Oral components
By using a specific ratio of nonionic surfactant with pyridoxine or its salt, and optionally adding sweeteners and antioxidants, the oral composition stabilizes against discoloration and maintains sensory qualities.
Patent Information
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Current Assignee / Owner
- LION CORP
- Filing Date
- 2024-12-16
- Publication Date
- 2026-06-26
AI Technical Summary
Oral compositions containing pyridoxine or its salts can discolor over time due to storage or other factors, despite providing desirable properties such as an astringent sensation.
Incorporating a predetermined amount of nonionic surfactant with pyridoxine or its salt, maintaining a specific ratio within a certain range, and optionally including sweeteners and antioxidants to stabilize the composition.
The oral composition effectively suppresses discoloration over time while maintaining the astringent sensation and improving taste, ensuring stability and aesthetic appeal.
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Abstract
Description
Technical Field
[0001] The present invention relates to an oral composition.
Background Art
[0002] Conventionally, from the viewpoint of imparting a periodontal disease preventive effect, more specifically, a metabolic promotion effect, short-chain fatty acid reduction, glycation reaction inhibition effect, and anti-inflammatory effect, an aspect of blending pyridoxine (vitamin B6) or its salt in an oral composition is known.
[0003] Specifically, for example, in Patent Document 1 below, while suppressing a decrease in the bactericidal activity of a cationic bactericide and exerting a cell growth promoting action, for the purpose of alleviating, preventing or treating skin and periodontal diseases caused by various pathogenic bacteria, an aspect of adding one or more selected from vitamins such as pyridoxine hydrochloride having a cell growth promoting action to a combination of a cationic bactericide and a nonionic surfactant is described. In Patent Document 2 below, for the purpose of stably containing pyridoxine or its salt in an oral composition, an aspect of containing tocopherol nicotinate and / or tocopherol acetate in the oral composition together with pyridoxine or its salt is described. In Patent Document 3 below, for the purpose of suppressing the generation of precipitation by preparing a composition by combining pyridoxine hydrochloride and polyoxyethylene hydrogenated castor oil with dl-α-tocopherol 2-L-ascorbic acid phosphate diester, an aspect of further blending tranexamic acid is described.
Prior Art Documents
Patent Documents
[0004]
Patent Document 1
Patent Document 2
Patent Document 3
Summary of the Invention
[0005] Incorporating pyridoxine or its salts as an ingredient in oral compositions can impart desirable properties such as an astringent sensation to the oral mucosa. However, depending on the amount of pyridoxine or its salts included, the oral composition may discolor over time due to storage or other factors.
[0006] Therefore, the object of the present invention is to provide an oral composition that can effectively suppress discoloration over time. [Means for solving the problem]
[0007] The present inventors diligently conducted research to suppress discoloration over time in oral compositions containing a predetermined amount of pyridoxine or its salt. They discovered that the above problem could be solved by incorporating a predetermined amount of nonionic surfactant and setting the ratio of the nonionic surfactant content to the pyridoxine or its salt content within a predetermined range, thus completing the present invention. In other words, the present invention provides the following [1] to [7]. [1] (A) Components: Pyridoxine or a salt thereof, (B) Components: Contains nonionic surfactants, (A) The content of component is 0.01% by mass or more and less than 0.5% by mass, (B) The content of component is 0.01% or more and less than 1%, An oral composition in which the ratio of the content of component (B) to the content of component (A) ((B) / (A)) is 0.5 or more and less than 20. [2] The oral composition according to [1], wherein component (B) is one or more selected from the group consisting of polyoxyethylene hydrogenated castor oil, polyoxyethylene alkyl ether, polyoxyethylene polyoxypropylene alkyl ether, polyoxyethylene polyoxypropylene block copolymer, and polyoxyethylene-polyoxypropylene glycol. [3] The average number of ethylene oxide addition moles of polyoxyethylene hydrogenated castor oil is in the range of 20 to 100. The average number of ethylene oxide addition moles of the polyoxyethylene alkyl ether is in the range of 2 to 50, and the number of carbon atoms of the alkyl group is in the range of 10 to 20. The average number of moles of ethylene oxide added to the polyoxyethylene polyoxypropylene block copolymer is in the range of 50 to 300, and the average number of moles of propylene oxide added is in the range of 1 to 100. The average number of moles of ethylene oxide added to polyoxyethylene polyoxypropylene alkyl ether is in the range of 1 to 300, and the average number of moles of propylene oxide added is in the range of 1 to 70. The oral composition according to [2], wherein the average number of ethylene oxide moles added to polyoxyethylene polyoxypropylene glycol is in the range of 1 to 300, and the average number of propylene oxide moles added is in the range of 1 to 70. [4] (C) component: further comprising a sweetener, wherein (C) component comprises one or more selected from the group consisting of sodium saccharin, sucralose, xylitol, erythritol, maltitol, acesulfame potassium, trehalose, and mannitol, according to any one of [1] to [3]. [5] (D) component: The oral composition according to any one of [1] to [4], further comprising one or more selected from the group consisting of tocopherol acetate and tocopherol nicotinate. [6] An oral composition according to any one of [1] to [5], which is a liquid oral composition. [7] The oral composition according to [6], wherein the moisture content is 50% by mass or more. [Effects of the Invention]
[0008] According to the present invention, an oral composition containing a predetermined amount of pyridoxine can be provided that can suppress discoloration over time caused by the inclusion of pyridoxine or a salt thereof. [Modes for carrying out the invention]
[0009] The oral composition of the present invention will be described in detail below. The oral composition of the present invention comprises (A) component: pyridoxine or a salt thereof, and (B) component: a nonionic surfactant, wherein the content of component (A) is 0.01% by mass or more and less than 0.5% by mass, the content of component (B) is 0.01% or more and less than 1%, and the ratio of the content of component (B) to the content of component (A) ((B) / (A)) is 0.5 or more and less than 20.
[0010] First, we will describe components (A) and (B) included in the oral composition of this embodiment, components (C), (D), (E), and (F) which may be included in the oral composition of this embodiment, and any optional components.
[0011] [(A) Ingredients: Pyridoxine or its salt] (A) Pyridoxine or its salt, which is component (A), is a component that can impart a periodontal disease prevention effect. According to the oral composition of this embodiment, pyridoxine or its salt is a component that can also impart an astringent sensation, particularly on the oral mucosa, when used.
[0012] In this embodiment, the pyridoxine salt is not particularly limited as long as it is a pharmaceutically acceptable salt that exhibits the effects described above. Examples of pyridoxine salts include pyridoxine hydrochloride, pyridoxine sulfate, pyridoxine nitrate, pyridoxine hydrobromide, and pyridoxine phosphate. Among the pyridoxine salts, pyridoxine hydrochloride is preferred.
[0013] Here, pyridoxine hydrochloride (pyridoxine hydrochloride) is a salt of pyridoxine and is a type of vitamin B6. (A) The component may be pyridoxine or a salt thereof used alone, or two or more in combination, or a commercially available product may be used.
[0014] In the oral composition of the present embodiment, from the viewpoint of imparting good periodontal disease prevention effect and astringent feeling, the content of component (A) is 0.01% by mass or more, preferably 0.012% by mass or more, more preferably 0.015% by mass or more, or 0.02% by mass or more, when the total amount of the oral composition is 100% by mass. Further, the content of component (A) is less than 0.5% by mass, preferably 0.45% by mass or less, or 0.2% by mass or less, or 0.15% by mass or less, more preferably 0.12% by mass or less, or 0.1% by mass or less. Therefore, the content of component (A) is 0.01% by mass or more and less than 0.5% by mass, preferably 0.01% to 0.45% by mass, or 0.012% to 0.15% by mass, more preferably 0.015% to 0.12% by mass, or 0.02% to 0.1% by mass.
[0015] [Component (B): Nonionic surfactant] The nonionic surfactant as component (B) is a component that can effectively suppress the discoloration over time of the oral composition due to storage, etc. accompanying the blending of component (A) already described.
[0016] In the present embodiment, as component (B), preferably, one or more selected from the group consisting of polyoxyethylene hydrogenated castor oil, polyoxyethylene alkyl ether, polyoxyethylene polyoxypropylene alkyl ether, polyoxyethylene polyoxypropylene block copolymer, and polyoxyethylene polyoxypropylene glycol can be used. The nonionic surfactant that can be used in the present embodiment is not limited to the above nonionic surfactant.
[0017] Examples of the component (B) that can be used in the present embodiment include polyoxyethylene hydrogenated castor oil, polyoxyethylene alkyl ether, polyoxyethylene polyoxypropylene alkyl ether, polyoxyethylene polyoxypropylene block copolymer, polyoxyethylene polyoxypropylene glycol, polyglycerol fatty acid ester, polyoxyethylene fatty acid ester, sucrose fatty acid ester, maltose fatty acid ester, sugar alcohol fatty acid esters such as maltitol fatty acid ester and lactitol fatty acid ester, polysorbate, alkylolamide, alkyl glucoside, polyoxyethylene sorbitan fatty acid esters such as polyoxyethylene sorbitan monooleate, sorbitan fatty acid ester, glycerol fatty acid ester, polyoxyethylene glycerol fatty acid ester, polyoxyethylene glycol fatty acid ester, polyoxyethylene polyoxypropylene fatty acid ester, polyoxyethylene polyoxypropylene glycol, fatty acid ethanolamides such as monolauric acid or diethanolamide, polyoxyethylene alkenyl ether, polyoxyethylene higher alcohol ether, and polyoxyethylene alkyl phenyl ether.
[0018] The average number of moles of ethylene oxide added to polyoxyethylene hydrogenated castor oil is preferably in the range of 20 to 100, more preferably in the range of 40 to 100, and even more preferably in the range of 60 to 100 (hereinafter, the average number of moles of ethylene oxide added (EO) and the average number of moles of propylene oxide added (PO) may be indicated in parentheses). The average number of moles of ethylene oxide added to polyoxyethylene alkyl ether is preferably in the range of 2 to 50, more preferably in the range of 5 to 50, and even more preferably in the range of 5 to 30, and the number of carbon atoms in the alkyl chain is preferably in the range of 10 to 26, preferably in the range of 14 to 24, even more preferably in the range of 14 to 22, and even more preferably in the range of 14 to 20. The average number of moles of ethylene oxide added to polyoxyethylene polyoxypropylene alkyl ether is preferably in the range of 4 to 58, more preferably in the range of 10 to 40, the average number of moles of propylene oxide added is preferably in the range of 4 to 58, more preferably in the range of 10 to 40, and the number of carbon atoms in the alkyl chain is preferably in the range of 4 to 30, more preferably in the range of 8 to 24. The average number of moles of ethylene oxide added to polyoxyethylene polyoxypropylene block copolymer is preferably in the range of 50 to 300, more preferably in the range of 50 to 150, the average number of moles of propylene oxide added is preferably in the range of 1 to 100, more preferably in the range of 20 to 70. The average number of moles of ethylene oxide added to polyoxyethylene polyoxypropylene glycol is preferably in the range of 1 to 300, more preferably in the range of 1 to 40, and the average number of moles of propylene oxide added is preferably in the range of 1 to 70, more preferably in the range of 1 to 40. The fatty acids in the polyglycerol fatty acid ester are preferably those obtained by esterifying a fatty acid with 8 to 24 carbon atoms to polyglycerol, where the average degree of condensation of glycerol is 2 to 20, more preferably 5 to 12. More preferably, they are derived from fatty acids with 12 to 18 carbon atoms, and even more preferably from fatty acids with 12 to 14 carbon atoms, with monoesters being preferred. The number of carbon atoms in the alkyl chain of the alkylolamide is preferably in the range of 12 to 14.The number of carbon atoms in the alkyl chain of the alkyl glycoside is preferably in the range of 8 to 12. The number of carbon atoms derived from the fatty acid of the sucrose fatty acid ester is preferably in the range of 6 to 20, more preferably in the range of 10 to 18, and even more preferably in the range of 12 to 14. Examples of polyoxyethylene sorbitan fatty acid esters include those derived from fatty acids with 6 to 22 carbon atoms, and those derived from fatty acids with 12 to 20 carbon atoms are more preferred. Furthermore, the average number of moles of ethylene oxy groups added in the polyoxyethylene sorbitan fatty acid ester is preferably 5 to 40, and more preferably 5 to 20. Component (B) is preferably one with an HLB value in the range of 10 to 17. Here, "HLB value" is a value calculated by Griffin's method (the same applies to the following HLB values).
[0019] In this embodiment, component (B) is more preferably polyoxyethylene hydrogenated castor oil, polyoxyethylene cetyl ether, polyoxyethylene lauryl ether, polyglycerin fatty acid ester (decaglyceryl laurate, hexadecaglyceryl laurate), polyoxyethylene polyoxypropylene cetyl ether, and polyoxyethylene polyoxypropylene glycol, from the viewpoint of effectively suppressing discoloration of the oral composition over time. In this embodiment, component (B) may be one of the above-mentioned nonionic surfactants used alone, or two or more may be used in combination, or a commercially available product may be used.
[0020] In this embodiment, as component (B), from the viewpoint of effectively suppressing discoloration of the oral composition over time, one nonionic surfactant selected from the group consisting of polyoxyethylene (20) hydrogenated castor oil, polyoxyethylene (40) hydrogenated castor oil, polyoxyethylene (60) hydrogenated castor oil, polyoxyethylene (100) hydrogenated castor oil, polyoxyethylene (15) cetyl ether, and polyoxyethylene polyoxypropylene cetyl ether (20E.O.)(4P.O.) may be used alone, but it is preferable to use two or more in combination.
[0021] In the oral composition of this embodiment, the total content of component (B) is 0.01% by mass or more when the total amount of the oral composition is 100% by mass, and is preferably 0.1% by mass or more, and more preferably 0.2% by mass or more, from the viewpoint of effectively suppressing discoloration of the oral composition over time. Furthermore, the total content of component (B) is less than 1% by mass, and is preferably 0.9% by mass or less, more preferably 0.7% by mass or less, and more preferably 0.5% by mass or less, from the viewpoint of effectively imparting an astringent sensation by component (A). Therefore, the content of component (B) is 0.01% by mass or more and less than 1% by mass, and is preferably 0.01% by mass to 0.9% by mass, more preferably 0.1% by mass to 0.7% by mass, and even more preferably 0.2% by mass to 0.6% by mass, from the viewpoint of providing a good astringent sensation and effectively suppressing discoloration over time.
[0022] [(C) Ingredients: Sweetener] Component (C) of this embodiment is a sweetener selected from the group consisting of sodium saccharin, sucralose, xylitol, erythritol, maltitol, acesulfame potassium, trehalose, and mannitol.
[0023] Component (C) is an ingredient that can effectively suppress the unpleasantness that may arise when components (A) and (B), which have already been described, are used in combination.
[0024] In this embodiment, from the viewpoint of effectively suppressing any unpleasant taste that may arise when components (A) and (B) are used in combination, component (C) is preferably one or more selected from the group consisting of sodium saccharin, sucralose, xylitol, erythritol, maltitol, acesulfame potassium, trehalose, and mannitol, and it is more preferable to use sodium saccharin, sucralose, and / or xylitol. Component (C) may be used alone, in combination of two or more, or a commercially available product may be used.
[0025] Furthermore, sodium saccharin, sucralose, and acesulfame potassium are highly sensitive sweeteners. In this specification, "highly sensitive sweetener" refers to a sweetener having a sweetness level 100 to 1000 times that of sucrose.
[0026] In the oral composition of this embodiment, the content of component (C) is not particularly limited. The content of component (C) is preferably 0.005% by mass or more, or 0.01% by mass or more, more preferably 0.015% by mass or more, 0.02% by mass or more, or 0.1% by mass or more, when the total amount of the oral composition is 100% by mass. This makes it possible to improve the unpleasant taste during brushing and rinsing by using components (A) and (B) in combination. Alternatively, the content of component (C) is preferably 13% by mass or less, or 10% by mass or less, more preferably 7% by mass or less, 5% by mass or less, 2% by mass or less, or 1% by mass or less. This makes it possible to prevent unpleasant taste from being caused by the taste derived from component (C). Therefore, the content of component (C) is preferably 0.005% to 13% by mass, or 0.01% to 10% by mass, more preferably 0.015% to 7% by mass, 0.02% to 5% by mass, 0.1% to 2% by mass, or 0.1% to 1% by mass, based on the total amount of the oral composition.
[0027] In this embodiment, when the oral composition is a liquid oral composition, the content of component (C) is not particularly limited, but when the total amount of the oral composition is 100% by mass, it is preferably 0.00005% by mass or more, 0.00008% by mass or more, or 0.0001% by mass or more, more preferably 0.0005% by mass or more, 0.0008% by mass or more, or 0.001% by mass or more. This allows the effects of the present invention to be exhibited more favorably. Furthermore, the content of component (C) is preferably 15% by mass or less, 12% by mass or less, or 10% by mass or less, more preferably 8% by mass or less, 6% by mass or less, or 5% by mass or less. This allows the effects of the present invention to be exhibited more favorably. Therefore, the content of component (C) is preferably 0.00005% to 15% by mass, 0.00008% to 12% by mass, or 0.0001% to 10% by mass, and more preferably 0.0005% to 8% by mass, 0.0008% to 6% by mass, or 0.001% to 5% by mass. This allows the effects of the present invention to be exhibited more favorably.
[0028] In this embodiment, when the liquid oral composition contains only a highly sensitive sweetener as component (C), its content is not particularly limited, but is preferably 0.00008% by mass, or 0.0001% by mass or more, more preferably 0.001% by mass or more, or 0.0015% by mass or more, relative to the total amount of the oral composition. Furthermore, the content of component (C) is preferably 12% by mass or less, 1% by mass or less, 0.1% by mass or less, or 0.05% by mass or less, more preferably 0.01% by mass or less, or 0.006% by mass or less. Therefore, when the (C) component contains only a highly sensitive sweetener, its content is preferably 0.00008% to 12% by mass, 0.0001% to 1% by mass, 0.0001% to 0.1% by mass, or 0.0001% to 0.05% by mass, and more preferably 0.001% to 0.01% by mass, or 0.0015% to 0.006% by mass.
[0029] In this embodiment, when the liquid oral composition contains only a sweetener other than a highly sensitive sweetener, or both a highly sensitive sweetener and a sweetener other than a highly sensitive sweetener, the content is not particularly limited, but is preferably 0.00005% by mass or more, or 0.00008% by mass or more, and more preferably 1% by mass or more, relative to the total amount of the oral composition. Furthermore, the content of component (C) is preferably 15% by mass or less, or 12% by mass or less, more preferably 10% by mass or less, or 6% by mass or less. Therefore, when the content of component (C) contains only a sweetener other than a highly sensitive sweetener, or both a highly sensitive sweetener and a sweetener other than a highly sensitive sweetener, it is preferably 0.00005% by mass to 15% by mass, or 0.00008% by mass to 12% by mass, more preferably 1% by mass to 10% by mass, or 1% by mass to 6% by mass.
[0030] [(D) Components: Tocopherol acetate and tocopherol nicotinate] Component (D) is at least one selected from the group consisting of tocopherol acetate and tocopherol nicotinate. By including component (D), the unpleasant taste that may occur when the oral composition of the present invention is used in combination with components (A) and (B) can be improved.
[0031] In this embodiment, examples of the tocopherol acetate and tocopherol nicotinate esters that constitute component (D) include d-α-tocopherol acetate, dl-α-tocopherol acetate, d-α-tocopherol nicotinate, and dl-α-tocopherol nicotinate. Of these, d-α-tocopherol acetate, dl-α-tocopherol acetate, and dl-α-tocopherol nicotinate are preferred as component (D), it is more preferable to use dl-α-tocopherol acetate and / or dl-α-tocopherol nicotinate, and even more preferable to use dl-α-tocopherol acetate. (D) The component may be one of the above-mentioned components used alone, or two or more components may be used in combination, or a commercially available product may be used.
[0032] In the oral composition of this embodiment, the content of component (D) is not particularly limited. From the viewpoint of effectively suppressing unpleasant taste, the content of component (D) is preferably 0.01% by mass or more, 0.02% by mass or more, or 0.03% by mass or more, more preferably 0.04% by mass or more, or 0.05% by mass or more, when the total amount of the oral composition is 100% by mass. Furthermore, the content of component (D) is preferably 4% by mass or less, 3% by mass or less, or 2% by mass or less, more preferably 1.5% by mass or less, 1% by mass or less, and even more preferably 0.5% by mass or less, 0.3% by mass or less, or 0.2% by mass or less. Therefore, the content of component (D) is preferably 0.01% to 4% by mass, 0.02% to 3% by mass, or 0.03% to 2% by mass, more preferably 0.03% to 1.5% by mass, 0.03% to 0.5% by mass, 0.04% to 1.5% by mass, 0.05% to 1% by mass, 0.05% to 0.5% by mass, or 0.05% to 0.2% by mass.
[0033] In the oral composition of this embodiment, component (D) is more preferably used in combination with component (C) from the viewpoint of more effectively suppressing the unpleasant taste that may arise from the combined use of components (A) and (B).
[0034] [Content ratio] -(B) / (A)(mass ratio)- The ratio ((B) / (A)) of the content (mass%) of component (B) to the content (mass%) of component (A) is 0.5 or more, preferably 1.5 or more, and more preferably 2.5 or more. Also, the ratio ((B) / (A)) is less than 20, preferably 18 or less, and more preferably 15 or less. Therefore, the ratio ((B) / (A)) is 0.5 or more and less than 20, preferably 1.5 to 18, and more preferably 2.5 to 15. By setting the ratio ((B) / (A)) in this way, it is possible to ensure an astringent sensation on the oral mucosa during brushing and rinsing, and to effectively suppress discoloration over time.
[0035] -((A)+(B)) / (C)(mass ratio)- The ratio "((A)+(B)) / (C)" of the sum of the content of component (A) and the content of component (B) (mass%) to the content of component (C) (mass%) is preferably 0.001 or more, more preferably 0.003 or more, and more preferably 0.005 or more. Furthermore, the ratio "((A)+(B)) / (C)" is preferably 10000 or less, more preferably 7500 or less, and even more preferably 5000 or less. Therefore, the ratio "((A)+(B)) / (C)" is preferably 0.001 to 10000, more preferably 0.001 to 7500, even more preferably 0.003 to 7500, even more preferably 0.005 to 7500, and particularly preferably 0.005 to 5000.
[0036] When the oral composition of this embodiment is a liquid oral composition, the ratio "((A)+(B)) / (C)" is preferably 0.001 or more, more preferably 0.03 or more, even more preferably 0.005 or more, and still more preferably 0.01 or more. Also, the ratio "((A)+(B)) / (C)" is preferably 10000 or less, more preferably 5000 or less, even more preferably 3000 or less, and still more preferably 1000 or less. Therefore, the ratio "((A)+(B)) / (C)" is preferably 0.001 to 10000, more preferably 0.001 to 5000, even more preferably 0.003 to 5000, even more preferably 0.005 to 3000, and particularly preferably 0.01 to 3000 or 0.01 to 1000.
[0037] If the oral composition of this embodiment is a liquid oral composition and contains only a highly sensitive sweetener as component (C), then the ratio "((A)+(B)) / (C)" is preferably 0.01 or more, more preferably 0.03 or more, even more preferably 0.05 or more, and still more preferably 1 or more. Also, the ratio "((A)+(B)) / (C)" is preferably 10000 or less, more preferably 5000 or less, even more preferably 2000 or less, and still still more preferably 1000 or less. Therefore, the ratio "((A)+(B)) / (C)" is preferably 0.01 to 10000, more preferably 0.03 to 5000, even more preferably 0.05 to 5000, even more preferably 0.05 to 2000, and particularly preferably 1 to 2000 or 1 to 1000.
[0038] When the oral composition of this embodiment is a liquid oral composition and contains only sweeteners other than highly sensitive sweeteners, or both highly sensitive sweeteners and sweeteners other than highly sensitive sweeteners, the ratio "((A)+(B)) / (C)" is preferably 0.001 or more, more preferably 0.003 or more, even more preferably 0.005 or more, and still more preferably 0.01 or more. Also, the ratio "((A)+(B)) / (C)" is preferably 50 or less, more preferably 25 or less, even more preferably 10 or less, and still more preferably 5 or less. Therefore, the ratio "((A)+(B)) / (C)" is preferably 0.001 to 50, more preferably 0.003 to 25, even more preferably 0.005 to 25, and particularly preferably 0.01 to 10 or 0.01 to 5. By setting the ratio "((A)+(B)) / (C)" in this way, unpleasant odors after brushing and rinsing can be effectively suppressed.
[0039] -((A)+(B)) / (D)(mass ratio)- The ratio "((A)+(B)) / (D)" of the sum of the content of component (A) and the content of component (B) (mass%) to the content of component (D) (mass%) is preferably 0.04 or more, more preferably 0.1 or more, even more preferably 0.5 or more, and still more preferably 1 or more. Furthermore, the ratio "((A)+(B)) / (D)" is preferably 35 or less, more preferably 30 or less, even more preferably 25 or less, and still more preferably 20 or less. Thus, the ratio "((A)+(B)) / (D)" is preferably 0.04 to 35, more preferably 0.1 to 35, or 0.1 to 30, even more preferably 0.5 to 30, or 0.5 to 25, even more preferably 1 to 25, or 1 to 20. By setting the ratio "((A)+(B)) / (D)" in this way, unpleasant odors after brushing and rinsing can be effectively suppressed.
[0040] [Optional ingredients] The oral composition of this embodiment may contain optional components other than those already described, provided that the effects and benefits of the present invention are not impaired. These will be described in detail below.
[0041] In this embodiment, optional components include, when the oral composition is a toothpaste composition (paste, gel, or cream toothpaste), solvents, surfactants, sweeteners, fragrances, medicinal ingredients, oily ingredients, preservatives, humectants, abrasives, binders, pH adjusters, and colorants (pigments). When the oral composition is a liquid oral composition (mouthwash, etc.), optional components include, for example, solvents, humectants, surfactants, medicinal ingredients, oily ingredients, sweeteners, preservatives, binders, pH adjusters, fragrances, and colorants (pigments). These can be blended individually or in appropriate combinations of two or more. A detailed explanation follows below.
[0042] In this specification, the content of each component is based on the amount of each component used when manufacturing the oral composition.
[0043] -solvent- The oral composition of this embodiment may further contain a solvent. Preferably, water (purified water) or ethanol can be used as the solvent. The solvent may be one of the above solvents alone, two or more solvents in combination, or a commercially available product may be used.
[0044] In this embodiment, if the oral composition is a liquid oral composition and water (purified water) is used as the solvent, the amount of water is preferably 50% by mass or more, more preferably 60% by mass or more, or 70% by mass or more, and even more preferably 75% by mass or more, or 80% by mass or more, when the total amount of the oral composition is considered to be 100% by mass.
[0045] When ethanol is used as a solvent, the amount of ethanol is not particularly limited, but it may be 30% by mass or less of the total oral composition, preferably 20% by mass or less. It may also be 0% by mass or 1% by mass or more.
[0046] If the oral composition of this embodiment is a liquid oral composition and ethanol is used as a solvent, the amount is preferably 20% by mass or less, more preferably 8% by mass or less, when the total amount of the oral composition is 100% by mass, or it may be omitted and 0% by mass.
[0047] - Surfactants - The oral composition of this embodiment may further contain surfactants other than component (B). Examples of surfactants that can be used in the oral composition of this embodiment include anionic surfactants, cationic surfactants, and amphoteric surfactants.
[0048] Examples of anionic surfactants include alkyl sulfates, acyl amino acid salts, acyl taurine salts, α-olefin sulfonates, hydrogenated coconut fatty acid monoglyceride monosulfates, and lauryl sulfoacetate. The alkyl and acyl groups may be linear or branched, saturated or unsaturated, and have 10 to 20 carbon atoms, more preferably 12 to 18, and even more preferably 12 to 14. The salt can be selected from pharmacologically acceptable salts. Examples of pharmacologically acceptable salts include base addition salts and amino acid salts. Specific examples of pharmacologically acceptable salts include inorganic base salts such as sodium salts, potassium salts, calcium salts, magnesium salts, and ammonium salts; organic base salts such as triethylammonium salts, triethanolammonium salts, pyridinium salts, and diisopropylammonium salts; and basic amino acid salts such as arginine salts. Among these, inorganic base salts are preferred, alkali metal salts (e.g., sodium salts, potassium salts) or ammonium salts are more preferred, and sodium salts are even more preferred.
[0049] Examples of alkyl sulfates include lauryl sulfate (sodium lauryl sulfate) and myristoyl sulfate. Examples of acyl amino acid salts include acyl sarcosine salts such as lauroyl sarcosine salt and myristoyl sarcosine salt; acyl glutamates such as lauroyl glutamate, myristoyl glutamate, and palmitoyl glutamate; acyl glycine salts such as N-lauroyl-N-methylglycine salt and cocoyl glycine salt; acyl alanine salts such as N-lauroyl-β-alanine salt, N-myristyl-β-alanine salt, N-cocoyl-β-alanine salt, N-lauroyl-N-methyl-β-alanine salt, N-myristoyl-N-methyl-β-alanine salt, and N-methyl-N-acyl alanine salt; and acyl aspartates such as lauroyl aspartate salt. Examples of acyl taurine salts include lauroyl methyl taurine salt, N-methyl-N-acyl taurine salt, and N-cocoyl methyl taurine salt. Examples of α-olefin sulfonates include α-olefin sulfonates with 12 to 18 carbon atoms, such as tetradecene sulfonate. Other examples of anionic surfactants include hydrogenated coconut fatty acid monoglyceride monosulfate sodium and lauryl sulfoacetate sodium.
[0050] Examples of cationic surfactants include quaternary ammonium salt type cationic surfactants and amino acid-based cationic surfactants. Examples of quaternary ammonium salts include alkylpyridinium salts, benzethonium salts, benzalkonium salts, monoalkyltrimethylammonium salts, and dialkyldimethylammonium salts. Examples of salts include chloride salts and bromide salts. Examples of alkyl groups in alkylpyridinium salts, monoalkyltrimethylammonium salts, or dialkyldimethylammonium salts include alkyl groups having 8 to 22 carbon atoms. The upper or lower limit of the number of carbon atoms may be, for example, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, or 21. More specifically, it may be, for example, 9 to 21. Examples of quaternary ammonium salt type cationic surfactants include cetylpyridinium chloride, benzalkonium chloride, benzethonium chloride, stearyltrimethylammonium chloride, cetyltrimethylammonium chloride, stearyltrimethylammonium chloride, behenyltrimethylammonium chloride, distearyldimethylammonium chloride, laurylbenzyldimethylammonium chloride, hexadecyltrimethylammonium bromide, and stearyltrimethylammonium bromide. Examples of amino acid-based cationic surfactants include mono-N-long-chain acyl basic amino acid lower alkyl ester salts. Examples of basic amino acids constituting amino acid-based cationic surfactants include natural amino acids such as ornithine, lysine, and arginine. Synthetic amino acids such as α,γ-diaminobutyric acid can also be used. These may be optically active or racemic. The acyl group of the mono-N-long-chain acyl basic amino acid lower alkyl ester salt is preferably a saturated or unsaturated higher fatty acid residue with 8 to 22 carbon atoms. The upper or lower limit of the number of carbon atoms may be, for example, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, or 21. More specifically, it may be 9 to 21. Examples include single higher fatty acid residues such as lauroyl group, myristoyl group, palmitoyl group, and stearoyl group; and natural mixed higher fatty acid residues such as coconut oil fatty acid residues and beef tallow higher fatty acid residues. Examples of lower alkyl esters include alkyl esters having 1 to 8 carbon atoms. Specifically, these include methyl esters, ethyl esters, propyl esters, butyl esters, pentyl esters, hexyl esters, heptyl esters, and octyl esters. Lower alkyl esters are preferably in salt form, and examples include inorganic salts such as hydrochloride, bromate, sulfate, and phosphate; and organic salts such as glycolate, acetate, lactate, succinate, tartrate, citrate, acidic amino acid salts, higher fatty acid salts, L- or DL-pyrrolidone carboxylate salts, pyroglutamate, and p-toluenesulfonate. Examples of amino acid-based cationic surfactants include N-coconut oil fatty acid acyl-L-arginine ethyl DL-pyrrolidone carboxylate.
[0051] Examples of amphoteric surfactants include betaine-type amphoteric surfactants such as alkyldimethylaminoacetic acid betaine (e.g., lauryldimethylaminoacetic acid betaine) and fatty acid amidopropyl betaine (e.g., cocamidopropyl betaine); and imidazoline-type amphoteric surfactants such as N-fatty acid acyl-N-carboxymethyl-N-hydroxyethylethylenediamine salts (e.g., N-coconut oil fatty acid acyl-N-carboxymethyl-N-hydroxyethylimidazolinium betaine) and coconut oil fatty acid imidazolinium betaine). As for the surfactant, one of the above-mentioned surfactants may be used alone, two or more may be used in combination, or commercially available products may be used.
[0052] In this embodiment, the surfactant content is preferably 0.001% by mass or more, more preferably 0.01% by mass or more, and even more preferably 0.1% by mass or more, when the total amount of the oral composition is 100% by mass. Furthermore, the total amount of component (B) and the optional surfactant is preferably 10% by mass or less, more preferably 5% by mass or less, and even more preferably 3% by mass or less. Therefore, the total amount of component (B) and the optional surfactant is preferably 0.001% by mass to 10% by mass, more preferably 0.01% by mass to 5% by mass, and even more preferably 0.1% by mass to 3% by mass, when the total amount of the oral composition is 100% by mass.
[0053] -Sweetener- The oral composition of this embodiment may contain sweeteners other than component (C) in any suitable amount, as long as it does not impair the effects of the present invention.
[0054] In the oral composition of this embodiment, examples of optional sweeteners include aspartame, stevioside, stevia extract, paramethoxycinnamic aldehyde, neohesperidin dihydrochalcone, perillartin, thaumatin, and aspartylphenylalanine methyl ester. The sweeteners may be used individually, in combination of two or more, or commercially available products may be used.
[0055] -Fragrance (fragrance composition)- The oral composition of this embodiment may contain a conventionally known, optionally suitable fragrance (fragrance composition) in an optionally suitable amount. Including a fragrance in the oral composition can further improve the user experience.
[0056] Fragrances include, for example, natural essential oils such as peppermint oil, spearmint oil, Japanese mint oil, anise oil, cassia oil, clove oil, eucalyptus oil, wintergreen oil, mastic oil, neroli oil (orange blossom oil), lemongrass oil, jasmine oil, rose oil, iris oil, thyme oil, sage oil, cardamom oil, coriander oil, rosemary oil, laurel oil, chamomile oil, caraway oil, basil oil, marjoram oil, lemon oil, orange oil, grapefruit oil, lime oil, mandarin oil, yuzu oil, nutmeg oil, lavender oil, paraclete oil, vanilla oil, cinnamon oil, pimento oil, cinnamon leaf oil, and perilla oil; menthol, menthofran, carvone, cinnamic aldehyde, anethole, 1,8-cineole, methyl salicylate Fragrance components contained in the above natural essential oils, such as phosphate, eugenol, thymol, linalool, limonene, menthone, menthyl acetate, citral, decanal, camphor, borneol, pinene, spiranthol, n-decyl alcohol, citronellol, α-terpineol, linalyl acetate, phenylethyl glycidate, phenylethyl alcohol, allyl hexanoate, octanol, octanal, octyl acetate, caryophyllene, germacrene, viridiflorol, methyl cinnamate, methylheptin carbonate, ionone, ethyl-β-methylthiopropionate, cis-6-nonenol, carone, methyl jasmonate, citronellyl acetate, ethyl linalool, etc.Ethyl acetate, ethyl butyrate, isoamyl acetate, hexanal, hexenal, methyl anthranilate, ethyl methylphenyl glycidate, benzaldehyde, vanillin, ethyl vanillin, furaneol, ethylcyclopentenolone, 3-hydroxy-4,5-dimethylfuran-2-one, cyclotene, 2-methylbutyric acid, acetate acid, propionic acid, cis-3-hexenol, trans-2-hexenal, undecalact Fragrance components such as decalactone, hexyl acetate, ethyl-2-methyl butyrate, benzyl alcohol, N-ethyl-p-menthane-3-carboxamide (N-ethyl-2-isopropyl-5-methylcyclohexanecarboxamide), menthyl lactate, ethylene glycol-l-menthyl carbonate, maltol, ethyl maltol; plant extracts such as vanilla extract, chili pepper extract, ginger extract, pepper extract, Japanese pepper extract, cardamom extract;This also includes various blended flavors such as mint, fruit, and herb, which are created by combining several fragrance components and natural essential oils. Furthermore, fragrances that can also function as cooling agents include, for example, N-ethyl-p-menthane-3-carboxamide (N-ethyl-2-isopropyl-5-methylcyclohexanecarboxamide), N-[(ethoxycarbonyl)methyl)-p-menthane-3-carboxamide, Np-benzeneacetonitrile menthanecarboxamide, N-(2-(pyridine-2-yl)ethyl)-3-p-menthanecarboxamide, N-(2-hydroxy-2-phenylethyl)-2-isopropyl-5,5-dimethylcyclohexane-1-carboxamide, 2-(4-methylphenoxy)-N-(1H-pyrazole-3-yl)-N-(thiophen-2-ylmethyl)acetamide, menthyl lactate, menthyl monosuccinate, vanillyl butyl ether, isopuregol, menthol glycoside ketal, N-(4-cyanomethylphenyl)- Other examples include p-menthanecarboxamide, 3-l-menthoxypropane-1,2-diol, menthyl glyceryl ether, menthyl succinate, linalool oxide, vanillyl butyl ether, 5-methyl-2-propane-2-yl-N-(2-pyridine-2-ylethyl)cyclohexane-1-carboxamide, 3-(p-menthane-3carboxamide)ethyl acetate, 2-isopropyl-N,2,3-trimethylbutylamide, N-ethyl-2,2-diisopropylbutanamide, N-(1,1-dimethyl-2-hydroxyethyl)-2,2-diethylbutanamide, N-(2-hydroxyethyl)-2,3-dimethyl-2-isopropylbutanamide, menthyl glutarate, 2-(4-methylphenoxy)-N-(1H-pyrazole-yl)-N-(thiophen-2-ylmethyl)acetamide, and isopulegol. As for the fragrance, one of the fragrances exemplified above may be used alone, two or more may be used in combination (as a fragrance composition), or commercially available products may be used. Furthermore, when these fragrances are combined to form a fragrance composition, a solvent may be used. Examples of such solvents include ethanol, propylene glycol, glycerin fatty acid esters, and triacetin. If the oral composition contains a fragrance, its content is preferably 0.0000001 to 5% by mass, more preferably 0.00001 to 3% by mass, and even more preferably 0.01 to 2% by mass, based on 100% by mass of the total amount of the oral composition.
[0057] -Medicinal ingredients- Medicinal ingredients include, for example, enzymes such as dextranase, amylase, protease, and mutanase; anti-inflammatory agents such as tranexamic acid, allantoin, allantoin chlorohydroxyaluminum, ε-aminocaproic acid, azulene, sodium azulene sulfonate, glycyrrhizic acid or its salts (e.g., dipotassium glycyrrhizate), glycyrrhetinic acid or its salts (e.g., stearyl glycyrrhetinate), Phellodendron amurense, and Phellodendron amurense extract; cell activators such as sodium chloride and vitamins; bactericidal or antibacterial agents such as isopropylmethylphenol, cetylpyridinium chloride, benzalkonium chloride, benzethonium chloride, hinokitiol, thymol, lysozyme chloride, chlorhexidine, triclosan, zinc gluconate, and zinc citrate; and copper chlorophyll and gluco Examples of oral compositions include water-soluble copper compounds such as copper phosphate; tartar preventatives such as zeolites, ethane hydroxydiphosphonates, and polyphosphates (e.g., sodium polyphosphate); vitamins such as vitamin C (e.g., ascorbic acid) and vitamin E (e.g., vitamin E other than component (D), such as tocopherol); astringents such as sodium chloride, alum, and lysozyme chloride; hypersensitivity inhibitors such as potassium nitrate, aluminum lactate, and strontium chloride; amino acids such as alanine, glycine, proline, arginine, lysine, glutamine, and cysteine; peptides such as caropeptides; fluoride compounds such as sodium fluoride, sodium monofluorophosphate, and stannous fluoride; calcium compounds such as calcium glyceronate; and plant extracts such as thyme, scutellaria baicalensis, clove, and witch hazel. When an oral composition contains medicinal ingredients, the amount can be an effective amount within a range that does not hinder the effects of the present invention (a range that is pharmacologically acceptable). The medicinal ingredients may be used individually from the above list, in combination of two or more, or commercially available products may be used.
[0058] -Oily components- The oral composition of this embodiment may contain any suitable conventionally known oily components in any suitable amount. Examples of oily components include hydrocarbons such as squalane, (light) liquid paraffin, petrolatum, and microcrystalline wax; higher alcohols (e.g., alcohols with 8 to 22 carbon atoms such as lauryl alcohol, cetyl alcohol, cetostearyl alcohol, oleyl alcohol, and isostearyl alcohol); higher fatty acids (e.g., fatty acids with 8 to 22 carbon atoms such as lauric acid, myristic acid, oleic acid, and isostearic acid); vegetable oils such as olive oil, castor oil, and coconut oil; and fatty acid esters such as isopropyl myristate. The oily components may be used individually, in combination of two or more, or commercially available products may be used.
[0059] - Preservatives - The oral composition of this embodiment may contain a conventionally known, suitable preservative in a suitably appropriate amount. By including a preservative in the oral composition, preservative properties can be imparted to the oral composition.
[0060] Examples of preservatives that may be included in oral compositions include parahydroxybenzoic acid esters (e.g., methyl parahydroxybenzoate, ethyl parahydroxybenzoate, butyl parahydroxybenzoate), sodium benzoate, etc. The preservatives may be used individually, in combination of two or more, or commercially available products may be used.
[0061] -Wetting agent- The oral composition of this embodiment may contain a conventionally known and suitable wetting agent in an arbitrarily suitable amount. By including an arbitrary wetting agent in the oral composition, the user experience can be further improved.
[0062] As a wetting agent, sugar alcohols and polyhydric alcohols other than sugar alcohols are preferred. Examples of sugar alcohols include sugar alcohols such as sorbitol, lactitol, and reduced starch syrup; glycerin; and polyhydric alcohols such as ethylene glycol, propylene glycol, dipropylene glycol, butylene glycol, and polyethylene glycol. Examples of polyethylene glycols include polyethylene glycol with an average molecular weight of 150 to 6000, and preferably polyethylene glycol with an average molecular weight of 190 to 4000. Specifically, examples include PEG200, PEG300, PEG400, PEG600, and PEG4000. The average molecular weight is the average molecular weight described in the 2021 Japanese Standards for Raw Materials of Quasi-Drugs. If the oral composition may contain a wetting agent, its content is preferably 1% to 70% by mass, more preferably 1% to 65% by mass, even more preferably 1% to 60% by mass, and still more preferably 3% to 60% by mass, when the total amount of the oral composition is 100% by mass. As a humectant, one of the above humectants may be used alone, two or more may be used in combination, or commercially available products may be used.
[0063] -Abrasive- Either inorganic or organic abrasives may be used as the abrasive. Examples of inorganic abrasives include calcium hydroxide, aluminum hydroxide, trimagnesium phosphate, magnesium carbonate, calcium sulfate, bentonite, and hydroxyapatite. Examples of organic abrasives include synthetic resin-based abrasives and polymethyl methacrylate. The above abrasives may be used individually, in combination of two or more, or commercially available products may be used.
[0064] The amount of abrasive added is preferably 5 to 70% by mass, and more preferably 10 to 50% by mass, when the total amount of the oral composition is considered to be 100% by mass.
[0065] - Binding agent - The oral composition of this embodiment may contain a binder.
[0066] Examples of binders that can be included in oral compositions include conventionally known and suitable organic binders, such as polysaccharides, cellulosic binders (e.g., carboxymethylcellulose (CMC), hydroxyethylcellulose, hydroxypropylcellulose, hydroxypropylmethylcellulose, methylcellulose, cationized cellulose, etc., and pharmaceutically acceptable salts thereof such as their sodium salts), other polysaccharide thickeners (e.g., xanthan gum, guar gum, gellan gum, tragacanth gum, karaya gum, arabic gum, locust bean gum, carrageenan, sodium alginate), and synthetic water-soluble polymers (e.g., sodium polyacrylate, carboxyvinyl polymer, polyvinylpyrrolidone, polyvinyl alcohol, propylene glycol alginate). Furthermore, conventionally known and suitable inorganic binders may also be included. One or more of the above-exemplary binders can be included as binders, and commercially available products can also be used.
[0067] The binder content is preferably greater than 0% by mass, more preferably 0.0001% by mass or more, and even more preferably 0.01% by mass or more, when the total amount of the oral composition is considered as 100% by mass. Furthermore, the binder content is preferably 11% by mass or less, and more preferably 8% by mass or less. Therefore, the binder content is preferably greater than 0% by mass and 11% by mass or less, and more preferably 0.001% by mass to 10% by mass, or 0.01% by mass to 8% by mass. Alternatively, it may be omitted and 0% by mass.
[0068] - pH adjuster - The oral composition of this embodiment may contain a conventionally known and suitable pH adjusting agent in a suitably suitable amount. By including a pH adjusting agent in the oral composition, pH stability can be provided.
[0069] Examples of pH adjusters include organic acids such as phthalic acid, citric acid, succinic acid, tartaric acid, acetic acid, fumaric acid, malic acid, and lactic acid, or their salts (e.g., sodium citrate); inorganic acids such as phosphoric acid (e.g., orthophosphoric acid), or their salts (e.g., potassium salts, sodium salts, and ammonium salts); and hydroxides such as sodium hydroxide and potassium hydroxide. Examples of inorganic salts include disodium hydrogen phosphate, sodium dihydrogen phosphate, trisodium phosphate, sodium carbonate, and sodium bicarbonate. As a pH adjuster, one of the above pH adjusters may be used alone, two or more may be used in combination, or commercially available products may be used.
[0070] The amount of pH adjuster can be such that the pH of the oral composition after the addition of the pH adjuster is preferably 5.0 to 9.0, and more preferably 5.5 to 8.5.
[0071] In this specification, the pH value refers to the value obtained 3 minutes after the start of measurement at 25°C. The pH value can be measured using, for example, a pH meter (model number Hm-30S) manufactured by Toa Denpa Kogyo Co., Ltd.
[0072] -Suspension- This embodiment can be suitably used, especially when the oral composition is a liquid oral composition.
[0073] A premixed emulsion can be used as a suspending agent. A premixed emulsion is one in which the oily component contained in the emulsion particles consists of oils and fats that are liquid at 25°C. Such an emulsion can be an O / W type (oil-in-water) emulsion obtained by emulsifying the oily component with an emulsifier using a polyhydric alcohol such as glycerin or water as a dispersion medium, and it is preferable to add and blend an O / W type emulsion. In this case, in the liquid oral composition, the oil droplet particles of the O / W type emulsion are dispersed, and the dispersion medium mixes with the aqueous phase of the liquid oral composition, resulting in the existence of an O / W type emulsion.
[0074] Examples of oily components that are liquid at 25°C include liquid oils such as olive oil, camellia oil, and castor oil, as well as triglycerides with 6 to 12 carbon atoms. These oily components can be used individually or in combination of two or more. Examples of triglycerides include glyceryl tricaprylate, glyceryl tricaprate, and tri(caprylic / capric acid)glyceride. The amount of triglycerides is preferably 10% to 60% by mass, and more preferably 20% to 50% by mass, when the total amount of the emulsion is considered to be 100% by mass. As an emulsifier, one or more nonionic surfactants such as glycerin fatty acid esters, polyoxyethylene hydrogenated castor oil, and polyoxyethylene alkyl ethers can be used, and it is preferable to use an emulsifier with an HLB value of 10 to 16. The amount of emulsifier added is preferably 5% to 30% by mass of the total emulsion including the dispersion medium, and more preferably 5% to 20% by mass. As a dispersion medium, in addition to water, one or more polyhydric alcohols such as glycerin, dipropylene glycol, propylene glycol, 1,3-butylene glycol, and polyethylene glycol with an average molecular weight of 190 to 630 can be used. The emulsion preferably has an average particle size of 30 nm to 300 nm, more preferably 40 nm to 150 nm, and even more preferably 40 nm to 120 nm. The suspension may be used as a single substance, as a combination of two or more substances, or as a commercially available product. The content of the suspension agent is preferably 0.001% to 20% by mass, and more preferably 0.01% to more than 10% by mass, when the total amount of the oral composition is considered to be 100% by mass.
[0075] -Colorants- The oral composition of this embodiment may contain a conventionally known and suitable coloring agent in a suitably suitable amount.
[0076] Examples of colorants that may be included in an oral composition include natural pigments such as safflower red pigment, gardenia yellow pigment, gardenia blue pigment, perilla pigment, red yeast rice pigment, red cabbage pigment, carrot pigment, hibiscus pigment, cocoa pigment, spirulina blue pigment, and tamarind pigment, as well as legally approved colorants such as Red No. 2, Red No. 3, Red No. 104, Red No. 105, Red No. 106, Red No. 227, Yellow No. 4, Yellow No. 5, Green No. 3, and Blue No. 1, and riboflavin, copper chlorophyll sodium, and titanium dioxide. As colorants, one of the above colorants may be used alone, two or more may be used in combination, and commercially available products may be used. When an oral composition contains a colorant, its content is preferably 0.000010% to 3.0% by mass when the total amount of the oral composition is 100% by mass. The coloring agent may be used alone, in combination of two or more types, or a commercially available product may be used.
[0077] -Other optional components- The oral composition of this embodiment may contain other optional components in an optionally suitable amount.
[0078] In this embodiment, examples of other optional components that the oral composition may contain include inorganic compounds such as titanium mica, magnesium oxide, zirconium oxide, and hydroxyapatite; natural polymer compounds such as agar, gelatin, starch, and glucomannan; synthetic polymer compounds or copolymers thereof such as polyvinyl acetate, acrylic resin, polyurethane, polyester, polyvinyl chloride, nylon powder, and polyethylene powder; waxes such as carnauba wax, rosin, rice wax, microcrystalline wax, beeswax, and paraffin wax; higher alcohols such as cetanol and stearyl alcohol; polyisobutylene, polybutadiene, urethane, silicone, natural rubber, calcium salts: calcium glycerophosphate, polysaccharides: hyaluronic acid, pullulan, cyclic sugars: cyclodextrin, etc.
[0079] Other optional components may be used individually, in combination of two or more, or commercially available products may be used. The content of these other optional components can be appropriately set within a range that does not interfere with the effects of the present invention.
[0080] [Dosage form] The oral composition of this embodiment can be prepared in any suitable conventional dosage form by any suitable conventional method according to the usual procedures. Examples of dosage forms include liquids (liquid bodies such as solutions, emulsions, suspensions, and syrups), semi-solids (gels, creams, pastes, etc.), and solids (tablets, particulates, capsules, films, kneaded products, molten solids, waxy solids, elastic solids, soft capsules, etc.). The dosage form of the oral composition of this embodiment is preferably a liquid or a semi-solid. In this specification, "liquid oral composition" means an oral composition whose dosage form is "liquid". Furthermore, "toothpaste composition" may include oral compositions whose dosage form is "semi-solid," such as paste, gel, or cream.
[0081] The oral compositions of this embodiment can be widely used in oral applications. Examples of solid dosage forms include lozenges, gummies, gums, and toothpastes. Examples of semi-solid dosage forms include toothpastes and gel toothpastes. Examples of liquid dosage forms include mouthwashes (mouthwash, liquid toothpastes) and oral fresheners (sprays, etc.). In this specification, "liquid toothpaste" refers to a product used in conjunction with brushing, while "mouthwash" refers to a product used to rinse the mouth without brushing. Furthermore, "mouthwash" is a general term that includes "liquid toothpaste" and "mouth rinse."
[0082] In this embodiment, the pH (at 25°C) of the oral composition is preferably 5.0 to 9.0. The pH can be adjusted by adding a pH adjusting agent, changing the component composition, etc.
[0083] The oral composition of this embodiment can be adjusted to an appropriate viscosity depending on the dosage form, for example. When the dosage form is a paste, gel, or cream, it is preferable that the viscosity at 25°C, as measured with a BH viscometer, is between 20 Pa·s and 150 Pa·s.
[0084] Furthermore, if the oral composition is a liquid oral composition, the viscosity at 25°C measured with a BL-type viscometer should be 1000 mPa·s or less, and preferably between 0.7 mPa·s and 1000 mPa·s.
[0085] According to the oral composition of the present invention, by incorporating a predetermined amount of nonionic surfactant, discoloration that may occur over time due to pyridoxine or its salts can be effectively suppressed.
[0086] [Method for producing oral compositions] The method for producing the oral composition of the present invention is not particularly limited. When the oral composition of the present invention is a toothpaste composition, it can be produced by any suitable conventionally known method. Specifically, a method for producing a toothpaste composition may involve first preparing components that dissolve in a solvent, then mixing in other insoluble components, and, if necessary, performing degassing by, for example, reducing pressure. The toothpaste obtained in this way can be made into a product by placing it in a designated container (laminated tube). The shape and material of the container in which the toothpaste composition of the present invention can be contained are not particularly limited. Any suitable conventionally known container that is normally applied to toothpaste compositions can be used as the container. Examples of containers include plastic containers made of polyethylene, polypropylene, polyethylene terephthalate, and nylon.
[0087] When the oral composition of the present invention is a liquid oral composition, one possible method of manufacturing it is to sequentially add raw material components to a solvent such as purified water, stir, and dissolve them uniformly. The shape and material of the container in which the liquid oral composition of the present invention can be contained are not particularly limited. It can be used by filling it into a container that is normally used for oral compositions. Specifically, such containers can be laminated containers consisting of a polyethylene layer, an ethylene methacrylic acid copolymer layer, a polyethylene terephthalate layer, an aluminum layer, a glass vapor-deposited layer, a polyvinyl alcohol layer, an ethylene vinyl alcohol copolymer layer, an acrylonitrile copolymer layer, paper, a recycled plastic layer, etc., or polyethylene containers, polyethylene terephthalate containers, polypropylene containers, etc. Various containers that are normally used for oral compositions can be used, such as tubular containers, mechanical or differential pressure dispenser containers, film packaging containers such as pillow packaging, or pouch containers made of polyethylene or polypropylene such as linear polyethylene, low-density polyethylene, or high-density polyethylene. When the container is a pouch container, a pouch container made of low-density polyethylene, which has excellent flexibility, heat sealability, mechanical strength, heat resistance, etc., can be preferably used. [Examples]
[0088] The present invention will be specifically described below with reference to examples and comparative examples. The present invention is not limited to the examples described later. Unless otherwise specified, the numerical values described in these examples (including the values in the table below) represent mass percent.
[0089] [Components used in the examples and comparative examples] First, we will explain the components used in the examples and comparative examples. -(A) Ingredients: Pyridoxine or its salt- (A1) Pyridoxine hydrochloride (Kyowa Pharma Chemical Co., Ltd. "Pyridoxine Hydrochloride")
[0090] -(B) Ingredient: Nonionic surfactant- (B1) Polyoxyethylene hydrogenated castor oil (60) (manufactured by Nippon Surfactant Industry Co., Ltd., "HCO-60") (B2) Polyoxyethylene hydrogenated castor oil (100) (manufactured by Nippon Emulsion Co., Ltd., "EMALEXHC-100") (B3) Polyoxyethylene hydrogenated castor oil (40) (HCO-40, manufactured by Nippon Surfactant Industry Co., Ltd.) (B4) Polyoxyethylene hydrogenated castor oil (20) (HCO-20, manufactured by Nippon Surfactant Industry Co., Ltd.) (B5) Polyoxyethylene cetyl ether (15) (Aoki Oil & Fat Industry Co., Ltd. "Brownon CH-315L") (B6) Polyoxyethylene polyoxypropylene cetyl ether (20 E.O.) (4 P.O.) (SG-C420, manufactured by Nippon Surfactant Industry Co., Ltd.)
[0091] -(C) Ingredients: Sweeteners- (C1) Sodium saccharin (Sodium saccharin manufactured by Aisan Chemical Industry Co., Ltd.) (C2) Sucralose (Sucralose manufactured by San-Ei Gen F.F.I. Co., Ltd.) (C3) Acesulfame potassium (Sunnet Acesulfame K, manufactured by Celanese Japan) (C4) Maltitol (Amalti MR-100, manufactured by Mitsubishi Corporation Life Sciences Co., Ltd.) (C5) Erythritol (Erythritol manufactured by Mitsubishi Chemical Foods Corporation) (C6) Xylitol (manufactured by Mitsubishi Corporation Life Sciences Co., Ltd. as "Xylitol")
[0092] -(D) Component- (D1) Tocopherol acetate (dl-α-tocopherol acetate, manufactured by DSM Nutrition Japan) (D2) Tocopherol nicotinate (Eisai Food Chemical Co., Ltd.'s "Tocopherol Nicotinate")
[0093] -Optional components (components other than components (A) to (D)) Citric acid (manufactured by Komatsuya Co., Ltd., "Quasi-drug raw material standard citric acid") Sodium citrate (manufactured by Komatsuya Co., Ltd., "Quasi-drug ingredient standard: Sodium citrate") Sodium benzoate (Sodium benzoate manufactured by Fushimi Pharmaceutical Co., Ltd.) Fragrance composition A~S Water (purified water)
[0094] The compositions of fragrance compositions A to S used in the examples, comparative examples, and formulation examples are shown in Tables 1 and 2 below.
[0095] [Table 1]
[0096] [Table 2]
[0097] The compositions of flavors 1 to 7 and solvents used in the above-mentioned fragrance compositions A to S are shown in Tables 3 to 10 below.
[0098] [Table 3]
[0099] [Table 4]
[0100] [Table 5]
[0101] [Table 6]
[0102] [Table 7]
[0103] [Table 8]
[0104] [Table 9]
[0105] [Table 10]
[0106] Examples 1-34 and Comparative Examples 1-6 Using the above components as raw materials, liquid oral compositions having the formulations shown in Tables 11 to 15 below were prepared.
[0107] [Preparation of liquid oral compositions] The raw materials shown in Tables 11-15 were blended by conventional methods to obtain a liquid oral composition (mouthwash). The obtained liquid oral composition was then placed in a conventionally known and suitable container (vial).
[0108] The obtained liquid oral compositions (Examples 1-34 and Comparative Examples 1-6) were evaluated using the evaluation method described below. The evaluation results are shown in Tables 11-15 below.
[0109] [Evaluation Method] (1) Evaluation of the astringent sensation of the oral mucosa after use A sensory evaluation was conducted by 10 expert panelists regarding the presence and degree of astringency in the oral mucosa. Participants were asked to rinse their mouths with 20 mL of the liquid oral composition described in the examples and comparative examples, holding it in their mouths for 30 seconds. The astringency felt in the oral mucosa after rinsing (after use) was evaluated according to the scoring criteria shown below. The average score from the 10 expert panelists was calculated and judged on a five-point scale of A, B, C, D, and E according to the evaluation criteria below. A score of C or higher (A, B, and C) was judged as passing. (Scoring Criteria) 5 points: I feel a very strong astringent sensation in my mouth. 4 points: I felt a strong astringent sensation in my mouth. 3 points: There is a constricting sensation in the mouth. 2 points: There is a slight astringent sensation in the mouth. 1 point: No astringent feeling in the mouth. (Evaluation Criteria) A: Average score of 4.5 points or more B: Average score of 4.0 or higher but less than 4.5 C: Average score between 3.0 and 4.0 D: Average score between 2.0 and 3.0 E: Average score between 1.0 and 2.0 points
[0110] (2) Evaluation of discoloration over time The liquid oral compositions described in the examples and comparative examples were filled into 50 mL vials and visually observed and evaluated for their appearance (discoloration and its degree) after storage for one month at 60°C and -5°C. Specifically, the discoloration (or lack thereof) of the liquid oral composition stored at 60°C for one month was evaluated using the following scoring criteria, with the liquid oral composition stored at -5°C for one month as the baseline. The average score obtained from five similar tests was calculated and evaluated according to the following five-level evaluation criteria: A, B, C, D, and E. A score of C or higher (A, B, and C) was considered acceptable. (Scoring Criteria) 5 points: No discoloration at all. 4 points: There is a very slight discoloration to a pale yellow, but it is hardly noticeable. 3 points: There is a slight discoloration to a light yellow, but it is not noticeable during use. Two points: There is discoloration from dark yellow to brownish-red. 1 point: Discoloration to a dark reddish-brown color. (Evaluation Criteria) A: Average score of 4.5 points or more B: Average score of 4.0 or higher but less than 4.5 C: Average score between 3.0 and 4.0 D: Average score between 2.0 and 3.0 E: Average score less than 2.0 points
[0111] (3) Evaluation of sarcasm after use A sensory evaluation was conducted by 10 expert panelists to assess the presence and degree of any unpleasant aftertaste. Each panelist rinsed their mouth with 20 mL of the liquid oral composition described in the examples and comparative examples, holding it in their mouth for 30 seconds. After rinsing (after use), they evaluated the presence and degree of any unpleasant aftertaste according to the following scoring criteria. The average score from the 10 expert panelists was calculated and evaluated on a five-level scale (A, B, C, D, and E) according to the evaluation criteria below. A score of C or higher (A, B, and C) was considered a pass. (Scoring Criteria) 4 points: Not offensive 3 points: Almost no sarcasm. 2 points: Slightly sarcastic. 1 point: It's sarcastic. (Evaluation Criteria) A: Average score 4.0 points B: 3.5 points or higher, less than 4.0 points C: 3.0 points or higher, less than 3.5 points D: 2.0 points or higher, less than 3.0 points E: 1.0 points or more, less than 2.0 points
[0112] [Table 11]
[0113] [Table 12]
[0114] [Table 13]
[0115] [Table 14]
[0116] [Table 15]
[0117] In Examples 1 to 34, which used predetermined amounts of components (A) and (B) and set the ratio of component (B) content to component (A) content ((B) / (A)) within a predetermined range, both the astringent sensation of the oral mucosa and the discoloration over time were evaluated favorably. Furthermore, in Examples 18 to 34, which further included either one or both of components (C) and (D), the unpleasant taste after use could be further reduced, and in particular, Example 34, which included both components (C) and (D), was able to reduce the unpleasant taste after use more effectively. On the other hand, in Comparative Examples 1 to 6, which did not satisfy any of the requirements of the present invention, at least one of the astringent sensation of the oral mucosa and discoloration over time was inferior.
[0118] (Example prescription) Examples of formulations of oral compositions to which the present invention is applied are shown below.
[0119] In the prescription examples 1 to 56 shown below, the evaluations of the astringent sensation of the oral mucosa during brushing and rinsing, discoloration over time, and unpleasant taste after brushing and rinsing were all favorable.
[0120] Furthermore, in formulation examples 1 to 51, it was confirmed that the same effect was obtained even when the pH was adjusted to a range of 5 to 9 using a total amount of pH adjusters (citric acid / sodium citrate, sodium dihydrogen phosphate / disodium hydrogen phosphate) within the range of 0.2 to 1% by mass.
[0121] [Table 16-1]
[0122] [Table 16-2]
[0123] [Table 17-1]
[0124] Table 17-2
[0125] Table 18-1
[0126] Table 18-2
[0127] Table 19-1
[0128] Table 19-2
[0129] Table 20-1
[0130] Table 20-2
[0131] Table 21-1
[0132] Table 21-2
[0133] Table 22-1
[0134] [Table 22-2]
[0135] [Table 23]
[0136] [Table 24]
[0137] Prescription Example 52: Composition of Toothpaste (mass %) Pyridoxine hydrochloride: 0.2 Polyoxyethylene (5) hydrogenated castor oil: 0.8 Sodium saccharin: 0.18 Xylitol: 0.01 Sucralose: 0.01 Mannitol: 0.01 Tocopherol acetate: 0.1 Sodium fluoride: 0.32 Isopropylmethylphenol: 0.05 Allantoin: 0.1 Tranexamic acid: 0.05 Sodium lauroyl methyl taurate: 0.6 Sodium lauryl sulfate: 0.2 Polishable silica*1: 10 Thickening silica*2: 5 Titanium dioxide: 0.3 Coconut oil fatty acid amidopropyl betaine*3: 0.5 85% Glycerin: 35 Xanthan gum: 1.5 Sodium polyacrylate: 0.3 Citric acid: 1 Sodium citrate: 1 Anhydrous sodium sulfate: 1 Fragrance composition A: 1.3 Water: Balance Total: 100 *1 Abrasive silica: Zeodent 124 manufactured by Huber Co., Ltd. *2 Thickening silica: "Carplex #67Q (liquid absorption capacity: 2.3)" manufactured by DSL Japan Co., Ltd. *3 Coconut oil fatty acid amidopropyl betaine solution: A 30% pure solution was used, and the amount of the solution used is indicated.
[0138] Prescription Example 53: Composition of Toothpaste (mass %) Pyridoxine hydrochloride: 0.2 Polyoxyethylene (5) hydrogenated castor oil: 0.5 Sodium saccharin: 0.2 Tocopherol acetate: 0.1 Sodium fluoride: 0.32 Tranexamic acid: 0.05 Potassium nitrate: 5 Isopropylmethylphenol: 0.05 Sodium polyphosphate: 1 Sodium azulene sulfonate: 0.01 Sodium lauroyl methyl taurate: 0.2 Polishable silica*1: 10 Thickening silica*2: 3 Coconut oil fatty acid amidopropyl betaine*3: 0.5 70% sorbitol solution: 30 Xanthan gum: 0.5 Citric acid: 0.5 Sodium citrate: 0.5 Titanium mica: 0.3 Red No. 106: 0.00003 Yellow No. 4: 0.0003 Methylparaben: 0.2 Fragrance composition A: 1.3 Water: Balance Total: 100 *1 Abrasive silica: Zeodent 124 manufactured by EVONIK Corporation *2 Thickening silica: "Carplex #67Q (liquid absorption capacity 2.3)" manufactured by DSL Japan Co., Ltd. *3 Coconut oil fatty acid amidopropyl betaine solution: A 30% pure solution was used, and the amount of the solution used is indicated.
[0139] Prescription Example 54: Composition of Toothpaste (mass %) Pyridoxine hydrochloride: 0.2 Polyoxyethylene (5) hydrogenated castor oil: 0.5 Sodium saccharin: 0.1 Tocopherol acetate: 0.1 Sodium fluoride: 0.32 Isopropylmethylphenol: 0.1 Tranexamic acid: 0.1 Dipotassium glycyrrhizinate: 0.05 Sodium chloride: 10 Potassium nitrate: 4.5 Sodium polyphosphate: 0.3 Polishable silica*1: 10 Thickening silica*2: 5 Titanium dioxide: 0.4 Sodium lauroyl sarcosinate: 0.5 Sodium lauryl sulfate: 0.5 Polyethylene glycol 400:5 70% sorbitol solution: 30 Propylene glycol: 5 Xanthan gum: 2 Sodium polyacrylate: 1.5 Sodium citrate: 0.2 Methylparaben: 0.2 Sodium hydroxide (48% solution): 0.2 Fragrance: 1.6 Water: Balance Total: 100 *1 Thickening silica: "Carplex #67Q (liquid absorption capacity 2.3)" manufactured by DSL Japan Co., Ltd. *2 Thickening silica: "Aerosil 200 (liquid absorption capacity 4.2)" manufactured by Nippon Aerosil Co., Ltd.
[0140] Prescription Example 55: Composition of Toothpaste (mass %) Pyridoxine hydrochloride: 0.2 Polyoxyethylene (20) hydrogenated castor oil: 0.6 Sodium saccharin: 0.18 Tocopherol acetate: 0.05 Sodium fluoride: 0.32 Isopropylmethylphenol: 0.05 Allantoin: 0.07 Tranexamic acid: 0.1 Sodium azulene sulfonate: 0.01 Abrasive silica*1: 12 Thickening silica*2: 8 Titanium dioxide: 0.1 Sodium lauroyl methyl taurate: 0.5 Sodium lauryl sulfate: 0.5 Coconut oil fatty acid amidopropyl betaine*3: 0.5 85% Glycerin: 45 Propylene glycol: 5 Polyethylene glycol 4000: 1 Propylene glycol alginate: 0.05 Sodium alginate: 1.5 Xanthan gum: 1 Citric acid 0.6 Sodium citrate 0.6 Fragrance composition A 1.3 Water balance Total 100 *1 Abrasive silica: Zeodent 124 manufactured by EVONIK Corporation *2 Thickening silica: "Carplex #67Q (liquid absorption capacity 2.3)" manufactured by DSL Japan Co., Ltd. *3 Coconut oil fatty acid amidopropyl betaine solution: A 30% pure solution was used, and the amount of the solution used is indicated.
[0141] Prescription Example 56: Composition of Toothpaste (by mass) Pyridoxine hydrochloride: 0.2 Polyoxyethylene (20) hydrogenated castor oil: 0.3 Sodium saccharin: 0.2 Tocopherol acetate: 0.1 Sodium fluoride: 0.32 Tranexamic acid: 0.05 Potassium nitrate: 5 Isopropylmethylphenol: 0.05 Sodium polyphosphate: 1 Sodium azulene sulfonate: 0.01 Sodium lauroyl methyl taurate; 0.2 Abrasive silica*1: 8 Thickening silica*2: 8 70% sorbitol solution: 38 Propylene glycol: 5 Polyethylene glycol 4000: 0.1 Xanthan gum: 1 Sodium alginate: 1 Propylene glycol alginate: 0.1 Coconut oil fatty acid amidopropyl betaine*3: 0.6 Titanium mica: 0.7 Red No. 106: 0.000025 Yellow No. 4: 0.00025 Fragrance: 1 Water: Balance Total: 100 *1 Abrasive silica: Zeodent 124 manufactured by EVONIK Corporation *2 Thickening silica: "Carplex #67Q (liquid absorption capacity 2.3)" manufactured by DSL Japan Co., Ltd. *3 Coconut oil fatty acid amidopropyl betaine solution: A 30% pure solution was used, and the amount of the solution used is indicated.
[0142] Furthermore, in Examples 1 to 34 and Formulation Examples 1 to 56, oral compositions with the same composition were prepared except that fragrance compositions B to S were used instead of fragrance composition A. In all cases, the evaluation of the astringent sensation of the oral mucosa during brushing and rinsing, discoloration over time, and unpleasant taste after brushing and rinsing was favorable.
Claims
1. (A) Components: Pyridoxine or a salt thereof, (B) Component: Contains a nonionic surfactant, (A) The content of component is 0.01% by mass or more and less than 0.5% by mass, (B) The content of component is 0.01% or more and less than 1%, An oral composition in which the ratio of the content of component (B) to the content of component (A) ((B) / (A)) is 0.5 or more and less than 20.
2. The oral composition according to claim 1, wherein component (B) is one or more selected from the group consisting of polyoxyethylene hydrogenated castor oil, polyoxyethylene alkyl ether, polyoxyethylene polyoxypropylene alkyl ether, polyoxyethylene polyoxypropylene block copolymer, and polyoxyethylene-polyoxypropylene glycol.
3. The average number of moles of ethylene oxide added to polyoxyethylene hydrogenated castor oil is in the range of 20 to 100. The average number of ethylene oxide addition moles of the polyoxyethylene alkyl ether is in the range of 2 to 50, and the number of carbon atoms of the alkyl group is in the range of 10 to 20. The average number of moles of ethylene oxide added to the polyoxyethylene polyoxypropylene block copolymer is in the range of 50 to 300, and the average number of moles of propylene oxide added is in the range of 1 to 100. The average number of moles of ethylene oxide added to the polyoxyethylene polyoxypropylene alkyl ether is in the range of 1 to 300, and the average number of moles of propylene oxide added is in the range of 1 to 70. The oral composition according to claim 2, wherein the average number of ethylene oxide moles added to polyoxyethylene polyoxypropylene glycol is in the range of 1 to 300, and the average number of propylene oxide moles added is in the range of 1 to 70.
4. The oral composition according to any one of claims 1 to 3, further comprising (C) component: a sweetener, wherein (C) component comprises one or more selected from the group consisting of sodium saccharin, sucralose, xylitol, erythritol, maltitol, acesulfame potassium, trehalose, and mannitol.
5. (D) Component: The oral composition according to any one of claims 1 to 3, further comprising one or more selected from the group consisting of tocopherol acetate and tocopherol nicotinate.
6. An oral composition according to any one of claims 1 to 3, which is a liquid oral composition.
7. The oral composition according to claim 6, wherein the moisture content is 50% by mass or more.