WO2022014931A1 - Oral disintegrating film composition for animals, having effect of reducing halitosis, dental calculus, stomatitis, and periodontitis - Google Patents

Oral disintegrating film composition for animals, having effect of reducing halitosis, dental calculus, stomatitis, and periodontitis Download PDF

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Publication number
WO2022014931A1
WO2022014931A1 PCT/KR2021/008564 KR2021008564W WO2022014931A1 WO 2022014931 A1 WO2022014931 A1 WO 2022014931A1 KR 2021008564 W KR2021008564 W KR 2021008564W WO 2022014931 A1 WO2022014931 A1 WO 2022014931A1
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oral
extract
disintegrating film
animals
film
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PCT/KR2021/008564
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French (fr)
Korean (ko)
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한정석
이수경
김준기
고은정
정용운
이경진
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주식회사 경보제약
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Priority claimed from KR1020210087156A external-priority patent/KR102358743B1/en
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Publication of WO2022014931A1 publication Critical patent/WO2022014931A1/en

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    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23K—FODDER
    • A23K10/00—Animal feeding-stuffs
    • A23K10/20—Animal feeding-stuffs from material of animal origin
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23K—FODDER
    • A23K50/00—Feeding-stuffs specially adapted for particular animals
    • A23K50/40—Feeding-stuffs specially adapted for particular animals for carnivorous animals, e.g. cats or dogs
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/02—Cosmetics or similar toiletry preparations characterised by special physical form
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/30—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
    • A61K8/67—Vitamins
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/96—Cosmetics or similar toiletry preparations characterised by the composition containing materials, or derivatives thereof of undetermined constitution
    • A61K8/97—Cosmetics or similar toiletry preparations characterised by the composition containing materials, or derivatives thereof of undetermined constitution from algae, fungi, lichens or plants; from derivatives thereof
    • A61K8/9783—Angiosperms [Magnoliophyta]
    • A61K8/9789—Magnoliopsida [dicotyledons]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/96—Cosmetics or similar toiletry preparations characterised by the composition containing materials, or derivatives thereof of undetermined constitution
    • A61K8/97—Cosmetics or similar toiletry preparations characterised by the composition containing materials, or derivatives thereof of undetermined constitution from algae, fungi, lichens or plants; from derivatives thereof
    • A61K8/9783—Angiosperms [Magnoliophyta]
    • A61K8/9794—Liliopsida [monocotyledons]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/96—Cosmetics or similar toiletry preparations characterised by the composition containing materials, or derivatives thereof of undetermined constitution
    • A61K8/98—Cosmetics or similar toiletry preparations characterised by the composition containing materials, or derivatives thereof of undetermined constitution of animal origin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/96—Cosmetics or similar toiletry preparations characterised by the composition containing materials, or derivatives thereof of undetermined constitution
    • A61K8/99—Cosmetics or similar toiletry preparations characterised by the composition containing materials, or derivatives thereof of undetermined constitution from microorganisms other than algae or fungi, e.g. protozoa or bacteria
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61Q—SPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
    • A61Q11/00—Preparations for care of the teeth, of the oral cavity or of dentures; Dentifrices, e.g. toothpastes; Mouth rinses
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61Q—SPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
    • A61Q17/00—Barrier preparations; Preparations brought into direct contact with the skin for affording protection against external influences, e.g. sunlight, X-rays or other harmful rays, corrosive materials, bacteria or insect stings

Definitions

  • the present invention relates to a functional orally disintegrating film composition that can remove bad breath and tartar in animals and effectively improve stomatitis and periodontitis, and more specifically, to an animal containing propolis, green tea extract and sage extract as active ingredients. It relates to an oral disintegrating film composition for preventing or improving oral diseases, and an oral disintegrating film prepared from the composition.
  • pets are used in thimble or gauze used for brushing of pets.
  • thimble or gauze used for brushing of pets.
  • the above methods are not yet effective in maintaining the oral health of the pet.
  • the present inventors have tried to develop a material that can effectively improve stomatitis (or stomatitis) and periodontitis (or gingivitis) together with an oral film that can effectively remove the bad breath of pets. .
  • an oral disintegrating film containing propolis, green tea extract and sage extract as an active ingredient, Porphyromonas gingivalis , Provotella intermedia , and It has excellent antibacterial activity against oral bacteria such as Fusobacterium nucleatum , and can effectively improve stomatitis (or stomatitis) and periodontitis (or gingivitis) as well as improving bad breath and removing tartar.
  • an object of the present invention to provide an oral disintegrating film composition that can effectively prevent or improve oral diseases of animals.
  • Another object of the present invention is to provide an oral disintegrating film formulation for the prevention or improvement of oral diseases of animals prepared with the composition.
  • the present invention provides an oral disintegrating film composition for preventing or improving oral diseases of animals comprising propolis, green tea extract and sage extract as active ingredients.
  • the oral disease may be selected from the group consisting of stomatitis, stomatitis, bad breath, calculus, periodontitis and gingivitis.
  • the composition may further include spirulina extract or corn unsaponifiable extract as an active ingredient.
  • the composition may further include an edible polymer.
  • the edible polymer is hydroxypropyl cellulose, hydroxypropylmethyl cellulose, hydroxyethyl cellulose, carboxymethyl cellulose sodium, carboxymethyl cellulose calcium, carboxymethyl cellulose potassium, carboxymethyl It may be selected from the group consisting of cellulose and fullulane.
  • the present invention provides an orally disintegrating film for the prevention or improvement of oral diseases of animals prepared with the composition.
  • the orally disintegrating film may be attached to the tongue, roof of the mouth, sublingual or inner courtyard (buccal) of the animal.
  • Oral disintegrating film according to the present invention is easy to breed in the mouth of animals Porphyromonas gingivalis ( Porphyromonas gingivalis ), Provotella intermedia ( Prevotella intermedia ) and Fusobacterium nucleatum ( Fusobacterium nucleatum ) Oral such as It has very excellent antibacterial activity against internal bacteria, and can effectively improve stomatitis (or stomatitis) and periodontitis (or gingivitis) along with the effect of improving bad breath and removing tartar. Functionality for preventing or improving oral diseases of animals It can be usefully used as food.
  • 1 to 7 are photographs comparing the degree of calculus removal before and after feeding the oral disintegrating film containing the spirulina extract powder of the present invention to dogs for 30 days.
  • the term “animal” refers to carnivores such as dogs, cats, rodents, such as chinchillas, guinea pigs, degu, mice, gerbils, hamsters, rats, ferrets, and haemopods. , including all mammals kept as pets, for example rabbits. Preferably, it may be a cat or a dog.
  • the term “about” or “approximately” means within 20%, preferably within 10%, more preferably within 5% of a given value or range.
  • the present invention relates to an oral disintegrating film composition for preventing or improving oral diseases of animals comprising propolis, green tea extract and sage extract as active ingredients.
  • propolis is a substance collected from tree sap, bark of fruit trees, and stamens of flowers by bees, and used for self-defense of bees or repair of bees, mainly resin, beeswax, essential oil, pollen, It is composed of various organic and mineral substances and has been reported to have antibacterial, antifungal, antiviral, antitumor, and wound healing properties as well as antioxidant action.
  • Various organic and mineral substances in propolis contain a large amount of flavonoids, and it has been reported that these flavonoids exhibit a strong antibacterial effect.
  • the flavonoids of propolis are all aglycones, which is different from flavonoids of other plants, and this advantage is involved in the antibacterial action of propolis.
  • propolis since propolis does not have an antibacterial action against intestinal bacteria, it has no adverse effect on the intestinal flora useful to the human body, that is, bifidobacteria or lactic acid bacteria, even when administered orally. Therefore, propolis is a very safe natural antibacterial substance that is not toxic no matter how much it is ingested.
  • green tea refers to tea made using unfermented tea leaves. Green tea is known to help obese people easily lose body fat by affecting lipid metabolism and preferentially using fat as an energy source, as well as catechins reducing cholesterol and triglycerides.
  • green tea extract is an extract extracted from green tea leaves, and the green tea extract can be directly extracted from green tea leaves using a known method, or a commercially available product can be used.
  • green tea extract refers to an extract obtained by extracting green tea leaves, a diluted or concentrated liquid of the extract, a dried product obtained by drying the extract, a prepared or purified product of the extract, or a mixture thereof, such as the extract itself. And it is a concept including extracts of all formulations that can be formed using the extract.
  • “Sage ( Salvia officinalis )” is also called medicinal salvia.
  • Sage is also known as Common Sage, Garden Sage, and also commonly referred to as Salvia.
  • the stem is square, almost woody at the bottom, 30 ⁇ 90cm high, and the whole is fragrant.
  • the leaves are opposite, the petiole is short, and the tip is dull and the edge is flat in a long oval shape.
  • the underside of the leaf is gray-green with white hairs along with the stem, and the surface has fine wrinkles in the network.
  • the flowers bloom in May-July and are purple in color and are raceme in tiers at the tip of the branch, and the upper part rotates.
  • the flowers contain nectar, so it is a nectar plant where bees gather.
  • the calyx tube is bell-shaped and the corolla is 1.5 ⁇ 2cm long, and the two flowers at the top and bottom are split like upper and lower lips at the tip of the wide tube. There are 2 stamens, and the style is longer than the upper lip of the corolla. There are many varieties, some with blue and white flowers. Sowing in spring or autumn, picking leaves in August and drying them in the shade is called folia salvia and contains about 2% of essential oil. The main components of essential oil are pinene, sesquiterpene, and borneol. For medicinal purposes, the leaves are boiled and used for sore throat and gastroenteritis. It has antiseptic, antibacterial, anti-inflammatory, sterilizing and disinfecting effects, and is also used as an anti-inflammatory agent for inflammation. It also washes away fatigue after a stroke or intense exercise. It is native to southern Europe and has been widely cultivated as a household incense candle in Europe and America since ancient times.
  • sage extract is an extract extracted from sage sage extract, and the sage extract can be directly extracted from sage sage extract using a known method, or a commercially available product can be used.
  • the "sage extract” refers to an extract obtained by extracting sage whole plant, a diluted or concentrated liquid of the extract, a dried product obtained by drying the extract, a prepared or purified product of the extract, or a mixture thereof, the extract itself and It is a concept that includes extracts of all formulations that can be formed using the extract.
  • oral disease means a disease that can occur in the oral cavity of an animal, and specifically, stomatitis, stomatitis, bad breath, tartar, periodontitis, and gingivitis may be exemplified. It does not limit the type.
  • stomatitis refers to all inflammatory diseases that accompany pain in the oral cavity, and there are various classification methods for stomatitis according to symptoms, occurrence sites, causes, and physical examination findings, but uniformly for each disease It is difficult to apply. In general, stomatitis is divided into ulcerative stomatitis, bullous stomatitis, and erosive stomatitis.
  • cheilitis is an inflammation of the lips, which is caused by contact with a wound or an irritant on the lips.
  • stomatitis is a disease that only occurs in dogs among animal types, and may be caused by secondary infections caused by bacteria such as lip wounds, contact with irritants, and allergies. could be the cause
  • gingivitis is inflammation that appears in the surrounding soft tissue, also called periodontitis ( ⁇ ).
  • gingiva gingiva
  • gingivitis refers to an inflammatory disease occurring in the gingiva (gum) among periodontal tissues.
  • tartar means that minerals such as calcium (Ca) and phosphorus (P) derived from saliva and gingival sulcus (space between teeth and gums) are deposited on the dental plaque and hardened. do.
  • the composition is 75% inorganic and 6 to 15% organic, with the remainder being water.
  • a pellicle a bacterial film (dental plaque) is matured, followed by mineralization (calcium, phosphorus, magnesium, fluorine), and then crystals are formed.
  • "bad breath” is the volatile sulfur compound gas generated in the process of decomposition of proteins in the oral bacteria (P.gingivalis T.denticola, Fusobacterium sp. P.intermedia , Eubacterium sp.)
  • As the mouth odor in the mouth It is mainly generated by Volatile Sulfur Compounds (VSC), and the protein that serves as a nutrient for bacteria is mainly derived from food residues, saliva, and exfoliated oral mucosa cells.
  • the oral disintegrating film composition for preventing or improving oral diseases of animals contains the active ingredients (propolis, green tea extract and sage extract) as described above in an amount of 10 to 20% by weight based on 100% by weight of the total composition.
  • the propolis, green tea extract and sage extract may be blended in various mixing ratios, for example, 10 to 2: 10 to 2: 10 to 2 may be blended, Preferably, a mixing ratio of 10:3:2 is good.
  • an orally disintegrating film was prepared by mixing propolis, green tea extract and sage extract, which are the active ingredients of the present invention, in various mixing ratios, and their antibacterial activity against bacteria in the oral cavity was measured.
  • propolis, green tea extract, and sage extract were mixed in a ratio of 10: 3: 2
  • a remarkably superior antibacterial effect was confirmed compared to other mixing ratios (see ⁇ Experimental Example 2>).
  • the oral disintegrating film composition for preventing or improving oral diseases of animals of the present invention may further include spirulina extract or corn unsaponifiable extract in addition to propolis, green tea extract and sage extract as an active ingredient.
  • Spirulina is a type of cyanobacteria first isolated and reported by Turpin, a German algaeologist in 1827, and contains 55-70% protein, 6-9% fat, and 15-20% carbohydrate. It contains a large amount of minerals, vitamins, and fiber pigments.
  • the cell wall of Spirulina is low in cellulose and composed of soft mucopolysaccharide, and because it is very thin, it has a high digestibility and absorption rate.
  • the protein content and quality are excellent, so essential amino acids are contained in a balanced way, and the protein utilization rate (NPU) is high, so it is a protein food comparable to meat, milk, and eggs, which are complete protein foods.
  • Spirulina is rich in polyunsaturated essential fatty acids, linolenic acid (18:2) and gamma-linolenic acid, and also contains significant amounts of n-3 fatty acid, linoleic acid.
  • gamma-linolenic acid a precursor of prostaglandins, has the functions of inhibiting cholesterol rise, improving atopic dermatitis, alleviating premenstrual syndrome, decomposing and promoting alcohol metabolites, controlling blood pressure, preventing thrombosis, anti-asthma, and anti-tumor action.
  • Prostaglandins have been reported to have various functions, such as maintaining a constant blood pressure, participating in blood clotting, preventing platelets from sticking to each other, improving blood circulation, and reducing inflammation.
  • Spirulina extract is an extract extracted from spirulina powder or raw spirulina.
  • an organic solvent such as methanol or nucleic acid
  • a physical process such as ultrasonication or ultra-high pressure
  • purified water is added to dilute it. process can also be used.
  • Spirulina extract as the active ingredient of the present invention may be included in an amount of 10 to 20% by weight based on 100% by weight of the oral disintegrating film composition of the present invention.
  • corn unsaponifiable extract is a material separated from corn through various processes, and phytosterol and squalene composed of sitosterol, stigmsterol, ergosterol, etc. , carotene, and tocopherol.
  • Commercially available products may be used for the unsaponifiable corn extract.
  • the corn unsaponifiable extract as the active ingredient of the present invention may be included in an amount of 1 to 10% by weight based on 100% by weight of the oral disintegrating film composition of the present invention.
  • the oral disintegrating film composition for preventing or improving oral diseases of animals according to the present invention may further include an edible polymer in addition to the active ingredient.
  • the edible polymer refers to a film forming agent as a polymer that forms an orally disintegrating film.
  • the edible polymer is, for example, hydroxypropyl cellulose, hydroxypropylmethyl cellulose, hydroxyethyl cellulose, carboxymethyl cellulose sodium, carboxymethyl cellulose calcium, carboxymethyl cellulose potassium, carboxymethyl cellulose, fullulan , starch, modified starch (pregelatinized starch, etc.), gelatin, pectin, sodium alginate, maltodextrin, polymerized rosin, methylcellulose, crystalline cellulose, colicott, Eudragit, polyethylene oxide, polyvinyl pyrrolidone, It may be selected from the group consisting of polyvinyl alcohol, hyaluronic acid, hyaluronic acid derivatives, chitosan, chitosan derivatives, xanthan gum and carrageenan. These polymer
  • the edible polymer may have a viscosity of 1.0 to 30 mPa ⁇ s, but is not particularly limited thereto.
  • the orally disintegrating film composition of the present invention may be formed by mixing one or more plasticizers, sweeteners, flavoring agents, salivary secretion stimulants, surfactants, pigments, antioxidants, anti-foaming agents, etc., as needed together with an edible polymer.
  • the plasticizer is a material used to impart flexibility and elasticity to the oral disintegrating film composition, for example, acetyl triethyl citrate, polyethylene glycol, propylene glycol, glycerin, citrate ester, triacetin and triethyl citrate. It may be selected from the group consisting of and the like. These plasticizers may be used independently and may be used in combination of 2 or more type. The plasticizer may be included in an amount of 0.1 to 50% by weight based on 100% by weight of the oral disintegrating film composition of the present invention.
  • the sweetener is a substance that is easy to take by adding it to an unpleasant taste, for example, sucralose, acesulfame potassium, stevia, maltitol, isomaltooligosaccharide, sorbitol, xylitol, polyol, mannitol, sucrose, dextrose , fructose, alitam, neotame, saccharin and its salts, aspartame, glycyrrhizin, stebitene, acesulfame K, sodium saccharide and cyclomate.
  • the said sweetener may be used independently and may be used in combination of 2 or more type.
  • the sweetener may be included in an amount of 0.1 to 50% by weight based on 100% by weight of the oral disintegrating film composition of the present invention.
  • the flavoring agent is a substance imparting flavor, for example, beef flavor, natural flavoring (guarana, orange, lemon, peppermint, cinnamon, menthol, peppermint oil, winter green mint, clove, butterscotch, maple, apricot, peach flavor , cherry flavor, anise, strawberry flavor, vanillin, citrus flavor, licorice flavor, root beer flavor, gardenia, raspberry flavor, walnut flavor, chocolate flavor, etc.) and synthetic flavor.
  • the flavoring agent or taste-blocking agent may be used alone or in combination of two or more.
  • the flavoring agent may be included in an amount of 0.01 to 20% by weight based on 100% by weight of the oral disintegrating film composition of the present invention.
  • the salivary stimulating agent may be selected from the group consisting of citric acid, citrate, lactic acid, malic acid, ascorbic acid, tartaric acid and tartrate. These salivary stimulating agents may be used alone or in combination of two or more.
  • the salivary secretion stimulating agent may be included in an amount of 1 to 15% by weight based on 100% by weight of the oral disintegrating film composition of the present invention.
  • the surfactant may be selected from the group consisting of poloxamer, sodium lauryl sulfate, benzethonium chloride, polyoxyethylene fatty acid ester, polysorbate, and sorbitan ester.
  • the said surfactant may be used independently and may be used in combination of 2 or more type.
  • the surfactant may be included in an amount of 0.1 to 5% by weight based on 100% by weight of the oral disintegrating film composition of the present invention.
  • the pigment may be selected from the group consisting of natural pigments and synthetic pigments including red iron oxide, titanium oxide, silicon dioxide, and zinc oxide.
  • dye may be used independently and may be used in combination of 2 or more type.
  • the pigment may be included in an amount of 0.001 to 5% by weight based on 100% by weight of the oral disintegrating film composition of the present invention.
  • the antioxidant may be selected from the group consisting of sodium hydrogen sulfite, methyl paraben, propyl paraben, sodium benzoate, benzalkonium chloride and benzethonium chloride.
  • the said antioxidant may be used independently and may be used in combination of 2 or more type.
  • the antioxidant may be included in an amount of 0.01 to 2% by weight based on 100% by weight of the oral disintegrating film composition of the present invention.
  • the anti-foaming agent refers to an agent capable of removing bubbles generated during liquid preparation, for example, simethicone and the like may be used.
  • the present invention relates to an orally disintegrating film for the prevention or improvement of oral diseases of animals prepared with the composition.
  • the oral disintegrating film for preventing or improving oral diseases in animals according to the present invention may have a thickness of about 0.05 to 3 mm and a size of 1 cm2 to 15 cm2, and can be attached to the tongue, roof of the mouth, sublingual or buccal of the animal.
  • a film was prepared by adding water-soluble propolis, green tea extract, and sage extract so that the total amount of active ingredients was 15 mg (18.3%) in one film.
  • Water-soluble propolis used in the experiment was purchased from Unique Biotech, and green tea extract and sage extract were purchased from Mirae Biotech.
  • the prepared film preparation solution is poured on the base film paper, cast with a film applicator (1117, SI), dried at a high temperature of 80° C. or higher, and separated (peeled) from the base film paper to obtain an orally disintegrating film containing water-soluble propolis. got it
  • the prepared film preparation solution was poured on the base film paper, cast with a film applicator (1117, SI), dried at a high temperature of 80 ° C. or higher, and separated (peeled) from the base film paper to obtain an orally disintegrating film containing green tea extract. .
  • the prepared film preparation solution was poured on the base film paper, cast with a film applicator (1117, SI), dried at a high temperature of 80 ° C. or higher, and separated (peeled) from the base film paper to obtain an oral disintegrating film containing sage extract. .
  • the prepared film preparation liquid is poured on the base film paper, cast with a film applicator (1117, SI), dried at a high temperature of 80 ° C or higher, and separated (peeled) from the base film paper, and the oral shelf containing water-soluble propolis and green tea extract I got the film.
  • the prepared film preparation solution is poured on the base film paper, cast with a film applicator (1117, SI), dried at a high temperature of 80° C. or higher, and separated (peeled) from the base film paper, and the oral shelf containing water-soluble propolis and sage extract I got the film.
  • the prepared film preparation liquid is poured on the base film paper, cast with a film applicator (1117, SI), dried at a high temperature of 80 ° C or higher, and separated from the base film paper (peeled) to disintegrate orally containing green tea extract and sage extract got a film.
  • 340 g of purified water was put in a preparation container, glycerin 24.26 g, and polysorbate 80 1.2 g were added, and then dispersed by stirring.
  • 10 g of water-soluble propolis, 10 g of green tea extract, and 10 g of sage extract were added and stirred again to disperse completely.
  • 0.4 g of sucralose and 0.4 g of acesulfame potassium were added to the dispersed solution, followed by stirring again.
  • the prepared film preparation liquid is poured on the base film paper, cast with a film applicator (1117, SI), dried at a high temperature of 80 ° C or higher, and separated (peeled) from the base film paper to contain water-soluble propolis, green tea extract, and sage extract. An orally disintegrating film was obtained.
  • Example ⁇ 1-1> Example ⁇ 1-2>
  • Porphyromonas gingivalis KCTC 5352, Provotella intermedia ATCC 25611, and Fusobacterium nucleatum KCTC 2488 were used.
  • Porphyromonas gingivalis KCTC 5352 is Hemin (Sigma) (5 ⁇ g/mL) and menadione (Sigma) (0.5 ⁇ g/mL) added Tryptic soy (BD-Difco) broth and sheep Using TS blood agar medium (BD-Difco) (TS-HM) supplemented with red blood cells (Asan Co.) 5% was used and cultured anaerobically at 37° C. for 48 hours using the Steel wool method.
  • Provo telra Inter Media ATCC 25611 (Prevotella intermedia ATCC 25611) and Pugh jobak Te Solarium New Klee Atum KCTC 2488 (Fusobacterium nucleatum KCTC 2488) is Yeast extract (BD-Difco) ( 5 mg / mL), hemin (Sigma) (5 ⁇ g /mL) and menadione (0.5 ⁇ g/mL), Brain heart infusion (BD-Difco) broth, and BHI blood agar (BD-Difco) (BHI-HM) supplemented with 5% sheep red blood cells (Asan Co.). ) and incubated anaerobically at 37°C for 48 hours using the steel wool method.
  • BD-Difco Yeast extract
  • hemin Sigma
  • menadione 0.5 ⁇ g/mL
  • BHI-HM BHI blood agar
  • sheep red blood cells (Asan Co.).
  • the test strain was first cultured for 48 hours, and then each test strain was inoculated into BHI broth medium (BD-Difco) supplemented with yeast extract (BD-Difco) 5 mg/mL, hemin (Sigma) 5 ⁇ g/mL and menadione (Sigma) 0.5 ⁇ g/mL to obtain McFarland No. The concentration of the bacterial solution was adjusted to obtain a turbidity of 0.5.
  • BHI broth medium BD-Difco
  • yeast extract BD-Difco
  • hemin hemin
  • menadione Menadione
  • MIC minimum growth inhibitory concentration
  • 300 ⁇ L of each 15 mg/mL solution of each sample in Table 2 was inoculated into a 96 well micro plate, and then 2-fold to 256-fold through binary dilution with sterile distilled water. diluted to . Concentrations in each well were measured in McFarland No. After inoculating 150 ⁇ L of the appropriate bacterial solution with 0.5, anaerobic culture was performed at 37° C. for 48 hours according to the culture conditions of each experimental strain by the steel wool method. Then, the growth of the test strain was visually evaluated, and the lowest concentration among the wells in which the strain did not grow was measured as the MIC of each natural substance.
  • Example ⁇ 1-1 Active ingredient concentration of MIC test solution MIC test solution Active ingredient concentration
  • nucleatum KCTC 2488 in 30% DMSO solution used as a solvent for each sample all experimental strains were cultured in a 2-fold dilution of 30% DMSO solution. It was confirmed that there was no interference effect of the 30% DMSO solution on the MIC measurement of each sample.
  • the MIC value of the sample of Example ⁇ 1-7> for strain P. gingivalis KCTC 5352 was measured to be 0.23 mg/mL, which was the most It was determined that the potency was good, and the sample of Example ⁇ 1-4> showed the second highest potency at 0.47 mg/mL.
  • Examples ⁇ 1-1>, ⁇ 1-2>, ⁇ 1-6>, and ⁇ 1-7> for F. nucleatum KCTC 2488 strain were measured as 0.23 mg/mL, showing the highest efficacy.
  • the oral disintegrating film of Example ⁇ 1-7> (containing 5 mg of water-soluble propolis, 5 mg of green tea extract, 5 mg of sage extract) was the most It was confirmed that the antibacterial activity was excellent.
  • Water-soluble propolis, green tea extract, and sage extract are all included in order to derive an optimized ratio that inhibits the growth of bacteria in the oral cavity, and the total amount of active ingredients per film is 15 mg (18.3%), An orally disintegrating film was prepared.
  • 340 g of purified water was put in a preparation container, glycerin 24.26 g, and polysorbate 80 1.2 g were added, and then dispersed by stirring. 20 g of water-soluble propolis, 4 g of green tea extract, and 6 g of sage extract were added to the dispersed solution, and stirred again to disperse completely. Further, 0.4 g of sucralose and 0.4 g of acesulfame potassium were added to the dispersed solution, followed by stirring again.
  • the prepared film preparation solution is poured on the base film paper, cast with a film applicator (1117, SI), dried at a high temperature of 80° C. or higher, and separated (peeled) from the base film paper to contain water-soluble propolis, green tea extract and sage extract An orally disintegrating film was obtained.
  • 340 g of purified water was put in a preparation container, glycerin 24.26 g, and polysorbate 80 1.2 g were added, and then dispersed by stirring. 20 g of water-soluble propolis, 6 g of green tea extract, and 4 g of sage extract were added to the dispersed solution, and stirred again to disperse completely. Further, 0.4 g of sucralose and 0.4 g of acesulfame potassium were added to the dispersed solution, followed by stirring again.
  • the prepared film preparation solution is poured on the base film paper, cast with a film applicator (1117, SI), dried at a high temperature of 80° C. or higher, and separated (peeled) from the base film paper to contain water-soluble propolis, green tea extract and sage extract An orally disintegrating film was obtained.
  • 340 g of purified water was put in a preparation container, glycerin 24.26 g, and polysorbate 80 1.2 g were added, and then dispersed by stirring. 4 g of water-soluble propolis, 20 g of green tea extract, and 6 g of sage extract were added to the dispersed solution, and stirred again to disperse completely. Further, 0.4 g of sucralose and 0.4 g of acesulfame potassium were added to the dispersed solution, followed by stirring again.
  • the prepared film preparation solution is poured on the base film paper, cast with a film applicator (1117, SI), dried at a high temperature of 80° C. or higher, and separated (peeled) from the base film paper to contain water-soluble propolis, green tea extract and sage extract An orally disintegrating film was obtained.
  • 340 g of purified water was put in a preparation container, glycerin 24.26 g, and polysorbate 80 1.2 g were added, and then dispersed by stirring. 6 g of water-soluble propolis, 20 g of green tea extract, and 4 g of sage extract were added to the dispersed solution, and stirred again to disperse completely. Further, 0.4 g of sucralose and 0.4 g of acesulfame potassium were added to the dispersed solution, followed by stirring again.
  • the prepared film preparation solution is poured on the base film paper, cast with a film applicator (1117, SI), dried at a high temperature of 80° C. or higher, and separated (peeled) from the base film paper to contain water-soluble propolis, green tea extract and sage extract An orally disintegrating film was obtained.
  • 340 g of purified water was put in a preparation container, glycerin 24.26 g, and polysorbate 80 1.2 g were added, and then dispersed by stirring. 4 g of water-soluble propolis, 6 g of green tea extract, and 20 g of sage extract were added to the dispersed solution, and stirred again to disperse completely. Further, 0.4 g of sucralose and 0.4 g of acesulfame potassium were added to the dispersed solution, followed by stirring again.
  • the prepared film preparation solution is poured on the base film paper, cast with a film applicator (1117, SI), dried at a high temperature of 80° C. or higher, and separated (peeled) from the base film paper to contain water-soluble propolis, green tea extract and sage extract An orally disintegrating film was obtained.
  • 340 g of purified water was put in a preparation container, glycerin 24.26 g, and polysorbate 80 1.2 g were added, and then dispersed by stirring. 6 g of water-soluble propolis, 4 g of green tea extract, and 20 g of sage extract were added to the dispersed solution, and stirred again to disperse completely. Further, 0.4 g of sucralose and 0.4 g of acesulfame potassium were added to the dispersed solution, followed by stirring again.
  • the prepared film preparation solution is poured on the base film paper, cast with a film applicator (1117, SI), dried at a high temperature of 80° C. or higher, and separated (peeled) from the base film paper to contain water-soluble propolis, green tea extract and sage extract An orally disintegrating film was obtained.
  • the MIC value of the sample ⁇ 2-2> for strain P. gingivalis KCTC 5352 was 0.058 Measured in mg/mL, it was determined that the antibacterial effect was 2 to 8 times better than that of other samples.
  • the MIC value of the sample ⁇ 2-2> of Example ⁇ 2-2> against the F. nucleatum KCTC 2488 monarch was 0.058 mg/mL, showing an antibacterial effect 2 to 64 times higher than that of other samples, and P. intermedia ATCC 25611
  • the MIC measurement value in the sample of Example ⁇ 2-2> was 0.12 mg/mL, indicating a high antibacterial effect from 2 to 32 times compared to other samples.
  • Example ⁇ 2-2> in which water-soluble propolis, green tea extract, and sage extract had a mixing ratio of 10:3:2, was remarkably excellent in inhibiting the growth of bacteria in the oral cavity. Confirmed.
  • the value of bad breath according to the intake of the oral disintegrating film of Example 9 was measured.
  • intraoral air was collected using a 50mL syringe, and the collected oral air was injected into a bad breath meter (manufacturer TANITA, HC-150M) for 3 seconds, and the oral disintegrating film of Example 9 was single-shot. Halitosis was measured before and after feeding.
  • the value of the degree of bad breath is as follows.
  • Example ⁇ 2-2> in order to confirm the effect of removing bad breath of the oral disintegrating film of Example ⁇ 2-2>, which was confirmed as the optimal mixing ratio through ⁇ Experimental Example 2>, the The following experiments were performed by request. The effect of removing bad breath was confirmed when the oral disintegrating film of Example ⁇ 2-2> was applied to 102 dogs managed at 3 KPC affiliated animal hospitals.
  • spirulina extract powder was additionally added to prepare an oral disintegrating film.
  • Spirulina extract powder used in the experiment was purchased from Mirae Biotech.
  • 380 g of purified water was placed in a preparation container, and 24.26 g of glycerin and 1.2 g of polysorbate 80 were added, followed by stirring to disperse.
  • 20 g of water-soluble propolis, 6 g of green tea extract, 4 g of sage extract, and 24 g of spirulina extract were added to the dispersed solution, and stirred again to disperse completely.
  • 0.4 g of sucralose and 0.4 g of acesulfame potassium were added to the dispersed solution, followed by stirring again.
  • the prepared film preparation liquid is poured on the base film paper, cast with a film applicator (1117, SI), dried at a high temperature of 80° C. or higher, and separated from the base film paper (peeled) to obtain water-soluble propolis, green tea extract, sage extract and spirulina. An orally disintegrating film containing extract powder was obtained.
  • an orally disintegrating film was prepared by further adding corn unsaponifiable extract.
  • the corn unsaponifiable extract used in the experiment was purchased from Mirae Biotech.
  • the prepared film preparation liquid is poured on the base film paper, cast with a film applicator (1117, SI), dried at a high temperature of 80° C. or higher, and separated from the base film paper (peeled) to obtain water-soluble propolis, green tea extract, sage extract and corn An orally disintegrating film containing unsaponifiable extract was obtained.
  • the oral disintegration film containing corn saponification extract was fed for 60 days, and the effect of improving periodontal disease was confirmed.
  • Example containing corn saponification extract by measuring the depth of the periodontal pocket, the tooth junction between the teeth and gums, using a periodontal probe marked with a scale of 1 to 15 mm as a tool to evaluate the periodontal condition in the oral cavity
  • the periodontal state before and after ingestion of the oral disintegrating film of 15 was evaluated.
  • the average depth of the periodontal pocket is 1 to 3 mm, and if it measures 4 mm or more, it is diagnosed as having periodontal disease.
  • Periodontal pocket depth before and after ingestion of orally disintegrating film containing corn unsaponifiable extract of the present invention test subject Periodontal pocket depth before feeding (mm) Periodontal pocket depth after feeding (mm) test dog 1 4 3 test dog 2 4 2 test dog 3 5 5 test dog 4 6 5 test dog 5 6 4 test dog 6 5 3 test dog 7 6 5 test dog 8 5 4

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Abstract

The present invention relates to a functional oral disintegrating film composition capable of removing halitosis and dental calculus and effectively alleviating stomatitis and periodontitis in animals and, specifically, to an oral disintegrating film composition comprising propolis, a green tea extract, and a sage extract as active ingredients for preventing or alleviating animal oral diseases and an oral disintegrating film prepared with the composition. The oral disintegrating film according to the present invention has excellent antibacterial activity against oral bacteria such as Porphyromonas gingivalis, Prevotella intermedia, and Fusobacterium nucleatum, which are apt to proliferate in the mouth of pets, and can effectively alleviate stomatitis (or cheilitis) and periodontitis (or gingivitis) in addition to exhibiting halitosis reduction and dental calculus removal, thus finding advantageous applications in a functional food for prevention or alleviation of oral diseases in animals.

Description

구취제거, 치석제거, 구내염 및 치주염 개선 효과를 갖는 동물용 구강붕해필름 조성물Oral disintegrating film composition for animals having the effect of removing bad breath, removing tartar, stomatitis and periodontitis
본 발명은 동물의 입냄새 및 치석을 제거하고, 구내염 및 치주염을 효과적으로 개선시킬 수 있는 기능성 구강붕해필름 조성물에 관한 것으로, 자세하게는 프로폴리스, 녹차추출물 및 세이지추출물을 유효성분으로 포함하는 동물의 구강 질환의 예방 또는 개선용 구강붕해필름 조성물 및 상기 조성물로 제조된 구강붕해필름에 관한 것이다.The present invention relates to a functional orally disintegrating film composition that can remove bad breath and tartar in animals and effectively improve stomatitis and periodontitis, and more specifically, to an animal containing propolis, green tea extract and sage extract as active ingredients. It relates to an oral disintegrating film composition for preventing or improving oral diseases, and an oral disintegrating film prepared from the composition.
강아지, 고양이 등 애완동물 관련 시장이 급속하게 성장하며 반려동물의 건강에 대한 관심이 증대되고 있다. 이러한 애완동물 관련 산업에 있어서, 애완동물들 스스로가 건강과 보건을 관리하지 못하는 관계로 이를 개선하기 위한 관련 용품 분야의 성장은 비약적이다.As the pet-related market such as dogs and cats is growing rapidly, interest in the health of companion animals is increasing. In this pet-related industry, the growth of the related products field for improving the health and health of pets themselves is rapid because they cannot manage it.
애완동물의 사육이 일반화되면서, 아파트 등으로 대표되는 마당이 없는 주거형태에서 애완동물과 같이 생활하는데 있어서 문제점 중의 하나는 애완동물 특유의 냄새로서, 특히 구취이다. 실내에서 애완동물을 사육하는 경우에는 애완동물과 인간의 직접적인 접촉이 많아서 입맞춤하는 경우도 있다. 이 경우, 구취는 물론 병원균이 인간에게 옮겨올 수 있는 가능성도 배제할 수 없다.As the breeding of pets has become common, one of the problems in living with pets in a residential type without a yard represented by an apartment or the like is a peculiar smell of a pet, particularly bad breath. In the case of raising pets indoors, there is a lot of direct contact between pets and humans, so there is a case of kissing. In this case, not only bad breath, but also the possibility that pathogens can be transmitted to humans cannot be excluded.
애완동물은 다양한 음식물을 섭취하게 됨으로써 구강 내에 여러 종류의 세균이 번식하여 구취가 발생하게 된다. 애완동물의 입에서 나는 냄새의 원인은 다양한데, 그 중에서 가장 비중이 큰 원인으로는 애완동물의 구강내 염증질환(구내염, 구순염 등), 치주질환(치주염, 치은염 등) 및 치석 등과 관련해서 나는 냄새이다. 애완동물의 특성상 양치가 쉽지 않은데 반해, 간식을 많이 급여하기 때문에 음식물의 일부가 구강에 체류하는 시간이 늘어나기 때문에, 애완동물의 구취와 치석의 발생은 필연적이라고 할 수 있다.As pets consume a variety of foods, various types of bacteria multiply in the oral cavity, causing bad breath. There are various causes of odors from a pet's mouth, and the most important cause is odors related to inflammatory diseases in the pet's mouth (stomatitis, stomatitis, etc.), periodontal disease (periodontitis, gingivitis, etc.) and tartar. to be. On the other hand, it is not easy to brush teeth due to the characteristics of pets, but because a lot of snacks are fed, the time a part of food stays in the mouth increases, so bad breath and tartar in pets are inevitable.
최근에는 실내에서 인간과 같이 생활하는 애완동물의 구강 내 건강에 대한 관심이 고조되어 있는 바, 애완동물에 대한 치아와 구강 내의 청결을 유지하기 위하여, 애완동물의 칫솔질에 사용하는 골무 또는 거즈에 애완용 치약을 스며들게 하여 칫솔질에 사용하며, 또한 구강 내의 청결을 유지하기 위하여 입 안에 뿌려주는 세정액 또는 식용 껌을 사용하여 치아의 건강을 유지하기 위한 다양한 방법이 있었다. 그러나 상기 방법들은 애완동물의 구강 내의 건강을 유지하는 데에 있어서 실효성을 얻지 못하고 있는 실정이다.Recently, interest in the oral health of pets living indoors with humans has increased. In order to maintain the cleanliness of teeth and oral cavity for pets, pets are used in thimble or gauze used for brushing of pets. There have been various methods for maintaining the health of teeth by soaking toothpaste and using it for brushing, and also using a cleaning solution or edible gum sprayed in the mouth to keep the oral cavity clean. However, the above methods are not yet effective in maintaining the oral health of the pet.
이에, 본 발명자는 상기와 같은 문제점을 해결하기 위하여 애완동물의 입냄새를 효과적으로 제거할 수 있는 구강필름과 더불어 구내염(또는 구순염) 및 치주염(또는 치은염)을 효과적으로 개선시킬 수 있는 소재를 개발하고자 하였다. 그 결과 프로폴리스, 녹차추출물 및 세이지추출물을 유효성분으로 포함하는 구강붕해필름의 경우 애완동물의 입안에 번식하기 쉬운 포르피로모나스 진지발리스(Porphyromonas gingivalis), 프로보텔라 인터메디아(Prevotella intermedia) 및 퓨조박테리움 뉴클레아툼(Fusobacterium nucleatum) 등의 구강 내 세균에 대한 항균 활성이 매우 우수하며, 구취 개선 및 치석 제거 효과와 더불어, 구내염(또는 구순염) 및 치주염(또는 치은염)을 효과적으로 개선시킬 수 있음을 확인함으로써, 본 발명을 완성하게 되었다. Accordingly, in order to solve the above problems, the present inventors have tried to develop a material that can effectively improve stomatitis (or stomatitis) and periodontitis (or gingivitis) together with an oral film that can effectively remove the bad breath of pets. . As a result, in the case of an oral disintegrating film containing propolis, green tea extract and sage extract as an active ingredient, Porphyromonas gingivalis , Provotella intermedia , and It has excellent antibacterial activity against oral bacteria such as Fusobacterium nucleatum , and can effectively improve stomatitis (or stomatitis) and periodontitis (or gingivitis) as well as improving bad breath and removing tartar. By confirming that there is, the present invention has been completed.
따라서 본 발명의 목적은 동물의 구강 질환을 효과적으로 예방 또는 개선할 수 있는 구강붕해필름 조성물을 제공하는 것이다.Accordingly, it is an object of the present invention to provide an oral disintegrating film composition that can effectively prevent or improve oral diseases of animals.
본 발명의 다른 목적은 상기 조성물로 제조된 동물의 구강 질환의 예방 또는 개선용 구강붕해필름 제제를 제공하는 것이다.Another object of the present invention is to provide an oral disintegrating film formulation for the prevention or improvement of oral diseases of animals prepared with the composition.
상기 목적을 달성하기 위하여, In order to achieve the above object,
본 발명은 프로폴리스, 녹차추출물 및 세이지추출물을 유효성분으로 포함하는 동물의 구강 질환의 예방 또는 개선용 구강붕해필름 조성물을 제공한다.The present invention provides an oral disintegrating film composition for preventing or improving oral diseases of animals comprising propolis, green tea extract and sage extract as active ingredients.
본 발명의 일실시예에 있어서, 상기 구강 질환은 구내염, 구순염, 구취, 치석, 치주염 및 치은염으로 이루어진 군으로부터 선택될 수 있다.In one embodiment of the present invention, the oral disease may be selected from the group consisting of stomatitis, stomatitis, bad breath, calculus, periodontitis and gingivitis.
본 발명의 일실시예에 있어서, 상기 조성물은 유효성분으로 스피루리나 추출물 또는 옥수수불검화추출물을 더 포함할 수 있다.In one embodiment of the present invention, the composition may further include spirulina extract or corn unsaponifiable extract as an active ingredient.
본 발명의 일실시예에 있어서, 상기 조성물은 가식성 고분자를 더 포함할 수 있다.In one embodiment of the present invention, the composition may further include an edible polymer.
본 발명의 일실시예에 있어서, 상기 가식성 고분자는 히드록시프로필셀룰로오스, 히드록시프로필메틸셀룰로오스, 히드록시에틸셀룰로오스, 카복시메틸셀룰로오스·나트륨, 카르복시메틸셀룰로오스·칼슘, 카르복시메틸셀룰로오스·칼륨, 카르복시메틸셀룰로오스 및 플루란으로 이루어진 군으로부터 선택될 수 있다.In an embodiment of the present invention, the edible polymer is hydroxypropyl cellulose, hydroxypropylmethyl cellulose, hydroxyethyl cellulose, carboxymethyl cellulose sodium, carboxymethyl cellulose calcium, carboxymethyl cellulose potassium, carboxymethyl It may be selected from the group consisting of cellulose and fullulane.
또한, 본 발명은 조성물로 제조된 동물의 구강 질환의 예방 또는 개선용 구강붕해필름을 제공한다.In addition, the present invention provides an orally disintegrating film for the prevention or improvement of oral diseases of animals prepared with the composition.
본 발명의 일실시예에 있어서, 상기 구강붕해필름은 동물의 혀 위, 입천장, 설하 또는 입안안뜰(buccal)에 부착할 수 있다.In one embodiment of the present invention, the orally disintegrating film may be attached to the tongue, roof of the mouth, sublingual or inner courtyard (buccal) of the animal.
본 발명에 따른 구강붕해필름은 동물의 입안에 번식하기 쉬운 포르피로모나스 진지발리스(Porphyromonas gingivalis), 프로보텔라 인터메디아(Prevotella intermedia) 및 퓨조박테리움 뉴클레아툼(Fusobacterium nucleatum) 등의 구강 내 세균에 대한 항균 활성이 매우 우수하며, 구취 개선 및 치석 제거 효과와 더불어, 구내염(또는 구순염) 및 치주염(또는 치은염)을 효과적으로 개선시킬 수 있는바, 동물의 구강 질환의 예방 또는 개선을 위한 기능성 식품으로 유용하게 사용될 수 있다.Oral disintegrating film according to the present invention is easy to breed in the mouth of animals Porphyromonas gingivalis ( Porphyromonas gingivalis ), Provotella intermedia ( Prevotella intermedia ) and Fusobacterium nucleatum ( Fusobacterium nucleatum ) Oral such as It has very excellent antibacterial activity against internal bacteria, and can effectively improve stomatitis (or stomatitis) and periodontitis (or gingivitis) along with the effect of improving bad breath and removing tartar. Functionality for preventing or improving oral diseases of animals It can be usefully used as food.
도 1 내지 도 7은 본 발명의 스피루리나 추출분말 함유 구강붕해필름을 반려견에 30일 급여에 따른 급여 전·후의 치석 제거 정도를 비교한 사진이다.1 to 7 are photographs comparing the degree of calculus removal before and after feeding the oral disintegrating film containing the spirulina extract powder of the present invention to dogs for 30 days.
본 발명에서 사용되는 용어는 다르게 명시되지 않으면 당업계에서의 그들의 관습적인 의미를 가질 것이다.Terms used in the present invention shall have their conventional meanings in the art unless otherwise specified.
본 발명에서 사용되는 용어 예컨대 "구성된다", "구성된", "구성되는" 등은 특허법에서 그들에게 부여된 의미를 가질 수 있다는 점에 유의해야 한다; 예를 들어, 그들은 "포함한다", "포함한", "포함하는" 등을 의미할 수 있다.It should be noted that terms used herein, such as "consisting of," "consisting of," "consisting of," and the like, may have the meanings assigned to them in patent law; For example, they can mean "comprises", "including", "comprising", and the like.
본 발명에서 사용되는 용어 “하나” 또는 “한”의 사용은 본 발명의 요소 및 구성요소를 기재하는데 이용된다. 이는 단순히 편의를 위해 그리고 본 발명의 일반적인 의미를 제공하기 위한 것이다. 이러한 기재는 하나 또는 적어도 하나를 포함하는 것으로 해석되어야 하고, 단순형은 다르게 의미함이 분명하지 않으면 복수형을 또한 포함한다.The use of the term “a” or “an” as used in the present invention is used to describe the elements and components of the present invention. This is merely for convenience and to give a general meaning of the present invention. This description is to be construed as including one or at least one, and the simple also includes the plural unless it is clear that it is meant otherwise.
본 발명에서 사용되는 용어 “동물”은 육식동물, 예를 들어 개, 고양이, 설치동물, 예를 들어 친칠라, 기니아 피그, 데구, 생쥐, 게르빌루스쥐, 햄스터, 쥐, 흰족제비, 및 토끼목, 예를 들어 토끼와 같은 애완동물로서 기르는 모든 포유동물을 포함한다. 바람직하게는 고양이 또는 개일 수 있다.As used herein, the term “animal” refers to carnivores such as dogs, cats, rodents, such as chinchillas, guinea pigs, degu, mice, gerbils, hamsters, rats, ferrets, and haemopods. , including all mammals kept as pets, for example rabbits. Preferably, it may be a cat or a dog.
본 발명에서 사용되는 용어 “약” 또는 “대략”은 제시된 값 또는 범위의 20% 내, 바람직하게는 10% 내, 더욱 바람직하게는 5% 내를 의미한다.As used herein, the term “about” or “approximately” means within 20%, preferably within 10%, more preferably within 5% of a given value or range.
하나의 구현예에서, 본 발명은 프로폴리스, 녹차추출물 및 세이지추출물을 유효성분으로 포함하는 동물의 구강 질환의 예방 또는 개선용 구강붕해필름 조성물에 관한 것이다.In one embodiment, the present invention relates to an oral disintegrating film composition for preventing or improving oral diseases of animals comprising propolis, green tea extract and sage extract as active ingredients.
본 발명에서 “프로폴리스”는 꿀벌에 의해서 나무의 수액이나 유실수의 수피, 꽃의 수술로부터 채집되며, 꿀벌의 자기방어 또는 꿀벌집의 보수에 사용되는 물질로서, 주로 수지, 밀납, 정유, 화분, 각종 유기물 및 미네랄 물질로 구성되어 있으며, 항산화 작용 뿐만 아니라, 항균, 항진균, 항바이러스, 항종양, 상처 치유작용 등이 있는 것으로 보고되어 있다. 프로폴리스내의 각종 유기물과 미네랄 물질에는 플라보노이드가 다량으로 함유되어 있고, 이러한 플라보노이드는 강력한 항균효능을 나타내는 것으로 보고 되어 있다. 프로폴리스의 플라보노이드는 모두 아글리콘인 것이 다른 식물의 플라보노이드와는 다르며, 이점이 프로폴리스의 항균작용에 관여하고 있다. 또한 프로폴리스는 장내세균에 대해서는 항균작용을 하는 것이 아니기 때문에 경구투여하여도 인체에 유용한 장내 균총, 즉 비피더스균이나 유산균에는 악영향이 없다. 따라서 프로폴리스는 아무리 섭취해도 독성이 없는 매우 안전한 천연 항균성 물질인 것이다.In the present invention, “propolis” is a substance collected from tree sap, bark of fruit trees, and stamens of flowers by bees, and used for self-defense of bees or repair of bees, mainly resin, beeswax, essential oil, pollen, It is composed of various organic and mineral substances and has been reported to have antibacterial, antifungal, antiviral, antitumor, and wound healing properties as well as antioxidant action. Various organic and mineral substances in propolis contain a large amount of flavonoids, and it has been reported that these flavonoids exhibit a strong antibacterial effect. The flavonoids of propolis are all aglycones, which is different from flavonoids of other plants, and this advantage is involved in the antibacterial action of propolis. In addition, since propolis does not have an antibacterial action against intestinal bacteria, it has no adverse effect on the intestinal flora useful to the human body, that is, bifidobacteria or lactic acid bacteria, even when administered orally. Therefore, propolis is a very safe natural antibacterial substance that is not toxic no matter how much it is ingested.
본 발명에서 “녹차”란 발효시키지 않은 찻잎[茶葉]을 사용해서 만든 차를 의미한다. 녹차는 지질대사에 영향을 미쳐 지방을 에너지원으로 우선적으로 사용되게 함은 물론 카테킨 성분이 콜레스테롤과 중성지질을 감소시킴으로써 비만인들이 손쉽게 체지방을 감량하는 데 도움을 주는 것으로 알려져 있다. In the present invention, “green tea” refers to tea made using unfermented tea leaves. Green tea is known to help obese people easily lose body fat by affecting lipid metabolism and preferentially using fat as an energy source, as well as catechins reducing cholesterol and triglycerides.
본 발명에서 “녹차추출물”은, 녹차의 잎으로부터 추출된 추출물로서, 상기 녹차추추물은 공지된 방법을 이용하여 녹차 잎으로부터 직접 추출하거나, 또는 시판되는 제품을 사용할 수 있다. In the present invention, "green tea extract" is an extract extracted from green tea leaves, and the green tea extract can be directly extracted from green tea leaves using a known method, or a commercially available product can be used.
또한, 상기 “녹차추출물”은 녹차의 잎을 추출 처리하여 얻어지는 추출액, 상기 추출액의 희석액이나 농축액, 상기 추출액을 건조하여 얻어지는 건조물, 상기 추출액의 조정제물이나 정제물, 또는 이들의 혼합물 등, 추출액 자체 및 추출액을 이용하여 형성 가능한 모든 제형의 추출물을 포함하는 개념이다.In addition, the "green tea extract" refers to an extract obtained by extracting green tea leaves, a diluted or concentrated liquid of the extract, a dried product obtained by drying the extract, a prepared or purified product of the extract, or a mixture thereof, such as the extract itself. And it is a concept including extracts of all formulations that can be formed using the extract.
본 발명에서 “세이지(Salvia officinalis)”는 약용 살비야라고도 한다. 세이지는 Common Sage, Garden Sage라고도 하며 흔히 Salvia라는 이름으로도 불린다. 줄기는 사각형으로 밑부분이 거의 목질화되며, 높이 30~90cm이고 전체에서 향기가 난다. 잎은 마주나고 잎자루가 짧으며, 긴 타원형으로 끝이 둔하고 가장자리가 밋밋하다. 잎 뒷면은 줄기와 함께 백색 털이 있어 회록색이고, 표면은 망상의 잔 주름이 있다. 꽃은 5~7월에 피고 자주색인데 가지 끝에 층층으로 달린 총상꽃차례이며, 위는 돌려난다. 꽃에는 꿀이 있어 꿀벌이 모이는 밀원식물이다. 꽃받침통은 종 모양이고 화관은 길이 1.5~2cm로 위아래의 2개의 꽃이 넓은 통부의 선단에 상하 두 입술처럼 갈라지는데, 윗입술은 끝이 파지고 아랫입술은 넓게 3개로 갈라진다. 수술은 2개이고 암술대는 화관의 윗입술보다 길게 나온다. 변종이 많아서 청색과 백색 꽃이 피는 것도 있다. 봄 또는 가을에 파종하고 8월에 잎을 따서 그늘에 말린 것을 샐비아 잎(folia salvia)이라 하며 약 2%의 정유(精油)가 함유되어 있다. 정유의 주성분은 피넨, 세스퀴테르펜, 보르네올 등으로 향기가 있어 소스, 카레, 돼지고기 요리 등의 향미료로 사용한다. 약용으로는 잎을 삶아서 인후염 및 위장염에 사용한다. 방부, 항균, 항염 등 살균 소독작용이 있으며 염증의 소염제로도 이용한다. 또한 중풍이나 심한 운동 뒤의 피로도 씻어준다. 남부 유럽 원산이고 옛날부터 구미 각국에서 가정용 향초(香草)로 널리 재배한다.In the present invention, "Sage ( Salvia officinalis )" is also called medicinal salvia. Sage is also known as Common Sage, Garden Sage, and also commonly referred to as Salvia. The stem is square, almost woody at the bottom, 30~90cm high, and the whole is fragrant. The leaves are opposite, the petiole is short, and the tip is dull and the edge is flat in a long oval shape. The underside of the leaf is gray-green with white hairs along with the stem, and the surface has fine wrinkles in the network. The flowers bloom in May-July and are purple in color and are raceme in tiers at the tip of the branch, and the upper part rotates. The flowers contain nectar, so it is a nectar plant where bees gather. The calyx tube is bell-shaped and the corolla is 1.5~2cm long, and the two flowers at the top and bottom are split like upper and lower lips at the tip of the wide tube. There are 2 stamens, and the style is longer than the upper lip of the corolla. There are many varieties, some with blue and white flowers. Sowing in spring or autumn, picking leaves in August and drying them in the shade is called folia salvia and contains about 2% of essential oil. The main components of essential oil are pinene, sesquiterpene, and borneol. For medicinal purposes, the leaves are boiled and used for sore throat and gastroenteritis. It has antiseptic, antibacterial, anti-inflammatory, sterilizing and disinfecting effects, and is also used as an anti-inflammatory agent for inflammation. It also washes away fatigue after a stroke or intense exercise. It is native to southern Europe and has been widely cultivated as a household incense candle in Europe and America since ancient times.
본 발명에서 “세이지추출물”은 세이지 전초로부터 추출된 추출물로서, 상기 세이지추추물은 공지된 방법을 이용하여 세이지 전초로부터 직접 추출하거나, 또는 시판되는 제품을 사용할 수 있다.In the present invention, "sage extract" is an extract extracted from sage sage extract, and the sage extract can be directly extracted from sage sage extract using a known method, or a commercially available product can be used.
또한, 상기 “세이지추출물”은 세이지 전초를 추출 처리하여 얻어지는 추출액, 상기 추출액의 희석액이나 농축액, 상기 추출액을 건조하여 얻어지는 건조물, 상기 추출액의 조정제물이나 정제물, 또는 이들의 혼합물 등, 추출액 자체 및 추출액을 이용하여 형성 가능한 모든 제형의 추출물을 포함하는 개념이다.In addition, the "sage extract" refers to an extract obtained by extracting sage whole plant, a diluted or concentrated liquid of the extract, a dried product obtained by drying the extract, a prepared or purified product of the extract, or a mixture thereof, the extract itself and It is a concept that includes extracts of all formulations that can be formed using the extract.
본 발명에서 “구강 질환”이란 동물의 구강에서 발생될 수 있는 질환을 의미하며, 자세하게는, 구내염, 구순염, 구취, 치석, 치주염 및 치은염 등을 예시할 수 있으나, 구강에서 발생되는 질환이라면 특별히 그 종류를 한정하는 것은 아니다.In the present invention, "oral disease" means a disease that can occur in the oral cavity of an animal, and specifically, stomatitis, stomatitis, bad breath, tartar, periodontitis, and gingivitis may be exemplified. It does not limit the type.
본 발명에서 “구내염”은 구강에 발생하는 통증을 동반하는 염증성 질환을 통틀어 말하는 것으로, 구내염은 증상별, 발생 부위별, 원인별, 이학적 검사 소견에 따른 여러 가지 분류법들이 있으나 각 질환에 대하여 일률적으로 적용하기는 곤란하다. 일반적으로 구내염은 궤양성 구내염, 수포성 구내염, 미란성 구내염으로 나뉜다.In the present invention, “stomatitis” refers to all inflammatory diseases that accompany pain in the oral cavity, and there are various classification methods for stomatitis according to symptoms, occurrence sites, causes, and physical examination findings, but uniformly for each disease It is difficult to apply. In general, stomatitis is divided into ulcerative stomatitis, bullous stomatitis, and erosive stomatitis.
본 발명에서 “구순염”은 입술에 발생하는 염증으로, 입술에 난 상처나 자극물질과의 접촉 때문에 생기게 된다. 특히, 구순염은 동물의 종류 중 개에게만 발생하는 질병으로 입술 상처, 자극물 접촉, 알레르기 등의 염증이 생긴 곳이 세균에 의해 2차 감염이 발생하여 생길 수 있으며, 당뇨병, 비타민 부족, 감염증 및 신장병 등도 원인이 될 수 있다.In the present invention, “cheilitis” is an inflammation of the lips, which is caused by contact with a wound or an irritant on the lips. In particular, stomatitis is a disease that only occurs in dogs among animal types, and may be caused by secondary infections caused by bacteria such as lip wounds, contact with irritants, and allergies. could be the cause
본 발명에서 “치주염”은 이를 둘러싼 연조직에 나타나는 염증으로, 치주위염(齒周圍炎)이라고도 한다. 치주염이 있는 경우 잇몸이 붓고 딱딱해지며 나중에는 이가 빠지는데, 주위 조직을 침식하는 치석이 잇몸 밑의 이에 침착하여 생긴다. 한편, 본 발명에서“치은염”은 치주조직 중 치은(잇몸)에 생기는 염증 질환을 말한다.In the present invention, "periodontitis" is inflammation that appears in the surrounding soft tissue, also called periodontitis (齒周圍炎). In the case of periodontitis, the gums swell and harden, and later, the teeth fall out, and tartar that erodes the surrounding tissues is deposited on the teeth under the gums. Meanwhile, in the present invention, “gingivitis” refers to an inflammatory disease occurring in the gingiva (gum) among periodontal tissues.
본 발명에서 “치석”이란 치면세균막(dental plaque)에 타액과 치은열구(치아와 잇몸 사이의 공간)액에서 유래한 칼슘(Ca), 인(P)등의 무기질이 침착되어 단단하게 굳어진 것을 의미한다. 구성 성분은 무기물 75%, 유기물 6~15%이고 나머지가 수분이다. 균막(pellicle) 형성을 기초로 세균막(덴탈 플라크)이 성숙이 되고 이어 무기질화(칼슘, 인, 마그네슘, 불소)된 후에 결정체가 형성된다.In the present invention, “tartar” means that minerals such as calcium (Ca) and phosphorus (P) derived from saliva and gingival sulcus (space between teeth and gums) are deposited on the dental plaque and hardened. do. The composition is 75% inorganic and 6 to 15% organic, with the remainder being water. Based on the formation of a pellicle, a bacterial film (dental plaque) is matured, followed by mineralization (calcium, phosphorus, magnesium, fluorine), and then crystals are formed.
본 발명에서 “구취”란 입 안에서 나는 냄새로서 구강 세균(P.gingivalis T.denticola, Fusobacterium sp. P.intermedia, Eubacterium sp.)이 입 안에 있는 단백질을 분해하는 과정에서 발생되는 기체인 휘발성 황화합물(VSC: Volatile Sulfur Compounds)에 의해 주로 발생되며, 세균의 영양분이 되는 단백질은 주로 음식물 잔사, 타액, 탈락된 구강점막 세포로부터 유래된다.In the present invention, "bad breath" is the volatile sulfur compound gas generated in the process of decomposition of proteins in the oral bacteria (P.gingivalis T.denticola, Fusobacterium sp. P.intermedia , Eubacterium sp.) As the mouth odor in the mouth ( It is mainly generated by Volatile Sulfur Compounds (VSC), and the protein that serves as a nutrient for bacteria is mainly derived from food residues, saliva, and exfoliated oral mucosa cells.
본 발명에 따른 동물의 구강 질환의 예방 또는 개선용 구강붕해필름 조성물은 상기와 같은 유효성분(프로폴리스, 녹차추출물 및 세이지추출물)을 전체 조성물 100중량%에 대하여 10 내지 20중량%로 포함할 수 있다.The oral disintegrating film composition for preventing or improving oral diseases of animals according to the present invention contains the active ingredients (propolis, green tea extract and sage extract) as described above in an amount of 10 to 20% by weight based on 100% by weight of the total composition. can
본 발명의 일실시예에 있어서, 상기 프로폴리스, 녹차추출물 및 세이지추출물은 다양한 배합비로 배합될 수 있으며, 예를 들면, 10 ~ 2 : 10 ~ 2 : 10 ~ 2의 비율로 배합될 수 있으며, 바람직하게는 10 : 3 : 2의 배합비가 좋다.In one embodiment of the present invention, the propolis, green tea extract and sage extract may be blended in various mixing ratios, for example, 10 to 2: 10 to 2: 10 to 2 may be blended, Preferably, a mixing ratio of 10:3:2 is good.
하기 실험예에서는 본 발명의 유효성분인 프로폴리스, 녹차추출물 및 세이지추출물을 다양한 배합비로 배합하여 구강붕해필름을 제조하고, 이들의 구강 내 세균에 대한 항균 활성을 측정하였다. 그 결과 프로폴리스, 녹차추출물 및 세이지추출물이 10 : 3 : 2로 배합된 구강붕해필름의 경우 다른 배합비 대비 두드러지게 우수한 항균 효력을 확인하였다(<실험예 2> 참조).In the following experimental example, an orally disintegrating film was prepared by mixing propolis, green tea extract and sage extract, which are the active ingredients of the present invention, in various mixing ratios, and their antibacterial activity against bacteria in the oral cavity was measured. As a result, in the case of an oral disintegrating film in which propolis, green tea extract, and sage extract were mixed in a ratio of 10: 3: 2, a remarkably superior antibacterial effect was confirmed compared to other mixing ratios (see <Experimental Example 2>).
또한, 하기 실험예에서는 프로폴리스, 녹차추출물 및 세이지추출물을 유효성분으로 포함하는 본 발명의 구강붕해필름의 구취 개선 효과를 실험하기 위해 비임상시험위수탁기관 ㈜케이피씨(KPC)에 의뢰하여 10수의 시험견을 대상으로 직접적인 구취 개선 정도를 측정하고, 이와 더불어 반려견 102수 대상 구취 개선 설문 평가하였다. 그 결과 본 발명의 구강붕해필름을 급여한 경우 반려견의 구취가 개선되는 것을 확인하였다(<실험예 3> 및 <실험예 4> 참조).In addition, in the following experimental examples, in order to test the effect of improving bad breath of the oral disintegrating film of the present invention containing propolis, green tea extract and sage extract as active ingredients, the non-clinical testing consignment institution KPC (KPC) The degree of improvement in bad breath was directly measured in veterinary test dogs, and in addition, the bad breath improvement questionnaire was evaluated for 102 dogs. As a result, it was confirmed that when the oral disintegrating film of the present invention was fed, the bad breath of dogs was improved (see <Experimental Example 3> and <Experimental Example 4>).
본 발명의 동물의 구강 질환의 예방 또는 개선용 구강붕해필름 조성물은 유효성분으로 프로폴리스, 녹차추출물 및 세이지추출물 이외에 스피루리나 추출물 또는 옥수수불검화추출물을 더 포함할 수 있다.The oral disintegrating film composition for preventing or improving oral diseases of animals of the present invention may further include spirulina extract or corn unsaponifiable extract in addition to propolis, green tea extract and sage extract as an active ingredient.
본 발명에서 “스피루리나”는 1827년 독일의 해조류학자인 Turpin이 최초로 분리하여 보고한 시아노박테리아의 한 종류로 단백질이 55-70%, 지방이 6-9%, 탄수화물이 15-20% 함유되어 있고 다량의 무기질, 비타민, 섬유질 색소성분을 함유하고 있다. 스피루리나의 세포벽은 셀룰로즈가 적고 부드러운 점액다당으로 구성되어 있으며 매우 얇기 때문에 소화 흡수율이 높다. 또한, 단백질의 함량 및 질이 우수하여 필수 아미노산이 균형 있게 함유되어 있으며 단백질 이용율(NPU)도 높아 완전 단백질 식품인 육류, 우유, 계란과 견줄만한 단백질 식품이다. 스피루리나에는 고도불포화 필수지방산인 리놀렌산(18:2), 감마리놀렌산(γ-linolenic acid)이 풍부하며 n-3지방산인 리놀레익산(linoleic acid)도 상당량 함유되어 있다. 이중 프로스타글란딘의 전구물질인 감마리놀렌산은 콜레스테롤 상승억제, 아토피성 피부염 개선, 월경전증후군의 경감, 알코올대사산물의 분해·촉진작용, 혈압조절, 혈전방지, 항천식, 항종양작용 등이 있다. 프로스타글란딘은 혈압을 일정하게 유지시키고, 혈액응고에 관여하며, 혈소판이 서로 달라붙는 것을 막아주며 혈액 순환을 향상시키고, 염증을 줄여주는 등 다양한 기능성이 보고되어 있다.In the present invention, “Spirulina” is a type of cyanobacteria first isolated and reported by Turpin, a German algaeologist in 1827, and contains 55-70% protein, 6-9% fat, and 15-20% carbohydrate. It contains a large amount of minerals, vitamins, and fiber pigments. The cell wall of Spirulina is low in cellulose and composed of soft mucopolysaccharide, and because it is very thin, it has a high digestibility and absorption rate. In addition, the protein content and quality are excellent, so essential amino acids are contained in a balanced way, and the protein utilization rate (NPU) is high, so it is a protein food comparable to meat, milk, and eggs, which are complete protein foods. Spirulina is rich in polyunsaturated essential fatty acids, linolenic acid (18:2) and gamma-linolenic acid, and also contains significant amounts of n-3 fatty acid, linoleic acid. Among them, gamma-linolenic acid, a precursor of prostaglandins, has the functions of inhibiting cholesterol rise, improving atopic dermatitis, alleviating premenstrual syndrome, decomposing and promoting alcohol metabolites, controlling blood pressure, preventing thrombosis, anti-asthma, and anti-tumor action. Prostaglandins have been reported to have various functions, such as maintaining a constant blood pressure, participating in blood clotting, preventing platelets from sticking to each other, improving blood circulation, and reducing inflammation.
본 발명에서 “스피루리나 추출물”은 스피루리나 분말 또는 생 스피루리나로부터 추출된 추출물로서, 상기 스피루리나 추출물은 공지된 방법을 이용하여 스피루리나로부터 유효성분을 추출하는 통상의 방법을 적용하거나, 시판되는 제품을 사용할 수 있다. 예를 들어, 스피루리나 추출물을 제조하기 위하여 일반적으로 메탄올, 핵산등의 유기용매의 사용이나 초음파, 초고압 등의 물리적인 공정을 사용할 수 있으며, 또는, 생 스피루리나 농축액을 습식 분쇄한 후 정제수를 가하여 희석하는 공정을 사용할 수도 있다.In the present invention, "Spirulina extract" is an extract extracted from spirulina powder or raw spirulina. . For example, in order to prepare a spirulina extract, in general, the use of an organic solvent such as methanol or nucleic acid or a physical process such as ultrasonication or ultra-high pressure can be used, or, after wet grinding of a raw spirulina concentrate, purified water is added to dilute it. process can also be used.
본 발명의 유효성분인 스피루리나 추출물은 본 발명의 구강붕해필름 조성물 100중량%에 대하여, 10 내지 20중량%로 포함될 수 있다.Spirulina extract as the active ingredient of the present invention may be included in an amount of 10 to 20% by weight based on 100% by weight of the oral disintegrating film composition of the present invention.
본 발명에서 “옥수수불검화추출물”은 옥수수에서 여러 가지 과정을 거쳐 분리된 물질로서, 시토스테롤(sitosterol), 스티그마스테롤(stigmsterol), 에르고스테롤(ergosterol) 등으로 구성된 피토스테롤(physterol)과 스쿠알렌(squalene), 카로틴(carotene), 토코페롤(tocopherol) 등으로 구성되어 있다. 상기 옥수수불검화추출물은 시판되는 제품을 사용할 수 있다.In the present invention, "corn unsaponifiable extract" is a material separated from corn through various processes, and phytosterol and squalene composed of sitosterol, stigmsterol, ergosterol, etc. , carotene, and tocopherol. Commercially available products may be used for the unsaponifiable corn extract.
본 발명의 유효성분인 옥수수불검화추출물은 본 발명의 구강붕해필름 조성물 100중량%에 대하여, 1 내지 10중량%로 포함될 수 있다.The corn unsaponifiable extract as the active ingredient of the present invention may be included in an amount of 1 to 10% by weight based on 100% by weight of the oral disintegrating film composition of the present invention.
하기 실험예에서는 본 발명의 구강붕해필름이 유효성분으로 프로폴리스, 녹차추출물 및 세이지추출물 이외에 스피루리나 추출물을 더 포함하는 경우, 치석제거 효과가 우수함을 확인하였다(<실험예> 5 참조).In the following experimental example, when the oral disintegrating film of the present invention further contains spirulina extract in addition to propolis, green tea extract, and sage extract as an active ingredient, it was confirmed that the tartar removal effect was excellent (see <Experimental Example> 5).
또한, 하기 실험예에서는 본 발명의 구강붕해필름이 유효성분으로 프로폴리스, 녹차추출물 및 세이지추출물 이외에 옥수수불검화추출물을 더 포함하는 경우, 치주염 개선 효과가 우수함을 확인하였다(<실험예> 6 참조).In addition, in the following experimental examples, when the oral disintegrating film of the present invention further contains corn unsaponifiable extract in addition to propolis, green tea extract, and sage extract as active ingredients, it was confirmed that the periodontitis improvement effect was excellent (<Experimental Example> 6 Reference).
한편, 본 발명에 따른 동물의 구강 질환의 예방 또는 개선용 구강붕해필름 조성물은 상기 유효성분 이외에 가식성 고분자를 더 포함할 수 있다. On the other hand, the oral disintegrating film composition for preventing or improving oral diseases of animals according to the present invention may further include an edible polymer in addition to the active ingredient.
상기 가식성 고분자는 구강붕해필름을 형성하게 하는 고분자로서 필름형성제를 의미한다. The edible polymer refers to a film forming agent as a polymer that forms an orally disintegrating film.
상기 가식성 고분자는, 예를 들면, 히드록시프로필셀룰로오스, 히드록시프로필메틸셀룰로오스, 히드록시에틸셀룰로오스, 카복시메틸셀룰로오스·나트륨, 카르복시메틸셀룰로오스·칼슘, 카르복시메틸셀룰로오스·칼륨, 카르복시메틸셀룰로오스, 플루란, 전분, 변성 전분(전호화 전분 등), 젤라틴, 펙틴, 소디움 알지네이트, 말토덱스트린, 중합화된 로진, 메틸셀룰로스, 결정 셀룰로스, 콜리코트, 유드라짓, 폴리에틸렌 옥시드, 폴리비닐 피롤리돈, 폴리비닐 알콜, 히아론산, 히아론산 유도체, 키토산, 키토산 유도체, 잔탄검 및 카라게난 등으로 이루어진 군으로부터 선택될 수 있다. 이들 고분자는 단독으로 사용해도 되고, 2종 이상을 조합하여 사용해도 된다. 상기 고분자는 본 발명의 구강붕해필름 조성물 100중량%에 대하여 20 내지 80중량%로 포함될 수 있다.The edible polymer is, for example, hydroxypropyl cellulose, hydroxypropylmethyl cellulose, hydroxyethyl cellulose, carboxymethyl cellulose sodium, carboxymethyl cellulose calcium, carboxymethyl cellulose potassium, carboxymethyl cellulose, fullulan , starch, modified starch (pregelatinized starch, etc.), gelatin, pectin, sodium alginate, maltodextrin, polymerized rosin, methylcellulose, crystalline cellulose, colicott, Eudragit, polyethylene oxide, polyvinyl pyrrolidone, It may be selected from the group consisting of polyvinyl alcohol, hyaluronic acid, hyaluronic acid derivatives, chitosan, chitosan derivatives, xanthan gum and carrageenan. These polymer|macromolecules may be used independently and may be used in combination of 2 or more type. The polymer may be included in an amount of 20 to 80% by weight based on 100% by weight of the oral disintegrating film composition of the present invention.
본 발명의 일실시예에 있어서, 상기 가식성 고분자는 점도가 1.0 ~ 30 mPa·s일 수 있으나, 특별히 이를 한정하는 것은 아니다.In one embodiment of the present invention, the edible polymer may have a viscosity of 1.0 to 30 mPa·s, but is not particularly limited thereto.
또한, 본 발명의 구강붕해필름 조성물은 가식성 고분자와 함께 필요에 따라 가소제, 감미제, 향미제, 침분비 자극제, 계면활성제, 색소, 항산화제, 기포형성방지제 등을 1종 이상 배합하여 형성될 수 있다. In addition, the orally disintegrating film composition of the present invention may be formed by mixing one or more plasticizers, sweeteners, flavoring agents, salivary secretion stimulants, surfactants, pigments, antioxidants, anti-foaming agents, etc., as needed together with an edible polymer. can
상기 가소제는 구강붕해필름 조성물에 유연성과 탄력성을 부여하기 위해 사용되는 물질로서, 예를 들면, 아세틸 트리에틸 시트레이트, 폴리에틸렌글리콜, 프로필렌글리콜, 글리세린, 시트레이트 에스터, 트리아세틴 및 트리에틸 시트레이트 등으로 이루어진군으로부터 선택될 수 있다. 이들 가소제는 단독으로 사용해도 되고, 2종 이상을 조합하여 사용해도 된다. 상기 가소제는 본 발명의 구강붕해필름 조성물 100중량%에 대하여 0.1 내지 50중량%로 포함될 수 있다.The plasticizer is a material used to impart flexibility and elasticity to the oral disintegrating film composition, for example, acetyl triethyl citrate, polyethylene glycol, propylene glycol, glycerin, citrate ester, triacetin and triethyl citrate. It may be selected from the group consisting of and the like. These plasticizers may be used independently and may be used in combination of 2 or more type. The plasticizer may be included in an amount of 0.1 to 50% by weight based on 100% by weight of the oral disintegrating film composition of the present invention.
상기 감미제는 맛이 불쾌한 것에 첨가하여 복용하기 쉽게 하는 물질로서, 예를 들면, 수크랄로스, 아세설팜칼륨, 스테비아, 말티톨, 이소말토올리고당, 소르비톨, 크실리톨, 폴리올, 만니톨, 수크로스, 덱스트로스, 프룩토스, 알리탐, 네오탐, 사카린 및 그 염, 아스파탐, 글리시리진, 스테비텐, 아세설팜케이, 소듐 사카라이드 및　사이클러메이트로로 이루어진 군으로부터 선택될 수 있다. 상기 감미제는 단독으로 사용해도 되고, 2종 이상을 조합하여 사용해도 된다. 상기 감미제는 본 발명의 구강붕해필름 조성물 100중량%에 대하여, 0.1 내지 50중량%로 포함될 수 있다.The sweetener is a substance that is easy to take by adding it to an unpleasant taste, for example, sucralose, acesulfame potassium, stevia, maltitol, isomaltooligosaccharide, sorbitol, xylitol, polyol, mannitol, sucrose, dextrose , fructose, alitam, neotame, saccharin and its salts, aspartame, glycyrrhizin, stebitene, acesulfame K, sodium saccharide and cyclomate. The said sweetener may be used independently and may be used in combination of 2 or more type. The sweetener may be included in an amount of 0.1 to 50% by weight based on 100% by weight of the oral disintegrating film composition of the present invention.
상기 향미제는 향을 부여하는 물질로서, 예를 들면, 비프향, 천연향료(과라나, 오렌지, 레몬, 페퍼민트, 신나몬, 멘톨, 페파민트오일, 윈터그린 민트, 정향, 버터스카치, 메이플, 아프리코트, 복숭아향, 체리향, 아니스, 딸기향, 바닐린, 시트러스향, 리코리스향, 루트비어향, 가르데니아, 라즈베리향, 호두향, 초코릿향 등) 및 합성향료로 이루어진 군에서 선택될 수 있다. 상기 향미제 또는 맛차단제는 단독으로 사용해도 되고, 2종 이상을 조합하여 사용해도 된다. 상기 향미제는 본 발명의 구강붕해필름 조성물 100중량%에 대하여, 0.01 내지 20중량%로 포함될 수 있다.The flavoring agent is a substance imparting flavor, for example, beef flavor, natural flavoring (guarana, orange, lemon, peppermint, cinnamon, menthol, peppermint oil, winter green mint, clove, butterscotch, maple, apricot, peach flavor , cherry flavor, anise, strawberry flavor, vanillin, citrus flavor, licorice flavor, root beer flavor, gardenia, raspberry flavor, walnut flavor, chocolate flavor, etc.) and synthetic flavor. The flavoring agent or taste-blocking agent may be used alone or in combination of two or more. The flavoring agent may be included in an amount of 0.01 to 20% by weight based on 100% by weight of the oral disintegrating film composition of the present invention.
상기 침분비 자극제는 시트르산, 시트르산염, 젖산, 말산, 아스코르빈산, 주석산 및 주석산염으로 이루어진 군으로부터 선택될 수 있다. 이들 침분비자극제는 단독으로 사용해도 되고, 2종 이상을 조합하여 사용해도 된다. 상기 침분비자극제는 본 발명의 구강붕해필름 조성물 100중량%에 대하여, 1 내지 15중량%로 포함될 수 있다.The salivary stimulating agent may be selected from the group consisting of citric acid, citrate, lactic acid, malic acid, ascorbic acid, tartaric acid and tartrate. These salivary stimulating agents may be used alone or in combination of two or more. The salivary secretion stimulating agent may be included in an amount of 1 to 15% by weight based on 100% by weight of the oral disintegrating film composition of the present invention.
상기 계면활성제는 폴록사머, 소디움 라우릴설페이트, 염화 벤제토늄, 폴리옥시에틸렌 지방산 에스테르, 폴리소르베이트, 및 소르비탄 에스테르로 이루어진 군에서 선택될 수 있다. 상기 계면활성제는 단독으로 사용해도 되고, 2종 이상을 조합하여 사용해도 된다. 상기 계면활성제는 본 발명의 구강붕해필름 조성물 100중량%에 대하여, 0.1 내지 5중량%로 포함될 수 있다.The surfactant may be selected from the group consisting of poloxamer, sodium lauryl sulfate, benzethonium chloride, polyoxyethylene fatty acid ester, polysorbate, and sorbitan ester. The said surfactant may be used independently and may be used in combination of 2 or more type. The surfactant may be included in an amount of 0.1 to 5% by weight based on 100% by weight of the oral disintegrating film composition of the present invention.
상기 색소로는 적색산화철, 산화티타늄, 이산화실리콘, 산화아연을 포함하는 천연색소 및 합성색소로 이루어진 군으로부터 선택될 수 있다. 상기 색소는 단독으로 사용해도 되고, 2종 이상을 조합하여 사용해도 된다. 상기 색소는 본 발명의 구강붕해필름 조성물 100중량%에 대하여, 0.001 내지 5중량%로 포함될 수 있다.The pigment may be selected from the group consisting of natural pigments and synthetic pigments including red iron oxide, titanium oxide, silicon dioxide, and zinc oxide. The said pigment|dye may be used independently and may be used in combination of 2 or more type. The pigment may be included in an amount of 0.001 to 5% by weight based on 100% by weight of the oral disintegrating film composition of the present invention.
상기 항산화제는 아황산수소나트륨, 메틸 파라벤, 프로필 파라벤, 나트륨 벤조에이트, 염화 벤잘코늄 및 염화벤제토늄으로 이루어진 군으로부터 선택될 수 있다. 상기 항산화제는 단독으로 사용해도 되고, 2종 이상을 조합하여 사용해도 된다. 상기 항산화제는 본 발명의 구강붕해필름 조성물름 100중량%에 대하여, 0.01 내지 2중량%로 포함될 수 있다.The antioxidant may be selected from the group consisting of sodium hydrogen sulfite, methyl paraben, propyl paraben, sodium benzoate, benzalkonium chloride and benzethonium chloride. The said antioxidant may be used independently and may be used in combination of 2 or more type. The antioxidant may be included in an amount of 0.01 to 2% by weight based on 100% by weight of the oral disintegrating film composition of the present invention.
상기 기포형성방지제는 액 조제시 발생하는 기포를 제거할 수 있는 제제를 의미하며, 예를 들어, 시메티콘 등이 사용될 수 있다.The anti-foaming agent refers to an agent capable of removing bubbles generated during liquid preparation, for example, simethicone and the like may be used.
다른 구현예에서, 본 발명은 상기 조성물로 제조된 동물의 구강 질환의 예방 또는 개선용 구강붕해필름에 관한 것이다.In another embodiment, the present invention relates to an orally disintegrating film for the prevention or improvement of oral diseases of animals prepared with the composition.
본 발명에 따른 동물의 구강 질환의 예방 또는 개선용 구강붕해필름은 대략 두께 0.05 ~ 3mm 및 크기 1cm2 ~15cm2를 가질 수 있으며, 동물의 혀 위, 입천장, 설하 또는 입안안뜰(buccal)에 부착할 수 있다.The oral disintegrating film for preventing or improving oral diseases in animals according to the present invention may have a thickness of about 0.05 to 3 mm and a size of 1 cm2 to 15 cm2, and can be attached to the tongue, roof of the mouth, sublingual or buccal of the animal. can
이하 본 발명을 실시예에 의하여 더욱 상세하게 설명한다. 이들 실시예는 단지 본 발명을 보다 구체적으로 설명하기 위한 것으로, 본 발명의 범위가 이들 실시예에 국한되지 않는다는 것은 당업계에서 통상의 지식을 가진 자에게 있어서 자명할 것이다.Hereinafter, the present invention will be described in more detail by way of Examples. These examples are merely for illustrating the present invention in more detail, and it will be apparent to those of ordinary skill in the art that the scope of the present invention is not limited to these examples.
<실시예 1><Example 1>
유효성분별 구강붕해필름 제조Oral disintegration film production by active ingredient
필름 1매에 전체 유효성분의 총량이 15mg(18.3%)이 되도록 수용성 프로폴리스, 녹차추출물, 세이지추출액을 첨가하여 필름을 제조하였다. 실험에서 사용한 수용성 프로폴리스는 유니크바이오텍에서 구입하였으며, 녹차추출물 및 세이지추출액은 미래바이오텍에서 구입하였다.A film was prepared by adding water-soluble propolis, green tea extract, and sage extract so that the total amount of active ingredients was 15 mg (18.3%) in one film. Water-soluble propolis used in the experiment was purchased from Unique Biotech, and green tea extract and sage extract were purchased from Mirae Biotech.
실시예 <1-1>Example <1-1>
조제용기에 정제수 340g을 넣고, 글리세린 24.26g, 폴리소르베이트80 1.2g을 추가한 후 교반하여 분산시켰다. 분산된 용액에 수용성 프로폴리스 30g을 넣고 다시 교반하여 완전히 분산시켰다. 분산된 용액에 추가로 수크랄로스 0.4g, 아세설팜칼륨 0.4g을 투입한 후 다시 교반하였다. 340 g of purified water was put in a preparation container, glycerin 24.26 g, and polysorbate 80 1.2 g were added, and then dispersed by stirring. 30 g of water-soluble propolis was added to the dispersed solution and stirred again to disperse completely. After adding 0.4 g of sucralose and 0.4 g of acesulfame potassium to the dispersed solution, the mixture was stirred again.
마지막으로 플루란 100.74g, 옥수수전분 7.0g을 추가한 후 균질한 액이 될 때까지 교반하고, 감압 탈기하여 필름 제조액으로 사용하였다.Finally, 100.74 g of fullulane and 7.0 g of corn starch were added, stirred until a homogeneous solution was obtained, and then degassed under reduced pressure to be used as a film preparation solution.
제조된 필름조제액을 베이스 필름지 위에 붓고, 필름 어플리케이터(1117, SI)로 캐스팅한 뒤, 80℃ 이상의 고온으로 건조시키고, 베이스 필름지와 분리(박리)시켜 수용성 프로폴리스가 함유된 구강붕해필름을 얻었다.The prepared film preparation solution is poured on the base film paper, cast with a film applicator (1117, SI), dried at a high temperature of 80° C. or higher, and separated (peeled) from the base film paper to obtain an orally disintegrating film containing water-soluble propolis. got it
실시예 <1-2>Example <1-2>
조제용기에 정제수 340g을 넣고, 글리세린 24.26g, 폴리소르베이트80 1.2g을 추가한 후 교반하여 분산시켰다. 분산된 용액에 녹차추출물 30g을 넣고 다시 교반하여 완전히 분산시켰다. 분산된용액에 추가로 수크랄로스 0.4g, 아세설팜칼륨 0.4g을 투입한 후 다시 교반하였다.340 g of purified water was put in a preparation container, glycerin 24.26 g, and polysorbate 80 1.2 g were added, and then dispersed by stirring. 30 g of green tea extract was added to the dispersed solution and stirred again to disperse completely. In addition, 0.4 g of sucralose and 0.4 g of acesulfame potassium were added to the dispersed solution, followed by stirring again.
마지막으로 플루란 100.74g, 옥수수전분 7.0g을 추가한 후 균질한 액이 될 때까지 교반하고, 감압 탈기하여 필름 제조액으로 사용하였다.Finally, 100.74 g of fullulane and 7.0 g of corn starch were added, stirred until a homogeneous solution was obtained, and then degassed under reduced pressure to be used as a film preparation solution.
제조된 필름조제액을 베이스 필름지 위에 붓고, 필름 어플리케이터(1117, SI)로 캐스팅한 뒤, 80℃ 이상의 고온으로 건조시키고, 베이스 필름지와 분리(박리)시켜 녹차추출물이 함유된 구강붕해필름을 얻었다.The prepared film preparation solution was poured on the base film paper, cast with a film applicator (1117, SI), dried at a high temperature of 80 ° C. or higher, and separated (peeled) from the base film paper to obtain an orally disintegrating film containing green tea extract. .
실시예 <1-3>Example <1-3>
조제용기에 정제수 340g을 넣고, 글리세린 24.26g, 폴리소르베이트80 1.2g을 추가한 후 교반하여 분산시켰다. 분산된 용액에 세이지추출액 30g을 넣고 다시 교반하여 완전히 분산시켰다. 분산된 용액에 추가로 수크랄로스 0.4g, 아세설팜칼륨 0.4g을 투입한 후 다시 교반하였다.340 g of purified water was put in a preparation container, glycerin 24.26 g, and polysorbate 80 1.2 g were added, and then dispersed by stirring. 30 g of sage extract was added to the dispersed solution, and stirred again to disperse completely. After adding 0.4 g of sucralose and 0.4 g of acesulfame potassium to the dispersed solution, the mixture was stirred again.
마지막으로 플루란 100.74g, 옥수수전분 7.0g을 추가한 후 균질한 액이 될 때까지 교반하고, 감압 탈기하여 필름 제조액으로 사용하였다.Finally, 100.74 g of fullulane and 7.0 g of corn starch were added, stirred until a homogeneous solution was obtained, and then degassed under reduced pressure to be used as a film preparation solution.
제조된 필름조제액을 베이스 필름지 위에 붓고, 필름 어플리케이터(1117, SI)로 캐스팅한 뒤, 80℃ 이상의 고온으로 건조시키고, 베이스 필름지와 분리(박리)시켜 세이지추출액이 함유된 구강붕해필름을 얻었다.The prepared film preparation solution was poured on the base film paper, cast with a film applicator (1117, SI), dried at a high temperature of 80 ° C. or higher, and separated (peeled) from the base film paper to obtain an oral disintegrating film containing sage extract. .
실시예 <1-4>Example <1-4>
조제용기에 정제수 340g을 넣고, 글리세린 24.26g, 폴리소르베이트80 1.2g을 추가한 후 교반하여 분산시켰다. 분산된 용액에 수용성 프로폴리스 15g, 녹차추출물 15g을 넣고 다시 교반하여 완전히 분산시켰다. 분산된 용액에 추가로 수크랄로스 0.4g, 아세설팜칼륨 0.4g을 투입한 후 다시 교반하였다.340 g of purified water was put in a preparation container, glycerin 24.26 g, and polysorbate 80 1.2 g were added, and then dispersed by stirring. 15 g of water-soluble propolis and 15 g of green tea extract were added to the dispersed solution, and stirred again to disperse completely. After adding 0.4 g of sucralose and 0.4 g of acesulfame potassium to the dispersed solution, the mixture was stirred again.
마지막으로 플루란 100.74g, 옥수수전분 7.0g을 추가한 후 균질한 액이 될 때까지 교반하고, 감압 탈기하여 필름 제조액으로 사용하였다.Finally, 100.74 g of fullulane and 7.0 g of corn starch were added, stirred until a homogeneous solution was obtained, and then degassed under reduced pressure to be used as a film preparation solution.
제조된 필름조제액을 베이스 필름지 위에 붓고, 필름 어플리케이터(1117, SI)로 캐스팅한 뒤, 80℃ 이상의 고온으로 건조시키고, 베이스 필름지와 분리(박리)시켜 수용성 프로폴리스, 녹차추출물이 함유된 구강붕해필름을 얻었다.The prepared film preparation liquid is poured on the base film paper, cast with a film applicator (1117, SI), dried at a high temperature of 80 ° C or higher, and separated (peeled) from the base film paper, and the oral shelf containing water-soluble propolis and green tea extract I got the film.
실시예 <1-5>Example <1-5>
조제용기에 정제수 340g을 넣고, 글리세린 24.26g, 폴리소르베이트80 1.2g을 추가한 후 교반하여 분산시켰다. 분산된 용액에 수용성 프로폴리스 15g, 세이지추출액 15g을 넣고 다시 교반하여 완전히 분산시켰다. 분산된 용액에 추가로 수크랄로스 0.4g, 아세설팜칼륨 0.4g을 투입한 후 다시 교반하였다.340 g of purified water was put in a preparation container, glycerin 24.26 g, and polysorbate 80 1.2 g were added, and then dispersed by stirring. 15 g of water-soluble propolis and 15 g of sage extract were added to the dispersed solution, and stirred again to disperse completely. After adding 0.4 g of sucralose and 0.4 g of acesulfame potassium to the dispersed solution, the mixture was stirred again.
마지막으로 플루란 100.74g, 옥수수전분 7.0g을 추가한 후 균질한 액이 될 때까지 교반하고, 감압 탈기하여 필름 제조액으로 사용하였다.Finally, 100.74 g of fullulane and 7.0 g of corn starch were added, stirred until a homogeneous solution was obtained, and then degassed under reduced pressure to be used as a film preparation solution.
제조된 필름조제액을 베이스 필름지 위에 붓고, 필름 어플리케이터(1117, SI)로 캐스팅한 뒤, 80℃ 이상의 고온으로 건조시키고, 베이스 필름지와 분리(박리)시켜 수용성 프로폴리스, 세이지추출액이 함유된 구강붕해필름을 얻었다.The prepared film preparation solution is poured on the base film paper, cast with a film applicator (1117, SI), dried at a high temperature of 80° C. or higher, and separated (peeled) from the base film paper, and the oral shelf containing water-soluble propolis and sage extract I got the film.
실시예 <1-6>Example <1-6>
조제용기에 정제수 340g을 넣고, 글리세린 24.26g, 폴리소르베이트80 1.2g을 추가한 후 교반하여 분산시켰다. 분산된 용액에 녹차추출물 15g, 세이지추출액 15g을 넣고 다시 교반하여 완전히 분산시켰다. 분산된 용액에 추가로 수크랄로스 0.4g, 아세설팜칼륨 0.4g을 투입한 후 다시 교반하였다.340 g of purified water was put in a preparation container, glycerin 24.26 g, and polysorbate 80 1.2 g were added, and then dispersed by stirring. Into the dispersed solution, 15 g of green tea extract and 15 g of sage extract were added and stirred again to disperse completely. After adding 0.4 g of sucralose and 0.4 g of acesulfame potassium to the dispersed solution, the mixture was stirred again.
마지막으로 플루란 100.74g, 옥수수전분 7.0g을 추가한 후 균질한 액이 될 때까지 교반하고, 감압 탈기하여 필름 제조액으로 사용하였다.Finally, 100.74 g of fullulane and 7.0 g of corn starch were added, stirred until a homogeneous solution was obtained, and then degassed under reduced pressure to be used as a film preparation solution.
제조된 필름조제액을 베이스 필름지 위에 붓고, 필름 어플리케이터(1117, SI)로 캐스팅한 뒤, 80℃ 이상의 고온으로 건조시키고, 베이스 필름지와 분리(박리)시켜 녹차추출물, 세이지추출액이 함유된 구강붕해필름을 얻었다.The prepared film preparation liquid is poured on the base film paper, cast with a film applicator (1117, SI), dried at a high temperature of 80 ° C or higher, and separated from the base film paper (peeled) to disintegrate orally containing green tea extract and sage extract got a film.
실시예 <1-7>Example <1-7>
조제용기에 정제수 340g을 넣고, 글리세린 24.26g, 폴리소르베이트80 1.2g을 추가한 후 교반하여 분산시켰다. 분산된 용액에 수용성 프로폴리스 10g, 녹차추출물 10g, 세이지추출액 10g을 넣고 다시 교반하여 완전히 분산시켰다. 분산된 용액에 추가로 수크랄로스 0.4g, 아세설팜칼륨 0.4g을 투입한 후 다시 교반하였다.340 g of purified water was put in a preparation container, glycerin 24.26 g, and polysorbate 80 1.2 g were added, and then dispersed by stirring. Into the dispersed solution, 10 g of water-soluble propolis, 10 g of green tea extract, and 10 g of sage extract were added and stirred again to disperse completely. Further, 0.4 g of sucralose and 0.4 g of acesulfame potassium were added to the dispersed solution, followed by stirring again.
마지막으로 플루란 100.74g, 옥수수전분 7.0g을 추가한 후 균질한 액이 될 때까지 교반하고, 감압 탈기하여 필름 제조액으로 사용하였다.Finally, 100.74 g of fullulane and 7.0 g of corn starch were added, stirred until a homogeneous solution was obtained, and then degassed under reduced pressure to be used as a film preparation solution.
제조된 필름조제액을 베이스 필름지 위에 붓고, 필름 어플리케이터(1117, SI)로 캐스팅한 뒤, 80℃ 이상의 고온으로 건조시키고, 베이스 필름지와 분리(박리)시켜 수용성 프로폴리스, 녹차추출물, 세이지추출액이 함유된 구강붕해필름을 얻었다.The prepared film preparation liquid is poured on the base film paper, cast with a film applicator (1117, SI), dried at a high temperature of 80 ° C or higher, and separated (peeled) from the base film paper to contain water-soluble propolis, green tea extract, and sage extract. An orally disintegrating film was obtained.
본 발명의 필름 제조에 사용된 성분 및 이의 중량을 하기 표 1에 나타내었다.The components used for preparing the film of the present invention and their weights are shown in Table 1 below.
본 발명의 필름 제조에 사용된 성분 및 이의 중량 (mg/매)Components used to prepare the film of the present invention and their weight (mg/sheet)
성분ingredient 실시예 <1-1>Example <1-1> 실시예 <1-2>Example <1-2> 실시예 <1-3>Example <1-3> 실시예 <1-4>Example <1-4> 실시예 <1-5>Example <1-5> 실시예 <1-6>Example <1-6> 실시예 <1-7>Example <1-7> 함유율
(질량%)content
(mass%)
수용성 프로폴리스water-soluble propolis 1515 　 　 7.57.5 7.57.5 　 5.0 5.0 18.318.3
녹차추출물green tea extract 　 1515 　 7.57.5 　 7.57.5 5.0 5.0
세이지추출액sage extract 　 　 1515 　 7.57.5 7.57.5 5.0 5.0
플루란fullulan 50.3750.37 50.3750.37 50.3750.37 50.3750.37 50.3750.37 50.3750.37 50.3750.37 61.4361.43
옥수수전분corn starch 3.53.5 3.53.5 3.53.5 3.53.5 3.53.5 3.53.5 3.53.5 4.274.27
글리세린glycerin 12.1312.13 12.1312.13 12.1312.13 12.1312.13 12.1312.13 12.1312.13 12.1312.13 14.7914.79
폴리소르베이트80Polysorbate 80 0.60.6 0.60.6 0.60.6 0.60.6 0.60.6 0.60.6 0.60.6 0.730.73
수크랄로스sucralose 0.20.2 0.20.2 0.20.2 0.20.2 0.20.2 0.20.2 0.20.2 0.240.24
아세설팜칼륨acesulfame potassium 0.20.2 0.20.2 0.20.2 0.20.2 0.20.2 0.20.2 0.20.2 0.240.24
합계Sum 8282 8282 8282 8282 8282 8282 8282 100100
정제수Purified water 170170 170170 170170 170170 170170 170170 170170 --
<실험예 1><Experimental Example 1>
유효성분별 구강붕해필름의 구강 내 세균에 대한 항균 효과Antibacterial effect of oral disintegrating film by active ingredient on oral bacteria
본 실험에서는 상기 <실시예 1>을 통해 준비된 유효성분을 달리하여 제조된 구강붕해필름의 항균 효과를 확인하기 위하여, 구강 내 균주인 포르피로모나스 진지발리스, 프로보텔라 인터메디아 및 퓨조박테리움 뉴클레아툼을 대상으로 최소발육억제농도 (Minimum inhibitory concentration; MIC) 및 최소살균농도 (Minimum bactericidal concentration; MBC)를 측정함으로써 구강 균주에 대한 발육억제 효능을 평가하였다.In this experiment, in order to confirm the antibacterial effect of the oral disintegrating film prepared by different active ingredients prepared in <Example 1>, oral strains Porphyromonas gingivalis, Provotella intermedia, and Fuzobacter By measuring the minimum inhibitory concentration (MIC) and the minimum bactericidal concentration (MBC) for Lium nucleatum, the growth inhibitory efficacy against oral strains was evaluated.
실험예 <1-1> 균주 준비 및 배양Experimental Example <1-1> Preparation and culture of strains
포르피로모나스 진지발리스 KCTC 5352(Porphyromonas gingivalis KCTC 5352), 프로보텔라 인터메디아 ATCC 25611(Prevotella intermedia ATCC 25611) 및 퓨조박테리움 뉴클레아툼 KCTC 2488(Fusobacterium nucleatum KCTC 2488)를 사용하였다. Porphyromonas gingivalis KCTC 5352, Provotella intermedia ATCC 25611, and Fusobacterium nucleatum KCTC 2488 were used.
포르피로모나스 진지발리스 KCTC 5352(Porphyromonas gingivalis KCTC 5352)는 Hemin (Sigma) (5 μg/mL) 및 menadione (Sigma) (0.5 μg/mL)이 첨가된 Tryptic soy (BD-Difco) 액체배지와 면양 적혈구 (Asan Co.)가 5% 첨가된 TS 혈액한천배지 (BD-Difco) (TS-HM)를 사용하여 37℃에서 48시간, Steel wool method를 사용하여 혐기적으로 배양하였다. Porphyromonas gingivalis KCTC 5352 (Porphyromonas gingivalis KCTC 5352) is Hemin (Sigma) (5 μg/mL) and menadione (Sigma) (0.5 μg/mL) added Tryptic soy (BD-Difco) broth and sheep Using TS blood agar medium (BD-Difco) (TS-HM) supplemented with red blood cells (Asan Co.) 5% was used and cultured anaerobically at 37° C. for 48 hours using the Steel wool method.
프로보텔라 인터메디아 ATCC 25611(Prevotella intermedia ATCC 25611) 및 퓨조박테리움 뉴클레아툼 KCTC 2488(Fusobacterium nucleatum KCTC 2488)은 Yeast extract (BD-Difco) (5 mg/mL), hemin (Sigma) (5 μg/mL) 및 menadione (0.5 μg/mL)이 첨가된 Brain heart infusion (BD-Difco) 액체배지와 면양 적혈구 (Asan Co.)가 5% 첨가된 BHI 혈액한천배지 (BD-Difco) (BHI-HM)를 사용하여 37℃에서 48시간, Steel wool method를 사용하여 혐기적으로 배양하였다.Provo telra Inter Media ATCC 25611 (Prevotella intermedia ATCC 25611) and Pugh jobak Te Solarium New Klee Atum KCTC 2488 (Fusobacterium nucleatum KCTC 2488) is Yeast extract (BD-Difco) ( 5 mg / mL), hemin (Sigma) (5 μg /mL) and menadione (0.5 μg/mL), Brain heart infusion (BD-Difco) broth, and BHI blood agar (BD-Difco) (BHI-HM) supplemented with 5% sheep red blood cells (Asan Co.). ) and incubated anaerobically at 37°C for 48 hours using the steel wool method.
실험예 <1-2> 최소발육억제농도(Minimum inhibitory concentration, MIC) 및 최소살균농도(Minimum bactericidal concentration, MBC) 측정Experimental Example <1-2> Minimum inhibitory concentration (MIC) and minimum bactericidal concentration (MBC) measurement
사용 균주에 대한 상기 <실시예 1>을 통해 준비된 유효성분을 달리하여 제조된 구강붕해필름의 최소발육억제농도(MIC)를 측정하기 위하여, 먼저 실험 균주를 48시간 배양한 후, 각 실험 균주를 yeast extract (BD-Difco) 5 mg/mL, hemin (Sigma) 5 μg/mL 및 menadione (Sigma) 0.5 μg/mL를 첨가한 BHI broth medium (BD-Difco)에 접종하여 McFarland No. 0.5의 탁도가 되도록 균액 농도를 조정하였다. 한편, 시험에 사용하는 상기 <실시예 1>을 통해 준비된 유효성분을 달리하여 제조된 구강붕해필름 10장을 30% DMSO 용액 10mL에 희석 후 0.45 μm PVDF 필터하여 용액 상태로 시험에 사용하였다. 시험에 사용한 시험액의 총 유효성분의 농도는 아래 표 2에 나타내었다.In order to measure the minimum growth inhibitory concentration (MIC) of the oral disintegrating film prepared by varying the active ingredient prepared through the <Example 1> for the strain to be used, the test strain was first cultured for 48 hours, and then each test strain was inoculated into BHI broth medium (BD-Difco) supplemented with yeast extract (BD-Difco) 5 mg/mL, hemin (Sigma) 5 μg/mL and menadione (Sigma) 0.5 μg/mL to obtain McFarland No. The concentration of the bacterial solution was adjusted to obtain a turbidity of 0.5. On the other hand, 10 oral disintegrating films prepared by different active ingredients prepared in <Example 1> used for the test were diluted in 10 mL of 30% DMSO solution, and then filtered with 0.45 μm PVDF and used in the test as a solution. The concentrations of the total active ingredients of the test solution used for the test are shown in Table 2 below.
최소발육억제농도(MIC) 측정을 위해, 표 2의 각각의 시료 15mg/mL 용액을 각각 96 well micro plate에 300 μL씩 접종한 뒤, 멸균된 증류수로 2진 단계희석을 통하여 2배부터 256배까지 희석하였다. 각 well에 농도를 McFarland No. 0.5로 적정한 균액을 150 μL씩 접종한 뒤 각 실험균주의 배양조건에 따라 37℃, 48시간 steel wool method로 혐기배양하였다. 이후 육안으로 실험균주의 증식을 평가하여 균주가 증식하지 않은 well 중 가장 낮은 농도를 각 천연물질의 MIC로 측정하였다. 또한 실험결과의 정확을 기하기 위하여 620 nm에서 흡광도를 측정하여 흡광도가 0.10 ± 0.01보다 낮게 측정될 경우 균주의 배양이 되지 않은 것으로 판정하였다. 한편, MIC 측정 시 30% DMSO 용액으로 인한 MIC 측정의 실험오차를 방지하기 위하여 30% DMSO 용액에 대하여 위와 같은 방식으로 MIC의 측정을 수행하였으며, 실험 오차를 줄이기 위하여 3회 반복 실험을 통해 각 시료의 MIC를 측정하였다.In order to measure the minimum growth inhibitory concentration (MIC), 300 μL of each 15 mg/mL solution of each sample in Table 2 was inoculated into a 96 well micro plate, and then 2-fold to 256-fold through binary dilution with sterile distilled water. diluted to . Concentrations in each well were measured in McFarland No. After inoculating 150 μL of the appropriate bacterial solution with 0.5, anaerobic culture was performed at 37° C. for 48 hours according to the culture conditions of each experimental strain by the steel wool method. Then, the growth of the test strain was visually evaluated, and the lowest concentration among the wells in which the strain did not grow was measured as the MIC of each natural substance. In addition, in order to ensure the accuracy of the experimental results, absorbance was measured at 620 nm, and when the absorbance was measured to be lower than 0.10 ± 0.01, it was determined that the strain was not cultured. On the other hand, in order to prevent the experimental error of MIC measurement due to the 30% DMSO solution during MIC measurement, the MIC measurement was performed in the same manner as above for the 30% DMSO solution. In order to reduce the experimental error, each sample was repeated three times. MIC was measured.
MIC 시험액의 유효성분 농도Active ingredient concentration of MIC test solution
MIC 시험액MIC test solution 유효성분 농도Active ingredient concentration
실시예 <1-1>의 시료Sample of Example <1-1> 15 mg/mL15 mg/mL
실시예 <1-2>의 시료Samples of Example <1-2> 15 mg/mL15 mg/mL
실시예 <1-3>의 시료Samples of Example <1-3> 15 mg/mL15 mg/mL
실시예 <1-4>의 시료Samples of Example <1-4> 15 mg/mL15 mg/mL
실시예 <1-5>의 시료Samples of Example <1-5> 15 mg/mL15 mg/mL
실시예 <1-6>의 시료Samples of Example <1-6> 15 mg/mL15 mg/mL
실시예 <1-7>의 시료Samples of Example <1-7> 15 mg/mL15 mg/mL
또한, MIC 측정 실험에서 시료별로 균주의 증식을 억제한 모든 well을 MBC 측정 항목으로 선정하였다. MBC 측정 범위에 해당하는 well의 배양액 100 μL씩을 실험균주별로 적합한 agar medium plate에 도말하였다. 이후 각 실험균주별 배양조건에 따라 37℃, 48시간 steel wool method로 혐기배양한 후 plate 상에서 육안으로 증식이 확인되지 않는 최소 농도를 MBC로 측정하였으며, 실험 오차를 줄이기 위하여 3회 반복 실험을 통해 각 시료의 MBC를 측정하였다. 한편, 각 시료의 용매로 사용한 30% DMSO 용액에 대한 P. gingivalis KCTC 5352, P. intermedia ATCC 25611 및 F. nucleatum KCTC 2488의 배양 결과, 30% DMSO 용액의 2배 희석액에서 모든 실험균주가 배양된 것을 확인하였으며, 각 시료의 MIC 측정에 대한 30% DMSO 용액의 간섭효과는 없는 것으로 판단되었다.In addition, in the MIC measurement experiment, all wells that inhibited the growth of strains for each sample were selected as MBC measurement items. 100 μL of each well of the culture solution corresponding to the MBC measurement range was spread on an agar medium plate suitable for each experimental strain. After anaerobic culture at 37°C and 48 hours steel wool method according to the culture conditions of each experimental strain, the minimum concentration at which no growth was observed with the naked eye on the plate was measured with MBC. MBC of each sample was measured. Meanwhile, as a result of culturing P. gingivalis KCTC 5352, P. intermedia ATCC 25611, and F. nucleatum KCTC 2488 in 30% DMSO solution used as a solvent for each sample, all experimental strains were cultured in a 2-fold dilution of 30% DMSO solution. It was confirmed that there was no interference effect of the 30% DMSO solution on the MIC measurement of each sample.
각 시료의 MIC 3회 반복 측정 시험 결과, 3회 시험간 결과가 모두 동일하게 나타났으며, 흡광도 측정에 의한 MIC 판정과 육안평가 결과가 동일하게 나타났다. 하기 표 3 내지 표 5에서 P. gingivalis KCTC 5352, P. intermedia ATCC 25611, F. nucleatum KCTC 2488 균주에 대한 각 시료의 육안평가 MIC 값을 굵은 글씨의 이탤릭체로 나타내었으며, MBC 값은 회색 박스로 표시하였다. 또한 표 6 내지 표 8에 P. gingivalis KCTC 5352, P. intermedia ATCC 25611, F. nucleatum KCTC 2488 균주에 대한 흡광도 측정값을 기재하였다.As a result of the MIC repeated measurement test for each sample three times, the results between the three tests were all the same, and the MIC determination by absorbance measurement and the visual evaluation result were the same. In Tables 3 to 5, the visual evaluation MIC values of each sample for P. gingivalis KCTC 5352, P. intermedia ATCC 25611, and F. nucleatum KCTC 2488 strains are shown in bold italics, and MBC values are shown in gray boxes. did In addition, the absorbance values for P. gingivalis KCTC 5352, P. intermedia ATCC 25611, and F. nucleatum KCTC 2488 strains were described in Tables 6 to 8.
Figure PCTKR2021008564-appb-img-000001
Figure PCTKR2021008564-appb-img-000001
Figure PCTKR2021008564-appb-img-000002
Figure PCTKR2021008564-appb-img-000002
Figure PCTKR2021008564-appb-img-000003
Figure PCTKR2021008564-appb-img-000003
Figure PCTKR2021008564-appb-img-000004
Figure PCTKR2021008564-appb-img-000004
Figure PCTKR2021008564-appb-img-000005
Figure PCTKR2021008564-appb-img-000005
Figure PCTKR2021008564-appb-img-000006
Figure PCTKR2021008564-appb-img-000006
유효성분의 총 함유량이 동일한 각각의 실시예 시료로 최소발육억제농도 시험을 실시한 결과, 균주 P. gingivalis KCTC 5352에 대한 실시예 <1-7> 시료의 MIC 값이 0.23 mg/mL로 측정되어 가장 효력이 좋은 것으로 판정되었으며, 실시예 <1-4>의 시료가 0.47mg/mL로 두 번째로 높은 효력을 보여주었다.As a result of performing the minimum growth inhibitory concentration test with each Example sample having the same total content of active ingredients, the MIC value of the sample of Example <1-7> for strain P. gingivalis KCTC 5352 was measured to be 0.23 mg/mL, which was the most It was determined that the potency was good, and the sample of Example <1-4> showed the second highest potency at 0.47 mg/mL.
F. nucleatum KCTC 2488 균주에 대한 실시예 <1-1>, <1-2>, <1-6>, <1-7>의 MIC 값은 0.23 mg/mL로 측정되어 가장 높은 효력을 보였으며, P. intermedia ATCC 25611 균주의 경우 실시예 <1-5>, <1-7>에서 MIC 측정값이 0.23mg/mL로 가장 높은 효력을 보여주었다.The MIC values of Examples <1-1>, <1-2>, <1-6>, and <1-7> for F. nucleatum KCTC 2488 strain were measured as 0.23 mg/mL, showing the highest efficacy. , In the case of P. intermedia ATCC 25611 strain, Examples <1-5> and <1-7> showed the highest potency with a MIC value of 0.23 mg/mL.
결론적으로, 본 발명의 유효성분별 구강붕해필름의 구강 세균에 대한 항균시험 결과, 실시예 <1-7>(수용성 프로폴리스 5mg, 녹차추출물 5mg, 세이지추출액 5mg 함유)의 구강붕해필름이 가장 항균력이 우수한 것으로 확인되었다. In conclusion, as a result of the antibacterial test on oral bacteria of the oral dispersible film of the present invention, the oral disintegrating film of Example <1-7> (containing 5 mg of water-soluble propolis, 5 mg of green tea extract, 5 mg of sage extract) was the most It was confirmed that the antibacterial activity was excellent.
<실시예 2><Example 2>
유효성분의 다양한 배합비에 따른 구강붕해필름 제조Oral disintegration film production according to various mixing ratios of active ingredients
구강 내 세균의 증식을 억제하는 최적화된 비율을 도출하기 위하여 수용성 프로폴리스, 녹차추출물 및 세이지추출액을 모두 포함하며, 필름 1매에 전체 유효성분의 총량이 15mg(18.3%)이며 각 성분이 비율별로 포함되는 구강붕해필름을 제조하였다.Water-soluble propolis, green tea extract, and sage extract are all included in order to derive an optimized ratio that inhibits the growth of bacteria in the oral cavity, and the total amount of active ingredients per film is 15 mg (18.3%), An orally disintegrating film was prepared.
실시예 <2-1>Example <2-1>
조제용기에 정제수 340g을 넣고, 글리세린 24.26g, 폴리소르베이트80 1.2g을 추가한 후 교반하여 분산시켰다. 분산된 용액에 수용성 프로폴리스 20g, 녹차추출물 4g, 세이지추출액 6g을 넣고 다시 교반하여 완전히 분산시켰다. 분산된 용액에 추가로 수크랄로스 0.4g, 아세설팜칼륨 0.4g을 투입한 후 다시 교반하였다.340 g of purified water was put in a preparation container, glycerin 24.26 g, and polysorbate 80 1.2 g were added, and then dispersed by stirring. 20 g of water-soluble propolis, 4 g of green tea extract, and 6 g of sage extract were added to the dispersed solution, and stirred again to disperse completely. Further, 0.4 g of sucralose and 0.4 g of acesulfame potassium were added to the dispersed solution, followed by stirring again.
마지막으로 플루란 100.74g, 옥수수전분 7.0g을 추가한 후 균질한 액이 될 때까지 교반하고, 감압 탈기하여 필름 제조액으로 사용하였다.Finally, 100.74 g of fullulane and 7.0 g of corn starch were added, stirred until a homogeneous solution was obtained, and then degassed under reduced pressure to be used as a film preparation solution.
제조된 필름조제액을 베이스 필름지 위에 붓고, 필름 어플리케이터(1117, SI)로 캐스팅한 뒤, 80℃ 이상의 고온으로 건조시키고, 베이스 필름지와 분리(박리)시켜 수용성 프로폴리스, 녹차추출물 및 세이지추출액이 함유된 구강붕해필름을 얻었다.The prepared film preparation solution is poured on the base film paper, cast with a film applicator (1117, SI), dried at a high temperature of 80° C. or higher, and separated (peeled) from the base film paper to contain water-soluble propolis, green tea extract and sage extract An orally disintegrating film was obtained.
실시예 <2-2>Example <2-2>
조제용기에 정제수 340g을 넣고, 글리세린 24.26g, 폴리소르베이트80 1.2g을 추가한 후 교반하여 분산시켰다. 분산된 용액에 수용성 프로폴리스 20g, 녹차추출물 6g, 세이지추출액 4g을 넣고 다시 교반하여 완전히 분산시켰다. 분산된 용액에 추가로 수크랄로스 0.4g, 아세설팜칼륨 0.4g을 투입한 후 다시 교반하였다.340 g of purified water was put in a preparation container, glycerin 24.26 g, and polysorbate 80 1.2 g were added, and then dispersed by stirring. 20 g of water-soluble propolis, 6 g of green tea extract, and 4 g of sage extract were added to the dispersed solution, and stirred again to disperse completely. Further, 0.4 g of sucralose and 0.4 g of acesulfame potassium were added to the dispersed solution, followed by stirring again.
마지막으로 플루란 100.74g, 옥수수전분 7.0g을 추가한 후 균질한 액이 될 때까지 교반하고, 감압 탈기하여 필름 제조액으로 사용하였다.Finally, 100.74 g of fullulane and 7.0 g of corn starch were added, stirred until a homogeneous solution was obtained, and then degassed under reduced pressure to be used as a film preparation solution.
제조된 필름조제액을 베이스 필름지 위에 붓고, 필름 어플리케이터(1117, SI)로 캐스팅한 뒤, 80℃ 이상의 고온으로 건조시키고, 베이스 필름지와 분리(박리)시켜 수용성 프로폴리스, 녹차추출물 및 세이지추출액이 함유된 구강붕해필름을 얻었다.The prepared film preparation solution is poured on the base film paper, cast with a film applicator (1117, SI), dried at a high temperature of 80° C. or higher, and separated (peeled) from the base film paper to contain water-soluble propolis, green tea extract and sage extract An orally disintegrating film was obtained.
실시예 <2-3>Example <2-3>
조제용기에 정제수 340g을 넣고, 글리세린 24.26g, 폴리소르베이트80 1.2g을 추가한 후 교반하여 분산시켰다. 분산된 용액에 수용성 프로폴리스 4g, 녹차추출물 20g, 세이지추출액 6g을 넣고 다시 교반하여 완전히 분산시켰다. 분산된 용액에 추가로 수크랄로스 0.4g, 아세설팜칼륨 0.4g을 투입한 후 다시 교반하였다.340 g of purified water was put in a preparation container, glycerin 24.26 g, and polysorbate 80 1.2 g were added, and then dispersed by stirring. 4 g of water-soluble propolis, 20 g of green tea extract, and 6 g of sage extract were added to the dispersed solution, and stirred again to disperse completely. Further, 0.4 g of sucralose and 0.4 g of acesulfame potassium were added to the dispersed solution, followed by stirring again.
마지막으로 플루란 100.74g, 옥수수전분 7.0g을 추가한 후 균질한 액이 될 때까지 교반하고, 감압 탈기하여 필름 제조액으로 사용하였다.Finally, 100.74 g of fullulane and 7.0 g of corn starch were added, stirred until a homogeneous solution was obtained, and then degassed under reduced pressure to be used as a film preparation solution.
제조된 필름조제액을 베이스 필름지 위에 붓고, 필름 어플리케이터(1117, SI)로 캐스팅한 뒤, 80℃ 이상의 고온으로 건조시키고, 베이스 필름지와 분리(박리)시켜 수용성 프로폴리스, 녹차추출물 및 세이지추출액이 함유된 구강붕해필름을 얻었다.The prepared film preparation solution is poured on the base film paper, cast with a film applicator (1117, SI), dried at a high temperature of 80° C. or higher, and separated (peeled) from the base film paper to contain water-soluble propolis, green tea extract and sage extract An orally disintegrating film was obtained.
실시예 <2-4>Example <2-4>
조제용기에 정제수 340g을 넣고, 글리세린 24.26g, 폴리소르베이트80 1.2g을 추가한 후 교반하여 분산시켰다. 분산된 용액에 수용성 프로폴리스 6g, 녹차추출물 20g, 세이지추출액 4g을 넣고 다시 교반하여 완전히 분산시켰다. 분산된 용액에 추가로 수크랄로스 0.4g, 아세설팜칼륨 0.4g을 투입한 후 다시 교반하였다.340 g of purified water was put in a preparation container, glycerin 24.26 g, and polysorbate 80 1.2 g were added, and then dispersed by stirring. 6 g of water-soluble propolis, 20 g of green tea extract, and 4 g of sage extract were added to the dispersed solution, and stirred again to disperse completely. Further, 0.4 g of sucralose and 0.4 g of acesulfame potassium were added to the dispersed solution, followed by stirring again.
마지막으로 플루란 100.74g, 옥수수전분 7.0g을 추가한 후 균질한 액이 될 때까지 교반하고, 감압 탈기하여 필름 제조액으로 사용하였다.Finally, 100.74 g of fullulane and 7.0 g of corn starch were added, stirred until a homogeneous solution was obtained, and then degassed under reduced pressure to be used as a film preparation solution.
제조된 필름조제액을 베이스 필름지 위에 붓고, 필름 어플리케이터(1117, SI)로 캐스팅한 뒤, 80℃ 이상의 고온으로 건조시키고, 베이스 필름지와 분리(박리)시켜 수용성 프로폴리스, 녹차추출물 및 세이지추출액이 함유된 구강붕해필름을 얻었다.The prepared film preparation solution is poured on the base film paper, cast with a film applicator (1117, SI), dried at a high temperature of 80° C. or higher, and separated (peeled) from the base film paper to contain water-soluble propolis, green tea extract and sage extract An orally disintegrating film was obtained.
실시예 <2-5>Example <2-5>
조제용기에 정제수 340g을 넣고, 글리세린 24.26g, 폴리소르베이트80 1.2g을 추가한 후 교반하여 분산시켰다. 분산된 용액에 수용성 프로폴리스 4g, 녹차추출물 6g, 세이지추출액 20g을 넣고 다시 교반하여 완전히 분산시켰다. 분산된 용액에 추가로 수크랄로스 0.4g, 아세설팜칼륨 0.4g을 투입한 후 다시 교반하였다.340 g of purified water was put in a preparation container, glycerin 24.26 g, and polysorbate 80 1.2 g were added, and then dispersed by stirring. 4 g of water-soluble propolis, 6 g of green tea extract, and 20 g of sage extract were added to the dispersed solution, and stirred again to disperse completely. Further, 0.4 g of sucralose and 0.4 g of acesulfame potassium were added to the dispersed solution, followed by stirring again.
마지막으로 플루란 100.74g, 옥수수전분 7.0g을 추가한 후 균질한 액이 될 때까지 교반하고, 감압 탈기하여 필름 제조액으로 사용하였다.Finally, 100.74 g of fullulane and 7.0 g of corn starch were added, stirred until a homogeneous solution was obtained, and then degassed under reduced pressure to be used as a film preparation solution.
제조된 필름조제액을 베이스 필름지 위에 붓고, 필름 어플리케이터(1117, SI)로 캐스팅한 뒤, 80℃ 이상의 고온으로 건조시키고, 베이스 필름지와 분리(박리)시켜 수용성 프로폴리스, 녹차추출물 및 세이지추출액이 함유된 구강붕해필름을 얻었다.The prepared film preparation solution is poured on the base film paper, cast with a film applicator (1117, SI), dried at a high temperature of 80° C. or higher, and separated (peeled) from the base film paper to contain water-soluble propolis, green tea extract and sage extract An orally disintegrating film was obtained.
실시예 <2-6>Example <2-6>
조제용기에 정제수 340g을 넣고, 글리세린 24.26g, 폴리소르베이트80 1.2g을 추가한 후 교반하여 분산시켰다. 분산된 용액에 수용성 프로폴리스 6g, 녹차추출물 4g, 세이지추출액 20g을 넣고 다시 교반하여 완전히 분산시켰다. 분산된 용액에 추가로 수크랄로스 0.4g, 아세설팜칼륨 0.4g을 투입한 후 다시 교반하였다.340 g of purified water was put in a preparation container, glycerin 24.26 g, and polysorbate 80 1.2 g were added, and then dispersed by stirring. 6 g of water-soluble propolis, 4 g of green tea extract, and 20 g of sage extract were added to the dispersed solution, and stirred again to disperse completely. Further, 0.4 g of sucralose and 0.4 g of acesulfame potassium were added to the dispersed solution, followed by stirring again.
마지막으로 플루란 100.74g, 옥수수전분 7.0g을 추가한 후 균질한 액이 될 때까지 교반하고, 감압 탈기하여 필름 제조액으로 사용하였다.Finally, 100.74 g of fullulane and 7.0 g of corn starch were added, stirred until a homogeneous solution was obtained, and then degassed under reduced pressure to be used as a film preparation solution.
제조된 필름조제액을 베이스 필름지 위에 붓고, 필름 어플리케이터(1117, SI)로 캐스팅한 뒤, 80℃ 이상의 고온으로 건조시키고, 베이스 필름지와 분리(박리)시켜 수용성 프로폴리스, 녹차추출물 및 세이지추출액이 함유된 구강붕해필름을 얻었다.The prepared film preparation solution is poured on the base film paper, cast with a film applicator (1117, SI), dried at a high temperature of 80° C. or higher, and separated (peeled) from the base film paper to contain water-soluble propolis, green tea extract and sage extract An orally disintegrating film was obtained.
본 발명의 필름 제조에 사용된 성분 및 이의 중량을 하기 표 9에 나타내었다.The components and their weights used to prepare the film of the present invention are shown in Table 9 below.
본 발명의 필름 제조에 사용된 성분 및 이의 중량 (mg/매)Ingredients used to prepare the film of the present invention and its weight (mg/sheet)
성분ingredient 실시예 <2-1>Example <2-1> 실시예 <2-2>Example <2-2> 실시예 <2-3>Example <2-3> 실시예 <2-4>Example <2-4> 실시예 <2-5>)Example <2-5>) 실시예 <2-6>Example <2-6> 함유율 (질량%)Content rate (mass %)
수용성 프로폴리스water-soluble propolis 1010 1010 22 33 22 33 18.318.3
녹차추출물green tea extract 22 33 1010 1010 33 22
세이지 추출액sage extract 33 22 33 22 1010 1010
플루란fullulan 50.3750.37 50.3750.37 50.3750.37 50.3750.37 50.3750.37 50.3750.37 61.4361.43
옥수수전분corn starch 3.53.5 3.53.5 3.53.5 3.53.5 3.53.5 3.53.5 4.274.27
글리세린glycerin 12.1312.13 12.1312.13 12.1312.13 12.1312.13 12.1312.13 12.1312.13 14.7914.79
폴리소르베이트80Polysorbate 80 0.60.6 0.60.6 0.60.6 0.60.6 0.60.6 0.60.6 0.730.73
수크랄로스sucralose 0.20.2 0.20.2 0.20.2 0.20.2 0.20.2 0.20.2 0.240.24
아세설팜칼륨acesulfame potassium 0.20.2 0.20.2 0.20.2 0.20.2 0.20.2 0.20.2 0.240.24
합계Sum 8282 8282 8282 8282 8282 8282 100100
정제수Purified water 170170 170170 170170 170170 170170 170170 --
<실험예 2><Experimental Example 2>
유효성분의 다양한 배합비에 따른 구강붕해필름의 구강 내 세균에 대한 항균 효과Antibacterial effect of oral disintegrating film on bacteria in the oral cavity according to various mixing ratios of active ingredients
본 실험에서는 상기 <실시예 2>를 통해 준비된 유효성분의 배합비를 달리하여 제조된 구강붕해필름의 구강 내 세균에 대한 항균 효과를 확인하였다. 구강 내 세균에 대한 항균력을 입증함으로써 구내염 및 치주염 예방 및 개선 효과, 항염 효과에 따른 구취 개선에 대한 입증자료로 사용 가능할 것으로 판단된다.In this experiment, the antibacterial effect on oral bacteria of the oral disintegrating film prepared by changing the mixing ratio of the active ingredient prepared in <Example 2> was confirmed. By proving the antibacterial activity against bacteria in the oral cavity, it is judged that it can be used as evidence for the prevention and improvement of stomatitis and periodontitis, and the improvement of bad breath according to the anti-inflammatory effect.
구강 내 세균인 포르피로모나스 진지발리스 KCTC 5352(Porphyromonas gingivalis KCTC 5352), 프로보텔라 인터메디아 ATCC 25611(Prevotella intermedia ATCC 25611) 및 퓨조박테리움 뉴클레아툼 KCTC 2488(Fusobacterium nucleatum KCTC 2488)를 대상으로 최소발육억제농도 (Minimum inhibitory concentration; MIC) 및 최소살균농도 (Minimum bactericidal concentration; MBC)를 측정함으로써 구강 균주에 대한 발육억제 효능을 평가하였다. 시험방법은 상기 <실험예 1>과 동일하게 진행하였다.Targeting oral bacteria Porphyromonas gingivalis KCTC 5352, Provotella intermedia ATCC 25611 and Fusobacterium nucleatum KCTC 2488 Growth inhibitory efficacy against oral strains was evaluated by measuring the minimum inhibitory concentration (MIC) and the minimum bactericidal concentration (MBC). The test method was carried out in the same manner as in <Experimental Example 1>.
시험결과 각 시료의 MIC 3회 반복 측정 결과가 모두 동일하게 나타났으며, 흡광도 측정에 의한 MIC 판정과 육안평가 결과가 동일하게 나타났다. 하기 표 10 내지 표 12에 P. gingivalis KCTC 5352, P. intermedia ATCC 25611, F. nucleatum KCTC 2488 균주에 대한 각 시료의 육안평가 MIC 값을 굵은 글씨의 이탤릭체로 나타내었으며, MBC 값은 회색 박스로 표시하였다. 또한 표 13 내지 표 15에 P. gingivalis KCTC 5352, P. intermedia ATCC 25611, F. nucleatum KCTC 2488 균주에 대한 흡광도 측정값을 기재하였다.As a result of the test, the results of three repeated MIC measurements of each sample were the same, and the MIC determination by absorbance measurement and the visual evaluation results were the same. In Tables 10 to 12, the visual evaluation MIC values of each sample for P. gingivalis KCTC 5352, P. intermedia ATCC 25611, and F. nucleatum KCTC 2488 strains are shown in bold italics, and MBC values are shown in gray boxes. did In addition, the absorbance values for P. gingivalis KCTC 5352, P. intermedia ATCC 25611, and F. nucleatum KCTC 2488 strains were described in Tables 13 to 15.
Figure PCTKR2021008564-appb-img-000007
Figure PCTKR2021008564-appb-img-000007
Figure PCTKR2021008564-appb-img-000008
Figure PCTKR2021008564-appb-img-000008
Figure PCTKR2021008564-appb-img-000009
Figure PCTKR2021008564-appb-img-000009
Figure PCTKR2021008564-appb-img-000010
Figure PCTKR2021008564-appb-img-000010
Figure PCTKR2021008564-appb-img-000011
Figure PCTKR2021008564-appb-img-000011
Figure PCTKR2021008564-appb-img-000012
Figure PCTKR2021008564-appb-img-000012
유효성분의 총 함유량이 동일하나 서로 다른 비율별로 제조한 각각의 실시예 시료로 최소발육억제농도 시험을 실시한 결과, 균주 P. gingivalis KCTC 5352에 대한 실시예 <2-2> 시료의 MIC 값이 0.058 mg/mL로 측정되어, 다른 시료에 비해 2배에서 8배 항균 효력이 좋은 것으로 판정되었다. 또한, F. nucleatum KCTC 2488 군주에 대한 실시예 <2-2> 시료의 MIC 값은 0.058 mg/mL로 측정되어 다른 시료에 비해 2배에서 64배 높은 항균 효력을 보였으며, P. intermedia ATCC 25611 균주의 경우도 실시예<2-2> 시료에서 MIC 측정값이 0.12mg/mL로 나타나, 다른 시료들에 비해 2배에서 32배로 높은 항균 효력을 보였주었다.As a result of performing the minimum growth inhibition concentration test with each Example sample prepared at different ratios with the same total content of active ingredients, the MIC value of the sample <2-2> for strain P. gingivalis KCTC 5352 was 0.058 Measured in mg/mL, it was determined that the antibacterial effect was 2 to 8 times better than that of other samples. In addition, the MIC value of the sample <2-2> of Example <2-2> against the F. nucleatum KCTC 2488 monarch was 0.058 mg/mL, showing an antibacterial effect 2 to 64 times higher than that of other samples, and P. intermedia ATCC 25611 In the case of the strain, the MIC measurement value in the sample of Example <2-2> was 0.12 mg/mL, indicating a high antibacterial effect from 2 to 32 times compared to other samples.
결과를 종합하여 볼 때, 수용성 프로폴리스, 녹차추출물 및 세이지추출액이 10 : 3 : 2의 배합비를 갖는 실시예 <2-2>의 구강붕해필름이 구강 내 세균의 증식 억제력이 두드러지게 우수한 것으로 확인되었다.Taken together, it was found that the oral disintegrating film of Example <2-2>, in which water-soluble propolis, green tea extract, and sage extract had a mixing ratio of 10:3:2, was remarkably excellent in inhibiting the growth of bacteria in the oral cavity. Confirmed.
<실험예 3><Experimental Example 3>
본 발명의 최적의 배합비를 갖는 구강붕해필름의 구취 개선 효과The effect of improving bad breath of the orally disintegrating film having the optimal mixing ratio of the present invention
본 실험에서는 상기 <실험예 2>를 통해 최적의 배합비로 확인된 실시예 <2-2>의 구강붕해필름의 구취 제거 효과를 확인하기 위하여, 비임상시험위수탁기관 ㈜케이피씨(KPC)에 의뢰하여 이하의 실험을 수행하였다.In this experiment, in order to confirm the effect of removing bad breath of the oral disintegrating film of Example <2-2>, which was confirmed as the optimal mixing ratio through <Experimental Example 2>, the The following experiments were performed by request.
비글 시험견 10수에 대하여 실시예 9의 구강붕해필름의 섭취에 따른 구취의 값을 측정하였다. 비글 시험견을 구개 후 50mL의 주사기를 이용하여 구강 내 공기를 채취하고, 채취된 비글견 구강 공기를 구취 측정기(제조사 TANITA, HC-150M)에 3초간 주입하여 실시예 9의 구강붕해필름 단회 급여 전·후의 구취를 측정하였다.For 10 beagle test dogs, the value of bad breath according to the intake of the oral disintegrating film of Example 9 was measured. After palatalizing the beagle test dog, intraoral air was collected using a 50mL syringe, and the collected oral air was injected into a bad breath meter (manufacturer TANITA, HC-150M) for 3 seconds, and the oral disintegrating film of Example 9 was single-shot. Halitosis was measured before and after feeding.
이때, 구취의 정도의 값은 하기와 같다.At this time, the value of the degree of bad breath is as follows.
0: 구취가 전혀 없음0: no bad breath
1: 보통1: Normal
2: 조금 불쾌한 구취가 남2: Slightly unpleasant bad breath
3: 불쾌한 구취가 남3: Bad breath
4: 매우 불쾌한 구취가 남4: Very unpleasant bad breath
본 발명 실시예 <2-2>의 구강붕해필름 섭취 전·후 구취 변화 시험Halitosis change test before and after ingestion of the oral disintegrating film of Example <2-2> of the present invention
급여 전before salary 급여 후after salary
시험견 1test dog 1 44 22
시험견 2test dog 2 33 1One
시험견 3test dog 3 33 1One
시험견 4test dog 4 44 33
시험견 5test dog 5 22 22
시험견 6test dog 6 33 33
시험견 7test dog 7 44 1One
시험견 8test dog 8 44 22
시험견 9test dog 9 33 33
시험견 10test dog 10 22 00
상기 표 16의 결과에 나타난 바와 같이, 시험 비글견 10수의 급여 전·후의 구취 변화를 확인한 결과 70%(7수)의 시험견에서 구취 개선의 효과를 확인하였다. As shown in the results of Table 16 above, as a result of confirming the change in bad breath before and after feeding 10 test beagle dogs, the effect of improving bad breath was confirmed in 70% (7 numbers) of test dogs.
<실험예 4><Experimental Example 4>
본 발명의 최적의 배합비를 갖는 구강붕해필름의 구취 개선 설문 평가Questionnaire evaluation of the improvement of bad breath of the orally disintegrating film having the optimal mixing ratio of the present invention
본 실험에서는 상기 <실험예 2>를 통해 최적의 배합비로 확인된 실시예 <2-2>의 구강붕해필름의 구취제거 효과를 확인하기 위하여, 비임상시험위수탁기관 ㈜케이피씨(KPC)에 의뢰하여 이하의 실험을 수행하였다. ㈜케이피씨 제휴 동물병원 3곳에서 관리되는 반려견 102수에 대하여 실시예 <2-2>의 구강붕해필름을 급여 시 구취 제거 효과를 확인하였다.In this experiment, in order to confirm the effect of removing bad breath of the oral disintegrating film of Example <2-2>, which was confirmed as the optimal mixing ratio through <Experimental Example 2>, the The following experiments were performed by request. The effect of removing bad breath was confirmed when the oral disintegrating film of Example <2-2> was applied to 102 dogs managed at 3 KPC affiliated animal hospitals.
1일 1회 1매, 30일 급여 전·후의 반려견 구취의 변화를 견주 대상으로 설문 평가를 하였다.The change of bad breath in dogs before and after feeding 1 sheet once a day, 30 days before and after feeding, a questionnaire evaluation was conducted with dog owners.
반려견 102수 대상으로 한 본 발명 실시예 <2-2>의 구강붕해필름 섭취 전·후 구취 변화 설문 결과Results of a change in bad breath before and after ingestion of the oral disintegrating film of Example <2-2> of the present invention for 102 dogs
급여 전 구취 정도Degree of bad breath before feeding 30일 급여 후 구취 변화Bad breath change after 30 days of feeding 개수Count %%
구취 없음no bad breath 매우 개선됨very improved 00 --
개선됨improved 44 33.333.3
보통usually 77 58.358.3
약간 개선됨slightly improved 00 --
개선되지 않음no improvement 1One 8.38.3
합계Sum 1212 100100
약간 있음slightly present 매우 개선됨very improved 1One 4.24.2
개선됨improved 1010 41.741.7
보통usually 66 2525
약간 개선됨slightly improved 55 20.820.8
개선되지 않음no improvement 22 8.38.3
합계Sum 2424 100100
보통usually 매우 개선됨very improved 1010 3737
개선됨improved 99 33.333.3
보통usually 22 7.47.4
약간 개선됨slightly improved 33 11.111.1
개선되지 않음no improvement 33 11.111.1
합계Sum 2727 100100
심하다Severe 매우 개선됨very improved 66 28.628.6
개선됨improved 77 33.333.3
보통usually 22 9.59.5
약간 개선됨slightly improved 33 14.314.3
개선되지 않음no improvement 33 14.314.3
합계Sum 2121 100100
매우 심하다very severe 매우 개선됨very improved 88 44.444.4
개선됨improved 22 11.111.1
보통usually 1One 5.65.6
약간 개선됨slightly improved 55 27.827.8
개선되지 않음no improvement 22 11.111.1
합계Sum 1818 100100
총 합계total 102102 100100
상기 표 17의 결과에 나타난 바와 같이, 1일 1회 1매, 30일 급여 후 반려견의 구취 개선효과가 102수 중 91수(89.2%)에서 구취 개선의 효과를 보였으며, 개선 또는 매우 개선된 개체수의 경우 102수 중 57수(55.9%)로 구취 개선의 효과가 확인되었다. 특히 구취가 매우 심한 반려견 18수에 대해서 8수(44.4%)의 수가 구취 개선에 매우 좋은 효과를 확인하였다.As shown in the results of Table 17 above, after feeding once a day for 30 days, the effect of improving bad breath in dogs was shown in 91 out of 102 (89.2%) of 102 cases (89.2%), and improved or very improved In the case of the number of individuals, the effect of improving bad breath was confirmed in 57 out of 102 (55.9%) cases. In particular, the number of 8 dogs (44.4%) for 18 dogs with very severe bad breath had a very good effect on improving bad breath.
<실시예 3><Example 3>
스피루리나 함유 구강붕해필름 제조Manufacture of oral disintegrating film containing spirulina
본 발명의 유효성분인 프로폴리스, 녹차추출물 및 세이지추출액 이외에 스피루리나 추출분말을 추가로 첨가하여 구강붕해필름을 제조하였다. 실험에서 사용한 스피루리나 추출분말은 미래바이오텍에서 구입하였다.In addition to the active ingredients of the present invention, propolis, green tea extract and sage extract, spirulina extract powder was additionally added to prepare an oral disintegrating film. Spirulina extract powder used in the experiment was purchased from Mirae Biotech.
조제용기에 정제수 380g을 넣고, 글리세린 24.26g, 폴리소르베이트80 1.2g을 추가한 후 교반하여 분산시켰다. 분산된 용액에 수용성 프로폴리스 20g, 녹차추출물 6g, 세이지추출액 4g, 스피루리나 추출분말 24g을 넣고 다시 교반하여 완전히 분산시켰다. 분산된 용액에 추가로 수크랄로스 0.4g, 아세설팜칼륨 0.4g을 투입한 후 다시 교반하였다.380 g of purified water was placed in a preparation container, and 24.26 g of glycerin and 1.2 g of polysorbate 80 were added, followed by stirring to disperse. 20 g of water-soluble propolis, 6 g of green tea extract, 4 g of sage extract, and 24 g of spirulina extract were added to the dispersed solution, and stirred again to disperse completely. Further, 0.4 g of sucralose and 0.4 g of acesulfame potassium were added to the dispersed solution, followed by stirring again.
마지막으로 플루란 100.74g, 옥수수전분 7.0g을 추가한 후 균질한 액이 될 때까지 교반하고, 감압 탈기하여 필름 제조액으로 사용하였다.Finally, 100.74 g of fullulane and 7.0 g of corn starch were added, stirred until a homogeneous solution was obtained, and then degassed under reduced pressure to be used as a film preparation solution.
제조된 필름조제액을 베이스 필름지 위에 붓고, 필름 어플리케이터(1117, SI)로 캐스팅한 뒤, 80℃ 이상의 고온으로 건조시키고, 베이스 필름지와 분리(박리)시켜 수용성 프로폴리스, 녹차추출물, 세이지추출액 및 스피루리나 추출분말이 함유된 구강붕해필름을 얻었다.The prepared film preparation liquid is poured on the base film paper, cast with a film applicator (1117, SI), dried at a high temperature of 80° C. or higher, and separated from the base film paper (peeled) to obtain water-soluble propolis, green tea extract, sage extract and spirulina. An orally disintegrating film containing extract powder was obtained.
본 발명의 필름 제조에 사용된 성분 및 이의 중량을 하기 표 18에 나타내었다.The components and their weights used to prepare the film of the present invention are shown in Table 18 below.
본 발명의 스피루리나 추출분말 함유 구강붕해필름의 제조Preparation of orally disintegrating film containing spirulina extract powder of the present invention
성분ingredient 첨가량 (mg/매)Added amount (mg/sheet) 함유율 (질량%)Content rate (mass %)
수용성 프로폴리스water-soluble propolis 1010 10.6410.64
녹차추출물green tea extract 33 2.132.13
세이지추출액sage extract 22 3.193.19
스피루리나 추출분말Spirulina Extract Powder 1212 12.7712.77
플루란fullulan 50.3750.37 53.5953.59
옥수수전분corn starch 3.53.5 3.723.72
글리세린glycerin 12.1312.13 12.912.9
폴리소르베이트80Polysorbate 80 0.60.6 0.640.64
수크랄로스sucralose 0.20.2 0.210.21
아세설팜칼륨acesulfame potassium 0.20.2 0.210.21
합계Sum 9494 100100
정제수Purified water 190190 --
<실험예 5><Experimental Example 5>
본 발명의 스피루리나 추출분말 함유 구강붕해필름의 치석제거 효과Tartar removal effect of the oral disintegrating film containing spirulina extract powder of the present invention
본 실험에서는 상기 <실시예 3>을 통해 제조된 스피루리나 추출분말을 함유하는 구강붕해필름의 치석제거 효과를 확인하기 위하여, 비임상시험위수탁기관 ㈜케이피씨(KPC)에 의뢰하여 이하의 실험을 수행하였다. ㈜케이피씨 제휴 동물병원에서 관리되는 여러 품종의 반려견 10수에 대하여 스피루리나 추출분말 함유 구강붕해필름을 30일 급여 시 치석 제거 효과를 확인하였다.In this experiment, in order to confirm the tartar removal effect of the oral disintegrating film containing the spirulina extract powder prepared in <Example 3>, the following experiment was requested by the non-clinical testing consignment organization KPC (KPC). carried out. For 10 dogs of various breeds managed by KPC Co., Ltd. affiliated animal hospital, oral disintegrating film containing spirulina extract powder was administered for 30 days, and the effect of tartar removal was confirmed.
그 결과 도 1 내지 7에서 나타낸 바와 같이, 10수의 반려견에 대한 스피루리나 추출분말 함유 구강붕해필름 30일 급여 전후의 치석 개선 효과를 확인한 결과 70%(7수)의 시험견에서 치석 개선의 효과를 확인하였다.As a result, as shown in FIGS. 1 to 7, the effect of tartar improvement in 70% (7 numbers) of test dogs after confirming the tartar improvement effect before and after 30 days feeding of the oral disintegrating film containing spirulina extract powder for 10 dogs was confirmed.
<실시예 4><Example 4>
옥수수불검화추출물 함유 구강붕해필름 제조Manufacture of orally disintegrating film containing corn unsaponifiable extract
본 발명의 유효성분인 프로폴리스, 녹차추출물 및 세이지추출액 이외에 옥수수불검화추출물을 추가로 첨가하여 구강붕해필름을 제조하였다. 실험에서 사용한 옥수수불검화추출물은 미래바이오텍에서 구입하였다.In addition to the active ingredients of the present invention, propolis, green tea extract, and sage extract, an orally disintegrating film was prepared by further adding corn unsaponifiable extract. The corn unsaponifiable extract used in the experiment was purchased from Mirae Biotech.
조제용기에 정제수 360g을 넣고, 글리세린 24.26g, 폴리소르베이트80 1.2g을 추가한 후 교반하여 분산시켰다. 분산된 용액에 수용성 프로폴리스 20g, 녹차추출물 6g, 세이지추출액 4g, 옥수수불검화추출물 8g을 넣고 다시 교반하여 완전히 분산시켰다. 분산된 용액에 추가로 수크랄로스 0.4g, 아세설팜칼륨 0.4g을 투입한 후 다시 교반하였다.360 g of purified water was placed in a preparation container, glycerin 24.26 g and polysorbate 80 1.2 g were added, and then dispersed by stirring. 20 g of water-soluble propolis, 6 g of green tea extract, 4 g of sage extract, and 8 g of saponified corn extract were added to the dispersed solution and stirred again to disperse completely. Further, 0.4 g of sucralose and 0.4 g of acesulfame potassium were added to the dispersed solution, followed by stirring again.
마지막으로 플루란 100.74g, 옥수수전분 7.0g을 추가한 후 균질한 액이 될 때까지 교반하고, 감압 탈기하여 필름 제조액으로 사용하였다.Finally, 100.74 g of fullulane and 7.0 g of corn starch were added, stirred until a homogeneous solution was obtained, and then degassed under reduced pressure to be used as a film preparation solution.
제조된 필름조제액을 베이스 필름지 위에 붓고, 필름 어플리케이터(1117, SI)로 캐스팅한 뒤, 80℃ 이상의 고온으로 건조시키고, 베이스 필름지와 분리(박리)시켜 수용성 프로폴리스, 녹차추출물, 세이지추출액 및 옥수수불검화추출물이 함유된 구강붕해필름을 얻었다.The prepared film preparation liquid is poured on the base film paper, cast with a film applicator (1117, SI), dried at a high temperature of 80° C. or higher, and separated from the base film paper (peeled) to obtain water-soluble propolis, green tea extract, sage extract and corn An orally disintegrating film containing unsaponifiable extract was obtained.
본 발명의 필름 제조에 사용된 성분 및 이의 중량을 하기 표 19에 나타내었다.The components used for preparing the film of the present invention and their weights are shown in Table 19 below.
본 발명의 옥수수불검화추출물 함유 구강붕해필름의 제조Preparation of orally disintegrating film containing corn unsaponifiable extract of the present invention
성분ingredient 첨가량 (mg/매)Added amount (mg/sheet) 함유율 (질량%)Content rate (mass %)
수용성 프로폴리스water-soluble propolis 1010 11.6311.63
녹차추출물green tea extract 33 2.332.33
세이지추출액sage extract 22 3.493.49
옥수수불검화추출물Corn Unsaponifiable Extract 44 4.654.65
플루란fullulan 50.3750.37 58.5758.57
옥수수전분corn starch 3.53.5 4.074.07
글리세린glycerin 12.1312.13 14.114.1
폴리소르베이트80Polysorbate 80 0.60.6 0.70.7
수크랄로스sucralose 0.20.2 0.230.23
아세설팜칼륨acesulfame potassium 0.20.2 0.230.23
합계Sum 8686 100100
정제수Purified water 180180 --
<실험예 6><Experimental Example 6>
본 발명의 옥수수불검화추출물 함유 구강붕해필름의 치주질환 개선 효과Periodontal disease improvement effect of orally disintegrating film containing corn unsaponifiable extract of the present invention
본 실험에서는 상기 <실시예 4>를 통해 제조된 옥수수불검화추출물을 함유하는 구강붕해필름의의 치주 질환(치은염 및 치주염) 개선 효과를 확인하기 위하여, 비임상시험위수탁기관 ㈜케이피씨(KPC)에 의뢰하여 이하의 실험을 수행하였다. In this experiment, in order to confirm the improvement effect of periodontal disease (gingivitis and periodontitis) of the oral disintegrating film containing the corn unsaponifiable extract prepared in <Example 4>, the non-clinical testing agency KPC (KPC) ) to perform the following experiments.
치주질환이 있는 시험견 8수에 대하여 옥수수불검화추출물 함유 구강붕해필름을 60일 급여 시 치주질환 개선 효과를 확인하였다.For 8 test dogs with periodontal disease, the oral disintegration film containing corn saponification extract was fed for 60 days, and the effect of improving periodontal disease was confirmed.
구강 내 치주상태를 평가하는 도구로 1에서 15mm의 눈금이 표기되어있는 치주 탐촉자(Periodontal Probe)를 이용하여 치아와 잇몸이 닿는 치아 연접부인 치주낭의 깊이를 측정하여 옥수수불검화추출물이 함유된 실시예 15의 구강붕해필름 섭취 전후의 치주 상태를 평가하였다. 개의 경우 치주낭의 깊이가 1에서 3mm가 평균이며, 4mm 이상 측정된 경우 치주 질환이 있는 것으로 진단된다.Example containing corn saponification extract by measuring the depth of the periodontal pocket, the tooth junction between the teeth and gums, using a periodontal probe marked with a scale of 1 to 15 mm as a tool to evaluate the periodontal condition in the oral cavity The periodontal state before and after ingestion of the oral disintegrating film of 15 was evaluated. In the case of dogs, the average depth of the periodontal pocket is 1 to 3 mm, and if it measures 4 mm or more, it is diagnosed as having periodontal disease.
본 발명의 옥수수불검화추출물 함유 구강붕해필름의 섭취 전·후 치주낭 깊이Periodontal pocket depth before and after ingestion of orally disintegrating film containing corn unsaponifiable extract of the present invention
실험 대상test subject 급여 전 치주낭 깊이(mm)Periodontal pocket depth before feeding (mm) 급여 후 치주낭 깊이(mm)Periodontal pocket depth after feeding (mm)
시험견 1test dog 1 44 33
시험견 2test dog 2 44 22
시험견 3test dog 3 55 55
시험견 4test dog 4 66 55
시험견 5test dog 5 66 44
시험견 6test dog 6 55 33
시험견 7test dog 7 66 55
시험견 8test dog 8 55 44
치주질환이 있는 시험견 8수에 대하여 본 발명의 옥수수불검화추출물 함유 구강붕해필름을 1일 1매 60일 급여 후 치주낭의 깊이를 평가한 결과, 상기 표 20에서 나타난 바와 같이, 평균 1.25mm으로 치주낭의 깊이가 감소하였으며, 8수 중 7수(87.5%)의 시험견에서 치주질환의 개선효과를 확인할 수 있었다.As a result of evaluating the depth of the periodontal pocket after feeding the oral disintegrating film containing the corn unsaponifiable extract of the present invention to 8 test dogs with periodontal disease, once a day for 60 days, as shown in Table 20, an average of 1.25 mm As a result, the depth of the periodontal pocket was reduced, and the improvement effect of periodontal disease was confirmed in 7 out of 8 (87.5%) test dogs.
이제까지 본 발명에 대하여 그 바람직한 실시예들을 중심으로 살펴보았다. 본 발명이 속하는 기술 분야에서 통상의 지식을 가진 자는 본 발명이 본 발명의 본질적인 특성에서 벗어나지 않는 범위에서 변형된 형태로 구현될 수 있음을 이해할 수 있을 것이다. 그러므로 개시된 실시예들은 한정적인 관점이 아니라 설명적인 관점에서 고려되어야 한다. 본 발명의 범위는 전술한 설명이 아니라 특허청구범위에 나타나 있으며, 그와 동등한 범위 내에 있는 모든 차이점은 본 발명에 포함된 것으로 해석되어야 할 것이다.So far, with respect to the present invention, the preferred embodiments have been looked at. Those of ordinary skill in the art to which the present invention pertains will understand that the present invention can be implemented in a modified form without departing from the essential characteristics of the present invention. Therefore, the disclosed embodiments are to be considered in an illustrative rather than a restrictive sense. The scope of the present invention is indicated in the claims rather than the foregoing description, and all differences within the scope equivalent thereto should be construed as being included in the present invention.

Claims (7)

  1. 프로폴리스, 녹차추출물 및 세이지추출물을 유효성분으로 포함하는 동물의 구강 질환의 예방 또는 개선용 구강붕해필름 조성물.An oral disintegrating film composition for preventing or improving oral diseases of animals, comprising propolis, green tea extract and sage extract as active ingredients.
  2. 제1항에 있어서,According to claim 1,
    상기 구강 질환은 구내염, 구순염, 구취, 치석, 치주염 및 치은염으로 이루어진 군으로부터 선택되는 것을 특징으로 하는, 동물의 구강 질환의 예방 또는 개선용 구강붕해필름 조성물.The oral disease is stomatitis, stomatitis, halitosis, tartar, periodontitis and gingivitis, characterized in that selected from the group consisting of, oral disintegration film composition for preventing or improving oral diseases in animals.
  3. 제1항에 있어서,According to claim 1,
    상기 조성물은 유효성분으로 스피루리나 추출물 또는 옥수수불검화추출물을 더 포함하는 것을 특징으로 하는, 동물의 구강 질환의 예방 또는 개선용 구강붕해필름 조성물.The composition is an oral disintegrating film composition for the prevention or improvement of oral diseases in animals, characterized in that it further comprises a spirulina extract or a corn saponification extract as an active ingredient.
  4. 제1항에 있어서,According to claim 1,
    상기 조성물은 가식성 고분자를 더 포함하는 것을 특징으로 하는, 동물의 구강 질환의 예방 또는 개선용 구강붕해필름 조성물.The composition further comprises an edible polymer, an oral disintegrating film composition for the prevention or improvement of oral diseases in animals.
  5. 제4항에 있어서,5. The method of claim 4,
    상기 가식성 고분자는 히드록시프로필셀룰로오스, 히드록시프로필메틸셀룰로오스, 히드록시에틸셀룰로오스, 카복시메틸셀룰로오스·나트륨, 카르복시메틸셀룰로오스·칼슘, 카르복시메틸셀룰로오스·칼륨, 카르복시메틸셀룰로오스 및 플루란으로 이루어진 군으로부터 선택되는 것을 특징으로 하는, 동물의 구강 질환의 예방 또는 개선용 구강붕해필름 조성물.The edible polymer is selected from the group consisting of hydroxypropyl cellulose, hydroxypropylmethyl cellulose, hydroxyethyl cellulose, carboxymethyl cellulose sodium, carboxymethyl cellulose calcium, carboxymethyl cellulose potassium, carboxymethyl cellulose, and fullulan An oral disintegrating film composition for the prevention or improvement of oral diseases in animals, characterized in that it becomes.
  6. 제1항 내지 제5항 중 어느 한 항의 조성물로 제조된 동물의 구강 질환의 예방 또는 개선용 구강붕해필름.An orally disintegrating film for the prevention or improvement of oral diseases of animals prepared with the composition of any one of claims 1 to 5.
  7. 제6항에 있어서,7. The method of claim 6,
    상기 구강붕해필름은 동물의 혀 위, 입천장, 설하 또는 입안안뜰(buccal)에 부착하는 것을 특징으로 하는, 동물의 구강 질환의 예방 또는 개선용 구강붕해필름.The oral disintegrating film is an oral disintegrating film for the prevention or improvement of oral diseases in animals, characterized in that it is attached to the tongue, roof of the mouth, sublingual or buccal of the animal.
PCT/KR2021/008564 2020-07-15 2021-07-06 Oral disintegrating film composition for animals, having effect of reducing halitosis, dental calculus, stomatitis, and periodontitis WO2022014931A1 (en)

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Publication number Priority date Publication date Assignee Title
KR20050029905A (en) * 2003-09-24 2005-03-29 주식회사 엘지생활건강 A film for reducing and removing mouth odor and composition for manufacturing the same
JP2014508136A (en) * 2011-01-24 2014-04-03 ビーエーエスエフ ソシエタス・ヨーロピア Composition for improving oral hygiene
KR20190117466A (en) * 2015-11-10 2019-10-16 주식회사 엘지생활건강 Removable tooth-attached patch by brushing
KR20190135123A (en) * 2018-05-28 2019-12-06 주식회사 아미코스메틱 A method and system for providing gene customized oral-care product
KR20200071360A (en) * 2018-12-11 2020-06-19 주식회사 엘리바이오 Toothpaste Composition Comprising Rosa Canina Extract
KR102147468B1 (en) * 2020-04-07 2020-08-24 주식회사 바이오360 Oral Dissolving Film Containing Propolis Extract And Manufacturing Method Thereof

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR20050029905A (en) * 2003-09-24 2005-03-29 주식회사 엘지생활건강 A film for reducing and removing mouth odor and composition for manufacturing the same
JP2014508136A (en) * 2011-01-24 2014-04-03 ビーエーエスエフ ソシエタス・ヨーロピア Composition for improving oral hygiene
KR20190117466A (en) * 2015-11-10 2019-10-16 주식회사 엘지생활건강 Removable tooth-attached patch by brushing
KR20190135123A (en) * 2018-05-28 2019-12-06 주식회사 아미코스메틱 A method and system for providing gene customized oral-care product
KR20200071360A (en) * 2018-12-11 2020-06-19 주식회사 엘리바이오 Toothpaste Composition Comprising Rosa Canina Extract
KR102147468B1 (en) * 2020-04-07 2020-08-24 주식회사 바이오360 Oral Dissolving Film Containing Propolis Extract And Manufacturing Method Thereof

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