Oral composition

Abstract

To provide a composition for oral cavity having good fluorine ion retentivity and good low-temperature storage stability.SOLUTION: This composition for the oral cavity comprises (A) sodium fluoride, (B) one or more kinds selected from the group consisting of calcium lactate, calcium gluconate, calcium chloride and calcium pantothenate, (C) one or more kinds selected from the group consisting of condensed phosphoric acids and their alkali metal salts and (D) isopropylmethylphenol.SELECTED DRAWING: None

Description

[Technical Field]

[0001] The present invention relates to an oral composition. [Background technology]

[0002] Fluorides such as sodium fluoride are widely used as medicinal ingredients in oral compositions such as dentifrices because of their caries prevention effect. To ensure that fluoride acts effectively, it is effective to retain fluoride ions on the oral mucosa and tooth surfaces for a long period of time, and it is desirable to leave many fluoride ions in the oral cavity even after gargling and rinsing with water after use. Patent Document 1 discloses an oral composition that has a high retention of fluoride ions in the oral cavity, which contains a complex formed in an aqueous solution containing a polyphosphate salt, a calcium salt, and a fluoride salt. [Prior art documents] [Patent documents]

[0003] [Patent Document 1] Japanese Patent Application Laid-Open No. 2009-137863 Summary of the Invention [Problem to be solved by the invention]

[0004] However, according to the investigations of the present inventors, the homogeneity of an oral composition containing the above complex may be lost when stored at low temperatures. For example, when the oral composition is a toothpaste, wrinkles or grains may appear on the paste surface after storage at low temperatures. An object of the present invention is to provide an oral composition that has good fluoride ion retention and good low-temperature storage stability. [Means for solving the problem]

[0005] The present invention has the following aspects. [1] An oral composition containing (A) sodium fluoride, (B) one or more members selected from the group consisting of calcium lactate, calcium gluconate, calcium chloride, and calcium pantothenate, (C) one or more members selected from the group consisting of condensed phosphoric acid and alkali metal salts thereof, and (D) isopropylmethylphenol. [2] The oral composition according to [1], wherein the component (C) comprises at least one selected from the group consisting of pyrophosphoric acid and alkali metal pyrophosphates. [3] The oral composition according to [1] or [2], wherein (D) / (A+B+C), which represents the molar ratio of the sum of the (A) component, the (B) component, and the (C) component to the (D) component, is 0.001 to 0.5. [4] The oral composition according to any one of [1] to [3], which is a dentifrice. [Effects of the Invention]

[0006] According to the present invention, an oral composition having good fluoride ion retention and good low-temperature storage stability can be obtained. DETAILED DESCRIPTION OF THE INVENTION

[0007] As used herein, "oral composition" means a composition intended primarily for use in the oral cavity. In this specification, "water-soluble" means that the solubility in water at 20°C is 1 g / 100 g or more. In this specification, the use of "to" to indicate a range of values ​​means that the values ​​before and after it are included as the lower and upper limits.

[0008] [Oral composition] The oral composition of the present invention contains component (A), component (B), component (C), and component (D).

[0009] <Component (A)> Component (A) is sodium fluoride (NaF). Component (A) is a source of fluoride ions, which have caries prevention effects, and contributes to fluoride ion retention. Component (A) can be a commercially available product.

[0010] <(B) component> Component (B) is one or more water-soluble calcium salts selected from the group consisting of calcium lactate, calcium gluconate, calcium chloride, and calcium pantothenate. Component (B) may be a combination of two or more types. Component (B) contributes to improving fluoride ion retention. In addition, it contributes to reducing the unpleasant taste caused by component (D). Component (B) can be a commercially available product.

[0011] <(C) component> Component (C) is at least one selected from the group consisting of condensed phosphoric acid and alkali metal salts thereof. Component (C) may be a combination of two or more types. Component (C) contributes to improving retention of fluoride ions.

[0012] As the condensed phosphoric acid or its alkali metal salt, a water-soluble condensed phosphoric acid or its salt can be preferably used. Examples of condensed phosphoric acid include linear polyphosphoric acids such as pyrophosphoric acid, tripolyphosphoric acid, and tetrapolyphosphoric acid; and cyclic polyphosphoric acids such as trimetaphosphoric acid, tetrametaphosphoric acid, and hexametaphosphoric acid. Examples of the alkali metal salt of condensed phosphoric acid include sodium salt and potassium salt. As component (C), alkali metal pyrophosphates, alkali metal tripolyphosphates, and alkali metal hexametaphosphates are preferred, with alkali metal pyrophosphates being particularly preferred, and potassium pyrophosphate and sodium pyrophosphate being more preferred. Component (C) can be a commercially available product.

[0013] Component (C) preferably includes component (C1), which is at least one selected from the group consisting of pyrophosphoric acid and alkali metal pyrophosphates. Component (C1) is particularly effective in improving fluoride ion retention. The proportion of the (C1) component relative to the total mass of the (C) component may be, for example, 90 mass% or more, 95 mass% or more, 96 mass% or more, 97 mass% or more, 98 mass% or more, or 99 mass% or more, or may be 100 mass%.

[0014] <(D) component> Component (D) is isopropylmethylphenol. The inclusion of component (D) provides excellent low-temperature storage stability.

[0015] <Content of each ingredient> The content of component (A) is preferably 0.09 to 1.3% by mass, more preferably 0.10 to 1.1% by mass, based on the total mass of the oral composition. When the content of component (A) is equal to or greater than the above-mentioned lower limit, the fluoride ion retention is superior. When the content of component (A) is equal to or less than the above-mentioned upper limit, the low-temperature storage stability is superior.

[0016] The content of component (B) is preferably 0.02 to 5.0% by mass, more preferably 0.03 to 3.0% by mass, based on the total mass of the oral cavity composition. When the content of component (B) is equal to or greater than the above lower limit, the fluoride ion retention is better. When the content of component (B) is equal to or less than the above upper limit, the fluoride ion retention is better. Furthermore, by blending component (B), the unpleasant taste caused by component (D) can be reduced. When the content of component (B) is within the above range, the unpleasant taste specific to component (D) is lessened and the flavor of the oral composition is improved.

[0017] The content of component (C) is preferably 0.02 to 3.0% by mass, more preferably 0.03 to 1.3% by mass, based on the total mass of the oral cavity composition. When the content of component (C) is equal to or greater than the above lower limit, the fluoride ion retention is superior. When the content of component (C) is equal to or less than the above upper limit, the low-temperature storage stability is superior.

[0018] The content of component (D) is preferably 0.01 to 0.2% by mass, more preferably 0.02 to 0.1% by mass, based on the total mass of the oral composition. When the content of component (D) is equal to or greater than the above-mentioned lower limit, the low-temperature storage stability is improved. When the content of component (D) is equal to or less than the above-mentioned upper limit, the unpleasant taste specific to component (D) is reduced, and the flavor of the oral composition is improved.

[0019] (D) / (A+B+C), which represents the molar ratio of the sum of components (A), (B), and (C) to component (D), is preferably 0.001 to 0.5, more preferably 0.008 to 0.25, and even more preferably 0.02 to 0.22. When (D) / (A+B+C) is equal to or greater than the lower limit, low-temperature storage stability is improved. When (D) / (A+B+C) is equal to or less than the upper limit, fluoride ion retention is improved.

[0020] <Water> The oral composition typically further contains water, such as purified water, sterilized purified water, and water for injection. The content of water in the oral composition can be appropriately set depending on the product form and method of use of the oral composition. For example, when the oral composition is a toothpaste, the content of water relative to the total mass of the oral composition is preferably 5 to 90 mass%, more preferably 10 to 60 mass%, and even more preferably 20 to 50 mass%.

[0021] <Other ingredients> The oral composition may further contain other components in addition to the components (A), (B), (C), (D) and water. The other components can be appropriately selected from known components taking into consideration the form and method of use of the oral composition, etc. Examples of other components include abrasives, binders, thickeners, surfactants, colorants, sweeteners, preservatives, flavorings, active ingredients other than isopropyl methylphenol, and pH adjusters.

[0022] As the surfactant, any surfactant known in oral compositions can be used, including, for example, a nonionic surfactant, an amphoteric surfactant, an anionic surfactant, etc.

[0023] Examples of nonionic surfactants include polyoxyethylene alkyl ethers, polyoxyethylene hydrogenated castor oil, sorbitan fatty acid esters, polyoxyethylene sorbitan fatty acid esters (e.g., polyoxyethylene sorbitan monostearate), alkylolamides, polyoxyethylene fatty acid esters, polyoxyethylene alkenyl ethers, glycerin fatty acid esters, sucrose fatty acid esters (e.g., maltose fatty acid esters), sugar alcohol fatty acid esters (e.g., maltitol fatty acid esters, lactitol fatty acid esters), fatty acid diethanolamides (e.g., lauric acid mono- or diethanolamide), polyoxyethylene polyoxypropylene copolymers, polyoxyethylene polyoxypropylene fatty acid esters, polyoxyethylene polyoxypropylene (EOPO) copolymers, alkyl glucosides, and fatty acid polyglyceryl. The alkyl group of the polyoxyethylene alkyl ether usually has 12 to 18 carbon atoms, preferably 14 to 18 (for example, lauryl or stearyl group), and the average number of moles of ethylene oxide added is usually 5 to 30 moles, preferably 15 to 30 moles. The average number of moles of ethylene oxide added in polyoxyethylene hydrogenated castor oil is usually 5 to 100 moles, preferably 20 to 100 moles, and more preferably 20 to 60 moles. The number of carbon atoms in the fatty acid of the sorbitan fatty acid ester is usually 12 to 18. The number of carbon atoms in the fatty acid of the polyoxyethylene sorbitan fatty acid ester is usually 16 to 18, and the average number of moles of ethylene oxide added is usually 10 to 40 moles. The alkyl chain of the alkylolamide usually has 12 to 14 carbon atoms. The polyoxyethylene polyoxypropylene (EOPO) copolymer preferably has an average number of moles of ethylene oxide added of 20 to 210 and an average number of moles of propylene oxide added of 15 to 60, and may be a block copolymer or a random copolymer.

[0024] Examples of amphoteric surfactants include betaine-type amphoteric surfactants and amino acid-type amphoteric surfactants. Examples of betaine-type amphoteric surfactants include fatty acid amidopropyl betaines (e.g., coconut oil fatty acid amidopropyl betaine), alkyl acetate betaines (e.g., alkylamino acetate betaines such as lauryl dimethylamino acetate betaine), and alkyl imidazolinium betaines (e.g., alkylcarboxymethyl hydroxyethyl imidazolinium betaine). Among these, fatty acid amidopropyl betaines and alkyl acetate betaines are preferred, and coconut oil fatty acid amidopropyl betaine is more preferred. When the amphoteric surfactant has an alkyl group or an acyl group, they may be either linear or branched, and may be either saturated or unsaturated. The number of carbon atoms in the alkyl group or acyl group is preferably 10 to 20, more preferably 12 to 18, and even more preferably 14 to 16.

[0025] Examples of anionic surfactants include alkyl sulfates (e.g., sodium dodecyl sulfate (SDS)), α-olefin sulfonates (AOS), lauroyl methyl taurine (LMT), sulfosuccinic acid, GluNa, and alaninate. The alkyl group and acyl group may be either linear or branched, and may be either saturated or unsaturated. The number of carbon atoms in the alkyl group or acyl group is, for example, preferably 10 to 20, more preferably 12 to 18, and even more preferably 14 to 16. The salt can be selected from pharmacologically acceptable salts. Examples of pharmacologically acceptable salts include base addition salts and amino acid salts. Examples of salts include inorganic base salts such as sodium salt, potassium salt, calcium salt, magnesium salt, and ammonium salt; organic base salts such as triethylammonium salt, triethanolammonium salt, pyridinium salt, and diisopropylammonium salt; and basic amino acid salts such as arginine salt. Among these, inorganic base salts are preferred, alkali metal salts (e.g., sodium salt, potassium salt) or ammonium salts are more preferred, and sodium salts are even more preferred.

[0026] When the oral composition contains a surfactant, the content of the surfactant is preferably 0.05 to 10.0% by mass, more preferably 0.1 to 8.0% by mass, relative to the total mass of the oral composition.

[0027] Examples of abrasives include silica-based abrasives such as silicic acid anhydride, precipitated silica, silica gel, aluminosilicate, and zirconosilicate; dibasic calcium phosphate dihydrate or anhydrate, monobasic calcium phosphate, tribasic calcium phosphate, tetrabasic calcium phosphate, calcium carbonate, calcium hydroxide, aluminum hydroxide, insoluble sodium metaphosphate, tribasic magnesium phosphate, and magnesium carbonate. Silica-based abrasives are particularly preferred. The content of the abrasive is, for example, preferably 0 to 60% by mass, more preferably 0 to 30% by mass, and may be 25% by mass or less, relative to the total mass of the oral composition. An abrasive content of 0% by mass means that no abrasive is contained.

[0028] Examples of binders include organic binders selected from water-soluble polymeric substances such as cellulose derivatives such as sodium carboxymethylcellulose, methylcellulose, hydroxymethylcellulose, and hydroxyethylcellulose; gums such as xanthan gum, tragacanth gum, karaya gum, and gum arabic; and polyacrylates such as sodium polyacrylate; and inorganic binders such as thickening silica, thickening aluminum silica, Veegum, and Laponite. The content of the binder is preferably, for example, 0.05 to 13.0% by mass relative to the total mass of the oral composition. When the binder contains an organic binder, the blending amount of the organic binder is more preferably 0.1 to 3 mass %, and even more preferably 0.5 to 2.5 mass %, relative to the total mass of the oral composition. When the binder contains an inorganic binder, the content of the inorganic binder is more preferably 0 to 10.0 mass %, and even more preferably 0 to 8.0 mass %, relative to the total mass of the oral composition, in terms of the adsorption of fluoride ions to the tooth surface.

[0029] Examples of thickening agents include sugar alcohols such as sorbitol, xylitol, erythritol, and maltitol, and polyhydric alcohols such as glycerin, propylene glycol, and polyethylene glycol having an average molecular weight of 160 to 400 (average molecular weight according to the Quasi-drug Raw Materials Standards 2006). The content of the thickener is, for example, preferably 20 to 70% by mass, more preferably 25 to 65% by mass, relative to the total mass of the oral composition.

[0030] Examples of colorants include Red No. 2, Red No. 3, Red No. 225, Red No. 226, Yellow No. 4, Yellow No. 5, Yellow No. 205, Blue No. 1, Blue No. 2, Blue No. 201, Blue No. 204, Green No. 3, titanium mica, and titanium oxide. Examples of sweeteners include saccharin sodium, aspartame, stevioside, stevia extract, paramethoxycinnamic aldehyde, neohesperidin dihydrochalcone, and perillartine. Examples of preservatives include parahydroxybenzoic acid esters such as methylparaben, ethylparaben, and butylparaben, and benzoic acid or a salt thereof such as sodium benzoate.

[0031] Examples of fragrances include peppermint oil, spearmint oil, anise oil, eucalyptus oil, wintergreen oil, cassia oil, clove oil, thyme oil, sage oil, lemon oil, orange oil, peppermint oil, cardamom oil, coriander oil, mandarin oil, lime oil, lavender oil, rosemary oil, laurel oil, chamomile oil, caraway oil, marjoram oil, bay oil, lemongrass oil, origanum oil, pine needle oil, neroli oil, rose oil, jasmine oil, and grapefruit oil. Natural fragrances such as citrus oil, sweetie oil, yuzu oil, iris concrete, peppermint absolute, rose absolute, orange flower, and processed fragrances (front distillation, tail distillation, liquid-liquid extraction, essence, powder fragrance, etc.) of these natural fragrances, menthol, carvone, anethole, cineole, methyl salicylate, cinnamic aldehyde, eugenol, 3-l-menthoxypropane-1,2-diol, thymol, linalool, linalyl aqua Examples of flavoring materials that can be used include single flavors such as acetate, limonene, menthone, menthyl acetate, N-substituted-paramenthan-3-carboxamide, pinene, octyl aldehyde, citral, pulegone, carbyl acetate, anisaldehyde, ethyl acetate, ethyl butyrate, allyl cyclohexane propionate, methyl anthranilate, ethyl methylphenyl glycidate, vanillin, undecalactone, hexanal, butanol, isoamyl alcohol, hexenol, dimethyl sulfide, cyclotene, furfural, trimethylpyrazine, ethyl lactate, and ethyl thioacetate, and compound flavors such as strawberry flavor, apple flavor, banana flavor, pineapple flavor, grape flavor, mango flavor, butter flavor, milk flavor, fruit mix flavor, and tropical fruit flavor. These flavoring materials can also be used in combination with other flavoring materials known for oral compositions. The content of the flavoring material is not particularly limited, but the content of the above-mentioned flavoring material is preferably 0.000001 to 1% by mass relative to the total mass of the oral composition. The content of the flavoring material used for flavoring is preferably 0.05 to 2% by mass relative to the total mass of the oral composition.

[0032] Examples of active ingredients include bactericides such as cetylpyridinium chloride, water-soluble phosphate compounds such as potassium and sodium orthophosphate (excluding component (C)), enzymes such as dextranase, mutanase, amylase, and protease, tranexamic acid, epsilon aminocaproic acid, triclosan, lysozyme chloride, aluminum chlorohydroxyallantoin, hinokitiol, ascorbic acid, tocopherol acetate, dihydrocholesterol, α-bisabolol, chlorhexidine salts, azulene, water-soluble copper compounds such as copper chlorophyllin sodium, chlorophyll, and copper gluconate, aluminum lactate, strontium chloride, potassium nitrate, berberine, hydroxamic acid or a derivative thereof, glycyrrhizic acid or a salt thereof, glycyrrhetinic acid or a derivative thereof, and anti-tartar agents. The above active ingredients can be incorporated in effective amounts within a range that does not interfere with the effects of the present invention.

[0033] An example of a pH adjuster is sodium hydroxide.

[0034] <Form, dosage form> The oral composition can be prepared in various forms, for example, liquid, paste, gel, or solid. The dosage form of the oral composition is not particularly limited. The dosage form of the oral composition is typically an oral preparation that is expelled from the oral cavity after use. Examples of oral preparations include dentifrices (liquid dentifrices, liquid dentifrices, toothpastes, lubricating dentifrices, powder dentifrices, etc.), mouthwashes, mouthwashes, liniments, mouth sprays, patches, sheets, oral sustained-release agents, chewable agents, oral dissolving agents, oral disintegrating agents, tongue care agents, mouth fresheners, denture care agents, etc. Among the above, the oral composition of the present embodiment is suitable as a dentifrice, and is particularly suitable as a toothpaste.

[0035] The oral composition of this embodiment can be prepared by a known method, for example, by mixing components (A), (B), (C), and (D), and optionally other components, by a conventional method.

[0036] In oral compositions, the formation of a complex between fluoride ions, calcium ions, and phosphorus ions increases the retention of fluoride ions. However, this complex carries an anionic charge and is prone to gelling at low temperatures, which is thought to be the cause of reduced low-temperature storage stability. The formation of the complex can be confirmed by observing the crystallite size by X-ray crystal structure analysis and the exothermic peak observed when water of crystallization near the phosphate group is released at around 450 °C by calorimetry (TG-DTA measurement). In other words, when the complex is formed, the crystallite size determined from the diffraction peaks attributable to CaF2 becomes less than 10 nm due to the complexation with the phosphate group. Furthermore, the appearance of a peak for water of crystallization indicates that the CaF2 observed in X-ray crystal structure analysis is not a crystal composed only of calcium and fluoride ions, but forms a complex in which the phosphate group interacts. Specifically, the formation of a complex is confirmed by the fact that the crystallite size is less than 10 nm as determined by the following method (1) and the presence of an exothermic peak at 450°C as determined by the following method (2). (1) Crystallite size The sample was measured using an X-ray structural diffractometer (light source Cu:Kα, 40 kV, 20 mA, divergence slit 1 / 2 deg, scattering slit 1 / 2 deg, receiving slit 0.15 mm, scan speed 4,000° / min, 2θ = 2,000 to 80,000°), and the crystallite diameter was calculated using the following formula (Scherrer's formula) to evaluate whether or not a complex was formed. L=Kλ / (βcosθ) L: crystallite diameter, K: coefficient 0.9, β: half-width, λ: 1.54056 Å, θ: diffraction angle (2) TG-DTA measurement (exothermic peak) Heating speed: 5℃ / min, Measurement range: 25℃~600℃

[0037] The method for forming the above-mentioned complex is not particularly limited, but when preparing the oral composition, it is preferable to adopt, for example, a process of blending component (A) and component (C) and then blending component (B), or a process of blending component (B) and component (C) and then blending component (A). Note that if component (A) and component (B) are blended simultaneously, calcium fluoride may be partially produced, which may result in a lower efficiency of complex formation.

[0038] The oral composition described above contains components (A), (B), (C), and (D), and therefore has good fluoride ion retention and good low-temperature storage stability. For example, when the oral composition is a toothpaste, it has an excellent paste texture after low-temperature storage. [Example]

[0039] The present invention will be described in detail below with reference to examples, but the present invention is not limited to the following description. In the following examples, the unit of content "%" refers to "% by mass" unless otherwise specified.

[0040] <Raw materials used> [Component (A)] Sodium fluoride: manufactured by Stella Chemifa Co., Ltd. Also referred to as "NaF" hereinafter.

[0041] [(B) Component] Calcium lactate hydrate: trade name "Calcium lactate" manufactured by Taihei Chemical Industry Co., Ltd. Also referred to as "Ca lactate" hereinafter. Calcium gluconate: manufactured by Fuso Chemical Co., Ltd. Hereinafter also referred to as "Calcium gluconate." Calcium chloride: manufactured by Tomita Pharmaceutical Co., Ltd. Hereinafter also referred to as "Ca chloride." Calcium pantothenate: manufactured by BASF. Hereinafter also referred to as "Ca pantothenate."

[0042] [(C) component] Tetrapotassium pyrophosphate: manufactured by Taihei Chemical Industry Co., Ltd. Hereinafter also referred to as "K pyrophosphate." Sodium pyrophosphate: Taihei Chemical Industry Co., Ltd., product name "Sodium pyrophosphate (anhydrous)". Hereinafter, also referred to as "Na pyrophosphate". Sodium tripolyphosphate: manufactured by Taihei Chemical Industry Co., Ltd. Hereinafter also referred to as "sodium tripolyphosphate."

[0043] [(D) component] Isopropylmethylphenol: 4-isopropyl-3-methylphenol, manufactured by Osaka Kasei Co., Ltd., product name "Biosol." Hereinafter also referred to as "IPMP."

[0044] [Fragrance] Fragrance composition A as described in Table 5 below. [water] Purified water. [Common component (arbitrary component)] Silica anhydrous (abrasive silica) 10%, sorbitol solution (70% concentration, thickener) 40%, propylene glycol (thickener) 3%, xanthan gum (binder) 0.5%, sodium polyacrylate (binder) 0.5%, sodium lauryl sulfate 0.5%, and sodium saccharin (sweetener) 0.2%. Total 44.7%.

[0045] <Examples 1 to 21 and Comparative Examples 1 to 4> Oral compositions (toothpastes) having the compositions shown in Tables 1 to 4 were prepared by conventional methods. The components were mixed in the following order to prepare a premix: an aqueous solution of component (C), an aqueous solution of component (B), and an aqueous solution of component (A). The amount of water was the amount necessary to achieve the composition shown in the table. Phase A was prepared by adding and dissolving water-soluble components (liquid sorbitol, sodium saccharin) to this premix. Phase B was prepared by dissolving and dispersing sodium polyacrylate, xanthan gum, and sodium lauryl sulfate in propylene glycol at room temperature. Phase B was then added to and mixed with phase A while stirring to prepare phase C. Phase D was then prepared by dissolving and dispersing isopropyl methylphenol in a flavoring agent at room temperature. Phase D and silicic anhydride were added to phase C, and the mixture was mixed at room temperature using a 1.5 L kneader (manufactured by Ishiyama Kosakusho Co., Ltd.). The mixture was then degassed at a reduced pressure of 4 kPa to obtain 1.0 kg of toothpaste. In each toothpaste, it was confirmed by the above-mentioned method that fluoride ions, calcium ions, and phosphorus ions formed a complex. A blank space in the table indicates that the component is not blended. The "balance" of purified water indicates the amount that makes the total amount of the oral composition 100%. The resulting oral compositions (toothpastes) were evaluated as follows, and the results are shown in the table.

[0046] <Evaluation method> [Fluoride ion retention] The retention of fluoride ions in enamel was evaluated by the following method. The oral composition was diluted 4 times with purified water and applied to a 6 x 6 mm square slice of bovine enamel for 3 minutes, then immediately washed with purified water three times. After drying, the slice was treated with 120 μL of artificial saliva for 3 minutes, and the extracted fluoride ion concentration (unit: ppm (by mass)) was measured using an ion meter (product name: Orion 1115000 4-Star, manufactured by Thermo Fisher Scientific Co., Ltd.). The average value of N = 3 was calculated and evaluated according to the following criteria. (Evaluation criteria) ◎: 0.3 ppm or more. 〇: 0.2 ppm or more, less than 0.3 ppm. △: 0.1 ppm or more, less than 0.2 ppm. ×: Less than 0.1 ppm.

[0047] [Low temperature storage stability (appearance stability of the kneaded surface)] 50 g of the oral composition was filled into three tube containers (material: 26 mm diameter laminated tube (manufactured by Dai Nippon Printing Co., Ltd.) with the innermost layer made of linear low-density polyethylene) and stored in an atmosphere of -5°C for one month. In an atmosphere of -5°C, three 15cm tubes of the composition were dispensed from the tube onto an evaluation paper, the evaluation paper was folded to slightly crush the composition, and the paper was opened to its original state, and the kneaded surface of the composition was evaluated according to the following rating scale. The three tubes were evaluated in the same way, and the average score was evaluated according to the following rating scale. (Grading criteria) 5 points: No wrinkles or grains, the surface is glossy. 4 points: Some wrinkles and no shine. 3 points: There are some wrinkles or grains. 2 points: Wrinkles and grains are uniformly observed. 1 point: Many wrinkles and grains are uniformly observed, and the composition is not uniform. (Evaluation criteria) ◎: Average score 4.6 or higher. ○: Average score is 4.3 or more but less than 4.6 points. △: Average score is 4.0 or more but less than 4.3 points. ×: Average score less than 4.0 points.

[0048] [Flavor (non-offensive)] The evaluation was carried out by a sensory test conducted by 10 expert panelists. 1 g of the oral composition was squeezed out of a tube container containing the oral composition and placed on a toothbrush (manufactured by Lion Corporation, Clinica Toothbrush 4-row head, medium), and brushed for 3 minutes. The taste perceived during use was evaluated using the following rating scale. The average of the scores of the 10 panelists was calculated, and the flavor (sweetness) was evaluated using the following rating scale. (Grading criteria) 4 points: Not unpleasant at all. 3 points: Almost no unpleasantness. 2 points: A little unpleasant. 1 point: It's unpleasant. (Evaluation criteria) ◎: Average score of 3.5 points or more. ○: Average score is 3.0 or more but less than 3.5 points. △: Average score is between 2.0 and 3.0 points. ×: Average score less than 2.0 points.

[0049] [Table 1]

[0050] [Table 2]

[0051] [Table 3]

[0052] [Table 4]

[0053] As shown in the above results, the oral compositions of Examples 1 to 21 had excellent fluoride ion retention and low-temperature storage stability. In addition, they were free of the unpleasant taste peculiar to isopropyl methylphenol and had an excellent flavor. On the other hand, Comparative Example 1, which did not contain component (A), Comparative Example 2, which did not contain component (B), and Comparative Example 3, which did not contain component (C), had good low-temperature storage stability but poor fluoride ion retention. Comparative Example 2 also had poor flavor. (D) Comparative Example 4, which did not contain isopropylmethylphenol, had a good flavor but was poor in low-temperature storage stability.

[0054] <Prescription example> All of the following formulation examples were excellent in fluoride ion retention, low-temperature storage stability, and flavor (non-offensive). <Prescription Example 1: Toothpaste> Sodium fluoride 0.32% Calcium lactate 0.2% Sodium pyrophosphate 0.1% Isopropylmethylphenol 0.05% Silica anhydride 10% Sorbitol solution (70%) 40% Propylene glycol 3% Xanthan gum 0.3% Coconut oil fatty acid amidopropyl betaine 0.5% Sodium saccharin 0.2% Fragrance composition A 1% Purified water remainder

[0055] <Prescription Example 2: Toothpaste> Sodium fluoride 0.32% Calcium lactate 0.2% Sodium pyrophosphate 0.1% Isopropylmethylphenol 0.05% Silica anhydride 10% Sorbitol solution (concentration 70%) 40% Propylene glycol 3% Xanthan gum 0.5% Sodium polyacrylate 0.5% Polyoxyethylene hydrogenated castor oil 0.5% Sodium saccharin 0.2% Fragrance composition A 1% Purified water remainder

[0056] <Formulation Example 3: Toothpaste> Sodium fluoride 0.32% Calcium lactate 0.2% Potassium pyrophosphate 0.1% Isopropylmethylphenol 0.05% Silica anhydride 10% Sorbitol solution (concentration 70%) 40% Propylene glycol 3% Xanthan gum 0.5% Sodium polyacrylate 0.5% Polyoxyethylene hydrogenated castor oil 0.5% Sodium saccharin 0.2% Fragrance composition A 1% Purified water remainder

[0057] <Formulation Example 4: Liquid toothpaste> Sodium fluoride 0.32% Calcium lactate 0.2% Sodium pyrophosphate 0.1% Glycerin 7.5% Propylene glycol 3% Sorbitol solution (70%) 5% Coconut oil fatty acid amidopropyl betaine 0.3% Isopropylmethylphenol 0.05% Fragrance composition A 0.2% Purified water remainder

[0058] <Prescription Example 5: Mouthwash> Sodium fluoride 0.1% Calcium lactate 0.2% Sodium pyrophosphate 0.1% Isopropylmethylphenol 0.05% Propylene glycol 2% Sorbitol solution (70%) 3% Isopropylmethylphenol 0.05% Fragrance composition A 0.2% Purified water remainder

[0059] Furthermore, oral compositions were prepared with the same compositions as in Examples 1 to 21 and Formulation Examples 1 to 5 above, except that fragrance composition B to P shown in Tables 5 and 6 below were used instead of fragrance composition A. All of these compositions had good fluoride ion retention and low-temperature storage stability, were free of the unpleasant taste characteristic of isopropyl methylphenol, and had a good flavor. The compositions of flavors 1 to 7 and solvents described in Tables 5 and 6 are shown in Tables 7 to 14. In the table, "cut a% of the front end" means that the first a% is removed when the essential oil is distilled, and "cut b% of the front and back ends" means that the first b% and the last b% are removed when the essential oil is distilled.

[0060] [Table 5]

[0061] [Table 6]

[0062] [Table 7]

[0063] [Table 8]

[0064] [Table 9]

[0065] Table 10

[0066] Table 11

[0067] Table 12

[0068] Table 13

[0069] Table 14

Claims

1. (A) sodium fluoride, (B) one or more selected from the group consisting of calcium lactate, calcium gluconate, calcium chloride, and calcium pantothenate; (C) one or more members selected from the group consisting of condensed phosphoric acid and alkali metal salts thereof, and (D) isopropylmethylphenol, An oral composition comprising:

2. 2. The oral composition according to claim 1, wherein the component (C) comprises at least one member selected from the group consisting of pyrophosphoric acid and alkali metal pyrophosphates.

3. 2. The oral composition according to claim 1, wherein (D) / (A+B+C), which represents the molar ratio of the sum of the (A), (B), and (C) components to the (D) component, is 0.001 to 0.

5.

4. The oral composition according to any one of claims 1 to 3, which is a dentifrice.

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