WO2020138334A1 - 発泡性経口固形製剤 - Google Patents

発泡性経口固形製剤 Download PDF

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Publication number
WO2020138334A1
WO2020138334A1 PCT/JP2019/051234 JP2019051234W WO2020138334A1 WO 2020138334 A1 WO2020138334 A1 WO 2020138334A1 JP 2019051234 W JP2019051234 W JP 2019051234W WO 2020138334 A1 WO2020138334 A1 WO 2020138334A1
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mass
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component
solid preparation
acid
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PCT/JP2019/051234
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English (en)
French (fr)
Japanese (ja)
Inventor
健吉 山本
山本　真士
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花王株式会社
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Priority to KR1020217019510A priority Critical patent/KR20210095905A/ko
Priority to CN201980086373.6A priority patent/CN113226046A/zh
Publication of WO2020138334A1 publication Critical patent/WO2020138334A1/ja

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2068—Compounds of unknown constitution, e.g. material from plants or animals
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23G—COCOA; COCOA PRODUCTS, e.g. CHOCOLATE; SUBSTITUTES FOR COCOA OR COCOA PRODUCTS; CONFECTIONERY; CHEWING GUM; ICE-CREAM; PREPARATION THEREOF
    • A23G3/00—Sweetmeats; Confectionery; Marzipan; Coated or filled products
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23G—COCOA; COCOA PRODUCTS, e.g. CHOCOLATE; SUBSTITUTES FOR COCOA OR COCOA PRODUCTS; CONFECTIONERY; CHEWING GUM; ICE-CREAM; PREPARATION THEREOF
    • A23G3/00—Sweetmeats; Confectionery; Marzipan; Coated or filled products
    • A23G3/34—Sweetmeats, confectionery or marzipan; Processes for the preparation thereof
    • A23G3/36—Sweetmeats, confectionery or marzipan; Processes for the preparation thereof characterised by the composition containing organic or inorganic compounds
    • A23G3/48—Sweetmeats, confectionery or marzipan; Processes for the preparation thereof characterised by the composition containing organic or inorganic compounds containing plants or parts thereof, e.g. fruits, seeds, extracts
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23G—COCOA; COCOA PRODUCTS, e.g. CHOCOLATE; SUBSTITUTES FOR COCOA OR COCOA PRODUCTS; CONFECTIONERY; CHEWING GUM; ICE-CREAM; PREPARATION THEREOF
    • A23G3/00—Sweetmeats; Confectionery; Marzipan; Coated or filled products
    • A23G3/34—Sweetmeats, confectionery or marzipan; Processes for the preparation thereof
    • A23G3/50—Sweetmeats, confectionery or marzipan; Processes for the preparation thereof characterised by shape, structure or physical form, e.g. products with supported structure
    • A23G3/52—Aerated, foamed, cellular or porous products
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L2/00—Non-alcoholic beverages; Dry compositions or concentrates therefor; Their preparation
    • A23L2/40—Effervescence-generating compositions
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L27/00—Spices; Flavouring agents or condiments; Artificial sweetening agents; Table salts; Dietetic salt substitutes; Preparation or treatment thereof
    • A23L27/10—Natural spices, flavouring agents or condiments; Extracts thereof
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
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    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • A61K31/194—Carboxylic acids, e.g. valproic acid having two or more carboxyl groups, e.g. succinic, maleic or phthalic acid
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    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/88—Liliopsida (monocotyledons)
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12—Carboxylic acids; Salts or anhydrides thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • A—HUMAN NECESSITIES
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    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
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    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/0056—Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
    • A—HUMAN NECESSITIES
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    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/006—Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays
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    • A61K9/2004—Excipients; Inactive ingredients
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    • A—HUMAN NECESSITIES
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    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
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    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
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    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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    • A61P1/02—Stomatological preparations, e.g. drugs for caries, aphtae, periodontitis
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    • A23V—INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
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    • A23V—INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
    • A23V2250/00—Food ingredients
    • A23V2250/20—Natural extracts
    • A23V2250/21—Plant extracts

Definitions

  • the present invention relates to an effervescent oral solid preparation.
  • Saliva is important for maintaining homeostasis in the oral cavity, and is known to have self-cleaning action, buffering action, mucosal protection action, and antibacterial/antiviral action.
  • salivary glands There are three salivary glands, a parotid gland that mainly opens in the buccal mucosa, and a sublingual gland and a submandibular gland that open under the tongue. It has been reported that the antiviral action of saliva is higher in saliva derived from the tongue/submandibular gland than in saliva derived from the parotid gland (Non-patent Document 1). Therefore, in order to enhance the antiviral effect of saliva and prevent viral infection, it is particularly useful to promote secretion of tongue/submandibular saliva.
  • Patent Document 1 carbonic acid foaming with organic acids and carbonates or bicarbonates
  • Patent Document 2 fruits of plants belonging to the genus Salmaria, crushed products thereof, pressed products thereof or extracts thereof
  • Patent Document 2 is saliva. It has been reported to promote secretion, and an oral solid preparation containing an effervescent ingredient and a spice extract has been proposed.
  • Patent Document 1 Japanese Patent Laid-Open No. 2002-184
  • Patent Document 2 Japanese Patent Laid-Open No. 2011-68642
  • Non-Patent Document 1 Oral Microbiology Immunology 2009, 24(1), p. 18-24
  • the present invention comprises the following components (A), (B) and (C): (A) Spice extract 0.001% by mass or more and 0.11% by mass or less (B) Carbonate 7% by mass or more and 40% by mass or less (C) Organic acid or salt thereof is contained, and acid group of component (C) Is 50 mmol/100 g or more and 600 mmol/100 g or less, and the ratio of the number of moles (mol) of the component (B) to the number of moles of the acid group of the component (C) [the number of moles of the (B) salt ( The molar number (mol) of the acid group of (mol)/(C)] is 0.25 or more and 3.0 or less.
  • the present invention relates to providing an effervescent oral solid preparation which enhances the secretion of tongue/submandibular saliva and maintains the secretion of tongue/submandibular saliva, which is not harmful to the oral mucosa.
  • the present inventor as a result of diligent studies, contains a spice extract, a carbonate and an organic acid or a salt thereof in a specific amount, and specifies the number of moles of the carbonate and the number of acid groups of the organic acid or the salt. It was found that, by setting the ratio to the ratio, the effervescent oral solid preparation that enhances the secretion of tongue/submandibular saliva without causing harm to the oral mucous membrane and is excellent in its sustainability can be obtained.
  • the present invention it is possible to provide an effervescent oral solid preparation that enhances secretion of tongue/submandibular saliva and sustains the secretion of tongue/submandibular saliva. Since the effervescent oral solid preparation of the present invention is not harmful to the oral mucosa and tooth enamel, it has a good feeling in use.
  • the “effervescent oral solid preparation” means a preparation in a solid state at 20° C. ⁇ 15° C., which generates carbon dioxide gas by contacting with water such as saliva in the oral cavity.
  • Specific formulations include, for example, tablets (including chewable tablets and the like), capsules, granules, powders, troches and the like. Among them, tablets or lozenges are preferable, and lozenges are more preferable, from the viewpoint of improving the amount of saliva secreted from the tongue/submandibular gland and improving the persistence of secretion of tongue/submandibular saliva.
  • the effervescent oral solid preparation of the present invention contains a spice extract as component (A).
  • the “spice extract” is an extract obtained from spices, and may be in a liquid form at room temperature, a solid form, or a semisolid form.
  • the spices are not particularly limited, and those prepared from plant seeds, fruits, leaves, flowers, buds, stems, bark, root masses, rhizomes and the like can be used, for example, pepper, ginger, pepper , Horseradish, pepper, sage, thyme, salmon, garlic and the like. These can be used alone or in combination of two or more. Among them, ginger and pepper are preferable, and ginger is more preferable, from the viewpoint of improving the secretion sustainability of tongue/submandibular saliva.
  • the extraction method for obtaining the spice extract may be any of dipping, infusion, leaching, reflux extraction, distillation, supercritical extraction, ultrasonic extraction, microwave extraction and the like.
  • the extraction solvent may be either a polar solvent or a non-polar solvent, and examples thereof include water; alcohols such as methanol and ethanol; subcritical or supercritical carbon dioxide; fats, waxes and other oils; and mixtures thereof. ..
  • the amount of the solvent used in the extraction and the extraction conditions are not particularly limited as long as sufficient extraction can be performed, and can be appropriately adjusted.
  • the spice extract may be a crudely purified product, and if necessary, it may be inactive by known techniques such as liquid-liquid distribution, solid-liquid distribution, filtration membrane, activated carbon, adsorption resin, ion exchange resin, and precipitation. It may be one that has been subjected to treatments such as removal of impurities, deodorization, and decolorization. Further, the purity may be increased by appropriately combining known separation and purification methods. Examples of the purification means include organic solvent precipitation, centrifugation, ultrafiltration membrane, high performance liquid chromatograph and column chromatograph.
  • the spice extract commercially available products such as 6-gingeol (Fujifilm Wako Pure Chemical Industries, Ltd., purity 100%), 6-shogaol (Fujifilm Wako Pure Chemical Industries, Ltd., purity 100%) are used. It is also possible to use, for example, a powdered extract obtained by using an excipient such as dextrin or maltitol, such as Ginger Extract Powder E (Ikeda Gokuka Kogyo Co., Ltd.).
  • the component (A) is a ginger extract
  • 6-gingerol and 6-shogaol may be contained individually, but it is preferable that 6-gingerol and 6-shogaol are contained.
  • the ginger extract preferably contains 6-gingerol and 6-shogaol in a total amount of 50% by mass or more with respect to the total amount of the ginger extract, from the viewpoint of improving the secretion sustainability of the tongue/submandibular saliva.
  • the content is more preferably 80% by mass or more, further preferably 100% by mass. That is, the ginger extract is preferably 6-gingerol and 6-gingaol.
  • the component (A) is a pepper extract, it preferably contains capsaicin.
  • the pepper extract preferably contains 50 mass% or more of capsaicin, more preferably 80 mass% or more, based on the total amount of pepper extract. It is preferable that the content is 100% by mass. That is, the pepper extract is preferably capsaicin. 6-gingerol and 6-shogaol, as well as capsaicin can be analyzed according to the methods described in the examples below.
  • the component (A) is xavicin and piperine in the case of pepper extract, sinigulin in the case of wasabi extract, and sinigulin, allyl isothiocyanate, cinarubin and p-hydroxybenzyl benzyl isoate in the case of pepper extract.
  • Thiocyanate, salvan, pinene, cineole and borneol in the case of sage extract, thymol and carvacrol in the case of thyme extract, and the active ingredients of salmon extract are sanshool, dipentene, citronellal, geraniol and ferrandrene.
  • the garlic extract preferably contains diallyl disulfide, propyl allyl disulfide and diallyl trisulfide, respectively.
  • Each of the above extracts preferably contains 50% by mass or more of each of the above components, more preferably 80% by mass or more, and further preferably 100% by mass with respect to the total amount of the extract. preferable.
  • allyl disulfide and diallyl trisulfide can be carried out by a method that is generally known and suitable for the situation of the measurement sample.
  • the content of the component (A) in the effervescent oral solid preparation of the present invention is 0.001% by mass or more and 0.11% by mass or less.
  • the preparation can improve the amount of saliva secretion of the tongue/submandibular gland and the persistence of secretion of the tongue/submandibular saliva. Further, since it does not cause harm to the oral mucosa and the like, discomfort can be reduced.
  • the content of the component (A) in the effervescent oral solid preparation is 0.001 mass from the viewpoint of increasing the amount of tongue/submandibular saliva secretion and improving the sustainability of tongue/submandibular saliva secretion.
  • % Or more preferably 0.002 mass% or more, more preferably 0.005 mass% or more, still more preferably 0.006 mass% or more, still more preferably 0.008 mass% or more, and From the viewpoint of reducing the discomfort of the mucous membrane, it is 0.11% by mass or less, preferably 0.10% by mass or less, more preferably 0.07% by mass or less, further preferably 0.03% by mass or less, and further It is preferably 0.025 mass% or less.
  • the content of the component (A) in the effervescent oral solid preparation is 0.001 to 0.11% by mass, preferably 0.002 to 0.10% by mass, more preferably 0.005 to 0.07.
  • the amount is preferably 0.006 to 0.03% by mass, more preferably 0.006 to 0.025% by mass, and further preferably 0.008 to 0.025% by mass.
  • the effervescent oral solid preparation of the present invention contains a carbonate as the component (B).
  • the carbonate include sodium carbonate, sodium hydrogen carbonate, potassium carbonate, potassium hydrogen carbonate, ammonium carbonate, sodium sesquicarbonate and the like. These can be used alone or in combination of two or more. Of these, sodium carbonate, sodium hydrogen carbonate, and potassium carbonate are preferable, and sodium hydrogen carbonate is more preferable, from the viewpoint of improving the amount of saliva secreted from the tongue/submandibular gland.
  • the content of the component (B) in the effervescent oral solid preparation of the present invention is 7% by mass or more and 40% by mass or less.
  • the content of the component (B) in the effervescent oral solid preparation is 7% by mass or more from the viewpoint of increasing the tongue/submandibular saliva secretion amount and improving the sustainability of tongue/submandibular saliva secretion.
  • the content of the component (B) in the effervescent oral solid preparation is 7 to 40% by mass, preferably 10 to 35% by mass, more preferably 15 to 30% by mass. In this specification, the content of the component (B) is a carbonic acid equivalent value.
  • the number of moles (mmol/100 g) of component (B) in the effervescent oral solid preparation of the present invention refers to the number of moles when converted to carbonate ions or bicarbonate ions in component (B).
  • the content of component (B) in the effervescent oral solid preparation is preferably 80 mmol/from the viewpoint of increasing the secretion of tongue/submandibular saliva and improving the sustainability of secretion of tongue/submandibular saliva.
  • the number of moles (mmol/100g) of the component (B) in the effervescent oral solid preparation is preferably 80 to 480mmol/100g, more preferably 115 to 420mmol/100g, and further preferably 175 to 360mmol/100g. ..
  • the content ratio [(A)/(B)] of the component (A) to the component (B) increases the tongue/submandibular salivary secretion, the tongue/jaw.
  • it is preferably 0.0001 or more, more preferably 0.0002 or more, still more preferably 0.00025 or more.
  • it is preferably 0.0035 or less, more preferably 0.0015 or less, still more preferably 0.001 or less, still more preferably 0.0007. It is as follows.
  • the content mass ratio [(A)/(B)] of the component (A) to the component (B) is preferably 0.0001 to 0.0035, more preferably 0.0002 to 0.0015. , More preferably 0.0002 to 0.001, and still more preferably 0.00025 to 0.0007.
  • the effervescent oral solid preparation of the present invention contains an organic acid or a salt thereof as the component (C).
  • the organic acid or salt thereof is not particularly limited, but is preferably one or more selected from hydroxycarboxylic acid, dicarboxylic acid, ascorbic acid and salts thereof.
  • the hydroxycarboxylic acid include lactic acid, citric acid, isocitric acid, malic acid, tartaric acid, gluconic acid, quinic acid and the like.
  • Examples of the dicarboxylic acid include oxalic acid, malonic acid, succinic acid, glutaric acid, adipic acid, fumaric acid, maleic acid and the like.
  • Ascorbic acid includes the stereoisomers L-ascorbic acid and erythorbic acid.
  • the salt is preferably an alkali metal salt, more preferably one selected from sodium salt and potassium salt, and further preferably sodium salt.
  • hydroxycarboxylic acid and ascorbic acid are preferable from the viewpoints of increasing the tongue/submandibular salivary secretion, improving the secretion persistence of the tongue/submandibular saliva, and reducing mucosal discomfort.
  • one or more selected from salts thereof more preferably citric acid, tartaric acid, and L-ascorbic acid, and still more preferably citric acid from the viewpoint of reducing discomfort in the mucous membrane.
  • the number of moles (mmol/100 g) of the acid group of the component (C) is 50 mmol/100 g or more and 600 mmol/100 g or less.
  • the mol number (mmol/100g) of the acid group of the component (C) in the effervescent oral solid preparation improves the secretion persistence of the tongue/submandibular saliva from the viewpoint of increasing the tongue/submandibular saliva secretion amount. From the viewpoint and from the viewpoint of reducing discomfort of the mucous membrane, it is 50 mmol/100 g or more, preferably 70 mmol/100 g or more, more preferably 110 mmol/100 g or more, further preferably 150 mmol/100 g or more, further preferably 200 mmol/100 g.
  • 600 mmol/100 g or less preferably 500 mmol/100 g or less, more preferably 470 mmol/100 g or less, further preferably 360 mmol/100 g or less, and further preferably 280 mmol/100 g or less. is there.
  • the number of moles (mmol/100 g) of the acid group of the component (C) in the effervescent oral solid preparation is 50 to 600 mmol/100 g, preferably 70 to 500 mmol/100 g, more preferably 110 to 470 mmol/100 g, and further The amount is preferably 150 to 470 mmol/100 g, more preferably 150 to 360 mmol/100 g, and further preferably 200 to 280 mmol/100 g.
  • ascorbic acid is an organic acid having one acid group, and the number of moles of the acid group is calculated.
  • the content of the component (C) in the effervescent oral solid preparation of the present invention is such that the amount of tongue/submandibular saliva secretion is increased, the amount of tongue/submandibular saliva secretion is improved, and From the viewpoint of reducing discomfort, it is preferably 5% by mass or more, more preferably 7% by mass or more, further preferably 10% by mass or more, further preferably 13% by mass or more, and from the same viewpoint, preferably It is 40 mass% or less, more preferably 30 mass% or less, further preferably 25 mass% or less, and further preferably 18 mass% or less.
  • the content of the component (C) in the effervescent oral solid preparation is preferably 5 to 40% by mass, more preferably 7 to 30% by mass, further preferably 10 to 25% by mass, further preferably 13 to 18% by mass.
  • the content of the component (C) is an organic acid conversion value.
  • the effervescent oral solid preparation of the present invention has a ratio [moles (mol)/(C) of (B)] of the number of mols (mol) of the component (B) and the mols (mol) of acid groups of the component (C).
  • the number of moles (mol) of the acid group of is 0.25 or more and 3.0 or less.
  • the mucosal discomfort can be reduced by setting the number of moles of the carbonate and the number of moles of the acid group of the organic acid or its salt to such a specific ratio.
  • the secretion of saliva of the tongue/submandibular gland can be increased, and the amount of saliva secretion of the tongue/submandibular gland can be increased, and its sustainability is also improved.
  • Ratio of the number of moles (mol) of component (B) and the number of moles (mol) of acid groups of component (C) [the number of moles of (B) (mol)/the number of moles of acid groups of (C) (mol)] Is 0.25 or more, preferably from the viewpoint of increasing the amount of saliva secretion of the tongue/submandibular gland, improving the sustainability of secretion of the tongue/submandibular saliva, and reducing discomfort of the mucous membrane, Is 0.3 or more, more preferably 0.5 or more, still more preferably 0.8 or more, and from the same viewpoint, it is 3.0 or less, preferably 2.6 or less, more preferably 2 or less.
  • Ratio of the number of moles (mol) of component (B) and the number of moles (mol) of acid groups of component (C) [the number of moles of (B) (mol)/the number of moles of acid groups of (C) (mol)] Is 0.25 to 3.0, preferably 0.3 to 2.6, more preferably 0.3 to 2.5, further preferably 0.5 to 2, and further preferably 0.5 to 1. 0.5, and more preferably 0.8 to 1.5.
  • the content ratio [(B)/(C)] of the component (B) to the component (C) increases the tongue/submandibular salivary secretion, the tongue/jaw. From the viewpoint of improving the secretion sustainability of the parotid saliva and reducing the discomfort of the mucous membrane, it is preferably 0.35 or more, more preferably 0.4 or more, still more preferably 0.65 or more. Yes, still more preferably 1.0 or more, and from the same viewpoint, preferably 4.0 or less, more preferably 3.3 or less, further preferably 2.7 or less, and More preferably, it is 2.0 or less.
  • the content mass ratio [(B)/(C)] of the component (B) to the component (C) is preferably 0.3 to 4.0, more preferably Is 0.4 to 3.3, more preferably 0.65 to 2.7, and even more preferably 1.0 to 2.0.
  • the content mass ratio [((B)+(C))/(A)] of the total amount of the components (B) and (C) to the component (A) is From the viewpoint of reducing discomfort in the mucous membrane, increasing the amount of salivary secretion of the tongue/submandibular gland, and improving the sustainability of secretion of submandibular saliva, preferably 500 or more, more preferably 1,000 or more. , More preferably 3,000 or more, preferably 30,000 or less, more preferably 20,000 or less, still more preferably 7,000 or less.
  • the content mass ratio [((B)+(C))/(A)] of the total amount of the components (B) and (C) to the component (A) is It is preferably 500 to 30,000, more preferably 1,000 to 20,000, and further preferably 3,000 to 7,000.
  • Effervescent oral solid preparation of the present invention sweeteners, vitamins, minerals, epigallocatechin gallate, tea catechins such as theaflavin and oolong homobisflavan, extracts in the range that does not impair the effects of the present invention in addition to the above components.
  • a kind, a fragrance, a coloring agent, a preservative and the like may be appropriately mixed.
  • the content of the additive can be appropriately set within a range that does not impair the object of the present invention.
  • the content of the acidulant other than the component (C) is preferably 1% by mass or less, more preferably 0.5% by mass or less, from the viewpoint of reducing discomfort of the mucous membrane. And more preferably 0.1% by mass or less, and even more preferably substantially 0% by mass.
  • the effervescent oral solid preparation of the present invention can contain an acceptable carrier as necessary.
  • excipients for example, monosaccharides such as glucose, galactose and fructose, disaccharides such as sucrose, lactose, maltose, trehalose and palatinose, sugar alcohols such as maltitol, xylitol, erythritol, sorbitol and reduced palatinose
  • Agents eg, hydroxypropylmethylcellulose, hydroxypropylcellulose, gelatin, pregelatinized starch, polyvinylpyrrolidone, polyvinyl alcohol, pullulan, methylcellulose, hydrogenated oil, etc.
  • disintegrants eg, carmellose, carmellose calcium, croscarmellose sodium, cross
  • lubricants eg, calcium stearate, magnesium stearate, sucrose
  • the effervescent oral solid preparation of the present invention contains sugar alcohol to reduce the discomfort of the mucous membrane, to increase the tongue/submandibular salivary secretion, and to secrete submandibular saliva. It is preferable from the viewpoint of improving sustainability.
  • the sugar alcohol may be anhydrous or hydrated.
  • the content of the sugar alcohol in the effervescent oral solid preparation is preferably 10% by mass or more, more preferably 20% by mass or more, and further preferably 30% by mass or more, from the viewpoint of reducing discomfort of the mucous membrane.
  • the content of sugar alcohol in the effervescent oral solid preparation is preferably 10 to 85% by mass, more preferably 20 to 85% by mass, and further preferably 30 to 80% by mass.
  • HPLC can be used as a quantitative method for the sugar alcohol.
  • an air impermeable container especially a carbon dioxide impermeable container is preferable, and various plastics such as a laminated packaging container made of metal such as aluminum or aluminum. It is possible to use a packaging container in which silica or the like is vapor-deposited, or a container using metal, glass or the like.
  • the carbon dioxide impermeability as used herein means that the carbon dioxide permeability is 50 cc/m 2 ⁇ day ⁇ atm (ASTD-1434) or less.
  • the effervescent oral solid preparation of the present invention can be produced according to a conventional method, and an appropriate method can be adopted.
  • the component (A), the component (B) and the component (C), a carrier and/or an additive as necessary, the content of the component (A) and the component (B), and the acid group of the component (C) Produced by mixing so that the number of moles is within the above range and the ratio of the number of moles (mol) of component (B) and the number of moles (mol) of the acid groups of component (C) is within the above range. can do.
  • the order of mixing the components is not particularly limited, and they may be added in any order or simultaneously.
  • the mixing system of the mixing device may be a container rotating type or a container fixed type.
  • the container rotation type for example, a horizontal cylinder type, a V type, a double cone type, a cubic type or the like can be adopted.
  • the container fixed type for example, a ribbon type, a screw type, a conical screw type, a paddle type, a fluidized bed type, a Phillips blender or the like can be adopted. Further, it may be granulated by a known granulation method.
  • Examples of the granulation method include spray granulation, fluidized bed granulation, compression granulation, tumbling granulation, stirring granulation, extrusion granulation and powder coating granulation.
  • Granulation conditions can be appropriately selected depending on the granulation method.
  • the granulated product may be compressed by a tablet molding machine to be molded.
  • a tableting machine such as a rotary tableting machine or a single-shot tableting machine can be used.
  • the compression molding pressure during tableting is preferably about 10 to 30 MPa from the viewpoint of maintaining the hardness of the molded product.
  • the tablet hardness is preferably a hardness that can withstand transportation, storage, etc., and is preferably about 10 N to 200 N.
  • the shape of the tablet may be various irregularly shaped tablets having a surface shape such as a circular shape, an elliptical shape, an oval shape, or a square shape, but a circular shape is preferable from the viewpoint of ingestion.
  • the diameter is preferably 3 to 30 mm, more preferably 10 to 20 mm, from the viewpoint of ingestability.
  • the weight of each tablet is 0.1 to 6 g, more preferably 0.3 to 3 g, in terms of simplicity and effectiveness.
  • the effervescent oral solid preparation of the present invention increases the secretion of tongue/submandibular saliva, which has high antiviral activity among saliva, and further sustains the secretion, frequent preventive measures are required on a daily basis. It is useful as a preparation for preventing viral infections such as influenza and cold.
  • the effervescent oral solid preparation of the present invention is Components (A), (B) and (C): (A) One or more selected from ginger extract and pepper extract 0.001% by mass or more and 0.11% by mass or less (B) Carbonate 7% by mass or more and 40% by mass or less (C) Organic acid or salt thereof And the number of moles of the acid group of the component (C) is 50 mmol/100 g or more and 600 mmol/100 g or less, and the number of moles (mol) of the component (B) and the number of moles (mol) of the acid group of the component (C) are The ratio [the number of moles of the salt of (B) (mol)/the number of moles of the acid group of (C)] is 0.25 or more and 3.0 or less, and the components
  • the effervescent oral solid preparation of the present invention from the viewpoint of reducing mucosal discomfort, increasing the amount of tongue/submandibular saliva secretion, and improving the persistence of secretion of tongue/submandibular saliva,
  • the number of moles of the acid group of the component (C) is 50 mmol/100 g or more and 600 mmol/100 g or less
  • the number of moles (mol) of the component (B) and the number of moles (mol) of the acid group of the component (C) are The ratio [(B) the number of moles of the salt (mol)/the number of moles of the acid group of (C)] is 0.25 or more and 3.0 or less, and the content mass of the component
  • the ratio [(A)/(B)] is 0.0001 or more and 0.0035 or less, and the content mass ratio of the total amount of the components (B) and (C) to the component (A) [((B)+( C))/(A)] is preferably an effervescent oral solid preparation having 500 or more and 30,000 or less.
  • the effervescent oral solid preparation of the present invention from the viewpoint of reducing mucosal discomfort, increasing the amount of tongue/submandibular saliva secretion, and improving the persistence of secretion of tongue/submandibular saliva,
  • the content mass ratio [((B)+(C))/(A)] of the total amount of the components (B) and (C) to the component (A) is It is preferably an effervescent oral solid preparation of 500 or more and 30,000 or less.
  • the present invention discloses the following effervescent oral solid preparation.
  • ⁇ 2> The effervescent oral solid preparation according to ⁇ 1>, wherein the component (A) is preferably one or more selected from ginger extract and pepper extract, and more preferably ginger extract.
  • the content of the ⁇ 3> component (A) is 0.001% by mass or more, preferably 0.002% by mass or more, more preferably 0.005% by mass or more, further preferably 0.006% by mass or more, More preferably 0.008 mass% or more, and 0.11 mass% or less, preferably 0.10 mass% or less, more preferably 0.07 mass% or less, still more preferably 0.03 mass%.
  • the component (B) is preferably one or more selected from sodium carbonate, sodium hydrogen carbonate, potassium carbonate, potassium hydrogen carbonate, calcium carbonate, magnesium carbonate and sodium sesquicarbonate, more preferably carbonic acid.
  • the content of the component (B) is 7% by mass or more, preferably 10% by mass or more, more preferably 15% by mass or more, and 40% by mass or less, preferably 35% by mass. Or less, more preferably 30% by mass or less, and 7 to 40% by mass, preferably 10 to 35% by mass, more preferably 15 to 30% by mass, any one of ⁇ 1> to ⁇ 4>
  • the content of the component (B) is preferably 80 mmol/100 g or more, more preferably 115 mmol/100 g or more, further preferably 175 mmol/100 g or more, and preferably 480 mmol/100 g or less, more preferably 420 mmol. /100 g or less, more preferably 360 mmol/100 g or less, preferably 80 to 480 mmol/100 g, more preferably 115 to 420 mmol/100 g, still more preferably 175 to 360 mmol/100 g ⁇ 1> to ⁇ 5>
  • the effervescent oral solid preparation according to any one of 1.
  • the content ratio [(A)/(B)] of the component (A) to the component (B) is preferably 0.0001 or more, more preferably 0.0002 or more, still more preferably 0.00025 or more. And preferably 0.0035 or less, more preferably 0.0015 or less, further preferably 0.001 or less, still more preferably 0.0007 or less, and preferably 0.0001 to 0.0035,
  • Oral solid formulation is preferably 0.0001 or more, more preferably 0.0002 or more, still more preferably 0.00025 or more.
  • Component (C) is preferably one or more selected from hydroxycarboxylic acid, dicarboxylic acid, ascorbic acid and salts thereof, more preferably lactic acid, citric acid, isocitric acid, malic acid, One or more selected from tartaric acid, gluconic acid, quinic acid, oxalic acid, malonic acid, succinic acid, glutaric acid, adipic acid, fumaric acid, maleic acid, L-ascorbic acid, erythorbic acid and salts thereof.
  • citric acid malic acid, tartaric acid, succinic acid, fumaric acid, L-ascorbic acid and salts thereof, and further preferably citric acid, tartaric acid, L-ascorbin.
  • ⁇ 1> to ⁇ 7> which is one or more selected from an acid and a salt thereof, and more preferably one or two or more selected from a citric acid and a salt thereof.
  • the number of moles (mmol/100g) of the acid group of the component (C) is 50 mmol/100 g or more, preferably 70 mmol/100 g or more, more preferably 110 mmol/100 g or more, still more preferably 150 mmol/100 g or more, More preferably 200 mmol/100 g or more, and 600 mmol/100 g or less, preferably 500 mmol/100 g or less, more preferably 470 mmol/100 g or less, further preferably 360 mmol/100 g or less, and further preferably 280 mmol/100 g or less.
  • the effervescent oral solid preparation according to any one of ⁇ 1> to ⁇ 8>, which is preferably 200 to 280 mmol/100 g.
  • the content of the ⁇ 10> component (C) is preferably 5% by mass or more, more preferably 7% by mass or more, further preferably 10% by mass or more, further preferably 13% by mass or more, and preferably 40% by mass or more.
  • Mass% or less more preferably 30 mass% or less, further preferably 25 mass% or less, further preferably 18 mass% or less, and preferably 5 to 40 mass%, more preferably 7 to 30 mass%,
  • Ratio of the number of moles (mol) of the component (B) and the number of moles of the acid group of the component (C) [the number of moles of (B) (mol)/the number of moles of the acid group of (C) ( mol)] is 0.25 or more, preferably 0.3 or more, more preferably 0.5 or more, still more preferably 0.8 or more, and 3.0 or less, preferably 2. 6 or less, more preferably 2.5 or less, further preferably 2 or less, further preferably 1.5 or less, and 0.25 to 3.0, preferably 0.3 to 2.6.
  • the effervescent oral solid preparation according to any one of 10>.
  • the content ratio [(B)/(C)] of the component (B) to the ⁇ 12> component (C) is preferably 0.35 or more, more preferably 0.4 or more, still more preferably 0.65 or more, It is even more preferably 1.0 or more, preferably 4.0 or less, more preferably 3.3 or less, still more preferably 2.7 or less, still more preferably 2.0 or less, and preferably Is 0.3 to 4.0, more preferably 0.4 to 3.3, still more preferably 0.65 to 2.7, still more preferably 1.0 to 2.0.
  • the content mass ratio [((B)+(C))/(A)] of the total amount of the components (B) and (C) to the component (A) is preferably 500 or more, more preferably 1 2,000 or more, more preferably 3,000 or more, preferably 30,000 or less, more preferably 20,000 or less, further preferably 7,000 or less, and preferably 500 to 30,000.
  • the content of the acidulant other than the component (C) is preferably 1% by mass or less, more preferably 0.5% by mass or less, still more preferably 0.1% by mass or less, still more preferably substantially 0% by mass. %, the effervescent oral solid preparation according to any one of ⁇ 1> to ⁇ 13>.
  • the content of ⁇ 16> sugar alcohol is preferably 10% by mass or more, more preferably 20% by mass or more, further preferably 30% by mass or more, and preferably 85% by mass or less, more preferably 80% by mass.
  • the effervescent oral solid preparation according to ⁇ 15> which is the following, preferably 10 to 85% by mass, more preferably 20 to 85% by mass, and further preferably 30 to 80% by mass.
  • ⁇ 17> The effervescent oral solid preparation according to any one of ⁇ 1> to ⁇ 16>, which is preferably sealed in an air impermeable container, more preferably in a carbon dioxide impermeable container. Any of ⁇ 1> to ⁇ 17>, wherein the ⁇ 18> form is preferably a tablet, capsule, granule, powder or troche, more preferably a tablet or troche, and further preferably a troche.
  • HPLC high performance liquid chromatography
  • Methanol was added to the sample, ultrasonic treatment was carried out for 10 minutes, and then a constant volume was used as an analytical sample for HPLC.
  • HPLC analysis conditions are as follows. ⁇ HPLC operating conditions> Column: Shim-pack FC-ODS ⁇ 4.6 mm ⁇ 7.5 cm (Shimadzu GC) Column temperature: 50°C Detector: Fluorescence detector (excitation wavelength: 283 nm, measurement wavelength: 316 nm) Mobile phase: Water, acetonitrile, acetic acid mixed solution Flow rate: 1.0 mL/min
  • the method for analyzing the content of carbonate in the effervescent oral solid preparation is as follows. 0.1 to 0.2 g of the effervescent oral solid preparation was collected, 10 mL of water and 2 mL of 50% phosphoric acid were added, and the container was sealed. After sonication for 10 minutes, one hour left headspace gas determine the amount of CO 2 was subjected to gas chromatography, was calculated from the generated amount of CO 2.
  • the method for analyzing the content of the organic acid in the effervescent oral solid preparation is as follows. 1 g of the effervescent oral solid preparation was added, 20 mL of 5% perchloric acid was added, and the mixture was shaken for 10 minutes for extraction. This was adjusted to 200 mL with water and sonicated for 10 minutes. After filtration, it was subjected to high performance liquid chromatography (HPLC).
  • HPLC high performance liquid chromatography
  • Ginger extract powder E (Ikeda Gokuka Kogyo Co., Ltd., 6-gingerol content: 0.93% by mass, 6-shogaol: 2.30% by mass, 6-gingerol+6-shogaol: 3.
  • Examples 1 to 16 and Comparative Examples 1 to 14 Each component was mixed with the composition shown in Table 1. Next, using a single-shot tableting machine (manufactured by RIKEN), tableting was performed with a tableting pressure of 18 MPa using a ring-shaped punch having a hole diameter of 15 mm to obtain a circular tablet having a tablet weight of 1 g/1 tablet and a diameter of 15 mm. ..
  • the composition for example, when a tablet is prepared using Ginger Extract Powder E (Ikeda Gokuka Kogyo Co., Ltd.), the composition inevitably contains an excipient such as dextrin. It is included in the maltitol content, not specifically stated in the table.
  • the obtained tablets were evaluated as follows.
  • Examples 17 and 18 Tablets were obtained in the same manner as in Example 1 by uniformly mixing the components with the composition shown in Table 2. The obtained tablets were measured and sensory evaluated in the same manner as in Example 1. The results are shown in Table 2.
  • Examples 19-21 Tablets were obtained in the same manner as in Example 1 by uniformly mixing the respective components with the blending composition shown in Table 3. The obtained tablets were measured and sensory evaluated in the same manner as in Example 1. The results are shown in Table 3.
  • the contents of the component (A) and the component (B), the number of moles of the acid group of the component (C) are within the specific ranges, and the number of moles (mol) of the component (B) and the component (C) are The ratio of the molar number (mol) of) is within a specific range to enhance the secretion of tongue/submandibular saliva, and to maintain the secretion of tongue/submandibular saliva. It was confirmed that a solid preparation was obtained. In addition, the effervescent oral solid preparation had less discomfort on the mucous membrane.
  • the following formulations can be prepared by a conventional method.

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JP2014080410A (ja) * 2012-10-18 2014-05-08 Kochi Univ 嚥下機能改善剤

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