다.As a result of the analysis, as shown in Table 1, in the group in which Lactobacillus pentosus KF8, Bacillus subtilis KF11, and Lactococcus lactis KF140, which are strains of the present invention, were respectively ingested, ALT ( It was shown that the levels of Alanine Aminotransferase) and AST (Aspartate Aminotransferase) were more effectively suppressed before ingesting the strain.
따라서 이러한 결과를 통해, 본 발명자들은 락토바실러스 펜토서스 KF8, 바실러스 서브틸리스 KF11 및 락토코쿠스 락티스 KF140의 균주를 간 기능 개선 및 간 질환의 예방과 치료를 위한 용도로 사용할 수 있음을 알 수 있었다.Therefore, through these results, the present inventors find that strains of Lactobacillus pentosus KF8, Bacillus subtilis KF11, and Lactococcus lactis KF140 can be used for improving liver function and preventing and treating liver diseases. there was.
<실시예 2><Example 2>
간 손상 유발 동물모델에서 본 발명의 균주 섭취에 따른 간기능 개선 효과 분석Analysis of the effect of improving liver function by ingestion of the strain of the present invention in an animal model causing liver damage
실험동물로는 체중 200g의 수컷 SD(Sprague-Dawley)계 랫트(SLC, Japan)를 사용하였고, 각 실험군 당 5마씩 분배하여 실험에 사용하였고 각 실험군은 다음과 같다.As experimental animals, male SD (Sprague-Dawley) rats (SLC, Japan) weighing 200 g were used, and 5 horses were distributed for each experimental group and used for the experiment. Each experimental group is as follows.
이때, 상기 사염화탄소는 옥수수유와 혼합된 50% 용액으로 하여 랫트에게 0.75 ml/kg의 용량으로 1주일에 2회 4주간 복강 투여하였고, 상기 실험군들은 준비예에서 제조한 본 발명의 균주 함유 기능성 분말식품 50 mg/kg 씩을 1% CMC 용액에 현탁하여 1일 1회, 1주일에 6회 경구 투여하였다. 이후 상기 투여를 4주간 지속한 후 동물을 치사시켜 혈청을 얻어 사염화탄소로 유도된 간손상에 대한 본 발명에 균주의 치료효과를 알아보기 위하여, ALT 및 AST 활성을 측정하였다.At this time, the carbon tetrachloride was used as a 50% solution mixed with corn oil and administered intraperitoneally to rats at a dose of 0.75 ml/kg twice a week for 4 weeks, and the experimental groups were functional powders containing the strain of the present invention prepared in Preparation Example Each 50 mg/kg of food was suspended in a 1% CMC solution and administered orally once a day and six times a week. Thereafter, after the administration was continued for 4 weeks, the animals were killed to obtain serum to determine the therapeutic effect of the strain in the present invention for carbon tetrachloride-induced liver damage, and ALT and AST activities were measured.
분석 결과, 상기 표 3에 나타낸 바와 같이, 본 발명의 균주를 섭취시킨 마우스군의 경우, 사염화탄소로 인해 혈청 내 상승한 ALT 및 AST가 효과적으로 억제되는 것으로 나타났다.As a result of the analysis, as shown in Table 3, in the case of the mouse group ingested with the strain of the present invention, it was found that the elevated ALT and AST in the serum due to carbon tetrachloride were effectively inhibited.
이러한 결과는 본 발명의 락토바실러스 펜토서스 KF8, 바실러스 서브틸리스 KF11 및 락토코쿠스 락티스 KF140 균주가 간독성에 대한 간보호 효과 및 간 기능 효과 우수하다는 것을 의미한다. These results indicate that the Lactobacillus pentosus KF8, Bacillus subtilis KF11, and Lactococcus lactis KF140 strains of the present invention have excellent hepatoprotective effects and liver function effects on hepatotoxicity.
<실시예 3><Example 3>
지방간 동물모델에서 본 발명의 균주 섭취에 따른 개선 효과 분석Analysis of the improvement effect of the intake of the strain of the present invention in the fatty liver animal model
실험동물로는 체중 20g의 수컷 C57BL/6계 마우스(중앙, Korea)를 사용하였고, 각 실험군 당 9마씩 분배하여 실험에 사용하였고 각 실험군은 다음과 같다. 지방간 유도 물질로 고지방식이(40% fat)를 펠렛 형태로 제공하고 매일 CML반응물을 10 mg/kg의 용량으로 매일 경구투여 하였다. 이후 본 발명의 균주를 각 마우스에 투여시킨 후, 지방간 개선 정도를 분석하였다.As an experimental animal, a male C57BL/6 mouse (center, Korea) weighing 20g was used, and 9 horses were distributed for each experimental group and used for the experiment. Each experimental group is as follows. A high fat diet (40% fat) was provided in the form of pellets as a fatty liver inducing substance, and the daily CML reaction was administered orally at a dose of 10 mg/kg. Thereafter, the strain of the present invention was administered to each mouse, and the degree of improvement in fatty liver was analyzed.
이때 상기 실험군들은 본 발명의 균주 1×107 CFU 씩을 0.9% saline 용액에 현탁하여 1일 1회, 1주일에 6회 경구 투여하였다. 이후 투여를 4주간 지속한 후 동물을 치사시켜 혈액을 체취한 후 간기능 관련 효소와 중성지방(Triglyceride)의 함량을 측정하였다.At this time, the experimental groups were suspended in a 0.9% saline solution of 1×10 7 CFU of the strain of the present invention and administered orally once a day, 6 times a week. After the administration was continued for 4 weeks, the animals were killed and blood was taken, and the contents of liver function-related enzymes and triglycerides were measured.
분석결과, 상기 표 7에 나타낸 바와 같이, 본 발명의 균주를 섭취시킨 마우스군의 경우, 간 손상에 의해 증가하는 AST와 ALT의 수치를 유의적으로 억제하였고, 추가로 중성지방의 함량도 마찬가지로 증가를 예방하는 효과를 확인하였다.As a result of the analysis, as shown in Table 7 above, in the case of the mouse group ingested with the strain of the present invention, the levels of AST and ALT increased by liver damage were significantly suppressed, and the content of triglycerides was also increased as well. It was confirmed the effect of preventing.
이러한 결과를 통해 본 발명자들은 본 발명의 락토바실러스 펜토서스 KF8, 바실러스 서브틸리스 KF11 또는 락토코쿠스 락티스 KF140 균주가 당독소 섭취에 의한 간손상을 예방하여 지방간과 같은 간질환을 개선 및 치료하는데 효과적일 수 있음을 알 수 있었다.Through these results, the present inventors suggested that the Lactobacillus pentosus KF8, Bacillus subtilis KF11, or Lactococcus lactis KF140 strains of the present invention prevent liver damage caused by ingestion of glycotoxins to improve and treat liver diseases such as fatty liver. It can be seen that it can be effective.
이제까지 본 발명에 대하여 그 바람직한 실시예들을 중심으로 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, the present invention has been looked at around its preferred embodiments. 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 (5)
상기 조성물은,
ALT(Alanine Aminotransferase) 또는 AST(Aspartate Aminotransferase) 활성을 억제시키고,
간 내 총 콜레스테롤 또는 중성지방의 농도 증가를 억제시키고, 또는
간 내 지방 축적을 억제하는 것을 특징으로 하는,
간 기능 개선용 건강식품 조성물.The method of claim 1,
The composition,
Inhibits ALT (Alanine Aminotransferase) or AST (Aspartate Aminotransferase) activity,
Inhibits an increase in the concentration of total cholesterol or triglycerides in the liver, or
Characterized in that it inhibits the accumulation of fat in the liver,
Health food composition for improving liver function.
상기 건강식품 조성물은 분말, 과립, 환, 정제, 캡슐, 캔디, 시럽 및 음료 중에서 선택된 어느 하나의 제형인 것을 특징으로 하는, 간 기능 개선용 건강식품 조성물.The method of claim 1,
The health food composition is a health food composition for improving liver function, characterized in that any one formulation selected from powders, granules, pills, tablets, capsules, candy, syrup and beverages.
상기 조성물은,
ALT(Alanine Aminotransferase) 또는 AST(Aspartate Aminotransferase) 활성을 억제시키고,
간 내 총 콜레스테롤 또는 중성지방의 농도 증가를 억제시키고, 또는
간 내 지방 축적을 억제하는 것을 특징으로 하는,
간 기능 개선용 약학적 조성물.The method of claim 4,
The composition,
Inhibits ALT (Alanine Aminotransferase) or AST (Aspartate Aminotransferase) activity,
Inhibits an increase in the concentration of total cholesterol or triglycerides in the liver, or
Characterized in that it inhibits the accumulation of fat in the liver,
A pharmaceutical composition for improving liver function.
Priority Applications (7)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| AU2020275363A AU2020275363A1 (en) | 2019-05-14 | 2020-05-11 | Strain showing liver function improving activity, and use thereof |
| CN202080036153.5A CN113939198A (en) | 2019-05-14 | 2020-05-11 | Strain having liver function improving activity and use thereof |
| CA3140061A CA3140061A1 (en) | 2019-05-14 | 2020-05-11 | Strain showing liver function improving activity, and use thereof |
| PCT/KR2020/006172 WO2020231127A1 (en) | 2019-05-14 | 2020-05-11 | Strain showing liver function improving activity, and use thereof |
| US17/611,240 US20220211781A1 (en) | 2019-05-14 | 2020-05-11 | Strain showing liver function improving activity, and use thereof |
| EP20805090.6A EP3970511A4 (en) | 2019-05-14 | 2020-05-11 | Strain showing liver function improving activity, and use thereof |
| JP2021568196A JP2022532643A (en) | 2019-05-14 | 2020-05-11 | Strains showing liver function improving activity and their uses |
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| KR20190056228 | 2019-05-14 | ||
| KR1020190056228 | 2019-05-14 |
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|---|---|---|---|---|
| KR20100035345A (en) * | 2008-09-26 | 2010-04-05 | 한국식품연구원 | Microorganism with physiological activity that can control rising of blood glucose and can improve liver function and food containing thereof |
| KR101841021B1 (en) * | 2017-04-06 | 2018-03-22 | 한국식품연구원 | Novel Lactococcus lactis strain having advanced glycation end products inhibitory activity effects and use of the same |
| KR101841023B1 (en) * | 2017-04-06 | 2018-03-22 | 한국식품연구원 | Novel Bacillus subtilis strain having advanced glycation end product inhibitory activity effects and use of the same |
| KR101869739B1 (en) * | 2017-06-23 | 2018-06-21 | 한국식품연구원 | Novel Lactobacillus pentosus strain having advanced glycation end products inhibitory activity effects and use of the same |
| KR20180070342A (en) * | 2016-12-16 | 2018-06-26 | 한국식품연구원 | Composition for preventing or treating of allergy comprising mixture of probiotics as an active ingredient |
| KR20180103772A (en) | 2017-03-09 | 2018-09-19 | 가톨릭대학교 산학협력단 | Composition for preventing or treating immune diseases comprising mixture of lactic acid bacteria |
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2020
- 2020-04-08 KR KR1020200042863A patent/KR102575452B1/en active IP Right Grant
- 2020-05-11 CA CA3140061A patent/CA3140061A1/en active Pending
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Patent Citations (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| KR20100035345A (en) * | 2008-09-26 | 2010-04-05 | 한국식품연구원 | Microorganism with physiological activity that can control rising of blood glucose and can improve liver function and food containing thereof |
| KR20180070342A (en) * | 2016-12-16 | 2018-06-26 | 한국식품연구원 | Composition for preventing or treating of allergy comprising mixture of probiotics as an active ingredient |
| KR20180103772A (en) | 2017-03-09 | 2018-09-19 | 가톨릭대학교 산학협력단 | Composition for preventing or treating immune diseases comprising mixture of lactic acid bacteria |
| KR101841021B1 (en) * | 2017-04-06 | 2018-03-22 | 한국식품연구원 | Novel Lactococcus lactis strain having advanced glycation end products inhibitory activity effects and use of the same |
| KR101841023B1 (en) * | 2017-04-06 | 2018-03-22 | 한국식품연구원 | Novel Bacillus subtilis strain having advanced glycation end product inhibitory activity effects and use of the same |
| KR101869739B1 (en) * | 2017-06-23 | 2018-06-21 | 한국식품연구원 | Novel Lactobacillus pentosus strain having advanced glycation end products inhibitory activity effects and use of the same |
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| CA3140061A1 (en) | 2020-11-19 |
| KR102575452B1 (en) | 2023-09-06 |
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