WO2007123236A1 - Composition containing microorganism cell which can prevent development of hansen's disease - Google Patents

Composition containing microorganism cell which can prevent development of hansen's disease Download PDF

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Publication number
WO2007123236A1
WO2007123236A1 PCT/JP2007/058798 JP2007058798W WO2007123236A1 WO 2007123236 A1 WO2007123236 A1 WO 2007123236A1 JP 2007058798 W JP2007058798 W JP 2007058798W WO 2007123236 A1 WO2007123236 A1 WO 2007123236A1
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Prior art keywords
food
leprosy
composition
bacterium
drink
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PCT/JP2007/058798
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French (fr)
Japanese (ja)
Inventor
Takao Fujimura
Wakoto Bukawa
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The Kitasato Institute
Combi Corporation
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Publication of WO2007123236A1 publication Critical patent/WO2007123236A1/en

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/66Microorganisms or materials therefrom
    • A61K35/74Bacteria
    • A61K35/741Probiotics
    • A61K35/744Lactic acid bacteria, e.g. enterococci, pediococci, lactococci, streptococci or leuconostocs
    • A61K35/747Lactobacilli, e.g. L. acidophilus or L. brevis
    • AHUMAN NECESSITIES
    • A23FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23LFOODS, 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
    • A23L33/00Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A23L33/135Bacteria or derivatives thereof, e.g. probiotics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/66Microorganisms or materials therefrom
    • A61K35/74Bacteria
    • A61K35/741Probiotics
    • A61K35/744Lactic acid bacteria, e.g. enterococci, pediococci, lactococci, streptococci or leuconostocs
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/66Microorganisms or materials therefrom
    • A61K35/74Bacteria
    • A61K35/741Probiotics
    • A61K35/744Lactic acid bacteria, e.g. enterococci, pediococci, lactococci, streptococci or leuconostocs
    • A61K35/745Bifidobacteria
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/04Antibacterial agents
    • A61P31/08Antibacterial agents for leprosy

Definitions

  • the present invention relates to a fungus body-containing composition having an effect of preventing the onset of Hansen's disease. More particularly, the present invention relates to a composition comprising a bacterium selected from the group consisting of gram positive bacteria isolated from animal intestines including humans or from fermented foods. The present invention also relates to a food / beverage product having an effect of preventing the onset of leprosy.
  • Nosensen's disease is one of the infections that mainly affect the skin and peripheral nerves by Mycobacterium leprae. In Japan, about 10 or less cases are reported annually, but it is said that there are still millions of people with leprosy in developing countries.
  • intestinal flora is closely related to the health and diseases of the host. Lactic acid bacteria, bifidobacteria, etc. There have been many attempts to use it to prevent various diseases and improve symptoms.
  • Japanese Patent Application Laid-Open No. 2000-125810 discloses a concentrated beverage comprising yeast and lactic acid bacteria and having an anti-inflammatory action.
  • JP-A-2001-48796 discloses an immunomodulator using a dead cell of a specific Enterococcus genus.
  • Enterococcus faecalis EC-12 which is one of the lactic acid bacteria, may be abbreviated as “EC-12” in the following. It has been reported to have action, antitumor action, skin allergy improvement action, etc. (for example, “Food and Development”, Vol.39, ⁇ .10, pp. 61-63). There is also a report on the effect of EC-12 on the host defense mechanism during Listeria monocytogenes infection (“New Drugs and Clinical” (J. New Rem. & Clin.), Vol. 53, No. 3). 2004, pp. 78-88).
  • the present inventors have significantly suppressed the growth of leiomycetes in living organisms by ingesting EC-12 strain, one of Gram-positive bacteria isolated from animal intestines including humans and fermented foods. It was unexpectedly found that symptoms associated with leprosy could be improved.
  • the present invention is based on strong knowledge.
  • the object of the present invention is to prevent, suppress or improve leprosy or a condition related to leprosy that can be easily taken in daily life and has very few side effects and can be used as a medicine or food and drink. It is providing the composition which has an effect.
  • composition according to the present invention comprises, as an active ingredient, at least one kind of Gram-positive bacteria isolated from animal intestines including humans or fermented foods. It is used for growth inhibition or reduction.
  • the bacterium is a dead cell.
  • the composition according to the present invention is used for prevention, suppression of progress or improvement of leprosy or a condition related thereto. More preferably, the composition according to the present invention is leprosy or related in a patient who is infected or suspected of being infected with leiomycetes or who is likely to be infected with leiomycetes. Used to prevent, suppress or improve progress.
  • a food or drink comprising the composition according to the present invention.
  • a food or drink comprising an effective amount of the active ingredient, which is used for suppressing or reducing the growth of leprosy in a living body.
  • a food or drink comprising an effective amount of the active ingredient, wherein the food or drink is displayed with a function for preventing, suppressing progression or improving leprosy or a state related thereto. Goods are provided.
  • [0018] is an effective amount of at least one or more kinds of gram positive bacteria isolated from animal intestines including human beings or fermented foods administered to a patient in need thereof? Or a method for preventing, inhibiting progression or ameliorating a leprosy symptom or a condition associated therewith comprising ingestion.
  • animal intestinal or fermented foods including humans for producing a composition for use in the prevention, progression inhibition or amelioration of leprosy or a condition related thereto.
  • Use of at least one gram positive bacterium to be isolated is provided.
  • Enterococcus faecalis EC-12 accession number FERM BP-10284
  • FERM BP-10284 accession number
  • the present invention by taking an active ingredient as a pharmaceutical or a food or drink, it is possible to suppress or reduce the growth of leprosy in living organisms. That is, according to the present invention, leprosy or Conditions associated with this can be prevented, progress suppressed or improved.
  • the active ingredient in the present invention is a bacterium from which animal intestines including humans or fermented foods are separated, or dead cells thereof, and it is clear from previous reports that there are almost no side effects and high safety. For this reason, the composition or food or drink according to the present invention has excellent safety with almost no side effects. Therefore, they can be taken easily in daily life. Therefore, since the composition of the present invention can be easily taken by children and adults without side effects, it effectively suppresses leprosy family infection and can effectively prevent childhood infection and increased leprosy infection in leprosy-contaminated areas. It is expected.
  • FIG. 1 is a morphological photograph showing the results of Examples in the case of EC-12 non-intake group (control group).
  • FIG. 2 is a morphological photograph showing the results of Examples in the EC-12 intake group.
  • Enterococcus faecalis EC-12 (Enterococcus faecalis EC-12) was issued on February 25, 2005 (original deposit date). 305-5466 Deposited at Tsukuba Sakai Higashi, 1-chome, 1-chome, 1-center, 6), Ibaraki, Japan. The accession number is FERM BP-10284.
  • the active ingredient of the composition and food / beverage product according to the present invention is at least one Gram-positive bacterium from which animal intestine including human or fermented food power is also separated.
  • This bacterium is a gram-positive bacterium that produces lactic acid, a so-called lactic acid bacterium.
  • the bacterium is Enterococcus, Bifidobacterium, Lactobacillus, Streptococcus, and Ratatococcus. Selected from the group consisting of bacteria belonging to (Lactococcus).
  • the bacteria belonging to the genus Enterococcus include, for example, Enterococcus faecalis, Enterococcus faecium, etc. Is mentioned.
  • bacteria belonging to the genus Bifidobacterium include, for example, Bifidobacterium longum, Bifidobacteri um breve, Bifidobacterium bifidum, etc.
  • Lactobacillus include Lactobacillus acidophilus, Lactobacillus casei, Lactobacillus salivarius and the like.
  • Examples of bacteria belonging to the genus Streptococcus include Streptococcus thermophilus.
  • bacteria belonging to the genus Ratatococcus include Lactococcus cremoris, Lactococcus lactis and the like.
  • the bacterium used as an active ingredient is a bacterium belonging to the genus Enterococcus. More preferably, the bacterium is Enter ococcus raecalis. .
  • Enterococcus faecalis examples include strains such as Enterococcus faecalis EC-12 (accession number FERM BP-10284), ATCC 19433, ATCC 14508, ATCC 23655, IF O 16803, IFO 16804, and mutants thereof. Can be illustrated. Of these, the EC-12 strain is most preferred as the bacterium used as the active ingredient.
  • mutant strain means that a specific strain has been mutated by a method well known to those skilled in the art within a range that does not change the property thereof, or is equivalent to that. The meaning includes things that can be confirmed.
  • the bacterium used as the active ingredient is a force capable of using live bacteria and Z or dead cells, preferably dead cells, and more preferably, the bacteria are sterilized by a known heat treatment method.
  • the heat-sterilized microbial cell obtained by using is used.
  • the heat-sterilized cells are collected from a culture obtained by culturing the bacteria according to a conventional method, for example, by filtration, centrifugation, or the like, washed with water, suspended in water, etc., and 120 ° C. Following (preferably 80 to 120 ° C), heat treatment within 30 minutes (3 seconds to 30 minutes), followed by concentration and drying as necessary.
  • entericococcus "Fuecharis” sterilized bacterial powder by heat treatment of the EC-12 strain is commercially available under the trade name "EC-12” (manufactured by Combi Co., Ltd.). For this reason, in the present invention, such a commercial product may be used as a bacterium used as an active ingredient.
  • the active ingredient according to the present invention has the effect of inhibiting or reducing the growth of gonococci / gonococci in the living body. That is, as shown in the Examples described later, the active ingredient according to the present invention is highly sensitive to bacterial infection, and when taken by a rat, it can be removed from a living organism in bacterial infection. Although it has the effect of inhibiting the growth of bacteria, it has been confirmed in practice (Examples, Fig. 1 and Fig. 2). That is, it was confirmed from the findings of the rats in the active ingredient administration group and the non-administration group according to the present invention that the progression of the disease state associated with the infection with the bacterium was reduced by the composition according to the present invention.
  • the active ingredient according to the present invention actually showed an effect of preventing and suppressing the progression of leprosy or a related condition. Therefore, the active ingredient in the present invention has the effect of suppressing the progression of symptoms such as alleviation of symptoms such as reduction of swelling, mitigation of symptoms, and improvement effects on patients infected with leprosy or those who are highly likely to be infected. It can also bring about a therapeutic effect on symptoms.
  • the active ingredient of the present invention can be safely used for mammals having low toxicity.
  • the growth of bacteria can be suppressed by the action of lactococci on the immune system, so that the growth of bacteria can be prevented. It can be prevented. Note that these are assumptions, and the present invention is not limited to them.
  • the active ingredient according to the present invention can be used for the prevention, progression inhibition or improvement of leprosy or a condition related thereto.
  • progression suppression or improvement of a symptom or condition is used in a sense encompassing adjustment of the symptom or condition, suppression of progression, delay, alleviation, improvement, prevention of re-progression of symptoms and the like.
  • leprosy refers to infection caused by infection with Mycobacterium leprae, which includes depigmentation or redness accompanied by sensory escape caused by infection with Leprosy. It also includes symptoms such as color eruption, peripheral nerve thickening, annular erythema, and leprosy reaction.
  • a growth inhibitor of leprosy comprising as an active ingredient at least one kind of gram-positive bacteria isolated from animal intestines including humans or fermented foods, Alternatively, a prophylactic agent, progression inhibitor or remedy for leprosy or a condition related thereto is provided.
  • These preparations can be used, for example, as an additive as a raw material for producing pharmaceuticals, a food additive, and the like.
  • an effective amount of at least one gram-positive bacterium isolated from the intestines of animals including humans or fermented foods is administered to a patient in need thereof.
  • a method for preventing, inhibiting progression, or ameliorating a leprosy symptom or related condition comprising power or ingestion is preferably a patient who is infected or suspected of being infected with leprosy, a person who is placed in an environment where there is a high possibility of being infected with leprosy, or leprosy. Patients with or suspected of developing.
  • the “effective amount” means the amount of the active ingredient that is required at least to exert its effect in order to suppress or improve the progression of symptoms or conditions.
  • the “patient” refers to a human or a mammal other than a human to be administered or ingested the composition or food or drink of the present invention (in particular, immunodeficient mice, rats, and armadillos that are susceptible to leprosy). , Monkeys, etc.).
  • administering” and “intake” mean that a target substance is taken into a living body orally or parenterally (preferably orally) to a subject patient.
  • the present invention from the intestinal or fermented foods of animals, including humans, for producing a composition used for the prevention, progression inhibition or improvement of leprosy or a condition related thereto.
  • a composition used for the prevention, progression inhibition or improvement of leprosy or a condition related thereto.
  • Use of at least one gram-positive bacterium to be isolated is provided.
  • the composition is a food composition.
  • composition or food or drink [0039] Composition or food or drink
  • composition according to the present invention comprises the aforementioned active ingredient.
  • composition according to the present invention uses a microbial cell or a dead microbial cell which is an active ingredient, and if necessary, a physiologically acceptable carrier, an excipient. It can be produced by mixing with an agent, a binder, a diluent and the like.
  • the composition according to the present invention can be administered or ingested orally or parenterally.
  • Oral forms include foods, granules, powders, tablets (including sugar-coated tablets), pills, capsules, syrups, emulsions and suspensions.
  • parenteral forms include injections, drops, and external preparations. These preparations can be formulated together with pharmaceutically acceptable carriers (for example, excipients and additives) by a method generally used in the art.
  • pharmaceutically acceptable carriers include excipients, binders, fragrances, buffers, thickeners, colorants, stabilizers, emulsifiers, dispersants, suspending agents, disintegrating agents, lubricants, Examples include preservatives. Specific examples include magnesium carbonate, magnesium stearate, talc, sugar, ratatoose, pectin, dextrin, starch, gelatin, tragacanth, methylcellulose, sodium carboxymethylcellulose, and a low melting wax.
  • auxiliary components that can be used in combination include, for example, vitamin components (eg, vitamin C, vitamin E), antibiotics, glycogen, amino acids, peptides, minerals (eg, zinc, iron, copper). , Manganese, etc.).
  • an oral preparation can be produced as follows.
  • Active ingredients include, for example, excipients (eg lactose, sucrose, starch, mannitol), disintegrants (eg calcium carbonate, carboxymethylcellulose calcium), or lubricants (eg talc, magnesium stearate, (Polyethylene glycol) can be added and compression molded, and then optionally coated by conventional methods for taste masking, enteric or sustained purposes.
  • excipients eg lactose, sucrose, starch, mannitol
  • disintegrants eg calcium carbonate, carboxymethylcellulose calcium
  • lubricants eg talc, magnesium stearate, (Polyethylene glycol)
  • talc eg talc, magnesium stearate, (Polyethylene glycol)
  • the coating agent for example, ethinoresenololose, hydroxymethenoresenorelose, polyoxyethyleneglycolanol and the like can be used.
  • the composition is preferably taken orally.
  • one or more medically effective active ingredients other than the active ingredient according to the present invention may be further added and blended.
  • one or more medically effective active ingredients other than the active ingredient according to the present invention are combined. It may be administered. Examples of such other active ingredients include growth hormones, calcium antagonists, protease inhibitors, steroids and the like.
  • composition according to the present invention is intended to be applied not only to pharmaceuticals but also to foods. Therefore, the food or drink according to the present invention comprises an effective amount of the active ingredient according to the present invention.
  • the active ingredient according to the present invention may be blended in the food and drink as it is or in the form of the composition as described above.
  • the food and drink according to the present invention are prepared by adding conventional additives such as stabilizers to the active ingredient according to the present invention as food and drink, various proteins, sugars, fats, trace elements, vitamins and the like. It may be prepared by blending, liquid, semi-liquid or solid, paste, or added to general food or drink.
  • the "food or drink” is other than a medicine and is not particularly limited as long as it can be ingested by mammals, and its form is also liquid, semi-liquid or solid. Any one may be used. For this reason, the form of a drink is also included in food and drink, for example.
  • the food or drink may also be in the form of a dietary supplement tablet such as a supplement.
  • the "food and drink” is classified as health food, functional food, food for specified health use, dietary supplement, food with a disease risk reduction label, or food for the sick.
  • the term “food or drink” may be used herein to include feed when used for mammals other than humans.
  • Specified health foods as used herein refer to laws and regulations in each country from the viewpoint of health when manufacturing or selling foods for the purpose of preventing, improving, or alleviating the above-mentioned diseases or related conditions. Refers to food that may be subject to any of the above restrictions.
  • Such foods can also be foods that indicate that the foods may reduce disease risk, that is, foods with a disease risk reduction label.
  • the disease risk reduction label is a label for foods that may reduce the disease risk, and is based on or based on the standards established by the FAOZWHO Joint Food Standards Committee (Codex Committee). Refer to the specified display or Can be a recognized indication.
  • the active ingredient according to the present invention has the above-described action. Therefore, the active ingredient of the present invention is used in foods, health foods, functional foods, and supplements (eg, foods containing one or more vitamins such as minerals such as calcium and magnesium and vitamin K) taken in daily life. By blending, a food having a function based on the above action can be provided.
  • a food and drink comprising an effective amount of the active ingredient according to the present invention, which is used for suppressing or reducing the growth of leprosy in a living body.
  • a food or drink comprising an effective amount of the active ingredient, which is used for prevention, progression inhibition or improvement of leprosy or a state related thereto. Provided.
  • a food or drink comprising an effective amount of the active ingredient according to the present invention, wherein the food or drink displaying a function of suppressing or reducing the growth of leprosy in a living body is provided.
  • a food or drink comprising an effective amount of the active ingredient, wherein the food or drink is displayed with a function for preventing, suppressing or improving the leprosy or a state related thereto. Goods are provided.
  • the function indications attached to foods and drinks here are, for example, product bodies, containers, packaging, instructions, package inserts, or promotional materials! , Can be missed.
  • Specific examples of the food and drink according to the present invention include juices, soft drinks, tea beverages, drinks, jelly-like beverages, functional beverages and other beverages; beer and other alcoholic beverages; Carbohydrate-containing foods such as breads and pasta; paste products such as fish ham, sausage, and fish paste products; retort products such as curry, ankake, and Chinese soup; soups; milk, milk drinks, ice cream, cheese, yogurt Dairy products such as miso, yogurt, lactic acid bacteria, fermented beverages such as fermented drinks, pickles; bean products; Western confectionery such as biscuits and cookies; Japanese confectionery such as buns and sheep candy; And confectionery such as frozen confectionery such as pudding and ice confectionery; instant foods such as instant soup and instant miso soup, and foods compatible with microwave ovens.
  • Sarakoko is powder, granule, tablet, capsule, liquid, Also included are health foods and drinks prepared in a single-stitch or jelly form.
  • the composition according to the present invention preferably comprises 0.01 to LOO wt% of the active ingredient based on the total amount of the composition, more preferably 0.05 to 50 wt%. preferable.
  • the amount of the composition added to the food or drink is preferably 0.01 to 80% by mass. 50% by mass is more preferable.
  • the dose or intake of the active ingredient according to the present invention is determined by the recipient, the age and weight of the recipient, symptoms, administration time, dosage form, It can be determined depending on the administration method, the combination of drugs and the like.
  • the daily intake per adult is in the range of 10 to 5000 mg as a dead bacterial powder amount of bacteria. More preferably, it is OOOmg. They can be administered in one or several daily dosage units.
  • the method of adding the microbial cell as an active ingredient to the composition or the food or drink is not particularly limited when the dead microbial cell is used, together with other raw materials used for each food or drink. It can be added from the beginning. Therefore, even if it is added to foods and drinks that require heat treatment (treatment under temperature conditions such as heat sterilization, baking, steaming, etc.), the effect is impaired. There is nothing.
  • SHRZNCrj-rnu nude rats having high susceptibility to infection with Mycobacterium leprae were used.
  • This rat can be easily obtained from related organizations including the present inventors.
  • those skilled in the art can use known literature ("Le prosy in hypertensive nude rat (SHR / N rj -run), Yasuko Yogi et ai., International Journal of Leprosy and Other Mycobacterial Diseases, 67: 435-445, 1999).
  • Corresponding components were EC-12 strain bactericidal cell powder, and EC-12 strain heat-treated bactericidal cell powder was EC-12 (trade name) (manufactured by Combi Corporation). Was used.
  • FIG. 1 shows the change in foo t-pad 6 months after inoculation with leprosy.
  • FIG. 1 shows the EC-12 non-intake group
  • FIG. 2 shows the EC 12 ingestion group.

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Abstract

Disclosed is a composition comprising at least one Gram-positive bacterium isolated from the intestine of an animal including human or a fermented food as an active ingredient. The composition can be used for inhibition or reduction of in vivo proliferation of Mycobacterium leprae. The composition can be used for prevention, progression prevention or amelioration of Hansen's disease or a condition associated with Hansen's disease. The composition can be ingested readily in a daily life, is safe, and develops reduced adverse side effects.

Description

明 細 書  Specification
ハンセン病発症予防作用のある菌体含有組成物  Bacteria-containing composition with leprosy prevention effect
関連出願の参照  Reference to related applications
[0001] 本願は、先行する日本国特許出願である特願 2006— 119175号(出願日:2006 年 4月 24日)に基づくものであって、その優先権の利益を主張するものであり、その 開示内容全体は参照することによりここに組み込まれる。  [0001] This application is based on Japanese Patent Application No. 2006-119175 (filing date: April 24, 2006), which is a prior Japanese patent application, and claims the benefit of its priority. The entire disclosure is hereby incorporated by reference.
発明の背景  Background of the Invention
[0002] 発明の分野 [0002] Field of the Invention
本発明は、ハンセン (Hansen)病発症予防作用のある菌体含有組成物に関する。よ り詳しくは、本発明は、ヒトを含む動物腸内または発酵食品から分離されるグラム陽性 細菌からなる群より選択される細菌を含んでなる組成物に関する。また本発明は、ハ ンセン病発症予防作用のある飲食品に関する。  The present invention relates to a fungus body-containing composition having an effect of preventing the onset of Hansen's disease. More particularly, the present invention relates to a composition comprising a bacterium selected from the group consisting of gram positive bacteria isolated from animal intestines including humans or from fermented foods. The present invention also relates to a food / beverage product having an effect of preventing the onset of leprosy.
[0003] 背景枝術 [0003] Background branching
ノヽンセン病とは、ら ヽ菌(Mycobacterium leprae)によって、主に皮膚や末梢神経が 冒される感染症の一つである。我が国においては年間 10名以下程度の発症例が報 告される程度であるが、発展途上国においてはハンセン病罹患者がなお数百万人 いるとも言われている。  Nosensen's disease is one of the infections that mainly affect the skin and peripheral nerves by Mycobacterium leprae. In Japan, about 10 or less cases are reported annually, but it is said that there are still millions of people with leprosy in developing countries.
[0004] 例えば、インドネシア、インド、アフリカでは、人口 1万人あたり 3〜4人、有病率の高 い地域はその 10倍ものハンセン病罹患者がいる。このような地域はハンセン病汚染 地域といわれ、これらの地域では、家族内感染によって幼少時期に感染する新患患 者が増加し、ハンセン病の発症を予防する対策が必要とされている。ハンセン病の治 療については、多剤併用治療 (MDT)が効果を挙げているが、その発症予防につい ては、いまだに有効な感染予防手段が見出されていない。このため、新たな感染者 の増加が依然として深刻である。さらに最近は多剤耐性を有するらい菌の発生が懸 念されており、従来の薬剤と関連性のない感染予防手段を見出すことは重要である。  [0004] For example, in Indonesia, India, and Africa, there are 3 to 4 people per 10,000 people, and there are 10 times more people with leprosy in areas with a high prevalence. Such areas are said to be leprosy-contaminated areas, and in these areas, new patients who are infected at an early age due to infection within the family increase, and measures to prevent the onset of leprosy are needed. For treatment of leprosy, multi-drug combination therapy (MDT) has been effective, but no effective means of preventing infection has yet been found to prevent its onset. For this reason, the increase in the number of newly infected people remains serious. More recently, the occurrence of leprosy having multidrug resistance has been a concern, and it is important to find infection prevention measures not related to conventional drugs.
[0005] さらに、発症予防を行う観点力 は、副作用が少なぐより安全に使用することがで きる薬剤または食品の提供が望まれている。このような薬剤または食品の提供は、患 者の QOL (クオリティ ·ォブ ·ライフ)の向上に役立つことが期待される。 [0005] Further, as a viewpoint power for preventing onset, it is desired to provide a drug or food that can be used safely with fewer side effects. The provision of such drugs or foods It is expected to help improve the quality of life of consumers.
[0006] 一方で、近年、腸内フローラの研究が進展し、腸内フローラが宿主の健康や疾病に 密接に関係して 、ることが明らかとなり、乳酸菌やビフィズス菌等をプロバイオテイクス などの様式で様々な疾病の予防や症状改善のために用いる試みが盛んに行われて いる。 [0006] On the other hand, in recent years, research on intestinal flora has progressed, and it has become clear that intestinal flora is closely related to the health and diseases of the host. Lactic acid bacteria, bifidobacteria, etc. There have been many attempts to use it to prevent various diseases and improve symptoms.
[0007] 例えば、特開 2000— 125810号公報には、酵母菌と乳酸菌とからなる、炎症抑制 作用のある濃縮飲料が開示されている。また特開 2001— 48796号公報には、特定 のェンテロコッカス属菌の死菌体を使用した免疫調整剤が開示されている。  [0007] For example, Japanese Patent Application Laid-Open No. 2000-125810 discloses a concentrated beverage comprising yeast and lactic acid bacteria and having an anti-inflammatory action. JP-A-2001-48796 discloses an immunomodulator using a dead cell of a specific Enterococcus genus.
[0008] 乳酸菌の一つであるェンテロコッカス ·フエカリス · EC— 12株 (Enterococcus faecali s EC-12) (以下において「EC— 12株」と略すことがある)は、その死菌体に、整腸作 用、抗腫瘍作用、皮膚アレルギー改善作用等があることが報告されている (例えば、「 食品と開発」、 Vol.39、 Νο.10、 61〜63頁)。 EC— 12株についてはまた、リステリア菌 感染の際に生体防御機構に及ぼす効果についての報告もある(「新薬と臨床」(J. Ne w Rem. & Clin.)、 Vol.53, No.3、 2004、 78〜88頁)。  [0008] Enterococcus faecalis EC-12, which is one of the lactic acid bacteria, may be abbreviated as “EC-12” in the following. It has been reported to have action, antitumor action, skin allergy improvement action, etc. (for example, “Food and Development”, Vol.39, Νο.10, pp. 61-63). There is also a report on the effect of EC-12 on the host defense mechanism during Listeria monocytogenes infection (“New Drugs and Clinical” (J. New Rem. & Clin.), Vol. 53, No. 3). 2004, pp. 78-88).
[0009] し力しながら、これらの菌についてのハンセン病発症予防効果に関しては本発明者 らの知る限り、何等報告されていない。らい菌の感染および発症メカニズムは、リステ リア菌感染や、上記した各種疾患の発症メカニズムとは全く異なるものである。  However, as far as the present inventors know, nothing has been reported on the leprosy prevention effect of these bacteria. The infection and development mechanism of leprosy is completely different from the infection mechanism of Listeria monocytogenes and the various diseases described above.
発明の概要  Summary of the Invention
[0010] 本発明者らは今般、ヒトを含む動物腸内または発酵食品から分離されるグラム陽性 細菌の一つである、 EC— 12菌株の摂取により、生体におけるらい菌の増殖が顕著 に抑制でき、ハンセン病に伴う症状を改善できることを予想外にも見出した。本発明 は力かる知見に基づくものである。  [0010] The present inventors have significantly suppressed the growth of leiomycetes in living organisms by ingesting EC-12 strain, one of Gram-positive bacteria isolated from animal intestines including humans and fermented foods. It was unexpectedly found that symptoms associated with leprosy could be improved. The present invention is based on strong knowledge.
[0011] 本発明の目的は、日常生活において容易に摂取することができ、かつ、副作用の 極めて少ない、医薬または飲食品として使用可能な、ハンセン病またはこれに関連 する状態の予防、進行抑制または改善効果を有する組成物を提供することにある。  [0011] The object of the present invention is to prevent, suppress or improve leprosy or a condition related to leprosy that can be easily taken in daily life and has very few side effects and can be used as a medicine or food and drink. It is providing the composition which has an effect.
[0012] 本発明による組成物は、ヒトを含む動物腸内または発酵食品から分離されるグラム 陽性細菌の少なくとも 1種以上を有効成分として含んでなるものであって、生体にお けるらい菌の増殖抑制または低減に用いられるものである。 [0013] 本発明の好ましい態様によれば、前記細菌は死菌体である。 [0012] The composition according to the present invention comprises, as an active ingredient, at least one kind of Gram-positive bacteria isolated from animal intestines including humans or fermented foods. It is used for growth inhibition or reduction. [0013] According to a preferred embodiment of the present invention, the bacterium is a dead cell.
[0014] 本発明の好ましい態様によれば、本発明による組成物は、ハンセン病またはこれに 関連する状態の予防、進行抑制または改善に用いられる。より好ましくは、本発明に よる組成物は、らい菌に感染もしくは感染の疑いのある患者、またはらぃ菌に感染す る可能性の高 、環境に置かれた者における、ハンセン病またはこれに関連する状態 の予防、進行抑制または改善に用いられる。 [0014] According to a preferred embodiment of the present invention, the composition according to the present invention is used for prevention, suppression of progress or improvement of leprosy or a condition related thereto. More preferably, the composition according to the present invention is leprosy or related in a patient who is infected or suspected of being infected with leiomycetes or who is likely to be infected with leiomycetes. Used to prevent, suppress or improve progress.
[0015] 本発明の別の態様によれば、本発明による組成物を含んでなる飲食品が提供され る。 [0015] According to another aspect of the present invention, there is provided a food or drink comprising the composition according to the present invention.
[0016] 本発明の別の態様によれば、前記有効成分を有効量含んでなる飲食品であって、 生体におけるらい菌の増殖抑制または低減に用いられる飲食品が提供される。  [0016] According to another aspect of the present invention, there is provided a food or drink comprising an effective amount of the active ingredient, which is used for suppressing or reducing the growth of leprosy in a living body.
[0017] 本発明のさらに別の態様によれば、前記有効成分を有効量含んでなる飲食品であ つて、ハンセン病またはこれに関連する状態を予防、進行抑制または改善する機能 が表示された飲食品が提供される。  [0017] According to yet another aspect of the present invention, a food or drink comprising an effective amount of the active ingredient, wherein the food or drink is displayed with a function for preventing, suppressing progression or improving leprosy or a state related thereto. Goods are provided.
[0018] 本発明の他の態様によれば、ヒトを含む動物腸内または発酵食品から分離されるグ ラム陽性細菌の少なくとも 1種以上の有効量を、それを必要とする患者に投与するか または摂取させることを含んでなる、ハンセン病の症状もしくはこれに関連する状態を 予防、進行抑制、または改善する方法が提供される。  [0018] According to another aspect of the present invention, is an effective amount of at least one or more kinds of gram positive bacteria isolated from animal intestines including human beings or fermented foods administered to a patient in need thereof? Or a method for preventing, inhibiting progression or ameliorating a leprosy symptom or a condition associated therewith comprising ingestion.
[0019] 本発明のさらに別の態様によれば、ハンセン病またはこれに関連する状態の予防、 進行抑制または改善に用いられる組成物を製造するための、ヒトを含む動物腸内ま たは発酵食品力 分離されるグラム陽性細菌の少なくとも 1種以上の使用が提供され る。  [0019] According to still another aspect of the present invention, animal intestinal or fermented foods including humans for producing a composition for use in the prevention, progression inhibition or amelioration of leprosy or a condition related thereto. Use of at least one gram positive bacterium to be isolated is provided.
[0020] 本発明の別の一つの態様によれば、ハンセン病またはこれに関連する状態の予防 [0020] According to another aspect of the present invention, prevention of leprosy or a condition related thereto.
、進行抑制または改善するための、ェンテロコッカス'フエカリス 'EC— 12株 (Enkme occus faecalis EC— 12) (受託番号 FERM BP— 10284)またはその変異株の使用が 提供される。 Use of Enterococcus faecalis EC-12 (accession number FERM BP-10284) or a mutant thereof is provided for inhibiting or improving progression.
[0021] 本発明によれば、有効成分を医薬品または飲食品として摂取することによって、生 体におけるらい菌の増殖抑制または低減することができる。すなわち、本発明によれ ば、有効成分を医薬品または飲食品として摂取することによって、ハンセン病または これに関連する状態を予防、進行抑制または改善することができる。本発明における 有効成分は、ヒトを含む動物腸内または発酵食品力も分離される細菌またはその死 菌体であり、これまでの報告から、副作用がほとんど無く安全性が高いことは明らかで ある。このため、本発明による組成物、または飲食品は、副作用が殆ど無ぐ安全性 に優れたものである。よって、これらは日常生活において容易に摂取することができ る。したがって、本発明の組成物は、小児や成人が副作用なく簡便に摂取できるため 、ハンセン病の家族内感染を効果的に抑制し、ハンセン病汚染地域における幼少期 の感染とハンセン病感染増加を効果的防止できると期待される。 [0021] According to the present invention, by taking an active ingredient as a pharmaceutical or a food or drink, it is possible to suppress or reduce the growth of leprosy in living organisms. That is, according to the present invention, leprosy or Conditions associated with this can be prevented, progress suppressed or improved. The active ingredient in the present invention is a bacterium from which animal intestines including humans or fermented foods are separated, or dead cells thereof, and it is clear from previous reports that there are almost no side effects and high safety. For this reason, the composition or food or drink according to the present invention has excellent safety with almost no side effects. Therefore, they can be taken easily in daily life. Therefore, since the composition of the present invention can be easily taken by children and adults without side effects, it effectively suppresses leprosy family infection and can effectively prevent childhood infection and increased leprosy infection in leprosy-contaminated areas. It is expected.
図面の簡単な説明  Brief Description of Drawings
[0022] [図 1]EC— 12非摂取群 (コントロール群)の場合の実施例の結果を示す、生物の形 態写真である。  [0022] FIG. 1 is a morphological photograph showing the results of Examples in the case of EC-12 non-intake group (control group).
[図 2]EC— 12摂取群の場合の実施例の結果を示す、生物の形態写真である。  FIG. 2 is a morphological photograph showing the results of Examples in the EC-12 intake group.
発明の具体的説明  Detailed description of the invention
[0023] 微生物の害託 [0023] Harmful microorganisms
ェンテロコッカス.フエカリス .EC— 12株(Enterococcus faecalis EC- 12)は、平成 17 年 (2005年) 2月 25日(原寄託日)付で独立行政法人産業技術総合研究所特許生 物寄託センター(〒 305-5466 日本国茨城県つくば巿東 1丁目 1番地 1中央第 6)に 寄託された。受託番号は、 FERM BP— 10284である。  Enterococcus faecalis EC-12 (Enterococcus faecalis EC-12) was issued on February 25, 2005 (original deposit date). 305-5466 Deposited at Tsukuba Sakai Higashi, 1-chome, 1-chome, 1-center, 6), Ibaraki, Japan. The accession number is FERM BP-10284.
[0024] 有効成分 [0024] Active ingredient
本発明による組成物および飲食品の有効成分は、前記したように、少なくとも 1種以 上の、ヒトを含む動物腸内または発酵食品力も分離されるグラム陽性細菌である。こ の細菌は、乳酸を生成するグラム陽性細菌、所謂、乳酸菌である。  As described above, the active ingredient of the composition and food / beverage product according to the present invention is at least one Gram-positive bacterium from which animal intestine including human or fermented food power is also separated. This bacterium is a gram-positive bacterium that produces lactic acid, a so-called lactic acid bacterium.
[0025] 本発明の好ましい態様によれば、前記細菌は、ェンテロコッカス属 (Enterococcus) 、ビフイドバタテリゥム属 (Bifidobacterium)、ラクトバシルス属 (Lactobacillus)、ストレプ トコッカス属 (Streptococcus)、および、ラタトコッカス属 (Lactococcus)に属する細菌か らなる群より選択される。  [0025] According to a preferred embodiment of the present invention, the bacterium is Enterococcus, Bifidobacterium, Lactobacillus, Streptococcus, and Ratatococcus. Selected from the group consisting of bacteria belonging to (Lactococcus).
[0026] ここで、ェンテロコッカス属に属する細菌としては、例えば、ェンテロコッカス'フエ力 リス (Enterococcus faecalis)、ェンァロコッカス ·フェンゥム (Enterococcus faecium)等 が挙げられる。ビフイドバタテリゥム属に属する細菌としては、例えば、ビフイドバタテリ ゥム 'ロンガム (Bifidobacterium longum)、ビフイドパクテリゥム ·プレーべ(Bifidobacteri um breve)、ビフイドバタテリゥム .ビフィダム (Bifidobacterium bifidum)等が挙げられる 。ラクトバシルス属に属する細菌としては、ラクトバシルス ·ァシドフィラス(Lactobacillu s acidophilus)、ラクトバシルス ·カゼィ (Lactobacillus casei)、ラクトバシルス ·サリバリ ウス (Lactobacillus salivarius)等が挙げられる。 [0026] Here, the bacteria belonging to the genus Enterococcus include, for example, Enterococcus faecalis, Enterococcus faecium, etc. Is mentioned. Examples of bacteria belonging to the genus Bifidobacterium include, for example, Bifidobacterium longum, Bifidobacteri um breve, Bifidobacterium bifidum, etc. Can be mentioned. Examples of bacteria belonging to the genus Lactobacillus include Lactobacillus acidophilus, Lactobacillus casei, Lactobacillus salivarius and the like.
[0027] また、ストレプトコッカス属に属する細菌としては、例えば、ストレプトコッカス ·サーモ フィラス (Streptococcus thermophilus)等が挙げられる。ラタトコッカス属に属する細菌 としては、例えば、ラクトコッカス ·クレモリス(Lactococcus cremoris)、ラクトコッカス 'ラ クテイス (Lactococcus lactis)等が挙げられる。  [0027] Examples of bacteria belonging to the genus Streptococcus include Streptococcus thermophilus. Examples of bacteria belonging to the genus Ratatococcus include Lactococcus cremoris, Lactococcus lactis and the like.
[0028] 本発明の好ましい態様によれば、有効成分として用いられる細菌は、ェンテロコッカ ス属に属する菌である。より好ましくは、該細菌は、ェンテロコッカス'フエカリス(Enter ococcus raecalis)であ。。  [0028] According to a preferred embodiment of the present invention, the bacterium used as an active ingredient is a bacterium belonging to the genus Enterococcus. More preferably, the bacterium is Enter ococcus raecalis. .
[0029] ェンテロコッカス'フエカリスとしては、例えば、ェンテロコッカス'フエカリス 'EC— 12 株(受託番号 FERM BP— 10284)、 ATCC 19433、 ATCC 14508、 ATCC 23655、 IF O 16803、 IFO 16804等の菌株またはその変異株が例示できる。有効成分として用い られる細菌としては、このうち、前記 EC— 12株が最も好ましい。  [0029] Examples of Enterococcus faecalis include strains such as Enterococcus faecalis EC-12 (accession number FERM BP-10284), ATCC 19433, ATCC 14508, ATCC 23655, IF O 16803, IFO 16804, and mutants thereof. Can be illustrated. Of these, the EC-12 strain is most preferred as the bacterium used as the active ingredient.
なおここで「変異株」とは、特定の菌株に対し、当業者に周知の方法により当業者が その性質に変化を及ぼさない範囲で変異させたもの、あるいは、それと同等であると 当業者が確認できるものを包含する意味である。  Here, the “mutant strain” means that a specific strain has been mutated by a method well known to those skilled in the art within a range that does not change the property thereof, or is equivalent to that. The meaning includes things that can be confirmed.
[0030] 有効成分として用いられる細菌は、生菌および Zまたは死菌体を用いることができ る力 好ましくは死菌体が用いられ、より好ましくは、前記細菌を公知の加熱処理手 段で殺菌して得られる加熱殺菌菌体が用いられる。加熱殺菌菌体は、前記細菌を常 法に従って培養して得られた培養物から、例えば、濾過、遠心分離等の方法により 菌体を回収し、水洗後、水等に懸濁して 120°C以下 (好ましくは 80〜120°C)、 30分 以内(3秒〜 30分間)加熱処理した後、必要に応じて濃縮、乾燥することにより調製 できる。なお、ェンテロコッカス 'フエカリス'前記 EC— 12株の加熱処理による殺菌菌 体粉末は、商品名「EC— 12」(コンビ株式会社製)として市販されている。このため、 本発明においては、有効成分として用いられる細菌として、このような市販品を用い てもよい。 [0030] The bacterium used as the active ingredient is a force capable of using live bacteria and Z or dead cells, preferably dead cells, and more preferably, the bacteria are sterilized by a known heat treatment method. The heat-sterilized microbial cell obtained by using is used. The heat-sterilized cells are collected from a culture obtained by culturing the bacteria according to a conventional method, for example, by filtration, centrifugation, or the like, washed with water, suspended in water, etc., and 120 ° C. Following (preferably 80 to 120 ° C), heat treatment within 30 minutes (3 seconds to 30 minutes), followed by concentration and drying as necessary. In addition, the entericococcus "Fuecharis" sterilized bacterial powder by heat treatment of the EC-12 strain is commercially available under the trade name "EC-12" (manufactured by Combi Co., Ltd.). For this reason, In the present invention, such a commercial product may be used as a bacterium used as an active ingredient.
[0031] 纖  [0031] 纖
本発明による有効成分は、生体におけるら!/ヽ菌の増殖抑制または低減させる効果 を有する。すなわち、後述する実施例に示されるように、本発明による有効成分は、ら V、菌感染に対して感受性の高 、ラットに摂取させることによって、ら 、菌の感染にお ける生体でのらい菌増殖を抑制する作用があるが実際に確認されている(実施例、 図 1および図 2)。すなわち、本発明による有効成分の投与群と非投与群のラットの所 見より、本発明による組成物によってらぃ菌感染に伴う病態の進行が軽減されたこと が確認された。このように、本発明による有効成分は、ハンセン病またはこれに関連 する状態を予防、進行抑制する効果を実際に示した。よって、本発明における有効 成分は、らい菌に感染した患者または感染する可能性の高い者に対し、その感染に 伴う症状、例えば腫脹の軽減等といった症状の進行抑制、症状の緩和、改善効果を もたらすことができ、さらには症状の治療効果も期待できる。また本発明の有効成分 は、毒性も低ぐ哺乳動物に対し安全に用いることができる。  The active ingredient according to the present invention has the effect of inhibiting or reducing the growth of gonococci / gonococci in the living body. That is, as shown in the Examples described later, the active ingredient according to the present invention is highly sensitive to bacterial infection, and when taken by a rat, it can be removed from a living organism in bacterial infection. Although it has the effect of inhibiting the growth of bacteria, it has been confirmed in practice (Examples, Fig. 1 and Fig. 2). That is, it was confirmed from the findings of the rats in the active ingredient administration group and the non-administration group according to the present invention that the progression of the disease state associated with the infection with the bacterium was reduced by the composition according to the present invention. As described above, the active ingredient according to the present invention actually showed an effect of preventing and suppressing the progression of leprosy or a related condition. Therefore, the active ingredient in the present invention has the effect of suppressing the progression of symptoms such as alleviation of symptoms such as reduction of swelling, mitigation of symptoms, and improvement effects on patients infected with leprosy or those who are highly likely to be infected. It can also bring about a therapeutic effect on symptoms. The active ingredient of the present invention can be safely used for mammals having low toxicity.
[0032] 本発明による有効成分によれば、乳酸球菌の免疫系への作用によって、細胞内寄 生細菌であるら 、菌の増殖を抑制することができ、その結果ノヽンセン病の発症を予 防できると考えられる。なおこれらは仮定であってこれによつて本発明が限定的に解 釈されるものではない。 [0032] According to the active ingredient of the present invention, the growth of bacteria can be suppressed by the action of lactococci on the immune system, so that the growth of bacteria can be prevented. It can be prevented. Note that these are assumptions, and the present invention is not limited to them.
[0033] したがって、本発明による有効成分は、ハンセン病またはこれに関連する状態の予 防、進行抑制または改善に用いることができる。ここで、症状または状態の「進行抑制 または改善」とは、症状または状態の、調節、進行の抑制、遅延、緩和、改善、症状 等の再進行の予防などを包含する意味で使用される。  [0033] Therefore, the active ingredient according to the present invention can be used for the prevention, progression inhibition or improvement of leprosy or a condition related thereto. Here, “progression suppression or improvement” of a symptom or condition is used in a sense encompassing adjustment of the symptom or condition, suppression of progression, delay, alleviation, improvement, prevention of re-progression of symptoms and the like.
[0034] 本発明にお 、て、「ハンセン病」は、ら 、菌 (Mycobacterium leprae)の感染による感 染症をいい、ここには、らい菌感染に伴い生ずる、知覚脱出を伴う脱色素もしくは紅 色皮疹、末梢神経肥厚、環状紅斑、およびらい反応等の症状をも包含する。  [0034] In the present invention, "leprosy" refers to infection caused by infection with Mycobacterium leprae, which includes depigmentation or redness accompanied by sensory escape caused by infection with Leprosy. It also includes symptoms such as color eruption, peripheral nerve thickening, annular erythema, and leprosy reaction.
[0035] 本発明による有効成分の効果は、四肢の腫脹の程度、後肢 (または足)のフットパッ ドの厚さ等を経時的に測定することにより確認することができる。 [0036] 本発明の他の態様によれば、ヒトを含む動物腸内または発酵食品から分離されるグ ラム陽性細菌の少なくとも 1種以上を有効成分として含んでなる、らい菌の増殖抑制 剤、または、ハンセン病またはこれに関連する状態の予防剤、進行抑制剤もしくは改 善剤が提供される。これらの製剤は、例えば、医薬品製造原料としての添加剤や、食 品添加剤などとして使用できる。 [0035] The effect of the active ingredient according to the present invention can be confirmed by measuring the degree of swelling of the extremities, the thickness of the footpads of the hind limbs (or legs), etc. over time. [0036] According to another aspect of the present invention, a growth inhibitor of leprosy comprising as an active ingredient at least one kind of gram-positive bacteria isolated from animal intestines including humans or fermented foods, Alternatively, a prophylactic agent, progression inhibitor or remedy for leprosy or a condition related thereto is provided. These preparations can be used, for example, as an additive as a raw material for producing pharmaceuticals, a food additive, and the like.
[0037] また本発明によれば、前記したように、ヒトを含む動物腸内または発酵食品から分 離されるグラム陽性細菌の少なくとも 1種以上の有効量を、それを必要とする患者に 投与する力または摂取させることを含んでなる、ハンセン病の症状もしくはこれに関連 する状態を予防、進行抑制、または改善する方法が提供される。ここで、「それを必 要とする患者」は、好ましくは、らい菌に感染もしくは感染の疑いのある患者、または らい菌に感染する可能性の高い環境に置かれた者、または、ハンセン病を発症また は発症の疑いのある患者である。またここで「有効量」とは、症状または状態の進行を 抑制するか、または改善するために、その効果を発揮する上で少なくとも必要とされ る有効成分の量を意味する。さらに、「患者」は、本発明の組成物または飲食品を、 投与または摂取する対象となるヒトまたはヒトを除く哺乳動物 (特に、らい菌に感受性 を有する、免疫不全マウス、ラット、および、アルマジロ、サル等)を意味する。「投与」 および「摂取」とは、対象となる患者に対し、目的とする物質を経口的または非経口的 に (好ましくは経口的に)生体内に取り込ませることを意味する。  [0037] According to the present invention, as described above, an effective amount of at least one gram-positive bacterium isolated from the intestines of animals including humans or fermented foods is administered to a patient in need thereof. Provided is a method for preventing, inhibiting progression, or ameliorating a leprosy symptom or related condition comprising power or ingestion. Here, the “patient in need thereof” is preferably a patient who is infected or suspected of being infected with leprosy, a person who is placed in an environment where there is a high possibility of being infected with leprosy, or leprosy. Patients with or suspected of developing. Here, the “effective amount” means the amount of the active ingredient that is required at least to exert its effect in order to suppress or improve the progression of symptoms or conditions. Furthermore, the “patient” refers to a human or a mammal other than a human to be administered or ingested the composition or food or drink of the present invention (in particular, immunodeficient mice, rats, and armadillos that are susceptible to leprosy). , Monkeys, etc.). “Administration” and “intake” mean that a target substance is taken into a living body orally or parenterally (preferably orally) to a subject patient.
[0038] さらに本発明によれば、前記したように、ハンセン病またはこれに関連する状態の 予防、進行抑制または改善に用いられる組成物を製造するための、ヒトを含む動物 腸内または発酵食品から分離されるグラム陽性細菌の少なくとも 1種以上の使用が提 供される。ここで好ましくは、組成物は食品組成物である。  [0038] Further, according to the present invention, as described above, from the intestinal or fermented foods of animals, including humans, for producing a composition used for the prevention, progression inhibition or improvement of leprosy or a condition related thereto. Use of at least one gram-positive bacterium to be isolated is provided. Here, preferably, the composition is a food composition.
[0039] 組成物または飲食品  [0039] Composition or food or drink
本発明による組成物は、前記した有効成分として含んでなるものである。  The composition according to the present invention comprises the aforementioned active ingredient.
[0040] ここで「有効成分として含んでなる」とは、所望する製品形態に応じた生理学的に許 容されうる担体を含んでいてもよいことは当然として、併用可能な他の補助成分を含 有する場合も包含する意味である。すなわち、本発明による組成物は、有効成分で ある菌体または死菌体を用いて、必要に応じて、生理学的に許容されうる担体、賦形 剤、結合剤、希釈剤などと混合することにより製造できる。本発明による組成物は、経 口または非経口的に投与または摂取することができる。経口用の形態としては、食品 、顆粒剤、散剤、錠剤 (糖衣錠を含む)、丸剤、カプセル剤、シロップ剤、乳剤、懸濁 剤が挙げられる。非経口用の形態としては、注射剤、点滴剤、外用剤が挙げられる。 これらの製剤は、当該技術分野で通常行われている手法により、薬学的に許容され る担体 (例えば、賦形剤、添加剤)とともに製剤化することができる。薬学的に許容さ れる担体としては、賦形剤、結合剤、香料、緩衝剤、増粘剤、着色剤、安定剤、乳化 剤、分散剤、懸濁化剤、崩壊剤、滑沢剤、防腐剤等が挙げられる。具体例としては、 例えば、炭酸マグネシウム、ステアリン酸マグネシウム、タルク、砂糖、ラタトース、ぺク チン、デキストリン、澱粉、ゼラチン、トラガント、メチルセルロース、ナトリウムカルボキ シメチルセルロース、低融点ワックス等が挙げられる。 [0040] Here, "comprising as an active ingredient" means that it may contain a physiologically acceptable carrier according to the desired product form, and other auxiliary ingredients that can be used in combination. The meaning of including is also included. That is, the composition according to the present invention uses a microbial cell or a dead microbial cell which is an active ingredient, and if necessary, a physiologically acceptable carrier, an excipient. It can be produced by mixing with an agent, a binder, a diluent and the like. The composition according to the present invention can be administered or ingested orally or parenterally. Oral forms include foods, granules, powders, tablets (including sugar-coated tablets), pills, capsules, syrups, emulsions and suspensions. Examples of parenteral forms include injections, drops, and external preparations. These preparations can be formulated together with pharmaceutically acceptable carriers (for example, excipients and additives) by a method generally used in the art. Pharmaceutically acceptable carriers include excipients, binders, fragrances, buffers, thickeners, colorants, stabilizers, emulsifiers, dispersants, suspending agents, disintegrating agents, lubricants, Examples include preservatives. Specific examples include magnesium carbonate, magnesium stearate, talc, sugar, ratatoose, pectin, dextrin, starch, gelatin, tragacanth, methylcellulose, sodium carboxymethylcellulose, and a low melting wax.
[0041] また併用可能な他の補助成分としては、例えば、ビタミン成分 (例えば、ビタミン C、 ビタミン E)、抗生物質、グリコーゲン、アミノ酸類、ペプチド類、ミネラル類 (例えば、亜 鉛、鉄、銅、マンガンなど)などが挙げられる。  [0041] Other auxiliary components that can be used in combination include, for example, vitamin components (eg, vitamin C, vitamin E), antibiotics, glycogen, amino acids, peptides, minerals (eg, zinc, iron, copper). , Manganese, etc.).
[0042] 製剤の内、例えば経口剤は、下記のようにして製造できる。有効成分に、例えば賦 形剤(例えば、乳糖、白糖、デンプン、マン-トール)、崩壊剤(例えば、炭酸カルシゥ ム、カルボキシメチルセルロースカルシウム)、または滑沢剤(例えば、タルク、ステア リン酸マグネシウム、ポリエチレングリコール)を添加して圧縮成形し、次いで必要によ り、味のマスキング、腸溶性もしくは持続性の目的のために慣用の方法でコーティン グすることによって、経口剤を製造することができる。コーティング剤としては、例えば 、ェチノレセノレロース、ヒドロキシメチノレセノレロース、ポリオキシエチレングリコーノレなど を用いることができる。  [0042] Among the preparations, for example, an oral preparation can be produced as follows. Active ingredients include, for example, excipients (eg lactose, sucrose, starch, mannitol), disintegrants (eg calcium carbonate, carboxymethylcellulose calcium), or lubricants (eg talc, magnesium stearate, (Polyethylene glycol) can be added and compression molded, and then optionally coated by conventional methods for taste masking, enteric or sustained purposes. As the coating agent, for example, ethinoresenololose, hydroxymethenoresenorelose, polyoxyethyleneglycolanol and the like can be used.
[0043] 本発明おいて、組成物は経口摂取されるものであることが好ましい。 [0043] In the present invention, the composition is preferably taken orally.
[0044] また必要に応じて、注射剤、外用剤等の他の製剤も慣用の方法により製造すること ができる。 [0044] If necessary, other preparations such as injections and external preparations can also be produced by conventional methods.
[0045] 製剤化にあたっては、本発明による有効成分以外の 1種以上の医療上有効な有効 成分をさらに添加し配合してもよい。また本発明による有効成分の投与にあたっては 、本発明による有効成分以外の 1種以上の医療上有効な有効成分を組み合わせて 投与してもよい。このような他の有効成分としては、例えば、成長ホルモン、カルシゥ ム拮抗剤、プロテアーゼ阻害剤、ステロイド剤等が挙げられる。 [0045] In formulating, one or more medically effective active ingredients other than the active ingredient according to the present invention may be further added and blended. In the administration of the active ingredient according to the present invention, one or more medically effective active ingredients other than the active ingredient according to the present invention are combined. It may be administered. Examples of such other active ingredients include growth hormones, calcium antagonists, protease inhibitors, steroids and the like.
[0046] 本発明による組成物は、医薬品への適用のみならず、食品への適用も意図されて いる。よって、本発明による飲食品は、本発明による有効成分を有効量含んでなるも のである。  [0046] The composition according to the present invention is intended to be applied not only to pharmaceuticals but also to foods. Therefore, the food or drink according to the present invention comprises an effective amount of the active ingredient according to the present invention.
[0047] ここで「有効成分を有効量含んでなる」とは、個々の飲食品を通常喫食される量摂 取した結果、有効成分としての効果を発揮しうるような量で有効成分を含有することを いう。本発明による飲食品には、本発明による有効成分をそのまままたは上記のよう な組成物の形態で、飲食品に配合してもよい。また、本発明による飲食品は、本発明 による有効成分に安定剤等の慣用の添加成分を加えて飲食品として調製したもの、 各種タンパク質、糖類、脂肪、微量元素、ビタミン類等をそれらにさらに配合して調製 したもの、液状、半液体状若しくは固体状にしたもの、ペースト状にしたもの、または、 一般の飲食品へ添カ卩したものであってもよ 、。  [0047] Here, "comprising an effective amount of an active ingredient" means that the active ingredient is contained in such an amount that an effect as an active ingredient can be exhibited as a result of taking the amount of each food or drink normally consumed. To do. In the food and drink according to the present invention, the active ingredient according to the present invention may be blended in the food and drink as it is or in the form of the composition as described above. In addition, the food and drink according to the present invention are prepared by adding conventional additives such as stabilizers to the active ingredient according to the present invention as food and drink, various proteins, sugars, fats, trace elements, vitamins and the like. It may be prepared by blending, liquid, semi-liquid or solid, paste, or added to general food or drink.
[0048] 本発明にお 、て、「飲食品」は、医薬以外のものであって、哺乳動物が摂取可能な ものであれば特に制限はなぐその形態も液状、半液体状または固体状のいずれの ものであってもよい。このため飲食品には、例えば飲料の形態も包含される。飲食品 はまた、サプリメントのような栄養補助食品の錠剤形態であってもよい。  [0048] In the present invention, the "food or drink" is other than a medicine and is not particularly limited as long as it can be ingested by mammals, and its form is also liquid, semi-liquid or solid. Any one may be used. For this reason, the form of a drink is also included in food and drink, for example. The food or drink may also be in the form of a dietary supplement tablet such as a supplement.
[0049] 本発明において「飲食品」には、健康食品、機能性食品、特定保健用食品、栄養 補助食品、疾病リスク低減表示を付した食品、または、病者用食品のような分類のも のも包含される。さらに「飲食品」という用語は、ヒト以外の哺乳動物を対象として使用 される場合には、飼料を含む意味でここで用いてもよい。ここでいう特定保健用食品 とは、上述した疾病またはそれに関連する状態の予防、改善、状態の緩和等を目的 として食品の製造または販売等を行う場合に、保健上の観点から、各国において法 上の何らかの制限を受けることがある食品をいう。このような食品は、食品が疾病リス クを低減する可能性があること表示した食品、すなわち、疾病リスク低減表示を付した 食品であることもできる。ここで、疾病リスク低減表示とは、疾病リスクを低減する可能 性のある食品の表示であって、 FAOZWHO合同食品規格委員会(コーデックス委 員会)の定める規格に基づいて、またはその規格を参考にして、定められた表示また は認められた表示であることができる。 [0049] In the present invention, the "food and drink" is classified as health food, functional food, food for specified health use, dietary supplement, food with a disease risk reduction label, or food for the sick. Are also included. Furthermore, the term “food or drink” may be used herein to include feed when used for mammals other than humans. Specified health foods as used herein refer to laws and regulations in each country from the viewpoint of health when manufacturing or selling foods for the purpose of preventing, improving, or alleviating the above-mentioned diseases or related conditions. Refers to food that may be subject to any of the above restrictions. Such foods can also be foods that indicate that the foods may reduce disease risk, that is, foods with a disease risk reduction label. Here, the disease risk reduction label is a label for foods that may reduce the disease risk, and is based on or based on the standards established by the FAOZWHO Joint Food Standards Committee (Codex Committee). Refer to the specified display or Can be a recognized indication.
[0050] 本発明による有効成分は、上述したような作用を有する。このため、日常生活で摂 取する食品、健康食品、機能性食品、サプリメント(例えば、カルシウム、マグネシウム 等のミネラル類、ビタミン K等のビタミン類を 1種以上含有する食品)に本発明の有効 成分を配合することにより、前記作用に基づく機能を併せ持つ食品を提供することが できる。  [0050] The active ingredient according to the present invention has the above-described action. Therefore, the active ingredient of the present invention is used in foods, health foods, functional foods, and supplements (eg, foods containing one or more vitamins such as minerals such as calcium and magnesium and vitamin K) taken in daily life. By blending, a food having a function based on the above action can be provided.
[0051] 本発明によれば、前記したように、本発明における有効成分を有効量含んでなる飲 食品であって、生体におけるらい菌の増殖抑制または低減に用いられる飲食品が提 供される。  [0051] According to the present invention, as described above, there is provided a food and drink comprising an effective amount of the active ingredient according to the present invention, which is used for suppressing or reducing the growth of leprosy in a living body. .
[0052] 本発明のまた別の態様によれば、前記有効成分を有効量含んでなる飲食品であつ て、ハンセン病またはこれに関連する状態の予防、進行抑制または改善に用いられ る飲食品が提供される。  [0052] According to still another aspect of the present invention, there is provided a food or drink comprising an effective amount of the active ingredient, which is used for prevention, progression inhibition or improvement of leprosy or a state related thereto. Provided.
[0053] 本発明の別の態様によれば、本発明における有効成分を有効量含んでなる飲食 品であって、生体におけるらい菌の増殖抑制または低減する機能が表示された飲食 品が提供される。また、本発明のさらに別の態様によれば、前記有効成分を有効量 含んでなる飲食品であって、ハンセン病またはこれに関連する状態を予防、進行抑 制または改善する機能が表示された飲食品が提供される。ここで飲食品に付される 機能表示は、例えば、製品の本体、容器、包装、説明書、添付文書、または宣伝物 の!、ずれかにすることができる。  [0053] According to another aspect of the present invention, there is provided a food or drink comprising an effective amount of the active ingredient according to the present invention, wherein the food or drink displaying a function of suppressing or reducing the growth of leprosy in a living body is provided. The According to yet another aspect of the present invention, there is provided a food or drink comprising an effective amount of the active ingredient, wherein the food or drink is displayed with a function for preventing, suppressing or improving the leprosy or a state related thereto. Goods are provided. The function indications attached to foods and drinks here are, for example, product bodies, containers, packaging, instructions, package inserts, or promotional materials! , Can be missed.
[0054] 本発明による飲食品の具体例としては、ジュース、清涼飲料水、茶飲料、ドリンク剤 、ゼリー状飲料、機能性飲料等の各種飲料;ビール等のアルコール飲料;飯類、麵類 、パン類およびパスタ類等の炭水化物含有食品;魚肉ハム、ソーセージ、水産練り製 品等の練製品;カレー、あんかけ、中華スープ等のレトルト製品;スープ類;牛乳、乳 飲料、アイスクリーム、チーズ、ヨーグルト等の乳製品;みそ、ヨーグルト、乳酸菌、発 酵飲料、漬け物等の発酵物;豆製品;ビスケット、クッキーなどの洋菓子類、饅頭や羊 羹等の和菓子類、キャンディ一類、ガム類、グミ、ゼリー、プリンなどの冷菓や氷菓な どの各種菓子類;インスタントスープ、インスタントみそ汁等のインスタント食品、電子 レンジ対応食品等が挙げられる。さら〖こは、粉末、穎粒、錠剤、カプセル剤、液状、ぺ 一スト状またはゼリー状に調製された健康飲食品も挙げられる。 [0054] Specific examples of the food and drink according to the present invention include juices, soft drinks, tea beverages, drinks, jelly-like beverages, functional beverages and other beverages; beer and other alcoholic beverages; Carbohydrate-containing foods such as breads and pasta; paste products such as fish ham, sausage, and fish paste products; retort products such as curry, ankake, and Chinese soup; soups; milk, milk drinks, ice cream, cheese, yogurt Dairy products such as miso, yogurt, lactic acid bacteria, fermented beverages such as fermented drinks, pickles; bean products; Western confectionery such as biscuits and cookies; Japanese confectionery such as buns and sheep candy; And confectionery such as frozen confectionery such as pudding and ice confectionery; instant foods such as instant soup and instant miso soup, and foods compatible with microwave ovens. Sarakoko is powder, granule, tablet, capsule, liquid, Also included are health foods and drinks prepared in a single-stitch or jelly form.
[0055] 本発明による飲食品の製造に当たっては、通常の飲食品の処方設計に用いられて いる糖類、香料、果汁、食品添加剤、安定剤などを適宜添加することができる。飲食 品の製造は、当該技術分野に公知の製造技術を参照して実施することができる。本 発明による飲食品は様々な形態を取ることができ、公知の医薬品の製造技術に準じ て本発明による飲食品を製造してもよい。その場合には、本発明による組成物の製 造の項目において述べたような担体や製剤用添加剤を用いて製造することができ、 具体的には、経口剤の欄に記載された担体や製造用添加剤を用いて製造すること ができる。また、本発明における機能以外の機能を発揮する他の成分あるいは他の 機能性食品と組み合わせることによって、多機能性の飲食品としてもよい。 [0055] In the production of foods and drinks according to the present invention, sugars, fragrances, fruit juices, food additives, stabilizers, and the like that are used in normal food and drink formulation design can be added as appropriate. Manufacture of food and drink can be carried out with reference to manufacturing techniques known in the art. The food / beverage products according to the present invention can take various forms, and the food / beverage products according to the present invention may be produced according to known pharmaceutical production techniques. In that case, it can be produced using a carrier or a pharmaceutical additive as described in the item of production of the composition according to the present invention. It can be manufactured using manufacturing additives. Moreover, it is good also as multifunctional food / beverage products by combining with the other component which exhibits functions other than the function in this invention, or another functional food.
[0056] 本発明による組成物は、有効成分を、組成物全量に対して、 0. 01〜: LOO重量% 含んでなることが好ましぐ 0. 05〜50重量%含んでなることがより好ましい。 [0056] The composition according to the present invention preferably comprises 0.01 to LOO wt% of the active ingredient based on the total amount of the composition, more preferably 0.05 to 50 wt%. preferable.
[0057] 本発明による組成物を飲食品に添加して使用する場合、飲食品中への該組成物 の添加量は、 0. 01〜80質量%とすることが好ましぐ 0. 05〜50質量%とすることが より好まし 、。 [0057] When the composition according to the present invention is used by adding to a food or drink, the amount of the composition added to the food or drink is preferably 0.01 to 80% by mass. 50% by mass is more preferable.
[0058] 本発明による組成物および飲食品を投与または摂取する場合、本発明による有効 成分の投与量または摂取量は、受容者、受容者の年齢および体重、症状、投与時 間、剤形、投与方法、薬剤の組み合わせ等に依存して決定できる。例えば、本発明 による有効成分を経口投与または経口摂取する場合、細菌の死菌体粉末量として、 成人 1人の一日当たり摂取量が、 10〜5000mgの範囲であることが好ましぐ 50〜4 OOOmgであることがより好ましい。これらは、一日 1または数回の投与単位に分割し て投与することができる。なお、これらの投与量または摂取量は、成人の体重を 60kg と仮定して、体重 60kgの成人 1人 1日あたりの有効成分の投与量もしくは摂取量とし て、必要に応じて計算することによって算出ことができる。  [0058] When the composition and food and drink according to the present invention are administered or ingested, the dose or intake of the active ingredient according to the present invention is determined by the recipient, the age and weight of the recipient, symptoms, administration time, dosage form, It can be determined depending on the administration method, the combination of drugs and the like. For example, when the active ingredient according to the present invention is orally administered or ingested, it is preferable that the daily intake per adult is in the range of 10 to 5000 mg as a dead bacterial powder amount of bacteria. More preferably, it is OOOmg. They can be administered in one or several daily dosage units. These doses or intakes are calculated as necessary as the dose or intake of the active ingredient per day for an adult with a body weight of 60 kg, assuming that the weight of an adult is 60 kg. Can be calculated.
[0059] なお、組成物または飲食品への有効成分である菌体の添加方法は、菌体の死菌 体を用いる場合は、特に制限はなぐ各飲食品に用いられる他の原料と一緒に最初 から添加することができる。したがって、加熱処理 (加熱殺菌、焼成、蒸煮等の菌体が 死滅するような温度条件下での処理)が必要な飲食品に添加しても効果が損われる ことがない。 [0059] In addition, the method of adding the microbial cell as an active ingredient to the composition or the food or drink is not particularly limited when the dead microbial cell is used, together with other raw materials used for each food or drink. It can be added from the beginning. Therefore, even if it is added to foods and drinks that require heat treatment (treatment under temperature conditions such as heat sterilization, baking, steaming, etc.), the effect is impaired. There is nothing.
実施例  Example
[0060] 本発明を以下の例によって詳細に説明するが、本発明はこれらに限定されるもので はない  [0060] The present invention will be described in detail by the following examples, but the present invention is not limited thereto.
[0061] 試験方法: [0061] Test method:
実験には、ら 、菌 (Mycobacterium leprae (M.leprae) )の感染に対して感受性の高 い SHRZNCrj— rnuヌードラットを用いた。なお、このラットは、本発明者らを含む関 連機関より容易に入手可能であるが、当業者であれば、必要に応じて公知文献 ("Le prosy in hypertensive nude rat(SHR/Nし rj- run) , Yasuko Yogi et ai., International J ournal of Leprosy and Other Mycobacterial Diseases, 67:435- 445,1999)を参照する ことによって、容易に作出することができる。また、本発明の有効成分に相当する成 分としては、 EC— 12株の殺菌菌体粉末を使用した。この EC— 12株の加熱処理に よる殺菌菌体粉末としては、 EC—12 (商品名)(コンビ株式会社製)を用いた。  In the experiment, SHRZNCrj-rnu nude rats having high susceptibility to infection with Mycobacterium leprae (M. leprae) were used. This rat can be easily obtained from related organizations including the present inventors. However, those skilled in the art can use known literature ("Le prosy in hypertensive nude rat (SHR / N rj -run), Yasuko Yogi et ai., International Journal of Leprosy and Other Mycobacterial Diseases, 67: 435-445, 1999). Corresponding components were EC-12 strain bactericidal cell powder, and EC-12 strain heat-treated bactericidal cell powder was EC-12 (trade name) (manufactured by Combi Corporation). Was used.
[0062] 実験ではまず、 4から 6週齢の SHRZNCrj—rnuヌードラットを 1群 3匹(雄 2匹、雌 1匹)として、 EC— 12摂取群と非摂取群の 2群に分けた。乳酸菌 EC— 12摂取群に は、実験動物用飼料 CE 2 (日本クレア株式会社製)に EC 12を 0. 5mgZgの割 合で混入した固形飼料を作成し、これを連日自由摂取させた。非摂取群には CE— 2 のみを自由摂取させた。  [0062] In the experiment, 4 to 6 week-old SHRZNCrj-rnu nude rats were first divided into 3 groups (2 males and 1 female) into two groups, EC-12 intake group and non-intake group. In the lactic acid bacteria EC-12 intake group, a solid feed in which EC 12 was mixed at a ratio of 0.5 mgZg to the experimental animal feed CE 2 (manufactured by Clea Japan Co., Ltd.) was freely taken every day. In the non-intake group, only CE-2 was ingested freely.
[0063] EC— 12摂取開始後 7日目に、 1足あたり 2. 5 X 108個の M.leprae Thai-53株(国立 感染症研究所ノヽンセン病研究センターより入手)を後肢両足の foot— padに接種し た。接種後、夫々の飼料の自由摂取を継続しつつ foot— padの変化を継時的に観 した。 [0063] On the 7th day after ingestion of EC-12, 2.5 x 10 8 M. leprae Thai-53 strains (obtained from the National Institute of Infectious Diseases, Nosensen Disease Research Center) on both legs The foot-pad was inoculated. After inoculation, the foot-pad changes were observed over time while continuing to freely consume each feed.
[0064] 結果は、図 1および図 2に示される通りであった。図は、らい菌接種後 6ヶ月目の foo t— padの変化を示すものである。この内、図 1は EC— 12非摂取群を示し、図 2は EC 12摂取群を示す。  [0064] The results were as shown in FIG. 1 and FIG. The figure shows the change in foo t-pad 6 months after inoculation with leprosy. Among these, FIG. 1 shows the EC-12 non-intake group, and FIG. 2 shows the EC 12 ingestion group.
[0065] 図からも明らかなように、 EC— 12非摂取群では全てのラットにらい菌の増殖を示す foot— padの腫脹が観察された。一方、 EC— 12摂取群では、腫脹の度合いは EC 12非摂取群と比較して弱ぐ試験群中の 2匹には腫脹がほとんど認められなかつ た。 [0065] As is apparent from the figure, in the EC-12 non-administration group, swelling of foot-pads showing the growth of leprosy was observed in all rats. On the other hand, in the EC-12 intake group, the degree of swelling was weaker than that in the non-EC 12 intake group. It was.
したがって、これらの結果は、 EC— 12摂取によって、らい菌の増殖が抑制されるこ とを強く示唆するものといえる。  Therefore, these results strongly suggest that the growth of leprosy is suppressed by EC-12 intake.

Claims

請求の範囲 The scope of the claims
[I] ヒトを含む動物腸内または発酵食品から分離されるグラム陽性細菌の少なくとも 1種 以上を有効成分として含んでなる、生体におけるら!/、菌の増殖抑制または低減に用 いられる、組成物。  [I] Composition comprising at least one gram-positive bacterium isolated from animal intestines including humans or fermented foods as an active ingredient, and used for inhibiting or reducing the growth of bacteria in living organisms! object.
[2] 細菌が、ェンテロコッカス属 (Enterococcus)、ビフイドバタテリゥム属 (Bifidobacteriu m)、ラクトバシルス属 (Lactobacillus)、ストレプトコッカス属 (Streptococcus)、および、 ラクトコッカス属 (Lactococcus)に属する細菌力 なる群より選択される、請求項 1に記 載の組成物。  [2] From the group of bacteria that belong to the genus Enterococcus, Bifidobacterium, Lactobacillus, Streptococcus, and Lactococcus The composition according to claim 1, which is selected.
[3] 細菌が、ェンテロコッカス属に属する細菌である、請求項 1に記載の組成物。  [3] The composition according to claim 1, wherein the bacterium belongs to the genus Enterococcus.
[4] 細菌が、ェンテロコッカス.フエカリス · EC— 12株(Enterococcus faecalis EC- 12) ( 受託番号 FERM BP— 10284)またはその変異株である、請求項 1に記載の組成物 [4] The composition according to claim 1, wherein the bacterium is Enterococcus faecalis EC-12 (accession number FERM BP-10284) or a mutant thereof.
[5] 細菌が死菌体である、請求項 1〜4のいずれか一項に記載の組成物。 [5] The composition according to any one of claims 1 to 4, wherein the bacteria are dead cells.
[6] ハンセン病またはこれに関連する状態の予防、進行抑制または改善に用いられる、 請求項 1〜5のいずれか一項に記載の組成物。  [6] The composition according to any one of claims 1 to 5, which is used for prevention, suppression or improvement of leprosy or a condition related thereto.
[7] らい菌に感染もしくは感染の疑いのある患者、またはらぃ菌に感染する可能性の高 い環境に置かれた者における、ハンセン病またはこれに関連する状態の予防、進行 抑制または改善に用いられる、請求項 1〜5のいずれか一項に記載の組成物。 [7] For the prevention, suppression or improvement of leprosy or related conditions in patients who are infected or suspected of being infected with leprosy, or who are placed in an environment that is likely to be infected with leprosy. The composition according to any one of claims 1 to 5, which is used.
[8] 経口摂取されるものである、請求項 1〜7のいずれか一項に記載の組成物。 [8] The composition according to any one of claims 1 to 7, which is taken orally.
[9] 医薬組成物である、請求項 1〜8のいずれか一項に記載の組成物。 [9] The composition according to any one of claims 1 to 8, which is a pharmaceutical composition.
[10] 請求項 1〜8のいずれか一項に記載の組成物を含んでなる、飲食品。 [10] A food or drink comprising the composition according to any one of claims 1 to 8.
[I I] 請求項 1に記載の有効成分を有効量含んでなる、飲食品であって、  [I I] A food or drink comprising an effective amount of the active ingredient according to claim 1,
生体におけるらい菌の増殖抑制または低減に用いられる、飲食品。  A food or drink used for suppressing or reducing the growth of leprosy in a living body.
[12] 請求項 1に記載の有効成分を有効量含んでなる、飲食品であって、  [12] A food or drink comprising an effective amount of the active ingredient according to claim 1,
ハンセン病またはこれに関連する状態を予防、進行抑制または改善する機能が表 示された、飲食品。  A food or drink product that displays functions to prevent, inhibit or improve leprosy or related conditions.
[13] 健康食品、機能性食品、特定保健用食品、栄養補助食品、疾病リスク低減表示が 付された食品、または病者用食品である、請求項 10〜12のいずれか一項に記載の 飲食品。 [13] The health food, the functional food, the food for specified health use, the dietary supplement, the food with the disease risk reduction label, or the food for the sick, according to any one of claims 10 to 12. Food and drink.
[14] ヒトを含む動物腸内または発酵食品から分離されるグラム陽性細菌の少なくとも 1種 以上の有効量を、それを必要とする患者に投与するかまたは摂取させることを含んで なる、ハンセン病の症状もしくはこれに関連する状態を予防、進行抑制、または改善 する方法。  [14] Leprosy, comprising administering or ingesting to a patient in need thereof an effective amount of at least one Gram-positive bacterium isolated from intestinal or fermented foods including animals. A method to prevent, inhibit or ameliorate symptoms or related conditions.
[15] 患者が、らい菌に感染もしくは感染の疑いのある患者、またはらぃ菌に感染する可 能性の高い環境に置かれた者、または、ハンセン病を発症または発症の疑いのある 患者である、請求項 14に記載の方法。  [15] Patients who are infected or suspected of being infected with leiomycetes, or who have been placed in an environment where they are likely to be infected with leiomycetes, or who have or are suspected to develop leprosy. 15. The method according to claim 14, wherein:
[16] 細菌が、ェンテロコッカス属 (Enterococcus)、ビフイドバタテリゥム属 (Bifidobacteriu m)、ラクトバシルス属 (Lactobacillus)、ストレプトコッカス属 (Strentococcus)、および、 ラタトコッカス属 (Lactococcus)に属する細菌力もなる群より選択される、請求項 14に 記載の方法。  [16] From the group of bacteria whose bacteria belong to the genus Enterococcus, Bifidobacterium, Lactobacillus, Strentococcus, and Lactococcus 15. A method according to claim 14, wherein the method is selected.
[17] 細菌が、ェンテロコッカス属に属する細菌である、請求項 14に記載の方法。  17. The method according to claim 14, wherein the bacterium is a bacterium belonging to the genus Enterococcus.
[18] 細菌が、ェンテロコッカス,フエカリス *EC— 1 2株(Enterococcus faecalis EC- 12) ( 受託番号 FERM BP— 10284)またはその変異株である、請求項 14に記載の方法 [18] The method according to claim 14, wherein the bacterium is Enterococcus faecalis EC-12 (accession number FERM BP-10284) or a mutant thereof.
[19] 細菌が死菌体である、請求項 14に記載の方法。 [19] The method according to claim 14, wherein the bacterium is a dead cell.
[20] ハンセン病またはこれに関連する状態の予防、進行抑制または改善に用いられる 組成物を製造するための、ヒトを含む動物腸内または発酵食品から分離されるグラム 陽性細菌の少なくとも 1種以上の使用。  [20] At least one or more Gram-positive bacteria isolated from animal intestines, including humans, or fermented foods, for producing a composition for use in the prevention, progression inhibition or amelioration of leprosy or related conditions use.
[21] 細菌が、ェンテロコッカス属 (Enterococcus)、ビフイドバタテリゥム属 (Bifidobacteriu m)、ラクトバシルス属 (Lactobacillus)、ストレプトコッカス属 (Streptococcus)、および、 ラタトコッカス属 (Lactococcus)に属する細菌力もなる群より選択される、請求項 20に 記載の使用。  [21] From the group in which the bacteria belong to the genus Enterococcus, Bifidobacterium, Lactobacillus, Streptococcus, and Lactococcus 21. Use according to claim 20, which is selected.
[22] 細菌が、ェンテロコッカス属に属する細菌である、請求項 20に記載の使用。  [22] The use according to claim 20, wherein the bacterium belongs to the genus Enterococcus.
[23] 細萠力 ェンテロコッカス ·フエカリス 'EC— 12株(Enterococcus faecalis EC- 12) ( 受託番号 FERM BP— 10284)またはその変異株である、請求項 20に記載の使用 [23] Use according to claim 20, which is Enterococcus faecalis EC-12 (accession number FERM BP-10284) or a mutant thereof.
[24] 細菌が死菌体である、請求項 20に記載の使用。 [24] The use according to claim 20, wherein the bacterium is a dead cell.
[25] 組成物が食品組成物である、請求項 20〜24のいずれか一項に記載の使用。  [25] Use according to any one of claims 20 to 24, wherein the composition is a food composition.
[26] ハンセン病またはこれに関連する状態の予防、進行抑制または改善するための、 ェンテロコッカス.フエカリス .EC— 12株(Enterococcus faecalis EC- 12) (受託番号 F[26] Enterococcus faecalis EC-12 (Enterococcus faecalis EC-12) (Accession number F) for the prevention, suppression or amelioration of leprosy or related conditions
ERM BP— 10284)またはその変異株の使用。 Use of ERM BP—10284) or its mutants.
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