Oral composition containing sodium hydroxide

Abstract

[Problem] To provide an oral composition that contains high concentrations of fluorine and hinokitiol, while achieving stabilization of hinokitiol. [Solution] An oral composition containing a fluorine compound, hinokitiol, and sodium hydroxide, wherein the fluorine content is 1000 ppm or more, and the sodium hydroxide content is less than 0.2 wt%.

Description

Oral composition containing sodium hydroxide

[0001] The present disclosure relates to an oral composition containing hinokitiol and a high concentration of fluorine, in which hinokitiol is stably present.

[0002] Conventionally, bactericides have been blended into oral compositions such as dentifrices and mouthwashes to reduce the number of pathogenic bacteria causing dental caries or periodontal disease. Various bactericides to be blended in oral compositions are known, and hinokitiol is widely used in oral compositions due to its low toxicity and broad antibacterial spectrum (Patent Document 1). However, hinokitiol has been conventionally known to have a peculiar taste similar to mint (Patent Document 2), and the off taste has caused a problem that consumers refuse to use dentifrices containing hinokitiol.

[0003] In addition, for the prevention of dental caries, the use of dentifrices blended with fluorine compounds is recommended as a daily self-care practice. Fluorine compounds impart resistance to acid produced by cariogenic bacteria to teeth, repair initial caries through remineralization, and restore the original healthy tooth structure, and thus are widely used in oral compositions. Furthermore, fluorine compounds also have an effect of suppressing the proliferation of cariogenic bacteria (Patent Document 3).

[0004] Japanese Patent Application Laid-Open No. 2017-007991, Japanese Patent Application Laid-Open No. 2002-047162, Japanese Patent Application Laid-Open No. 2021-107362

[0005] The present inventor conducted a monitor test on the off taste of hinokitiol in the formulation of an oral composition containing a fluorine compound and hinokitiol. The present inventor found that although the off taste of an oral composition containing hinokitiol can be masked by containing a high concentration of fluorine, the inventor faced the problem that high-concentration fluorine destabilizes hinokitiol. Destabilization of hinokitiol reduces the bactericidal action of the oral composition, and thus is an important problem that must be solved.

[0006] Accordingly, an object of the present disclosure is to provide an oral composition that contains high-concentration fluorine and hinokitiol while achieving stabilization of hinokitiol.

[0007] To achieve the above objective, an oral composition is provided comprising a fluorine compound, hinokitiol, and sodium hydroxide, wherein the fluorine content is 1000 ppm or more and the sodium hydroxide content is less than 0.2% by weight.

[0008] According to this disclosure, it is possible to provide an oral composition that contains a high concentration of fluoride and hinokitiol while achieving hinokitiol stabilization. The oral composition can exhibit a bactericidal effect due to hinokitiol and a caries prevention effect and flavoring effect due to the high concentration of fluoride, and the problem of hinokitiol destabilization caused by the high concentration of fluoride is solved by using less than 0.2% by weight of sodium hydroxide. Furthermore, the oral composition containing less than 0.2% by weight of sodium hydroxide exhibits superior effects compared to the oral composition containing 0.2% by weight or more of sodium hydroxide in preventing or improving periodontitis, gum swelling or bleeding, or bad breath, or in tightening the gums, and these effects were observed to be more pronounced in women than in men.

[0009] 1. Oral Composition of the Disclosure The Disclosure provides an oral composition comprising a fluorine compound, hinokitiol, and sodium hydroxide, wherein the fluorine content is 1000 ppm or more and the sodium hydroxide content is less than 0.2% by weight, the oral composition (oral composition of the Disclosure).

[0010] (Fluorine compounds) The oral compositions of this disclosure contain fluorine compounds.

[0011] In the oral composition of this disclosure, the fluorine compound is a known component that imparts resistance to acids produced by cariogenic bacteria to teeth, has the effect of remineralizing early caries, and also has the effect of suppressing the growth of cariogenic bacteria. In the oral composition of this disclosure, the fluorine compound also has a taste-correcting effect on the mint taste exhibited by hinokitiol, which will be described later.

[0012] The fluorine compounds used in the oral compositions of this disclosure are not particularly limited as long as they are applicable in the oral cavity, but examples include alkali metal fluorides, fluorophosphates, fluorophosphates, stannous fluoride, and silver diamine fluoride. The fluorine compounds may be used alone or in combination of two or more. From the viewpoint of obtaining the above-mentioned effects on dental caries and the above-mentioned flavor-correcting effects, the fluorine compounds preferably include at least one selected from the group consisting of alkali metal fluorides, fluorophosphates, and fluorophosphates, and more preferably fluorophosphates.

[0013] The alkali metal fluoride is not particularly limited as long as it is applicable in the oral cavity, but examples include sodium fluoride and potassium fluoride. The alkali metal fluoride may be used alone or in combination of two or more types. Among the alkali metal fluorides exemplified above, sodium fluoride is preferred from the viewpoint of obtaining the above-mentioned effects on dental caries and the above-mentioned flavoring effect.

[0014] The fluorophosphate is not particularly limited as long as it can be applied in the oral cavity, but examples include monofluorophosphate and difluorophosphate. The fluorophosphate may be used alone or in combination of two or more types. Among the fluorophosphates exemplified above, monofluorophosphate is preferred from the viewpoint of obtaining the above-mentioned effects on dental caries and the above-mentioned flavoring effect.

[0015] The fluorophosphate is not particularly limited as long as it can be applied in the oral cavity, but examples include alkali metal salts of fluorophosphate, specifically sodium salts and potassium salts of fluorophosphate. The fluorophosphate may be used alone or in combination of two or more types. Among the fluorophosphates exemplified above, sodium salts are preferred, and sodium monofluorophosphate is more preferred, from the viewpoint of obtaining the above-mentioned effects on dental caries and the above-mentioned flavoring effects.

[0016] In the oral composition of this disclosure, the fluorine content in the oral composition is 1000 ppm or more in order to impart the above-mentioned effects against dental caries and the above-mentioned flavoring effects. The oral composition of this disclosure contains a high concentration of fluorine of 1000 ppm or more, but because sodium hydroxide, as described later, is included in an amount of less than 0.2% by weight, the destabilization of hinokitiol caused by the high concentration of fluorine is suppressed.

[0017] In the oral composition of this disclosure, the lower limit of the fluorine content in the oral composition is 1000 ppm or more, preferably 1100 ppm or more, more preferably 1200 ppm or more, even more preferably 1300 ppm or more, and even more preferably 1400 ppm or more, from the viewpoint of imparting the above-mentioned effects against dental caries and the above-mentioned flavoring effects to the oral composition. Since the oral composition of this disclosure contains sodium hydroxide, which will be described later, the destabilization of hinokitiol can be suppressed even when the oral composition of this disclosure contains 1000 ppm or more of fluorine. Furthermore, in the oral composition of this disclosure, there is no particular upper limit to the fluorine content in the oral composition, but for example, it is 1500 ppm or less.

[0018] In one embodiment of the oral composition of the present disclosure, when the fluorine compound is sodium monofluorophosphate, the content of sodium monofluorophosphate is, for example, 0.76 to 1.14% by weight, preferably 0.83 to 1.14% by weight, more preferably 0.91 to 1.14% by weight, even more preferably 0.99 to 1.14% by weight, and most preferably 1.06 to 1.14% by weight, from the viewpoint of imparting the above-mentioned effects against dental caries and the above-mentioned flavoring effects to the oral composition.

[0019] (Hinokitiol) The oral compositions of this disclosure contain hinokitiol.

[0020] In the oral compositions of this disclosure, hinokitiol is a known component incorporated into oral compositions as a disinfectant, etc. Hinokitiol may be derived from natural products or may be chemically synthesized. Furthermore, the hinokitiol used in this disclosure may be a refined product or a crude product. When using a refined product, for example, a hinokitiol-containing essential oil obtained from a tree may be used.

[0021] In the oral composition of this disclosure, the hinokitiol content is appropriately set according to the formulation form and use of the oral composition, but is, for example, 0.1 to 1.2 parts by weight per 1 part by weight of fluorine. Furthermore, from the viewpoint of exhibiting excellent bactericidal activity and stabilizing the hinokitiol contained in the oral composition, the hinokitiol content is, for example, 0.27 to 0.4 parts by weight, preferably 0.27 to 0.36 parts by weight, more preferably 0.27 to 0.33 parts by weight, even more preferably 0.27 to 0.31 parts by weight, and most preferably 0.27 to 0.29 parts by weight per 1 part by weight of fluorine.

[0022] In one embodiment of the oral composition of the present disclosure, when the fluorine compound is sodium monofluorophosphate, the hinokitiol content is, for example, 0.01 to 0.15 parts by weight per 1 part by weight of sodium monofluorophosphate. Furthermore, from the viewpoint of exhibiting excellent bactericidal activity and stabilizing the hinokitiol contained in the oral composition, the hinokitiol content is, for example, 0.035 to 0.053 parts by weight, preferably 0.035 to 0.048 parts by weight, more preferably 0.035 to 0.044 parts by weight, even more preferably 0.035 to 0.041 parts by weight, and most preferably 0.035 to 0.038 parts by weight per 1 part by weight of sodium monofluorophosphate.

[0023] In the oral composition of this disclosure, the hinokitiol content is appropriately set according to the formulation form and use of the oral composition, but for example, it is 0.005 to 1% by weight. Furthermore, from the viewpoint of exhibiting excellent bactericidal activity and stabilizing the hinokitiol contained in the oral composition, the hinokitiol content is, for example, 0.01 to 0.5% by weight, preferably 0.02 to 0.3% by weight, more preferably 0.03 to 0.2% by weight, and even more preferably 0.04 to 0.1% by weight.

[0024] (Sodium hydroxide) The oral compositions of this disclosure contain sodium hydroxide.

[0025] In the oral composition of this disclosure, sodium hydroxide is incorporated into the oral composition to suppress the destabilization of hinokitiol caused by high concentrations of fluorine. Therefore, it is inferred that sodium hydroxide has the function of inhibiting the reaction between fluorine compounds and hinokitiol.

[0026] In the oral composition of this disclosure, the sodium hydroxide content needs to be appropriately adjusted according to the fluorine content in the oral composition, but is, for example, 0.5 to 4.0 parts by weight per 1 part by weight of fluorine. Furthermore, from the viewpoint of suppressing the destabilization of hinokitiol caused by high concentrations of fluorine, the sodium hydroxide content is, for example, 1.13 to 1.70 parts by weight, preferably 1.13 to 1.55 parts by weight, more preferably 1.13 to 1.42 parts by weight, even more preferably 1.13 to 1.31 parts by weight, and most preferably 1.13 to 1.21 parts by weight per 1 part by weight of fluorine.

[0027] In one embodiment of the oral composition of the present disclosure, when the fluorine compound is sodium monofluorophosphate, the sodium hydroxide content is, for example, 0.05 to 0.5 parts by weight per 1 part by weight of sodium monofluorophosphate. Furthermore, from the viewpoint of suppressing the destabilization of hinokitiol caused by high concentrations of fluorine, the sodium hydroxide content is, for example, 0.12 to 0.22 parts by weight, preferably 0.12 to 0.20 parts by weight, more preferably 0.12 to 0.19 parts by weight, even more preferably 0.12 to 0.17 parts by weight, and most preferably 0.12 to 0.16 parts by weight per 1 part by weight of sodium monofluorophosphate.

[0028] In the oral composition of this disclosure, the upper limit of the sodium hydroxide content is less than 0.2% by weight. If the sodium hydroxide content in the oral composition of this disclosure is 0.2% by weight or more, the destabilization of hinokitiol due to high concentrations of fluorine cannot be suppressed, and the problems of this disclosure cannot be solved. Therefore, from the viewpoint of suppressing the destabilization of hinokitiol due to high concentrations of fluorine, the upper limit of the sodium hydroxide content is preferably 0.19% by weight or less, more preferably 0.18% by weight or less. Furthermore, in the oral composition of this disclosure, the lower limit of the sodium hydroxide content is, for example, 0.1% by weight or more. From the viewpoint of suppressing the destabilization of hinokitiol due to high concentrations of fluorine, the lower limit of the sodium hydroxide content is preferably 0.11% by weight or more, more preferably 0.12% by weight or more.

[0029] (Dosage Form, Form of Use) In the oral compositions of this disclosure, the dosage form or form of use is not particularly limited as long as it can be applied to the oral cavity, but examples include liquid or semi-solid forms (e.g., gel, paste, etc.).

[0030] The dosage form or form of use of the oral composition of this disclosure is not particularly limited as long as it can be applied to the oral cavity and remain there for a certain period of time. Examples include oral hygiene agents such as liquid toothpaste, tooth paste, mouthwash (mouthwash is sometimes referred to as mouth rinse, mouthwash, dental rinse, etc.), oral fresheners (such as mouth spray), and oral ointment. Preferably, liquid toothpaste, tooth paste, and mouthwash are included.

[0031] The method for preserving the oral composition of this disclosure is not particularly limited as long as sodium hydroxide suppresses the destabilization of hinokitiol by high concentrations of fluorine, but for example, the storage temperature can be 0 to 45°C, preferably 0 to 30°C, and more preferably 0 to 15°C.

[0032] In addition to the components described above, the oral compositions of this disclosure may contain, depending on the form of the oral composition, components commonly used in the art, to the extent that they do not impair the effects of the pharmaceutical compositions of this disclosure, the bactericidal effect of hinokitiol, the caries prevention effect and flavoring effect of fluorine compounds, and the destabilization inhibitory effect of sodium hydroxide on hinokitiol. Examples of components commonly used in the art include anti-inflammatory agents, antibacterial agents, hemostatic agents, hypersensitivity inhibitors, stabilizers, wetting agents, solubilizers, thickeners, abrasives, whitening agents, astringents, flavoring agents, cleaning agents, pH adjusters, foaming agents, colorants, preservatives, bases, and cleaning agents.

[0033] Examples of anti-inflammatory agents include dipotassium glycyrrhizinate and β-glycyrrhetinic acid.

[0034] Examples of antibacterial agents include cetylpyridinium chloride.

[0035] Examples of hemostatic agents include ε-aminocaproic acid.

[0036] Examples of the dentin hypersensitivity inhibitor include aluminum lactate and the like.

[0037] Examples of the stabilizer include DL-alanine, disodium edetate, titanium oxide, metaphosphate and the like.

[0038] Examples of the humectant include concentrated glycerin, PG, sorbit solution and the like.

[0039] Examples of the solubilizer include ethanol, polyoxyethylene hydrogenated castor oil and the like.

[0040] Examples of the thickener include carrageenan, silicic anhydride, sodium carboxymethylcellulose and the like.

[0041] Examples of the abrasive include hydrated silicic acid, calcium pyrophosphate and the like.

[0042] Examples of the whitening agent include titanium oxide and the like.

[0043] Examples of the astringent include Angelica acutiloba extract (1), peony extract and the like.

[0044] Examples of the corrigent include sodium chloride, sodium saccharin and the like.

[0045] Examples of the detergent include Sapindus mukurossi peel extract and the like.

[0046] Examples of the pH adjuster include sodium hydroxide and the like.

[0047] Examples of the foaming agent include sodium N-lauroyl-L-glutamate, sodium lauryl sulfate, alkyl glycoside and the like.

[0048] Examples of the coloring agent include Yellow No. 203, Blue No. 1 and the like.

[0049] Examples of the preservative include ethyl parahydroxybenzoate, propyl parahydroxybenzoate, paraben and the like.

[0050] Examples of the base include purified water, sorbit solution and the like.

[0051] Examples of cleaning agents include propyldimethyloctadecylammonium chloride-bonded anhydrous silicic acid (Bionium).

[0052] (Prevention or improvement of periodontal disease, swollen or bleeding gums, or bad breath, or gum tightening) The oral compositions of this disclosure may be used to prevent or improve periodontal disease, swollen or bleeding gums, or bad breath, or gum tightening.

[0053] The oral compositions disclosed herein can be used as preventive or ameliorative agents for periodontal disease or gum swelling or bleeding because, when applied to the oral cavity, they can effectively kill bacteria that form biofilms that cause periodontal disease, gum swelling, or bleeding.

[0054] Furthermore, since biofilms formed in the oral cavity are also a cause of bad breath, the oral composition disclosed herein can also be used as a preventative or corrective agent for bad breath by suppressing the formation of biofilms in the oral cavity.

[0055] Furthermore, since bacteria in the oral cavity can induce inflammation of the gums and cause gum recession, the oral composition of this disclosure can also be used to tighten the gums by effectively killing bacteria in the oral cavity.

[0056] The above effects are superior in the oral composition of this disclosure containing less than 0.2% by weight of sodium hydroxide compared to the oral composition containing 0.2% by weight or more of sodium hydroxide; therefore, the oral composition of this disclosure containing 0.2% by weight or more of sodium hydroxide is more useful as an oral composition.

[0057] (For women) The oral compositions of this disclosure may be used as oral compositions for women.

[0058] The above effects are superior in the oral composition of this disclosure containing less than 0.2% by weight of sodium hydroxide compared to the oral composition containing 0.2% by weight or more of sodium hydroxide; therefore, the oral composition of this disclosure can be preferably used for women.

[0059] The amount of the oral composition of this disclosure to be applied to the oral cavity is set appropriately depending on the content of the active ingredient, the type of active ingredient, the formulation of the oral composition, and the expected effect. For example, it is sufficient to apply the oral composition of the present invention once to six times a day, with each application amount corresponding to an amount equivalent to approximately 1 to 10 mg of the active ingredient.

[0060] 2. Method for producing the oral composition of the present disclosure (or method for stabilizing hinokitiol of the present disclosure) The present disclosure provides a method for producing an oral composition, comprising the step of mixing a fluorine compound, hinokitiol, and sodium hydroxide, wherein the fluorine content in the oral composition is 1000 ppm or more and the sodium hydroxide content in the oral composition is less than 0.2% by weight. The present disclosure also provides a method for stabilizing hinokitiol in an oral composition, comprising mixing a fluorine compound, hinokitiol, and sodium hydroxide, wherein the fluorine content in the oral composition is 1000 ppm or more and the sodium hydroxide content in the oral composition is less than 0.2% by weight.

[0061] In the method for producing the oral composition of this disclosure (or the method for stabilizing hinokitiol of this disclosure), the fluorine compound, hinokitiol, and sodium hydroxide may be the same as those described in the oral composition of this disclosure.

[0062] A method for producing the oral composition of this disclosure (or a method for stabilizing hinokitiol of this disclosure) includes the step of mixing a fluorine compound, hinokitiol, and sodium hydroxide. The fluorine compound, hinokitiol, and sodium hydroxide may be mixed simultaneously, or (i) the fluorine compound and hinokitiol, (ii) the fluorine compound and sodium hydroxide, or (iii) hinokitiol and sodium hydroxide may be mixed beforehand and the remaining components mixed afterward.

[0063] Next, examples of the present disclosure will be described. However, the present disclosure is not limited to the following examples. Commercial reagents were used according to their respective protocols unless otherwise specified.

[0064] 1. Masking test for off-flavor of hinokitiol (1) Preparation of samples Each sample (Comparative Example 1, Examples 1-4) with the composition shown in Table 1 was prepared. Specifically, each liquid preparation was made by mixing hinokitiol, sodium monofluorophosphate, sodium hydroxide, and purified water.

[0065]

[0066] (2) Masking test: Approximately 0.5 g of each of the above samples was placed in the mouth, and the mint taste was judged when brushing with a toothbrush.

[0067] (3) Results: Comparative Example 1, which contained a low concentration of fluorine, had an off-flavor of hinokitiol, but no off-flavor of hinokitiol was detected in Examples 1 to 4, which contained a high concentration of fluorine. The results are shown in Table 2.

[0068]

[0069] 2. Hinokitiol Stability Evaluation Test Samples of the compositions shown in Table 3 (Example 5, Comparative Example 2) were prepared. Specifically, each component was mixed to prepare each paste-type toothpaste. Approximately 40 g of each toothpaste was filled into an aluminum laminate tube and stored for 3 months under 40°C conditions. For each toothpaste, the amount of remaining hinokitiol was measured by high-performance liquid chromatography under the following conditions.

[0070]

[0071] <Test Conditions> Equipment used: High-performance liquid chromatograph LC-20AD (Shimadzu Corporation) Detector: Ultraviolet absorbance spectrophotometer - measurement wavelength 350 nm Column: ODS column, length 15 cm Column temperature: 40°C Mobile phase: EDTA + phosphate buffer / acetonitrile mixture Flow rate: 1.0 mL / min

[0072] The stability of hinokitiol after storage of Comparative Example 2 and Example 5, prepared as described above, was tested under the above conditions. When stored for 3 months at 40°C, Comparative Example 2, which contained hinokitiol, a high concentration of fluorine, and 0.29% by weight of sodium hydroxide, showed problems with the stability of hinokitiol. On the other hand, in Example 5, which contained hinokitiol, a high concentration of fluorine, and 0.17% by weight of sodium hydroxide, the destabilization of hinokitiol was suppressed. The results are shown in Table 4.

[0073]

[0074] 3. Monitor Test (1) Purpose of the Study The purpose of this study was to verify the user experience of Comparative Example 2 and Example 6 using a physician-initiated blinding method, targeting users of Kobayashi Pharmaceutical's commercially available toothpaste (product name: Seiyo d).

[0075] (2) Overview of the survey Approximately 80 men and women who regularly use Kobayashi Pharmaceutical's commercially available toothpaste (product name: Seiyo d) and meet the requirements for survey participants were surveyed on their experience using Comparative Example 2 and Example 6 when brushing their teeth.

[0076] (3) Survey Design: Survey participants were given an explanation of the survey content using explanatory materials, and the survey was conducted only for those participants who agreed to the survey content.

[0077] (4) Samples and amounts used (a) Samples were prepared with the compositions shown in Table 5 (Example 6, Comparative Example 2). Specifically, each component was mixed to prepare each paste-type toothpaste.

[0078]

[0079] (i) Sample packaging: Each sample was filled into an aluminum laminate tube (100g capacity). (iii) Handling and storage of the sample: After filling the tube, it was stored at room temperature. (iv) Amount of sample to use: Take an appropriate amount onto a toothbrush and brush your teeth and gums. (5) Requirements for Survey Participants (a) Selection Criteria for Survey Participants (those who meet the conditions of (i) and (ii)) (i) Healthy men and women aged 20 or older (ii) Healthy men and women who regularly use Kobayashi Pharmaceutical's commercially available toothpaste (product name: Seiyo d) (b) Exclusion Criteria for Survey Participants (those who meet any of the conditions of (i) to (xi)) (i) Those who do not intend to use the sample at least once a day (ii) Those with drug sensitivities such as allergies (iii) Those who have one of the five major diseases (cancer, stroke, acute myocardial infarction, diabetes, mental illness), etc., and are receiving treatment at a medical institution or are scheduled to undergo surgery, etc. (iv) Pregnant women, those who may be pregnant, or breastfeeding women (v) Those who have taken antibiotics within the last month (vi) Those who have had a tooth extracted or undergone periodontal surgery, etc. within the last year (vii) Those who are currently receiving treatment for oral problems at a dental clinic (viii) Those who wear complete dentures (ix) Those with obvious injuries in the oral cavity (x) Individuals with severe gingivitis (xi) Others whom the research physician or principal investigator deems unsuitable as research participants

[0080] (5) Research Method (a) Research Flow A research company contacted individuals who had experience using Kobayashi Pharmaceutical's commercially available toothpaste (product name: Seiyo d) to gather research participants who met the above requirements and were able to participate in the study, and obtained their consent to participate in the study. The research participants were divided into two groups (Study A and Study B) and evaluated their user experience for two weeks as follows: (Study A) Comparative Example 2 was used for three days and the user experience was evaluated, followed by the use of Example 6 for three days and the user experience was evaluated. (Study B) Example 6 was used for three days and the user experience was evaluated, followed by the use of Comparative Example 2 for three days and the user experience was evaluated.

[0081] (6) Results Example 6 and Comparative Example 2 were evaluated for the prevention or improvement of periodontal disease, gum swelling or bleeding, or bad breath, or gum tightening. As a result, compared to Comparative Example 2, which contained hinokitiol, high concentration of fluoride, and 0.29% by weight of sodium hydroxide, Example 6, which contained hinokitiol, high concentration of fluoride, and 0.17% by weight of sodium hydroxide, showed a greater increase in the number of participants who felt the effects of preventing or improving periodontal disease, gum swelling or bleeding, or bad breath, or gum tightening. Furthermore, the above effects were more pronounced in women. The results are shown in Tables 6 to 9. In the tables, "◎" indicates that "5 or more people felt the effect," and "〇" indicates that "20 or more people felt the effect or somewhat felt the effect."

[0082]

[0083]

[0084]

[0085]

[0086] While the present disclosure has been described above with reference to embodiments, the present disclosure is not limited to the embodiments described above. Various modifications to the structure and details of the present disclosure may be made that will be understood by those skilled in the art within the scope of the present disclosure.

[0087] The patents, patent applications, and documents cited herein are incorporated herein by reference in the same manner as their contents are specifically described herein.

[0088] <Notes> Some or all of the above embodiments and examples may be described as follows, but are not limited to the following. <Oral compositions of the present disclosure> (Note 1) An oral composition comprising a fluorine compound and hinokitiol, wherein the fluorine content is 1000 ppm or more. (Note 2) The oral composition according to Note 1, further comprising sodium hydroxide, wherein the sodium hydroxide content is less than 0.2% by weight. (Note 3) The oral composition according to Note 1 or 2, wherein the fluorine compound is at least one selected from the group consisting of alkali metal fluorides, fluorophosphates, and salts of fluorophosphates. (Note 4) The oral composition according to any one of Notes 1 to 3, wherein the fluorine compound is sodium monofluorophosphate. (Note 5) The oral composition according to any one of Notes 1 to 4, wherein the fluorine content is 1500 ppm or less. (Note 6) An oral composition according to any one of Notes 1 to 5, which is a liquid toothpaste, a paste toothpaste, or a mouthwash. (Note 7) An oral composition according to any one of Notes 1 to 6, which is used for the prevention or improvement of periodontitis, swelling or bleeding of the gums, or bad breath, or for tightening the gums. (Note 8) An oral composition according to any one of Notes 1 to 7, which is for women. <Method for producing the oral composition of the present disclosure> (Note 9) A method for producing an oral composition, comprising the step of mixing a fluorine compound, hinokitiol, and sodium hydroxide, wherein the fluorine content in the oral composition is 1000 ppm or more, and the sodium hydroxide content in the oral composition is less than 0.2% by weight. <Method for stabilizing hinokitiol according to the present disclosure> (Appendix 10) A method for stabilizing hinokitiol in an oral composition, comprising the step of mixing a fluorine compound, hinokitiol, and sodium hydroxide, wherein the fluorine content in the oral composition is 1000 ppm or more, and the sodium hydroxide content in the oral composition is less than 0.2% by weight.

[0089] According to this disclosure, it is possible to provide an oral composition that contains a high concentration of fluoride and hinokitiol while achieving hinokitiol stabilization. The oral composition exhibits a bactericidal effect due to hinokitiol and a caries prevention effect due to a higher concentration of fluoride than conventional compositions, and the problem of hinokitiol destabilization is solved by using less than 0.2% by weight of sodium hydroxide. Furthermore, the oral composition containing less than 0.2% by weight of sodium hydroxide exhibits superior effects compared to the oral composition containing 0.2% by weight or more of sodium hydroxide in preventing or improving periodontal disease, gum swelling or bleeding, or bad breath, or in tightening the gums, and these effects were observed more significantly in women than in men.

Claims

1. An oral composition comprising a fluorine compound and hinokitiol, wherein the fluorine content is 1000 ppm or more.

2. The oral composition according to claim 1, further comprising sodium hydroxide, wherein the sodium hydroxide content is less than 0.2% by weight.

3. The oral composition according to claim 1 or 2, wherein the fluorine compound is at least one selected from the group consisting of alkali metal fluorides, fluorophosphates, and salts of fluorophosphates.

4. The oral composition according to any one of claims 1 to 3, wherein the fluorine compound is sodium monofluorophosphate.

5. The oral composition according to any one of claims 1 to 4, wherein the fluorine content is 1500 ppm or less.

6. An oral composition according to any one of claims 1 to 5, which is a liquid toothpaste, a paste toothpaste, or a mouthwash.

7. An oral composition according to any one of claims 1 to 6, used for the prevention or improvement of periodontitis, swelling or bleeding of the gums, or bad breath, or for tightening the gums.

8. An oral composition according to any one of claims 1 to 7, which is for use by women.

9. A method for producing an oral composition, comprising the step of mixing a fluorine compound, hinokitiol, and sodium hydroxide, wherein the fluorine content in the oral composition is 1000 ppm or more, and the sodium hydroxide content in the oral composition is less than 0.2% by weight.

10. A method for stabilizing hinokitiol in an oral composition, comprising the step of mixing a fluorine compound, hinokitiol, and sodium hydroxide, wherein the fluorine content in the oral composition is 1000 ppm or more, and the sodium hydroxide content in the oral composition is less than 0.2% by weight.

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