WO2019054491A1 - Produit ou préparation alimentaire et/ou de boisson destiné à améliorer la stabilité lacrymale et/ou le fonctionnement de la sécrétion lacrymale - Google Patents

Produit ou préparation alimentaire et/ou de boisson destiné à améliorer la stabilité lacrymale et/ou le fonctionnement de la sécrétion lacrymale Download PDF

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WO2019054491A1
WO2019054491A1 PCT/JP2018/034218 JP2018034218W WO2019054491A1 WO 2019054491 A1 WO2019054491 A1 WO 2019054491A1 JP 2018034218 W JP2018034218 W JP 2018034218W WO 2019054491 A1 WO2019054491 A1 WO 2019054491A1
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water
food
drink
glucomannan
maltitol
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PCT/JP2018/034218
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English (en)
Japanese (ja)
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一男 坪田
松本　光晴
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協同乳業株式会社
学校法人慶應義塾
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Priority to JP2019542313A priority Critical patent/JP7150282B2/ja
Publication of WO2019054491A1 publication Critical patent/WO2019054491A1/fr
Priority to JP2022123087A priority patent/JP7336105B2/ja

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    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23C—DAIRY PRODUCTS, e.g. MILK, BUTTER OR CHEESE; MILK OR CHEESE SUBSTITUTES; MAKING THEREOF
    • A23C19/00—Cheese; Cheese preparations; Making thereof
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23C—DAIRY PRODUCTS, e.g. MILK, BUTTER OR CHEESE; MILK OR CHEESE SUBSTITUTES; MAKING THEREOF
    • A23C9/00—Milk preparations; Milk powder or milk powder preparations
    • A23C9/152—Milk preparations; Milk powder or milk powder preparations containing additives
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23G—COCOA; COCOA PRODUCTS, e.g. CHOCOLATE; SUBSTITUTES FOR COCOA OR COCOA PRODUCTS; CONFECTIONERY; CHEWING GUM; ICE-CREAM; PREPARATION THEREOF
    • A23G9/00—Frozen sweets, e.g. ice confectionery, ice-cream; Mixtures therefor
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23G—COCOA; COCOA PRODUCTS, e.g. CHOCOLATE; SUBSTITUTES FOR COCOA OR COCOA PRODUCTS; CONFECTIONERY; CHEWING GUM; ICE-CREAM; PREPARATION THEREOF
    • A23G9/00—Frozen sweets, e.g. ice confectionery, ice-cream; Mixtures therefor
    • A23G9/04—Production of frozen sweets, e.g. ice-cream
    • A23G9/08—Batch production
    • A23G9/12—Batch production using means for stirring the contents in a non-moving container
    • 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
    • A23L2/00—Non-alcoholic beverages; Dry compositions or concentrates therefor; Their preparation
    • A23L2/52—Adding ingredients
    • 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
    • A23L33/125—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives containing carbohydrate syrups; containing sugars; containing sugar alcohols; containing starch hydrolysates
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/045—Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates
    • A61K31/047—Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates having two or more hydroxy groups, e.g. sorbitol
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7016—Disaccharides, e.g. lactose, lactulose
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/702—Oligosaccharides, i.e. having three to five saccharide radicals attached to each other by glycosidic linkages
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7028—Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages
    • A61K31/7032—Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages attached to a polyol, i.e. compounds having two or more free or esterified hydroxy groups, including the hydroxy group involved in the glycosidic linkage, e.g. monoglucosyldiacylglycerides, lactobionic acid, gangliosides
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/715—Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
    • A61K31/716—Glucans
    • A61K31/718—Starch or degraded starch, e.g. amylose, amylopectin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/715—Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
    • A61K31/732—Pectin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/715—Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
    • A61K31/736—Glucomannans or galactomannans, e.g. locust bean gum, guar gum
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P27/00—Drugs for disorders of the senses
    • A61P27/02—Ophthalmic agents
    • A61P27/04—Artificial tears; Irrigation solutions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/02—Immunomodulators
    • A61P37/06—Immunosuppressants, e.g. drugs for graft rejection
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

Definitions

  • the present invention relates to a food or drink or a preparation for improving lacrimation ability and / or lacrimal stability, which is formulated with a water-soluble indigestible component.
  • Dry eye refers to a state in which the ability to moisturize the surface of the eye is reduced (a decrease in tear fluid stability) due to a decrease in tear secretion (decrease in lacrimal secretion ability) or a decrease in tear quality.
  • causes of dry eye include diseases such as aging, stress, Sjogren's syndrome and the like.
  • the number of dry eye patients also tends to increase in recent years due to the use of personal computers and smartphones, the use of contact lenses, and the use of air conditioners.
  • indigestible carbohydrates such as inulin are known to suppress the rise of glucose in the blood by raising the ratio of the microflora of the gastrointestinal tract relative to the phyrite tract of the Bacteroides.
  • Patent Document 1 the possibility of treating dry eye syndrome has been suggested.
  • the present invention provides a food or drink or a preparation which is a composition for improving lacrimal secretion ability and / or lacrimal stability.
  • the present invention may be as follows.
  • a food or drink for improving lacrimal secretion ability and / or lacrimal stability comprising maltitol, galactooligosaccharides, glucomannan, lactose, fructooligosaccharides, isomaltooligosaccharides, cellobiose, xylooligosaccharides, xylitol,
  • the above food and drink containing one or more water-soluble indigestible components selected from the group consisting of sorbitol, erythritol, mannitol, pectin, resistant starch, resistant digestive dextrin and reduced resistant digestive dextrin.
  • the water-soluble indigestible ingredients to be incorporated into food and drink are as follows: (A) one or more water-soluble indigestible components selected from the group consisting of maltitol, galactooligosaccharides, glucomannan and lactose; (B) A combination of two water-soluble indigestible components selected from the group consisting of maltitol, galactooligosaccharides, glucomannan and lactose; (C) A combination of two water-soluble indigestible components selected from the group consisting of maltitol, galactooligosaccharides and glucomannan; (D) maltitol, galactooligosaccharides, glucomannan and lactose; or (e) maltitol, galactooligosaccharides and glucomannan; Food-drinks as described in said [1] or [2] which is it.
  • a preparation for improving lacrimal secretion and / or lacrimal stability which comprises maltitol, galactooligosaccharide, glucomannan, lactose, fructooligosaccharide, isomaltooligosaccharide, cellobiose, xylooligosaccharide, xylitol, sorbitol
  • the above-mentioned preparation comprising one or more water-soluble indigestible components selected from the group consisting of erythritol, mannitol, pectin, resistant starch, resistant digestive dextrin and reduced resistant digestive dextrin.
  • the water-soluble indigestible ingredients are as follows: (A) one or more water-soluble indigestible components selected from the group consisting of maltitol, galactooligosaccharides, glucomannan and lactose; (B) A combination of two water-soluble indigestible components selected from the group consisting of maltitol, galactooligosaccharides, glucomannan and lactose; (C) A combination of two water-soluble indigestible components selected from the group consisting of maltitol, galactooligosaccharides and glucomannan; (D) maltitol, galactooligosaccharides, glucomannan and lactose; or (e) maltitol, galactooligosaccharides and glucomannan; The formulation according to the above [9], which is
  • the disease or condition having tear secretion and / or tear stability disorder is dry eye (including dry keratoconjunctivitis), dry eye syndrome, VDT syndrome or Sjogren's syndrome as described above [12] The preventive or therapeutic / improvement agent described.
  • the food / beverage products or preparations of the present invention are useful as those capable of improving lacrimation ability and / or lacrimal stability.
  • FIG. 1 is a graph showing the evaluation results of the lacrimal secretion improving effect of milk added with a water-soluble indigestible ingredient mixture (galactooligosaccharide, maltitol, glucomannan).
  • FIG. 2 is a graph showing inter-group differences in VAS score by stratification analysis for the results of Example 2.
  • FIG. 3 is a graph showing intra-group changes of VAS score by stratification analysis with respect to the results of Example 2.
  • water-soluble indigestible component means a component which is difficult to be degraded by human digestive enzymes among components contained in food and is water-soluble.
  • water-soluble indigestible component is a concept which means a component including oligosaccharides, disaccharides, sugar alcohols, etc. centering on water-soluble dietary fibers which can not be degraded by human digestive enzymes. is there.
  • water-soluble resistant ingredient means either alone or in combination, unless otherwise specified.
  • Food and drink One aspect of the present invention relates to a food and drink for improving lacrimation ability and / or lacrimal stability, which is formulated with a water-soluble indigestible component.
  • the water-soluble indigestible components contained in the food and drink of the present invention include maltitol, galactooligosaccharides, glucomannan, lactose, fructooligosaccharides, isomaltooligosaccharides, cellobiose, xylooligosaccharides, xylitol, sorbitol, erythritol, mannitol, pectin, register It is one or more water-soluble indigestible components selected from the group consisting of starch starch, indigestible dextrin and reduced indigestible dextrin.
  • the water-soluble indigestible component contained in the food and drink of the present invention may be a combination of two or more types of water-soluble indigestible components selected from the above group.
  • the water-soluble indigestible component contained in the food and drink of the present invention is (A) one or more water-soluble indigestible components selected from the group consisting of maltitol, galactooligosaccharides, glucomannan and lactose; (B) A combination of two water-soluble indigestible components selected from the group consisting of maltitol, galactooligosaccharides, glucomannan and lactose; (C) A combination of two water-soluble indigestible components selected from the group consisting of maltitol, galactooligosaccharides and glucomannan; (D) maltitol, galactooligosaccharides, glucomannan and lactose; or (e) maltitol, galactooligosaccharides and glucomannan; It may be any water-soluble indigestible components selected from the group consisting of maltitol, galactooligosaccharides, glu
  • the food and drink of the present invention may contain other ingredients in addition to the above-mentioned water-soluble indigestible ingredients.
  • Such other components include, for example, turmeric, fructan, lactulose, raffinose, soy oligosaccharides, milk oligosaccharides, chitosan oligosaccharides, cyclic oligosaccharides, palatinose and the like.
  • Maltitol is 4-O- ⁇ -D-glucopyranosyl-D-glucitol, also called reduced maltose.
  • the galactooligosaccharide is 4'-galactosyl lactose.
  • Glucomannan is a polysaccharide in which glucose and mannose are linked in a linear manner with ⁇ -1,4-linkage in a ratio of about 2: 3.
  • the degree of polymerization of glucomannan used in the present invention is not particularly limited.
  • Fructooligosaccharides are polysaccharides in which one or more D-fructoses are linked via ⁇ -2,1-glycosidic bonds to the fructose portion of sucrose (sugar in which glucose and fructose are ⁇ -1,2-glycosidic bond).
  • the degree of polymerization of the fructooligosaccharide used in the present invention is not particularly limited.
  • Preferred fructooligosaccharides for use in the present invention include kestose, nystose and fructosyl nystose.
  • the isomalto-oligosaccharide is a polysaccharide having glucose as a basic constitutional unit, and contains one or more ⁇ -1,6-linkage, ⁇ -1,4-linkage, and ⁇ -1,3-linkage.
  • the degree of polymerization of the isomaltooligosaccharide used in the present invention is not particularly limited.
  • Preferable isomaltoligosaccharides used in the present invention include isomaltose, isomaltoliose and panose.
  • the xylooligosaccharide is a polysaccharide having a structure in which about 2 to 7 xylose are ⁇ -1,4-linked.
  • Pectin is a complex polysaccharide composed mainly of polygalacturonic acid in which galacturonic acid is ⁇ -1,4-linked.
  • the molecular weight of pectin which can be used in the present invention is not particularly limited.
  • Resistant starch is a generic term for starch and starch degradation products that reach the large intestine without being digested in the digestive tract up to human small intestine.
  • Resistant starch (RS) is classified into four types according to its characteristics.
  • Type 1 (RS1) is a starch that does not act on digestive enzymes such as ⁇ -amylase such as grain with low purification degree
  • type 2 (RS2) is starch with high amylose content
  • type 3 (RS3) is glued by cooking etc.
  • type 4 (RS4) is a modified starch (chemically modified starch). In the present invention, any type of resistant starch may be used.
  • Indigestible dextrin is a dietary fiber purified by adding a trace amount of acid to starch, hydrolyzing at high temperature, and hydrolyzing with ⁇ -amylase and glucoamylase.
  • the indigestible dextrin is a glucan having an average molecular weight of about 2,000, and in addition to the inherent alpha-1,4- and alpha-1,6-linkages of starch, alpha-1,2-linkage and alpha-1 , 3-bonds, etc., and have a branched and developed structure as compared to the raw material starch.
  • Reduced indigestible dextrin is obtained by subjecting indigestible dextrin to reduction treatment.
  • the addition amount of the water-soluble indigestible component or the combination of the water-soluble indigestible components in the food and drink of the present invention is not particularly limited, preferably, the combination of the water-soluble indigestible components or the water-soluble indigestible components is preferably 0 .01% w / w to 20% w / w, preferably 0.5% w / w to 15% w / w, more preferably 1% w / w to 10% w / w.
  • each component of the water-soluble indigestible component is not particularly limited, and can be appropriately set by those skilled in the art.
  • each component of the water-soluble indigestible component is preferably contained in a ratio of at least 1% or more, 10% or more, 20% or more with respect to the whole of the water-soluble indigestible component.
  • Each component of the water-soluble indigestible component may be contained in an equal amount to the whole of the water-soluble indigestible component.
  • Preferred examples of combinations of water-soluble indigestible components according to the invention are maltitol, galactooligosaccharides, glucomannan and lactose; or maltitol, galactooligosaccharides and glucomannan.
  • the addition amount of the water-soluble indigestible component in the food and drink of the present invention is not particularly limited, but if the amount is too large, there is a possibility of side effects of diarrhea.
  • the combination of the sex component or the water-soluble indigestible component is 0.2 g to 40 g, preferably 1 g to 30 g, more preferably 2 g to 20 g.
  • 0.1% w / w to 20% w / w preferably 0.5% w / w to 15% w / w, more preferably 1% w, based on the total weight / W to 10% w / w is included.
  • the concentration of maltitol contained in the beverage is 0.1% w / w to 3% w / w, preferably 0.5% w / w to 2.5% w / w
  • the concentration of galactooligosaccharides contained in the beverage may be from 0.1% w / w to 3% w / w, preferably 0.5% w / w.
  • the concentration of lactose contained in the beverage is preferably 1% w / w to 10% w / w.
  • the above concentration is the concentration relative to the weight of the beverage.
  • the daily intake amount is preferably one or two times of the above intake amount, and it is also possible to divide the amount per time into two times and so on.
  • the food and drink of the present invention may contain probiotics in addition to the water-soluble indigestible component.
  • probiotics refers to living microorganisms that produce beneficial effects in humans upon ingestion.
  • the probiotics contained in the food and drink of the present invention are not particularly limited, but belong to a microorganism understood as a lactic acid bacterium in the art, for example, a microorganism belonging to Lactobacillus, Bifidobacterium. Microorganisms, Lactococcus lactis, Enterococcus faecalis, Pediococcus pentosaceus may be mentioned.
  • the probiotics may comprise a single strain of the above mentioned microorganism, or it may comprise a combination of multiple species or strains.
  • Lactobacillus examples include Lactobacillus casei, Lactobacillus plantarum, Lactobacillus brevis, Lactobacillus rhamnosus, Lactobacillus gasseri, Lactobacillus deliburerikki, Lactobacillus helveticus, Lactobacillus paracasei. , Lactobacillus acidophilus, Lactobacillus reuteri, but not limited thereto.
  • microorganisms belonging to the genus Bifidobacterium include Bifidobacterium animalis animalis, Bifidobacterium animalis lactis, Bifidobacterium pseudocatenulatam, bifidobacterium catenulatam, bifidobacterium. Examples include, but are not limited to, um bifidum, bifidobacterium longum, bifidobacterium breve, bifidobacterium infantis and bifidobacterium addresscensis. Among these, Bifidobacterium animalis lactis can be preferably used. As one embodiment of Bifidobacterium animalis lactis, the LKM 512 strain can be used. The LKM 512 strain can be obtained from the trust organization (NITE Patent Organism Depositary) under the accession number FERMP-21998.
  • the amount of probiotics contained in the food or drink of the present invention is not particularly limited, and for example, 2 ⁇ 10 3 to 8 ⁇ 10 12 cfu, preferably 2 ⁇ 10 5 to 8 ⁇ 10 11 cfu, per 100 g of food or beverage More preferably, it can be formulated to contain 2 ⁇ 10 7 to 8 ⁇ 10 10 cfu.
  • cfu refers to colony forming units. The cfu may be measured using any method known to the person skilled in the art, for example by diluting the microorganism with phosphate buffer (PBS) and spreading the dilution on MRS medium at 37 ° C. After 48 hours of anaerobic culture, it can be measured by counting the number of grown colonies.
  • PBS phosphate buffer
  • the food and drink of the present invention is not particularly limited as long as it is a food or a beverage, but is preferably a dairy product or a western-style confection, or a soft drink.
  • the dairy product is not particularly limited as long as it is a food or beverage using raw milk or processed milk as a raw material, and includes, for example, milk drinks, cheese, fermented milk, lactic acid bacteria drinks and ice creams.
  • Preferred dairy products are milk drinks or lactic acid bacteria drinks.
  • the western-style confectionery but includes products using dairy products as raw materials, such as pudding.
  • the soft drink is not particularly limited as long as it is a drink other than a dairy product and a lactic acid bacteria drink and contains less than 1% of alcohol content, for example, juice (fruit drink and / or vegetable drink), coffee drink, tea system Beverages, carbonated beverages, sports drinks, mineral water, soy milk, etc. are included.
  • the food and drink of the present invention may be a health food, and may be classified as, for example, a special purpose food, a health functional food (a food for specified health use, a nutritional function food or a functional indication food) .
  • the food and drink of the present invention can improve the lacrimal secretion ability and tear stability of a subject who has ingested it.
  • the effect of improving tear secretion ability and tear stability of the food and drink of the present invention can be confirmed by evaluating changes in tear secretion ability and tear stability before and after ingestion of the food and drink.
  • the tear secretion ability and tear stability can be confirmed, for example, by the evaluation of tear volume and the evaluation of tear layer destruction time (BUT).
  • BUT tear layer destruction time
  • As a method of measuring the amount of tears for example, a Schirmer test using a cotton thread / filter paper for tears test may be mentioned.
  • the evaluation of tear film rupture time is to measure the time for the tear film to dry in a state in which eyelids are instilled with fluorescein dye and eyes are not opened.
  • the food or drink according to the present invention is a food or drink for preventing or alleviating a disease or symptom having a disorder of lacrimal secretion such as dry eye (including dry keratoconjunctivitis), dry eye syndrome, VDT syndrome, Sjogren's syndrome Can be.
  • a disease or symptom having a disorder of lacrimal secretion such as dry eye (including dry keratoconjunctivitis), dry eye syndrome, VDT syndrome, Sjogren's syndrome Can be.
  • the subject to which the food and drink of the present invention is to be ingested is not particularly limited. Not only patients who are diagnosed with dry eye, but also ordinary consumers, such as subjects with a tendency to dry eye (dry eye reserve group) (referred to as dry eye syndrome) and subjects who wish to prevent dry eye It can be a target.
  • dry eye means that tear film stability is reduced in a state in which the ability to moisturize the surface of the eye is reduced due to a decrease in tear secretion or a decrease in tear quality. And BUT is 5 seconds or less and there is a subjective symptom.
  • dry eye reserve group refers to a case where the dry eye condition does not correspond to the above-mentioned dry eye condition, but it indicates a symptom that satisfies one of the conditions.
  • One aspect of the present invention relates to a formulation for improving lacrimal secretion comprising a water-soluble resistant ingredient or a combination of water-soluble resistant ingredients.
  • the water-soluble indigestible component or the combination of the water-soluble indigestible component contained in the preparation of the present invention is as defined in the item of food and drink described above.
  • the amount of the water-soluble indigestible ingredient or the combination of the water-soluble indigestible ingredients in the preparation of the present invention is not particularly limited, but preferably, the water-soluble indigestible ingredient or water-soluble indigestible ingredient per intake or administration.
  • the combination of the sex components is formulated to contain 0.1 g to 20 g, preferably 0.5 g to 20 g, more preferably 1 g to 10 g.
  • the formulation of the present invention comprises 0.01% of a water-soluble resistant ingredient or a combination of water-soluble resistant ingredients in a formulation, in particular when it is a liquid, a suspension or an emulsion w / w to 20% w / w, preferably 0.5% w / w to 15% w / w, more preferably 1% w / w to 10% w / w It may be.
  • a w / w to 20% w / w preferably 0.5% w / w to 15% w / w, more preferably 1% w / w to 10% w / w It may be.
  • glucomannan is poorly soluble in water, preferably 0.01% w / w to 1% w / w in the preparation, more preferably 0.1% w / w to 1% w in the preparation / W may be included.
  • the ratio of each component of the water-soluble indigestible component is not particularly limited, and can be appropriately set by those skilled in the art.
  • the ratio of each component of the water-soluble indigestible component is not particularly limited, and can be appropriately set by those skilled in the art.
  • each component of the water-soluble indigestible component is preferably contained in a ratio of at least 5% or more, 10% or more, 20% or more with respect to the whole of the water-soluble indigestible component.
  • Each component of the water-soluble indigestible component may be contained in an equal amount to the whole of the water-soluble indigestible component.
  • the formulation of the present invention may contain other ingredients in addition to the above-mentioned water-soluble indigestible ingredients.
  • examples of such other components include the components described above in the section of food and drink.
  • the formulation of the present invention may further contain probiotics.
  • the probiotics contained in the preparation of the present invention are as defined above in the section of food and drink.
  • the formulation of the present invention may be one wherein the water-soluble indigestible ingredient or the combination of the water-soluble indigestible ingredient and the probiotics are contained in the same composition, or the water-soluble indigestible It may be a composition comprising a composition comprising a combination of a sex component or a water soluble resistant ingredient and a composition comprising a probiotic.
  • the composition comprising the water soluble resistant ingredient or the combination of the water soluble resistant ingredient and the composition comprising the probiotics may be taken or administered simultaneously, or separately It may be taken or administered.
  • the amount of probiotics in the preparation of the present invention is not particularly limited, but 2 ⁇ 10 3 to 8 ⁇ 10 12 cfu, preferably 2 ⁇ 10 5 to 8 ⁇ 10 11 cfu, more preferably 2 ⁇ 10 3 to 8 ⁇ 10 12 cfu per intake or administration. Can be formulated to contain 2 ⁇ 10 7 to 8 ⁇ 10 10 cfu.
  • the formulations of the present invention may be pharmaceuticals or quasi drugs.
  • the formulations of the present invention may be pharmaceutical compositions.
  • the preparation of the present invention may be a food such as a supplement.
  • the supplements may be classified into special purpose foods, health functional foods (specific health food, nutritive functional foods or functional labeling foods), but are not limited thereto.
  • the form of the preparation of the present invention is not particularly limited as long as it is a form suitable for human consumption or administration to humans, for example, liquid, suspension (dispersion liquid), emulsion, semisolid, paste, It may be in the form of powder, granules, tablets, capsules, jellies or pills.
  • the preparation of the present invention is a liquid, a suspension or an emulsion
  • the preparation may be in the form of a solution, an internal solution and / or a drink.
  • the formulation of the present invention may also contain additives such as sweeteners, preservatives, coloring agents, antioxidants, or flavors, or pharmaceutically acceptable excipients or carriers.
  • pharmaceutically acceptable is a component that does not produce toxic, irritating, allergic or other adverse reactions when administered to an animal, such as a human, and is other than the other components of the formulation. It means an ingredient that is compatible with the ingredient.
  • Pharmaceutically acceptable excipients or carriers can utilize ingredients commonly used in the art.
  • the preparation of the present invention can be a preparation for preventing or alleviating a disease or condition having tear secretion and / or tear stability disorder such as dry eye. Further, subjects to which the preparation of the present invention is to be ingested or administered are also as described above in the section of food and drink.
  • the present invention also relates to a method for improving the lacrimal ability and / or lacrimal stability of a subject, which comprises ingesting or administering the food or drink or the preparation of the present invention to the subject.
  • the present invention is also directed to a food or beverage formulated with a combination of a water soluble resistant ingredient or a combination of water soluble resistant ingredients as described above for use in a method of improving lacrimal secretion ability and / or tear fluid stability of a subject Products or preparations.
  • the present invention further relates to the use of the above-mentioned water-soluble resistant ingredient or a combination of water-soluble resistant ingredients for the preparation of a food or drink or a preparation having improved lacrimal secretion ability and / or tear liquid stability.
  • improving lacrimation ability may be to prevent or treat a disease or condition having lacrimation and / or tear stability disorders such as dry eye.
  • a "subject” is a mammal, preferably a human.
  • Example 1 Evaluation of tear secretion improvement effect by water-soluble indigestible component
  • Group 1 5% (w / w) lactose (aqueous solution dissolved in distilled water)
  • Group 2 5% (w / w) lactose + 1% (w / w) galactooligosaccharide + 1% (w / w) maltitol + 1% (w / w) glucomannan (aqueous solution dissolved in distilled water)
  • Group 3 (control): distilled water
  • the above solution was repeatedly administered by oral gavage with 0.5 mL / animal twice a day (morning, afternoon) for 19 days.
  • stress treatment was performed for 4 days.
  • the stress treatment was performed as follows. It was restrained for 4 hours a day in a 50 ml polypropylene centrifuge tube subjected to respirable / excretable treatment. During restraint, air was blown to the face of the mouse at a wind speed of 0.5 to 1.0 m / s. Food and drink were kept ad libitum in the cage except during restraint treatment time.
  • Measurement of lacrimal secretion was performed as follows before administration, 2 weeks after administration (before stress loading), on day 2 of stress loading, and on day 5 of stress loading. Insert a cotton thread (ZONE-QUICK (registered trademark), Showa Pharmaceutical Co., Ltd.) for 15 seconds in the left and right outer eye corners of the mouse, and measure the length of the cotton thread that turned brown due to the penetration of tears with an accuracy of 0.5 mm. did. The average value of the results obtained for the left and right eyes was taken as the tear secretion of the individual.
  • Example 2 Evaluation of dry eye preventive effect by water-soluble indigestible component
  • Methodhod> 1. subject Blood pressure and pulse rate measurement, tear film breakup time (BUT), Schirmer test, to 118 healthy Japanese men and women who routinely perform VDT (Visual Display Terminals) work between 20 and 60 years old The subjects were asked a questionnaire on eye symptoms, and the results showed that the subject had a dry eye reserve group (BUT should show a symptom that satisfies the condition of less than 5 seconds or one of the symptoms or less) that is expected to develop in the future. Elected as
  • Test beverage Ingredients prepared by adding 1.5% (w / w) of galactooligosaccharide, 1.0% (w / w) of maltitol, and 0.1% (w / w) of glucomannan as active ingredients based on non-adjusted milk and skimmed milk powder
  • the placebo used sucrose, a milk protein raw material, a flavor, etc., and the texture, the flavor, and the taste produced the drink almost the same as a test drink. After sterilizing, all were sealed in a white paper pack without a label at 200 mL / tube for test.
  • Study Design This study is a randomized, double-blind, parallel-group, controlled trial conducted from November to December when dry eye symptoms worsen.
  • the test drink group and the placebo group ingested 200 mL of each drink once a day for 3 weeks.
  • BUT examinations were performed with the left eye of the subject prior to the study (Week 0) and at 3 weeks of study drink or placebo intake (Week 3).
  • Week 0 the above test was performed after taking 200 ml of water in order to measure the basic value before taking the test drink.
  • Questionnaire tests were conducted before taking the test drink or placebo (Week 0), 1 week (Week 1), 2 weeks (Week 2), 3 weeks (Week 3).
  • Ophthalmic examination BUT evaluated keratoconjunctival epithelial disorder based on the fluorescein staining score of the cornea (Ocul Surf 14, 255-63 (2016)). That is, after instilling 2 ⁇ L of 1% fluorescein dye without preservative into the eye with a micropipette to avoid changes in tear fluid dynamics, the time from tearing up to tearing of the tear film is measured three times, The average value was calculated.
  • test paper for tear function examination (Tear production measuring strips; hereinafter, Schirmer paper) was placed on the outer third of the lower conjunctival fornix of the eye for 5 minutes. After 5 minutes, the test paper was removed and the wet length was measured. In order to avoid interference with conjunctival staining, Schirmer tests were performed at intervals of 10 minutes after BUT measurement when measuring background values.
  • VAS Visual analogue scale
  • FIG. 2 shows differences between groups. In the item of “eye-rolling”, at Week 3, the test drink group showed a significantly (p ⁇ 0.05) lower value than the placebo group (FIG. 2A). Also, in the items of “eyeache” and “red eyes” in Week 2, the test drink group showed significantly lower values (p ⁇ 0.01 and p ⁇ 0.05, respectively) compared to the placebo group (FIG. 2B And C).
  • Figure 3 shows intra-group changes observed at Week 0 and after intake (Week 1 to Week 3).

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Abstract

La présente invention concerne un produit ou une préparation alimentaire et/ou de boisson destiné à améliorer la stabilité lacrymale et/ou le fonctionnement de la sécrétion lacrymale, un composant indigeste soluble dans l'eau ayant été ajouté au produit ou à la préparation alimentaire et/ou de boisson. Il est possible d'utiliser ce produit ou cette préparation alimentaire et/ou de boisson pour prévenir ou atténuer l'œil sec.
PCT/JP2018/034218 2017-09-14 2018-09-14 Produit ou préparation alimentaire et/ou de boisson destiné à améliorer la stabilité lacrymale et/ou le fonctionnement de la sécrétion lacrymale WO2019054491A1 (fr)

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JP2022123087A JP7336105B2 (ja) 2017-09-14 2022-08-02 涙液分泌能・涙液安定性を改善するための飲食品または製剤

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