JP7087783B2 - Oral composition - Google Patents

Description

The present invention relates to an oral composition having excellent storage stability and retention / absorption in the oral cavity of vitamin E or a derivative thereof, and also having good formulation properties such as spinnability.

Vitamin E such as tocopherol or a derivative thereof has a peripheral circulation promoting action (blood circulation promoting action) of gingival tissue, and is therefore useful for preventing periodontal disease, and is widely blended in oral compositions such as dentifrices. .. In order to solubilize and formulate an oil-soluble vitamin E or a derivative thereof in an oral composition, it is common to use a surfactant, while vitamin E or a derivative thereof is a surfactant. Decomposition progressed over time under the influence of vitamins and abrasives, which sometimes affected the appearance of the pharmaceutical product. Further, in dentifrices such as dentifrice, since the coagulation-dispersion system is in a semi-stable state, the change in the dispersion state may cause adsorption of vitamin E or its derivative to a container or an abrasive, which is a basic characteristic. In some cases, it affected foaming. Therefore, it has been difficult to add vitamin E or a derivative thereof to the oral composition to stabilize it and sufficiently express its action in the oral cavity.
For example, the following proposals (Patent Documents 1 to 3) have been made as a technique for blending vitamin E or a derivative thereof in an oral composition, but vitamin E or a derivative thereof is stably blended to improve the action in the oral cavity. The development of new technologies to improve was desired.

In Patent Document 1 (Japanese Patent No. 2054209), tocopherol and its ester derivative are stabilized by a specific water-soluble compound such as an alkali metal salt and an amino acid, and tocopherol even if a surfactant sodium lauryl sulfate is blended. A polishing agent-containing kneaded tooth polish having an improved residual ratio of the ester derivative and its ester derivative has been proposed. Patent Document 2 (Japanese Patent No. 3894132) describes a poorly water-soluble nonionic medicinal ingredient such as tocopherol acetate by a combined system of polyoxyethylene hydrogenated toothpaste oil having an average added mole number of 5 to 30 of ethylene oxide and sodium lauryl sulfate. It is proposed that a dentifrice composition containing a polishing agent having a high foaming power can be obtained by preventing the adsorption of the dentifrice in the container and improving the residual ratio. Patent Document 3 (International Publication No. 2010/143589) combines vitamin E or a derivative thereof with an ascorbic acid phosphate ester or a salt thereof and a nonionic fungicide or a cationic fungicide, and adds ethylene oxide to them on average. When polyoxyethylene hydrogenated castor oil having 10 or more moles is added in an appropriate amount ratio, the plurality of medicinal ingredients can be stably blended at the same time to impart these effects, and the appearance stability (separation, discoloration) can be imparted. ) Also proposes to obtain a dentin composition containing a good phosphoric acid.

Japanese Patent No. 2054209 Japanese Patent No. 3894132 International Publication No. 2010/143589 Japanese Unexamined Patent Publication No. 2009-96747

INDUSTRIAL APPLICABILITY The present invention has been made in view of the above circumstances, and provides an oral composition having excellent storage stability and oral retention / absorption of vitamin E or a derivative thereof, and also having good formulation properties such as spinnability. The purpose is to do.

As a result of diligent studies to achieve the above object, the present inventors have carried out polyoxyethylene curing in which the average number of moles of ethylene oxide added is in a specific range in an oral composition containing a specific amount of vitamin E or a derivative thereof. When a specific amount of castor oil is blended and a specific amount of sodium fluoride is blended, vitamin E or its derivative is stabilized, the residual rate after storage is improved, and the retention and absorption rate in the oral cavity are high. It has been found that it is excellent in storage stability, retention in the oral cavity and absorbability, and can maintain good formulation properties such as spinnability, and has led to the present invention.

More specifically, one or more selected from (A) tocopherol and an ester thereof with an organic acid as vitamin E or a derivative thereof is blended in the oral composition, and the component (A) is solubilized and stabilized. For this purpose, when polyoxyethylene hydrogenated castor oil having an average number of moles of (B) ethylene oxide added of 3 to 7 mol is added as a nonionic surfactant, for example, even a toothpaste composition containing an abrasive is towed. There was a problem that the threadability deteriorated and the properties of the formulation such as the spinnability deteriorated. However, in the present invention, when the sodium (C) fluoride is further added in a specific amount or more to the system in which the components (A) and (B) are used in combination in a specific amount, the component (C) becomes (A) and (B). ) It has an unexpected effect of improving the deterioration of the physical characteristics of the preparation due to the component, whereby the residual rate of the component (A) after storage is improved by the component (B) without deteriorating the physical characteristics of the preparation, and the gums, etc. The retention and absorption rate in the oral mucosa was high, and excellent storage stability and retention / absorption in the oral cavity could be imparted. Further, when (D) a specific acylsarcosine salt was added, the oral retention / absorption of the component (A) could be further improved. Further, when (E) paraoxybenzoic acid ester was further added, the surface of the pharmaceutical product such as kneaded skin was further improved, and a good taste could be maintained.
In the present invention, the above-mentioned action and effect are specifically exhibited by blending the components (A), (B) and (C) in a specific amount in combination. As can be seen from the results of Comparative Examples described later, in Comparative Example 7 in which the component (C) was not blended, deterioration of the spinnability occurred. On the other hand, in Comparative Examples 3 and 6 in which the component (B) was not blended, and Comparative Examples 1 and 4 in which the amount of the component (A) or (B) was small, no deterioration in castor property was observed. In these examples, even if the component (C) is blended, the storage stability (residual rate) of the component (A) is low, and in Comparative Example 6, even if an inappropriate polyoxyethylene hydrogenated castor oil is blended. (A) The storage stability (residual rate) of the component and the retention / absorption in the oral cavity were low. Further, even if the components (A), (B) and (C) are blended, in Comparative Examples 2 and 5 in which the amount of the component (A) or (B) is too large, deterioration of the spinnability is observed, and ( C) In Comparative Example 8 in which the amount of the component was too small, deterioration of the spinnability was observed. On the other hand, the oral composition containing the components (A), (B) and (C) of the present invention in specific amounts (see Examples described later) has the storage stability of the component (A) and the oral cavity. It had excellent internal retention and absorption, good spinnability, and good taste and kneaded skin.
In Patent Document 4 (Japanese Unexamined Patent Publication No. 2009-96747), a specific polyoxyethylene hydrogenated castor oil is used for improving the storage stability and retention of the bactericide isopropylmethylphenol in the gums, and the oral cavity is also used. Tocopherol acetate and sodium fluoride are known as active ingredients of the composition for use. However, the present invention is an improvement in spinnability by the component (C), and the combination of the components (A), (B) and (C) gives a peculiar and special action and effect.

Therefore, the present invention provides the following oral compositions.
[1]
(A) 0.01 to 3% by mass of one or more selected from the ester of tocopherol and its organic acid.
(B) 0.1 to 4% by mass of polyoxyethylene hydrogenated castor oil having an average number of moles of ethylene oxide added of 3 to 7 mol.
And (C) sodium fluoride 0.3-1% by mass
An oral composition containing 0.5 to 15 by mass ratio of {(A) + (B)} / (C).
[2]
(D) The oral composition according to [1], which contains 0.01 to 2% by mass of an acylsarcosine salt having an acyl group having 10 to 18 carbon atoms.
[3]
(D) The oral composition according to [2], wherein the component is sodium lauroyl sarcosine.
[4]
The oral composition according to any one of [1] to [3], which further contains (E) a paraoxybenzoic acid ester in an amount of 0.01 to 1% by mass.
[5]
The oral composition according to any one of [1] to [4], which is a dentifrice composition containing an abrasive.

According to the present invention, it is possible to provide an oral composition having excellent storage stability and retention / absorption in the oral cavity of tocopherol or a derivative thereof, and having good pharmaceutical characteristics such as spinnability. Since this oral composition has high oral retention and absorbability of tocopherol or a derivative thereof, its action can be sufficiently expressed, and there are no problems with the surface or taste of the preparation, and the quality is also good.

Hereinafter, the present invention will be described in more detail. The oral composition of the present invention comprises (A) one or more selected from esters with tocopherol and an organic acid thereof, and (B) polyoxyethylene hydrogenated castor oil having an average addition mole number of 3 to 7 mol of ethylene oxide. And (C) sodium fluoride are contained, and the mass ratio of {(A) + (B)} / (C) is in a specific range.

The component (A) is tocopherol or a derivative thereof, and as the derivative, an ester of tocopherol with an organic acid or a salt thereof can be used. These may be used alone or in combination of two or more selected from these. The component (A) is a medicinal component having a blood flow promoting and tissue repairing action, and is an effective component for preventing or suppressing periodontal diseases such as gingival inflammation and periodontitis.

Examples of tocopherols include d-α-tocopherol, dl-α-tocopherol, β-tocopherol, γ-tocopherol, δ-tocopherol and the like. Examples of the tocopherol derivative include esters of the above tocopherol with organic acids such as acetic acid, nicotinic acid, succinic acid and linolenic acid, or salts thereof. Specifically, tocopherol acetate such as d-α-tocopherol acetate and dl-α-tocopherol acetate, tocopherol nicotinic acid ester such as nicotinic acid d-α-tocopherol, nicotinic acid dl-α-tocopherol, succinic acid d- Examples thereof include tocopherol succinates such as α-tocopherol and dl-α-tocopherol succinate, tocopherol linolenic acid esters such as d-α-tocopherol linolenic acid and dl-α-tocopherol linolenic acid, and tocopherol calcium succinate. Among them, tocopherol acetate, tocopherol nicotinic acid ester, and tocopherol, particularly tocopherol acetate, are preferable in terms of color tone and appearance of the preparation.
As these tocopherols or derivatives thereof, products conforming to the old cosmetic raw material standard (cosmetic raw material standard) or quasi-drug raw material standard 2006 can be used, manufactured by DSM Nutrition Japan, Eisai Food Chemical Co., Ltd., BASF Japan ( Commercially available products such as those manufactured by Co., Ltd. can be used.

The blending amount of the component (A) is 0.01 to 3% (mass%, the same applies hereinafter) of the entire composition, preferably 0.05 to 2%. Within the above range, the action and effect of the present invention are excellent. When the blending amount is less than 0.01%, the storage stability of the component (A) and the retention / absorption in the oral cavity are low. The larger the blending amount, the higher the preventive or ameliorating effect of periodontal disease, but if it exceeds 3%, the physical characteristics of the pharmaceutical product such as spinnability deteriorate. In the present invention, storage stability and oral retention / absorption are excellent even when the blending amount of the component (A) is 1% or less, particularly 0.5% or less of the entire composition.

(B) Polyoxyethylene hydrogenated castor oil having an average number of moles of ethylene oxide added of 3 to 7 mol has an effect of improving the storage stability of the component (A) and has good retention and absorption in the oral cavity. ..
Here, the average number of moles of ethylene oxide added is 3 mol or more and 7 mol or less, preferably 5 to 7 mol. Within the above range, the storage stability of the component (A) and the retention / absorption in the oral cavity are excellent. If it exceeds 7 mol, the effect of improving the storage stability of the component (A) and the retention / absorption in the oral cavity cannot be obtained. Those of less than 3 mol are difficult to manufacture and difficult to obtain as commercial products, and their use as a general raw material is not realistic.

As the component (B), one kind or two or more kinds can be used, and the blending amount thereof is 0.1 to 4%, preferably 0.1 to 3% of the whole composition. When the blending amount is 0.1% or more, the storage stability of the component (A) is improved, but when the blending amount exceeds 4%, the retention / absorption of the component (A) in the oral cavity is lowered. Moreover, the physical properties of the pharmaceutical product such as the spinnability deteriorate.

In the present invention, (C) sodium fluoride acts as an agent for improving the physical characteristics of a pharmaceutical product such as spinnability.
The blending amount of (C) sodium fluoride is 0.3 to 1%, preferably 0.3 to 0.8% of the whole composition. If the blending amount is less than 0.3%, the effect of improving the physical characteristics of the pharmaceutical product such as spinnability cannot be obtained, and if it exceeds 1%, the taste deteriorates.

In the present invention, {(A) + (B)} / (C) indicating the amount ratio between the total blending amount of the components (A) and (B) and the blending amount of the component (C) is 0. It is 5 to 15, preferably 1 to 14. Within the above range, the action and effect of the present invention can be obtained. If the mass ratio of {(A) + (B)} / (C) is less than 0.5, and if it exceeds 15, the taste is poor and it is not suitable for use.

It is preferable that the oral composition of the present invention further contains (D) acylsarcosine salt and / or (E) paraoxybenzoic acid ester.

In the present invention, when the (D) acylsarcosine salt is added as an anionic surfactant, the retention / absorption of the component (A) can be promoted and further improved.
The acyl group of the acyl sarcosine salt preferably has 10 to 18 carbon atoms, more preferably 10 to 14 carbon atoms, and the salt is an alkali metal salt such as sodium or potassium, or an alkaline earth metal salt.
Specific examples of the acyl sarcosine salt include lauroyl sarcosine sodium, cocoyl sarcosine sodium, myristoyl sarcosine sodium, palmitoyl sarcosine sodium, stearoyl sarcosine sodium and the like, and among them, lauroyl sarcosine sodium is preferable.
As the acyl sarcosine salt, a commercially available product such as Soipon SLP (sodium lauroyl sarcosine) manufactured by Kawaken Fine Chemicals Co., Ltd. can be used.

(D) When the acylsarcosine salt is blended, the blending amount thereof is preferably 0.01 to 2% of the total composition. When it is 0.01% or more, the effect of promoting retention and absorption of the component (A) can be sufficiently obtained. When it is 2% or less, the good taste can be maintained.

Further, in the present invention, the addition of (E) paraoxybenzoic acid ester can improve the surface of the pharmaceutical product such as kneaded skin.
Examples of the (E) paraoxybenzoic acid ester include methyl paraoxybenzoate and ethyl paraoxybenzoate. For these, commercially available products such as those manufactured by Ueno Fine Chemicals Industry Co., Ltd. can be used.

(E) When the paraoxybenzoic acid ester is blended, the blending amount thereof is preferably 0.01 to 1% of the total composition. When it is 0.01% or more, the effect of improving the surface of the pharmaceutical product such as kneaded skin can be sufficiently obtained. When it is 1% or less, the good taste can be sufficiently maintained.

The oral composition of the present invention is particularly suitable as a dentifrice composition for dentifrice and the like. Further, in addition to the above-mentioned components, other known additives can be arbitrarily added depending on the dosage form and the like as long as the effects of the present invention are not impaired. Examples thereof include abrasives, surfactants, thickeners, binders, sweeteners, preservatives, colorants, pH adjusters, fragrances, active ingredients, etc., and these components and water can be mixed and prepared. ..

Polishing agents include silica-based abrasives such as silica gel, precipitated silica, aluminosilicate, and zirconosilicate, calcium pyrophosphate, calcium carbonate, aluminum hydroxide, alumina, magnesium carbonate, tertiary magnesium phosphate, zeolite, zirconium silicate, and the like. Examples thereof include hydroxyapatite and synthetic resin-based abrasives.
The blending amount of the abrasive is preferably 5 to 30%, particularly 5 to 20%, particularly preferably 5 to 15% of the entire composition. The larger the blending amount, the more the pharmaceutical properties such as the spinnability can be sufficiently improved, but when the blending amount is not too large, the storage stability and the retention / absorption of the component (A) can be sufficiently improved.

As the surfactant, in addition to the component (B) and further, the component (D), a nonionic surfactant, an anionic surfactant, a cationic surfactant, and an amphoteric surfactant other than these are used. It can, for example, include those shown below. These can be blended alone or in combination of two or more.
Nonionic surfactant:
Sugar alcohol fatty acid esters such as sorbitan fatty acid ester, polyoxyethylene sorbitan fatty acid ester, sucrose fatty acid ester; polyhydric alcohol fatty acid ester such as glycerin fatty acid ester, polyglycerin fatty acid ester, polyoxyethylene glycerin fatty acid ester, polyethylene glycol fatty acid ester; Ether-type surfactants such as polyoxyethylene polyoxypropylene copolymers, polyoxyethylene alkylphenyl ethers, and polyoxyethylene alkyl ethers; fatty acid alkanolamide anionic surfactants such as lauric acid diethanolamide:
Alkyl sulfates such as sodium lauryl sulphate and sodium myristyl sulphate; sodium dodecylbenzene sulfonate, hydrogenated coconut fatty acid monoglyceride sodium monosulfate, sodium lauryl sulfoacetate, sodium α-olefin sulphonate Cationic surfactant:
Distealylmethylammonium chloride, stearyldimethylbenzylammonium chloride Zwitterionic surfactant;
Betaine types such as 2-alkyl-N-carboxymethyl-N-hydroxyethyl imidazolium betaine, N-alkyl-1-hydroxyethyl imidazoline betaine sodium, N-lauryl diaminoethyl glycine, N-myristyl diaminoethyl glycine and the like. Alkyl diaminoethyl glycine

The blending amount of the above-mentioned arbitrary surfactant is preferably 0.001 to 15%, particularly 0.2 to 10% of the whole composition.
The blending amount of an alkyl sulfate such as sodium lauryl sulfate, which is an anionic surfactant often used in oral compositions, is preferably 0.001 to 10% of the total composition. In the present invention, even if an alkyl sulfate is blended, the storage stability of the component (A) and the retention / absorption in the oral cavity are excellent.
The total amount of the nonionic surfactant to be blended is preferably 4% or less, particularly preferably 3% or less of the total composition in total with the blending amount of the component (B). In the present invention, a nonionic surfactant other than the component (B) may not be blended and may be 0%, and a polyoxyethylene hydrogenated castor oil other than the component (B) should not be blended (blending amount 0%).

The viscous agent is sugar alcohol such as sorbit, glycerin, xylitol, erythritol, reduced starch saccharified product, propylene glycol, pentylene glycol, hexylene glycol, octylene glycol, and an average molecular weight of 200 to 6,000 (raw material for non-medicinal products). Examples thereof include polyhydric alcohols such as polyethylene glycol, ethylene glycol, and 1,3-butylene glycol having an average molecular weight described in Standard 2006. The blending amount of the thickener is usually 5 to 55%, particularly 20 to 50% of the total composition.

As the binder, an organic binder and / or an inorganic binder can be used. Examples of the organic binder include cellulosic binders such as sodium carboxymethyl cellulose, hydroxyethyl cellulose, hydroxypropyl cellulose, hydroxypropylmethyl cellulose, hydroxymethyl ethyl cellulose, methyl cellulose, and cationized cellulose, xanthan gum, carrageenan, guagam, sodium alginate, gelatin, and the like. Examples include sodium polyacrylate. Examples of the inorganic binder include gelling silica, gelling aluminum silica, montmorillonite, kaolin, and bentonite.
The blending amount of the organic binder is preferably 0.1 to 5% of the whole composition, and the blending amount of the inorganic binder is preferably 0.1 to 10% of the whole composition.

Examples of the sweetening agent include saccharin sodium, aspartame, stebioside, stevia extract, paramethoxycinnamic aldehyde, neohesperidyl dihydrochalcone, perillartine and the like.
As the preservative, (E) paraoxybenzoic acid ester also acts as a preservative, but benzoic acid or a salt thereof and the like can be further blended.

Examples of the colorant include legal pigments such as Blue No. 1, Yellow No. 4, and Green No. 3, natural pigments such as caramel, and titanium oxide.
Examples of the pH adjuster include organic acids such as citric acid, lactic acid and malic acid or salts thereof, and inorganic compounds such as hydrochloric acid, sodium hydroxide, potassium hydroxide, disodium hydrogen phosphate and sodium dihydrogen phosphate.

As the fragrance, a general fragrance material for oral use can be used. For example, menthol, anator, carboxylic, eugenol, limonene, n-decyl alcohol, citronellol, α-terepineol, citronellyl acetate, cineole, linalol, ethyllinalol, vanillin, timole, sparemint oil, peppermint oil, lemon oil, orange oil, Examples thereof include sage oil, rosemary oil, katsura oil, pimento oil, katsura leaf oil, perilla oil, winter green oil, chopstick oil, and eucalyptus oil. The blending amount of the fragrance is preferably 0.000001 to 2% of the total composition.

The active ingredient is other than the components (A) and (C), for example, a bactericidal agent such as a nonionic bactericidal agent and a cationic bactericidal agent, an anti-inflammatory agent such as tranexamic acid and allantin, an enzyme such as dextranase, and a plant. Examples include extracts, tartar inhibitors, and plaque inhibitors. The blending amount of these active ingredients is an effective amount within a range that does not interfere with the effects of the present invention.

Hereinafter, the present invention will be specifically described with reference to Examples, Comparative Examples and Prescription Examples, but the present invention is not limited to the following Examples. In the following examples,% indicates mass% unless otherwise specified.

[Examples, comparative examples]
Toothpaste compositions (dentifrices) having the compositions shown in Tables 1 to 4 were prepared by a conventional method, filled in a general laminated tube container (polyethylene is contained in the innermost layer, and has a diameter of 8 mm), and evaluated by the following method. The results are also shown in the table.
The value in parentheses of the polyoxyethylene hydrogenated castor oil is the average number of moles of ethylene oxide added.

(1) Method for evaluating storage stability of vitamin E or its derivative The dentifrice composition of each example filled in the above container was stored in a constant temperature bath at 60 ° C. for 1 month. After allowing this to stand until it reaches room temperature, 10 g of it is taken, extracted with methanol, and then subjected to HPLC (high performance liquid chromatography, using the following equipment) by absolute calibration curve method according to the following test conditions, Vitamin E or its thereof. Derivatives were quantified.
(Used equipment)
・ Pump: Shimadzu Corporation, LC-20AD
・ Sample introduction section: Shimadzu Corporation, SIL-20AC
・ Detector: Shimadzu Corporation, SPD-20A
・ Column constant temperature bath: Shimadzu Corporation, CTO-20AC
・ Eluent flow rate: 1 mL / min
(Test conditions)
-Detector: Ultraviolet absorptiometer (measurement wavelength: 273 nm)
-Column: COSMOSIL 5C ₁₈ -MS-II
-Column temperature: 40 ° C
Eluent: Methanol The content of vitamin E or its derivative in the product stored for 1 month at 60 ° C was calculated and quantified in the same manner as above. Vitamin E or vitamin E in the product stored for 1 month at -5 ° C. The residual rate (residual rate of vitamin E or its derivative in the stored product at 60 ° C.) when the content of the derivative is 100% is determined, and vitamin E or its derivative ((A) component) is determined according to the following evaluation criteria. ) Was determined for storage stability.
Evaluation criteria ◎: Residual rate is 96% or more ○: Residual rate is 92% or more and less than 96% ×: Residual rate is less than 92%

(2) Evaluation method of oral retention / absorption of vitamin E or its derivative Place the skin of a 7-week-old male hairless mouse (Nippon SLC Co., Ltd .; Labskin) cut into 1.5 cm squares on a 6-well plate. 5 mL of artificial saliva was added, and the mixture was allowed to stand for 2 hours. A glass frame is placed on the skin so that the permeation area (about 0.8 cm ² ) is constant, and 300 μL of a solution obtained by diluting 5 g of the dentifrice composition of each example with artificial saliva 3 times is injected 5 times. It was allowed to stand for a minute. Then, the diluted solution was discarded, 5 mL of water was added, and the mixture was washed at 160 rpm for 1 minute using a shaker. The washing was repeated twice in total.
The washing liquid was discarded, the skin was collected in a tube, 1 mL of ethanol (EtOH 90%) was added, and an extraction operation was performed with a vortex mixer for 5 minutes. The extract was recovered, diluted with methanol at the same magnification, and then vitamin E or a derivative thereof was quantified by HPLC under the same test conditions using the same equipment as above.
As a control, the retention and absorption rate of each dentifrice composition when the retention / absorption amount of vitamin E or its derivative of the dentifrice composition of Comparative Example 6 is 100% (retention and absorption of vitamin E or its derivative of each example). Absorption rate) was calculated, and the retention / absorption in the oral cavity of vitamin E or its derivative (component (A)) was determined according to the following evaluation criteria.
Evaluation criteria ◎: Retention / absorption rate is over 150% ○: Retention / absorption rate is over 100% 150% or less ×: Retention / absorption rate is 100% or less

(3) Evaluation method of spinnability After placing about 1 g of the dentifrice composition filled in the above-mentioned 8 mm diameter laminated tube container on a toothbrush (Lion Corporation, Clinica Toothbrush 4-row head, medium), upward. The spinnability of the dentifrice composition when the tube container and the toothbrush were pulled apart was tested. The spinnability refers to the property that the dentifrice composition stretches like a thread when taken out from the tube container, and the length of the thread is measured and judged by the following evaluation criteria. It can be judged that the shorter the length of the thread, the better the spinnability.
Evaluation criteria ◎: Thread length is less than 0.5 cm and kneading is good ○: Thread length is 0.5 cm or more and less than 0.8 cm and kneading is slightly good △: Thread length is 0.8 cm or more and less than 1.2 cm, but acceptable level ×: Thread length is 1.2 cm or more, and there is a problem in use (unacceptable)

(4) Evaluation method of good taste Ten expert panelists evaluated by a sensory test by the following method.
Approximately 1 g of the dentifrice composition filled in the above 8 mm diameter laminated tube container was placed on a toothbrush (made by Lion Corporation, Clinica Different Habrush 4-row head, medium) and brushed for 3 minutes. , Evaluated according to the following scoring criteria. The average of the scoring results was calculated, and the good taste was judged by the following evaluation criteria.
Score criteria 4 points: No bitterness 3 points: Slightly bitter but no problem in use 2 points: Bitterness and some problems in use 1 point: Strong bitterness and problems in use Certain level evaluation criteria ◎: Average score is 3.5 points or more and 4 points or less ○: Average score is 3 points or more and less than 3.5 points ×: Average score is less than 3 points

(5) Evaluation method of dentifrice The dentifrice composition filled in the above-mentioned laminated tube container having a diameter of 8 mm was stored in a constant temperature bath at 60 ° C. for 1 month, returned to room temperature, and extruded from the tube container. The appearance (dentifrice) of the dentifrice was judged according to the following evaluation criteria for the dentifrice composition stored at −5 ° C. for 3 months in the same manner as described above.
Evaluation Criteria ◎: Equivalent to the target product, no wrinkles on the surface of the dentifrice composition, and no change in gloss ○: Slight wrinkles or surface gloss on the surface of the dentifrice composition compared to the target product However, there is a slight deterioration in quality, but there is no problem in quality.

Details of the main raw materials used are shown below.
(A) Tocopherol acetate:
DSM Nutrition Japan, dl-α-tocopherol acetate (A) tocopherol nicotinate:
Tocopherol nicotinate (A) tocopherol manufactured by Eisai Food Chemical Co., Ltd .:
DSM Nutrition Japan, dl-α-tocopherol (B) polyoxyethylene (3) hardened castor oil:
Brownon CW-3 manufactured by Aoki Oil & Fat Industry Co., Ltd.
(B) Polyoxyethylene (5) Hardened castor oil:
HC-5 manufactured by Nippon Emulsion Co., Ltd.
(B) Polyoxyethylene (7) Hardened castor oil:
HC-7 manufactured by Nippon Emulsion Co., Ltd.
Polyoxyethylene (20) hardened castor oil (comparative product):
HC-20 manufactured by Nippon Emulsion Co., Ltd.
(C) Sodium fluoride:
Sodium fluoride (D) lauroyl sarcosine sodium manufactured by Stella Chemipha Co., Ltd .:
NIKKOL Sarcocinate LN manufactured by Nikko Chemicals Co., Ltd.
(E) Methyl paraoxybenzoate:
Methyl paraoxybenzoate manufactured by Ueno Fine Chemicals Industry Co., Ltd.

＊；曳糸性の悪化がほとんど認められず、練り切れが良かった。

*; There was almost no deterioration in the spinnability, and the kneading was good.

Next, a prescription example is shown. When the toothpaste of the prescription example was prepared in the same manner as in the examples and evaluated in the same manner, the (A) component was excellent in storage stability, retention in the oral cavity and absorption, and good spinnability, good taste and kneaded skin. Met.

[Prescription example] Toothpaste (A) Acetic acid dl-α-tocopherol 0.1
(B) Polyoxyethylene (5) Hardened castor oil 1.5
(C) Sodium fluoride 0.32
(D) Sodium lauroyl sarcosine 0.2
(E) Methyl paraoxybenzoate 0.18
Sorbitol solution (70%) 45.0
Abrasive silica 12.0
Viscous silica 6.0
Propylene glycol 3.0
Xanthan gum 1.0
Fragrance 1.1
Purified water balance
100% in total
{(A) + (B)} / (C) (mass ratio) = 5.0

Claims (4)

(A) 0.01 to 3% by mass of one or more selected from the ester of tocopherol and its organic acid.
(B) 0.1 to 4% by mass of polyoxyethylene hydrogenated castor oil having an average number of moles of ethylene oxide added of 3 to 7 mol.
(C) 0.3 to 1% by mass of sodium fluoride
and
(D) 0.01 to 2% by mass of an acyl sarcosine salt having an acyl group having 10 to 18 carbon atoms.
An oral composition containing 0.5 to 15 by mass ratio of {(A) + (B)} / (C). (D) The oral composition according to claim 1 , wherein the component is sodium lauroyl sarcosine. The oral composition according to claim 1 or 2 , further comprising (E) a paraoxybenzoic acid ester in an amount of 0.01 to 1% by mass. The oral composition according to any one of claims 1 to 3 , which is a dentifrice composition containing an abrasive.