Oral components

Abstract

To provide an oral composition that contains Phellodendron bark extract stably over time, has a high oral biofilm bactericidal effect, and also has good usability and stable appearance.SOLUTION: An oral composition contains (A) Phellodendron bark extract, (B) sodium methyl lauroyl taurate and (C) sodium lauryl sulfate, with the mass ratio (C) / (B) of 0.03-30.SELECTED DRAWING: None

Description

[Technical Field]

[0001] The present invention relates to an oral composition which contains a stable phellodendron bark extract over time, has an excellent oral biofilm killing effect, has a good feel when used and good appearance stability, and is effective for preventing or suppressing periodontal disease. [Background technology]

[0002] Phellodendron bark extract is extracted from the bark of the citrus plant Amur cork, etc., and contains the alkaloid berberine, which has anti-inflammatory and antibacterial effects, and is incorporated into oral compositions as an active ingredient for preventing periodontal disease, etc. However, Phellodendron bark extract is easily affected by other ingredients, which can lead to a decrease in the residual rate of berberine over time, posing stability issues, and depending on the ingredients, can cause a deterioration in the appearance of the formulation, and in toothpaste, liquid separation can occur over time. Many techniques have been proposed for stably blending Phellodendron bark extract or berberine into oral compositions (Patent Documents 1 to 7).

[0003] Periodontal disease is an infectious disease caused by bacteria, primarily obligately anaerobic gram-negative bacilli such as Porphyromonas gingivalis. Penetrating sterilization of oral biofilms formed by bacteria such as these periodontal pathogens is effective in preventing or suppressing periodontal disease. However, the bactericidal action of Phellodendron bark extract is weak, and it was not able to satisfactorily sterilize the bacteria in the oral biofilms. Therefore, there has been a demand for the development of an oral composition containing Phellodendron bark extract that is stable over time and has a high oral biofilm-killing effect. [Prior art documents] [Patent documents]

[0004] [Patent Document 1] Special Publication No. 7-91178 [Patent Document 2] Japanese Patent Application Publication No. 8-175941 [Patent Document 3] Japanese Patent Application Laid-Open No. 2005-187329 [Patent Document 4] Japanese Patent Application Laid-Open No. 2011-132137 [Patent Document 5] Japanese Patent Application Laid-Open No. 2012-92042 [Patent Document 6] Japanese Patent Application Laid-Open No. 2012-148998 [Patent Document 7] Japanese Patent Application Laid-Open No. 2012-158559 Summary of the Invention [Problem to be solved by the invention]

[0005] The present invention has been made in consideration of the above circumstances, and aims to provide an oral composition that contains Phellodendron bark extract stably over time, has excellent oral biofilm killing effect, and has good usability and appearance stability. [Means for solving the problem]

[0006] As a result of intensive research conducted by the present inventors to achieve the above-mentioned object, they discovered that when an oral composition containing (A) Phellodendron Bark extract is combined with (B) sodium lauroyl methyl taurate and (C) sodium lauryl sulfate in a specific ratio, the stability of component (A) is improved, component (A) is stably incorporated over time, the oral biofilm bactericidal effect is excellent, and the foaming and palatable feel and appearance stability are ensured, which led to the present invention.

[0007] More specifically, when an anionic surfactant (B) sodium lauroyl methyl taurate was added to an oral composition containing (A) Phellodendron Bark Extract in order to enhance the bactericidal power against periodontal pathogens, etc., the penetrating bactericidal power into oral biofilms formed by periodontal pathogens, etc., increased, improving the oral biofilm bactericidal effect. However, on the other hand, the stability of component (A) decreased, the residual rate of berberine decreased over time, and the bitterness of components (A) and (B) combined to significantly worsen the taste, resulting in a significant decrease in palatability. However, by further incorporating (C) sodium lauryl sulfate within a specific range of the mass ratio of (C) / (B), the combined system of components (B) and (C) exhibits a unique action effect that cannot be obtained with combined systems of other anionic surfactants, thereby eliminating the above-mentioned problems, providing a high oral biofilm disinfecting effect, maintaining moderate foaming and a pleasant taste, significantly improving the stability of component (A), allowing a high percentage of berberine to remain even after long-term storage, and also preventing liquid separation over time, thereby ensuring stable appearance. In addition, in the present invention, by combining component (A) with components (B) and (C), it was possible to achieve both an improved oral biofilm disinfection effect, improved stability of component (A), and stable appearance, within a specific range of the mass ratio of (C) / (B). As is clear from the comparative examples described below, when component (A) was blended but components (B) and (C) were not blended, the stability of component (A) was poor, the oral biofilm (BF) bactericidal effect was low, and the taste and foaming were also poor (Comparative Example 1). When component (B) was blended but component (C) was not blended, the stability and taste of component (A) were poor, even when the anionic surfactant sodium lauroyl sarcosinate was further added (Comparative Examples 2 and 5). Furthermore, even when components (B) and (C) were blended, when the mass ratio of (C) / (B) was less than a specific value, the stability and taste of component (A) were poor (Comparative Example 4). When the mass ratio of (C) / (B) exceeded a specific value, the appearance stability (liquid separation stability of the formulation) was poor (Comparative Example 3). In contrast, the dentifrice composition shown in the examples, which contains the components (A), (B), and (C) and has a mass ratio of (C) / (B) within a specific range, exhibits excellent stability of the component (A) and BF bactericidal effect, as well as good taste, foaming, and appearance stability.

[0008] Therefore, the present invention provides the following oral compositions. [1] (A) Phellodendron Bark Extract, (B) Sodium Lauroyl Methyl Taurate and (C) Sodium lauryl sulfate and wherein the mass ratio of (C) / (B) is 0.03 to 30. [2] The oral composition according to [1], wherein the content of component (A) is 0.01 to 0.3% by mass. [3] The oral composition according to [1] or [2], wherein the content of component (B) is 0.01 to 3% by mass. [4] The oral composition according to any one of [1] to [3], wherein the content of component (C) is 0.05 to 2% by mass. [5] The oral composition according to any one of [1] to [4], wherein the mass ratio of (C) / ((A)+(B)) is 0.03 to 12. [6] The oral composition according to any one of [1] to [5], wherein the content of component (B) is 0.05 to 2.5% by mass, the content of component (C) is 0.05 to 2% by mass, and the total content of components (B) and (C) is 0.2 to 3% by mass. [7] The oral composition according to any one of [1] to [6], which is a toothpaste. [Effects of the Invention]

[0009] According to the present invention, there is provided an oral composition in which (A) Phellodendron Bark extract is stably incorporated over time, which has an excellent oral biofilm-killing effect, and which has good usability and appearance stability. The oral composition of the present invention has an excellent oral biofilm-killing effect in addition to the anti-inflammatory effect of component (A), and is therefore effective for preventing or suppressing periodontal disease. DETAILED DESCRIPTION OF THE INVENTION

[0010] The present invention will be described in further detail below. The oral composition of the present invention contains (A) Phellodendron Bark extract, (B) sodium lauroyl methyl taurate, and (C) sodium lauryl sulfate.

[0011] (A) Phellodendron bark extract is an active ingredient that has anti-inflammatory and antibacterial effects, and is effective in preventing periodontal disease. The Phellodendron Bark extract is a solvent extract of plants containing Phellodendron Bark (Phellodendron bark), and one obtained by a known method can be used. The Phellodendron Bark extract may be in a liquid form, a dried solid form, or a powdered extract may be used. Specifically, the raw material may be bark of a citrus plant such as Phellodendron amurense. The extraction solvent can be a hydrophilic solvent, such as water, lower monohydric alcohols such as ethanol and propanol, and polyhydric alcohols such as 1,3-butylene glycol and propylene glycol. A single solvent selected from these or a mixture of two or more solvents can be used. Among these, water and ethanol are preferred, with water, especially hot water, being particularly preferred. Conventional extraction conditions and post-treatment methods can be used. Moreover, the phellodendron bark extract preferably contains berberine in an amount of 1% by mass or more, more preferably 2 to 80% by mass.

[0012] The Phellodendron Bark extract may be Phellodendron Bark Powder listed in the 18th Revised Japanese Pharmacopoeia or Phellodendron Bark Extract listed in the Quasi-drug Raw Materials Standards 2021, or may be a commercially available product. Examples of commercially available products include Phellodendron Bark Extract S (trade name, manufactured by Ogi Pharmaceutical Co., Ltd.), which is a powdered extract obtained by hot water extraction of Phellodendron bark and spray drying, and Phellodendron Bark Extract-J (trade name, manufactured by Maruzen Pharmaceutical Co., Ltd.), which is a liquid extract containing ethanol. 18th Edition of the Japanese Pharmacopoeia "Phoenix bark powder"; This product is the bark of Phellodendron amurense Ruprecht or Phellodendron chinense Schneider (Rutaceae) without the periderm. When measuring this product, the dry matter of the crude drug is converted to berberine [berberine chloride (C)]. 20 H 18 Contains 1.2% or more as ClNO4:371.81). Quasi-drug Ingredient Standards 2021 "Phellodendron Bark Extract"; This product is an extract obtained by extracting the bark of Phellodendron amurense Rupr. (Rutaceae) or other plants of the same genus (with the periderm removed) with water, ethanol, propylene glycol, 1,3-butylene glycol, or a mixture of these.

[0013] The amount of (A) Phellodendron Bark extract is preferably 0.01 to 0.3% (mass %, hereinafter the same) of the total composition in terms of pure extract content excluding the solvent, more preferably 0.02 to 0.25%, and even more preferably 0.05 to 0.2%. The higher the amount, the greater the anti-inflammatory effect, but a blending amount of 0.3% or less is suitable for maintaining the stability of component (A) sufficiently and for ensuring a pleasant taste by sufficiently suppressing bitterness.

[0014] (B) Sodium lauroyl methyl taurate, when combined with component (A), improves the BF bactericidal power, provides a high BF bactericidal effect, and also contributes to ensuring foaming. As sodium lauroyl methyl taurate, commercially available products such as NIKKOL LMT-P (trade name) manufactured by Nikko Chemicals Co., Ltd. can be used. The amount of (B) sodium lauroyl methyl taurate is preferably 0.01 to 3% of the total composition, more preferably 0.05 to 2.5%, even more preferably 0.05 to 2%, and most preferably 0.1 to 1.5%. The greater the amount, the better the foaming and the stronger the BF sterilizing effect. At 0.01% or more, a sufficient BF sterilizing effect is exerted, and at 3% or less, the bitterness of the sodium lauroyl methyl taurate is sufficiently suppressed, ensuring a good taste.

[0015] (C) Sodium lauryl sulfate reduces the bitterness of components (A) and (B) and improves the stability of component (A). It also contributes to ensuring foaming. As sodium lauryl sulfate, commercially available products such as Texapon (registered trademark) OC-P, a product name of BASF Japan Ltd., can be used. The amount of (C) sodium lauryl sulfate blended is preferably 0.05 to 2% of the total composition, more preferably 0.07 to 1.8%, even more preferably 0.1 to 1.5%, and most preferably 0.1 to 1.0%. When the blending amount is 0.05% or more, the stability of component (A) is sufficiently improved and the bitterness is sufficiently suppressed, and when it is 2% or less, the appearance stability is sufficiently ensured.

[0016] Furthermore, the total amount of the (B) component and the (C) component, (B)+(C), can be 0.06 to 5% of the entire composition, but from the viewpoints of foaming and appearance stability in particular, it is preferably 0.2 to 3%, more preferably 0.25 to 2.5%, and even more preferably 0.3 to 2%.

[0017] In the present invention, (C) / (B), which represents the ratio of the amounts of component (B) to component (C), is a mass ratio of 0.03 to 30, preferably 0.1 to 25, more preferably 0.15 to 18, and most preferably 0.2 to 15. If the mass ratio of (C) / (B) is less than 0.03, the stability of component (A) is poor, and the bitterness derived from components (A) and (B) cannot be suppressed, resulting in a poor taste. If it exceeds 30, the appearance stability is poor.

[0018] Furthermore, the ratio of the amounts of component (A) and component (C), (C) / (A) (where the amount of component (A) is the pure amount of the extract excluding the solvent), is preferably 0.2 to 200 by mass, more preferably 0.3 to 150, and even more preferably 0.5 to 100. Within the above ranges, the stability of component (A) in particular is superior, and the appearance stability is also superior. The ratio of the amounts of components (A) and (B) to component (C), expressed as (C) / ((A)+(B)) (where the amount of component (A) is the pure amount of the extract excluding the solvent), is preferably 0.03 to 12 by mass, more preferably 0.05 to 11, and even more preferably 0.1 to 10. Within the above ranges, the bitterness derived from components (A) and (B) in particular is significantly suppressed, and the stability and good taste of component (A) are further improved.

[0019] The oral composition of the present invention is preferably prepared as a dentifrice, particularly as a toothpaste, in the form of a paste or gel. In this case, in addition to the above-mentioned components, other optional components may be blended as needed within a range that does not impair the effects of the present invention. Specifically, toothpaste may contain abrasives, binders, humectants, surfactants, and, if necessary, colorants, sweeteners, preservatives, flavorings, active ingredients, etc.

[0020] Examples of abrasives include silica-based abrasives such as silica gel, precipitated silica, aluminosilicate, and zirconosilicate, as well as calcium pyrophosphate, calcium carbonate, aluminum hydroxide, alumina, magnesium carbonate, tri-magnesium phosphate, zeolite, zirconium silicate, hydroxyapatite, and synthetic resin-based abrasives. The amount of abrasive blended is usually 3 to 30%, and particularly 5 to 25%, of the total composition. In the present invention, from the viewpoint of achieving the desired effect, it is not necessary for the abrasive to be blended (0% blending amount), and the composition may contain no abrasive.

[0021] The binder may be an organic binder or an inorganic binder. Examples of organic binders include cellulose-based binders such as carboxymethyl cellulose, hydroxyethyl cellulose, hydroxypropyl cellulose, hydroxypropylmethyl cellulose, hydroxymethylethyl cellulose, methyl cellulose, and cationized cellulose, as well as xanthan gum, carrageenan, guar gum, sodium alginate, montmorillonite, gelatin, and sodium polyacrylate. Examples of inorganic binders include thickening silica and thickening aluminum silica. The blending amount is usually 0.1 to 10%, and preferably 0.5 to 5%, of the total composition.

[0022] Examples of humectants include polyhydric alcohols such as propylene glycol, pentylene glycol, hexylene glycol, octylene glycol, polyethylene glycol with an average molecular weight of 200 to 6,000 (average molecular weight according to the Quasi-drug Raw Materials Standards 2006), ethylene glycol, 1,3-butylene glycol, reduced starch hydrolysates, sorbitol, glycerin, xylitol, and erythritol. The amount blended is usually 5 to 65%, and particularly 20 to 60%, of the total composition.

[0023] As the optional surfactant, anionic surfactants, nonionic surfactants, cationic surfactants, and amphoteric surfactants other than components (B) and (C) can be blended. Optional anionic surfactants include sodium myristyl sulfate, sodium dodecylbenzenesulfonate, hydrogenated coconut fatty acid monoglyceride sodium monosulfate, sodium lauryl sulfoacetate, sodium α-olefin sulfonate, and the like. Examples of nonionic surfactants include sugar alcohol fatty acid esters such as sorbitan fatty acid esters, polyoxyethylene sorbitan fatty acid esters, and sucrose fatty acid esters; polyhydric alcohol fatty acid esters such as glycerin fatty acid esters, polyglycerin fatty acid esters, polyoxyethylene glycerin fatty acid esters, and polyethylene glycol fatty acid esters; polyoxyethylene polyoxypropylene copolymers, polyoxyethylene alkylphenyl ethers, polyoxyethylene alkyl ethers, and fatty acid alkanolamides such as lauric acid diethanolamide. Examples of the cationic surfactant include distearylmethylammonium chloride and stearyldimethylbenzylammonium chloride. Examples of the zwitterionic surfactant include N-alkyldiaminoethylglycines such as 2-alkyl-N-carboxymethyl-N-hydroxyethylimidazolium betaine, N-lauryldiaminoethylglycine, and N-myristyldiaminoethylglycine, and N-alkyl-1-hydroxyethylimidazoline betaine sodium. When an optional surfactant is added, its amount is preferably 0.2 to 15%, particularly 0.5 to 10%, of the total composition, and the amount of nonionic surfactant is 4% or less, preferably 3% or less, of the total composition. Surfactants other than components (B) and (C), particularly anionic surfactants, may not be added, and nonionic surfactants may also not be added. In the present invention, even if no surfactants other than components (B) and (C) are added, the stability of component (A) is excellent and the BF sterilization effect is also excellent.

[0024] Examples of coloring agents include legally mandated dyes such as Blue No. 1, Blue No. 4, and Green No. 3, natural dyes such as caramel, and titanium oxide. Examples of sweeteners include saccharin sodium, aspartame, stevioside, stevia extract, paramethoxycinnamic aldehyde, neohesperidyl dihydrochalcone, and perillartine. Examples of the preservative include parahydroxybenzoic acid esters such as methyl parahydroxybenzoate, benzoic acid, and salts thereof.

[0025] Examples of fragrances include menthol, anethole, carvone, eugenol, limonene, n-decyl alcohol, citronellol, α-terpineol, citronellyl acetate, cineole, linalool, ethyl linalool, vanillin, thymol, spearmint oil, peppermint oil, lemon oil, orange oil, sage oil, rosemary oil, cinnamon oil, pimento oil, cinnamon leaf oil, perilla oil, wintergreen oil, clove oil, and eucalyptus oil. The amount of the fragrance to be added is preferably 0.000001 to 2% of the total composition.

[0026] Examples of pH adjusters include organic acids such as citric acid, lactic acid, malic acid, and the like, and salts thereof, and inorganic compounds such as hydrochloric acid, sodium hydroxide, potassium hydroxide, disodium hydrogen phosphate, and sodium dihydrogen phosphate.

[0027] Optional active ingredients include nonionic disinfectants such as isopropylmethylphenol, cationic disinfectants such as cetylpyridinium chloride, anti-inflammatory agents such as tranexamic acid and allantoin, enzymes such as dextranase, fluorine-containing compounds such as sodium fluoride and sodium monofluorophosphate, water-soluble phosphate compounds, inorganic salts such as sodium chloride, potassium nitrate and aluminum lactate, and vitamins. The active ingredient can be blended in an effective amount within a range that does not interfere with the effects of the present invention. [Example]

[0028] The present invention will be specifically described below with reference to examples, comparative examples, and formulation examples, but the present invention is not limited to the following examples. In the following examples, % indicates % by mass unless otherwise specified.

[0029] [Examples and Comparative Examples] Dentifrice compositions (toothpastes) having the compositions shown in Tables 1 to 3 were prepared by the following method, and 50 g of each was filled into a tube container (aluminum laminate tube; a laminate tube with an innermost layer made of linear low-density polyethylene and a diameter of 26 mm (LDPE55 / PET12 / LDPE20 / white LDPE60 / EMAA20 / AL10 / EMAA30 / LDPE20 / LLDPE30, thickness 257 μm, tube opening diameter 8 mm (manufactured by Dai Nippon Printing Co., Ltd.)), and evaluated by the methods described below. The results are also shown in the tables. The abbreviations and names of the layer structures of the laminated tubes used are as follows, and the numbers following the abbreviations indicate the thickness (μm) of each layer. LDPE: Low-density polyethylene White LDPE: White low-density polyethylene LLDPE: Linear low density polyethylene AL: Aluminum PET: Polyethylene terephthalate EMAA: Ethylene-methacrylic acid copolymer resin

[0030] <Preparation method> (1) Components (A) and (B), other water-soluble components, and a viscosity modifier (binder) were mixed and dissolved in purified water at room temperature (mixture X). (2) A binder was dispersed in propylene glycol at room temperature (mixture Y), and mixture Y was added to and mixed with mixture X while stirring to prepare mixture Z. (3) The flavor, component (C), water, and abrasive were mixed into mixture Z using a kneader at room temperature, and the mixture was defoamed under reduced pressure (5.3 kPa) to obtain a dentifrice composition. The dentifrice compositions of the comparative examples were prepared in accordance with the above method.

[0031] <Evaluation method> (1) Stability of Phellodendron Bark Extract Using the method described below, the berberine content of the dentifrice composition was measured immediately after preparation (initial stage) and after 6 months of storage at 40°C, and the stability of the Phellodendron Bark extract was evaluated based on the residual berberine rate. The internal standard solution (a methanol solution of quinoline yellow SS) and mobile phase were added to the dentifrice composition, and after uniform dispersion, the mixture was filtered using a liquid chromatography filter (0.45 μm) to obtain the sample solution. If necessary, the mixture was centrifuged after uniform dispersion. Separately, standard berberine chloride was dissolved in methanol, diluted with the mobile phase to match the berberine concentration in the dentifrice composition, and then the internal standard solution was accurately added to obtain the standard solution. 20 μL of the sample solution and standard solution were tested by liquid chromatography under the following conditions to determine QT (the ratio of the peak area of ​​the berberine in the sample solution to that of the internal standard) and QS (the ratio of the peak area of ​​the berberine in the standard solution to that of the internal standard). The berberine content was calculated using the following formula, and the residual berberine rate was calculated. Berberine content (ppm) = WS x (100-D) x (353.37 / 371.81) x (QT / QS) x (K / WT) WS: Standard amount of berberine chloride (g) WT: sample weight (g) D: Moisture content of standard berberine chloride (%) K: Constant (set by dilution concentration, etc.) 353.37: Molecular weight of berberine 371.81: Molecular weight of berberine chloride Internal standard solution: Quinoline Yellow SS in methanol Operating conditions Detector: ultraviolet absorption photometer (measurement wavelength: 345 nm) Column: ODS column Column temperature: room temperature Mobile phase: Water / acetonitrile / methanol = 2 / 2 / 1 (add appropriate amounts of sodium lauryl sulfate and tartaric acid) Flow rate: Adjusted so that the retention time of berberine is approximately 20 minutes Berberine residual rate (%) = [(berberine content at the opening of the tube after 6 months of storage at 40°C) / (initial berberine content)] x 100 The stability of the Phellodendron Bark extract was evaluated based on the residual rate of berberine according to the following criteria. Evaluation criteria ◎: 95% or more ○: 90% or more but less than 95% △: 85% or more but less than 90% ×: Less than 85%

[0032] (2) Biofilm (BF) sterilization effect (i) Method for preparing model biofilms The bacteria used to prepare the model biofilm were purchased from the American Type Culture Collection (ATCC) and precultured as follows. Actinomyces viscosus ATCC 43146, Fusobacterium nucleatum ATCC 10953, and Porphyromonas gingivalis ATCC 33277 were cultured in Todd-Heavitt Broth (Becton and Dickinson) medium [THBHM] supplemented with 5 mg / L hemin (Sigma) and 1 mg / L vitamin K (Fujifilm Wako Pure Chemical Industries, Ltd.), and Veillonella parvula ATCC 17745 was cultured in Todd-Heavitt Broth (Becton and Dickinson) medium [THBL] supplemented with 1.26% sodium lactate (Sigma). The culture was performed overnight at 37°C under an anaerobic atmosphere (80 vol% nitrogen, 10 vol% carbon dioxide, 10 vol% hydrogen). After the incubation, the bacterial solution was centrifuged (10,000 rpm, 10 min) to collect the bacteria. The collected bacteria were then stored in basal medium mucin broth (BMM). *1 After resuspending in 1,000 mL of the same medium, the number of bacteria was increased to 1 × 10 7The cells were inoculated at a density of 100 cells / mL and cultured overnight at 37°C under anaerobic conditions (95 vol% nitrogen, 5 vol% carbon dioxide). Subsequently, BMM was supplied at a rate of 100 mL / hour, and the culture medium was discharged at the same rate. The culture medium discharged from the culture tank was continuously supplied to another culture tank, where the liquid volume was maintained at 300 mL. A 7 mm diameter hydroxyapatite plate (manufactured by Pentax Corporation) was attached to the turntable (rotating at approximately 80 rpm) inside this culture tank as a support for biofilm adhesion. The culture was continued for 10 days using the above method, and a biofilm was formed on the hydroxyapatite plate. After the culture, the biofilm-formed hydroxyapatite plate was removed and soaked in phosphate-buffered saline. *2 The plates were washed twice with 5 mL of Phosphate Buffered Saline (hereinafter referred to as PBS) to obtain a model biofilm.

[0033] *1: Composition of BMM (expressed as mass per 1L) Proteose peptone (Becton and Dickinson): 4g / L Tryptone (Becton and Dickinson): 2g / L Yeast extract (Becton and Dickinson): 2g / L Mucin (Sigma): 5g / L Hemin (Sigma): 2.5 mg / L Vitamin K (Fujifilm Wako Pure Chemical Industries, Ltd.): 0.5 mg / L KCl (Fujifilm Wako Pure Chemical Industries, Ltd.): 1g / L Cysteine ​​(Fujifilm Wako Pure Chemical Industries, Ltd.): 0.2 g / L Distilled water: Remaining (The solution was adjusted to a total volume of 1 L and autoclaved at 121°C for 20 minutes.) *2: Composition of PBS (expressed as mass per 1L) NaCl (Fujifilm Wako Pure Chemical Industries, Ltd.): 8.0 g KCl (Fujifilm Wako Pure Chemical Industries, Ltd.): 0.2 g Na2HPO4·12H2O (Fujifilm Wako Pure Chemical Industries, Ltd.): 3.63g KH2PO4 (Fujifilm Wako Pure Chemical Industries, Ltd.): 0.24g Distilled water: Remaining (Adjust the pH to 7.4 with 1N HCl and dilute to a total volume of 1 L.)

[0034] (ii) Bactericidal effect on model biofilms The model biofilm formed was transferred to a 24-well multi-plate (Sumitomo Bakelite Co., Ltd.). A dentifrice composition with the composition shown in the table was diluted 3-fold with artificial saliva (50 mM potassium chloride, 1 mM potassium dihydrogen phosphate, 1 mM calcium chloride dihydrate, 0.1 M magnesium chloride hexahydrate, adjusted to pH 7) and dispersed therein, and 2 mL of the supernatant obtained by centrifugation was added and the plate was immersed for 3 minutes. After washing six times with 1 mL of PBS, the plate was transferred to a test tube (13 mm diameter x 100 mm) containing 4 mL of the same buffer (PBS) and dispersed by ultrasonic treatment (200 μA, 10 seconds). This dispersion was serially diluted 10 times with PBS and plated on a blood agar plate containing kanamycin sulfate. *3 50 μL of the culture medium was smeared onto a plate and cultured under anaerobic conditions. The number of colonies that grew was counted, and the number of viable bacteria (cfu / biofilm) per model biofilm was calculated. The biofilm disinfection effect was evaluated by determining the penetrating bactericidal ability of the culture medium against periodontal pathogenic biofilms using the following criteria. Evaluation criteria: ◎:10 6 less than ○:10 6 Over 10 7 less than △:10 7 Over 10 8 less than ×:10 8 End

[0035] *3: Composition of blood agar plates containing kanamycin sulfate (expressed as mass per 1 L) Trypticase Soy Agar (Becton and Dickinson): 40g / L Hemin (Sigma): 5mg / L Vitamin K (Fujifilm Wako Pure Chemical Industries, Ltd.): 1 mg / L Kanamycin sulfate (Meiji Pharmaceutical Co., Ltd.): 200 mg / L Distilled water: Remaining (Divided up to a total volume of 1 L.)

[0036] (3) Foaming Ten subject monitors squeezed 1 g of the dentifrice composition from the tube container onto a toothbrush (Lion Corporation, Clinica Toothbrush 4-row head, medium), brushed for 3 minutes to clean the oral cavity, and evaluated the foaming according to the following rating scale. The average of the scores of the 10 subjects was calculated, and the foaming (efficiency of foaming) was evaluated according to the following rating scale. Grading criteria 5 points: Good foaming 4 points: Slightly foamy 3 points: Neither 2 points: Slightly poor foaming 1 point: Poor foaming Evaluation criteria ◎: Average score 4.0 points or more ○: Average score 3.0 points or more and less than 4.0 points △: Average score 2.0 points or more and less than 3.0 points ×: Average score less than 2.0 points

[0037] (4) Taste The evaluation was carried out by a sensory test conducted by 10 expert panelists. 1 g of the dentifrice composition was squeezed out of the tube container and placed on a toothbrush (Lion Corporation, Clinica Toothbrush 4-row head, medium size), and brushed for 3 minutes. The taste (absence of bitterness) felt during use was judged according to the following rating scale. The average of the scores of the 10 panelists was calculated, and the taste (goodness of taste) was evaluated according to the following rating scale. Grading criteria 4 points: No bitterness 3 points: Slightly bitter, but not problematic for use 2 points: Bitter taste, causing problems in use 1 point: Strongly bitter taste Evaluation criteria ◎: Average score 3.5 points or more ○: Average score 3.0 points or more and less than 3.5 points △: Average score 2.0 points or more and less than 3.0 points ×: Average score less than 2.0 points

[0038] (5) Liquid separation stability of the formulation Three tubes of each dentifrice composition filled in tubes were stored at 50°C for one month, and then the dentifrice composition was squeezed out 10 cm from the tube onto a piece of straw paper, the length of the liquid that seeped onto the straw paper was measured, and the degree of liquid separation was evaluated using the following four-point rating scale. Note that the liquid separation stability of the formulations showed a tendency for liquid separation to be accelerated depending on the temperature, so 50°C was selected as the storage temperature that would allow evaluation within a one-month storage period. Grading criteria 4 points: No liquid separation observed 3 points: When squeezed out, slight liquid separation is observed at the opening, but this does not affect use. 2 points: When extruded, 1-3 cm of liquid separation is observed at the opening. 1 point: When extruded, liquid separation exceeding 3 cm is observed at the opening The average score of the three evaluations was calculated, and the degree of liquid separation was judged according to the following evaluation criteria. Those rated as ⊚ and ◯ were judged to be dentifrice compositions with excellent liquid separation stability when stored at 50°C. Evaluation criteria ◎: 3.5 points or more and 4.0 points or less ○: 3.0 points or more and less than 3.5 points △: 2.0 points or more and less than 3.0 points ×: Less than 2.0 points

[0039] Details of the raw materials used are shown below. (A) Phellodendron Bark Extract: Kogi Pharmaceutical Co., Ltd., product name: Phellodendron Bark Extract S, powder, berberine content 5% (B) Sodium lauroyl methyl taurate: Nikko Chemicals Co., Ltd., product name: NIKKOL LMT-P (C) Sodium lauryl sulfate: BASF Japan Ltd., trade name: Texapon (registered trademark) OC-P Sodium lauroyl sarcosinate (comparison product): Soypon (registered trademark) SLP, manufactured by Kawaken Fine Chemicals Co., Ltd.

[0040] [Table 1]

[0041] [Table 2]

[0042] [Table 3]

[0043] [Prescription Example 1] Toothpaste (A) Phellodendron Bark Extract 0.1% (B) Sodium lauroyl methyl taurate 0.3 (C) Sodium lauryl sulfate 1.0 Sorbitol solution (70%) 50 Abrasive Silica 12 Thickening Silica 5.0 Propylene Glycol 5.0 Xanthan gum 1.0 Sodium polyacrylate 0.5 Sodium fluoride 0.32 Sodium saccharin 0.1 Fragrance 1.0 Purified water balance Total 100% Mass ratio of (C) / (B): 3.3

[0044] [Prescription Example 2] Toothpaste (A) Phellodendron Bark Extract 0.05% (B) Sodium lauroyl methyl taurate 0.5 (C) Sodium lauryl sulfate 0.5 Sorbitol solution (70%) 45 Abrasive Silica 10.0 Thickening Silica 6.0 Propylene Glycol 4.0 Xanthan gum 1.2 Sodium polyacrylate 0.4 Sodium fluoride 0.32 Sodium saccharin 0.15 Fragrance 0.9 Purified water balance Total 100% Mass ratio of (C) / (B): 1

Claims

1. (A) Phellodendron Bark Extract, (B) Sodium lauroyl methyl taurate and (C) Sodium lauryl sulfate An oral composition comprising: The content of component (A) is 0.01 to 0.3% by mass of the total composition; The content of component (B) is 0.01 to 3% by mass of the total composition; The content of component (C) is 0.05 to 2% by mass of the total composition; The oral composition is a toothpaste, and the mass ratio of (C) / (B) is 0.03 to 30.

2. 2. The oral composition according to claim 1, wherein the mass ratio of (C) / ((A)+(B)) is 0.03 to 12.

3. 3. The oral composition according to claim 1, wherein the content of component (B) is 0.05 to 2.5% by mass, the content of component (C) is 0.05 to 2% by mass, and the total content of components (B) and (C) is 0.2 to 3% by mass.

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