TW202228712A - Emulsified composition for external application - Google Patents

Abstract

The purpose of the present invention is to provide an emulsified composition that is for external application, that contains urea and a salicylic acid-based anti-inflammatory agent, and that can suppress degradation of urea and phase separation resulting from being preserved. This emulsified composition for external application contains a sorbitan fatty acid ester and/or glycerin fatty acid ester in addition to urea and a salicylic acid-based anti-inflammatory agent, and is capable of suppressing degradation of urea and phase separation resulting from being preserved and can have excellent preservation stability.

Description

Emulsifying composition for external use

The present invention relates to an external-use emulsified composition, which contains urea and a salicylic acid-based anti-inflammatory agent, and which can inhibit phase separation and decomposition of urea due to storage.

Urea is used in external compositions due to its action of retaining water by forming hydrogen bonds with water in keratin, and its action of removing or softening unnecessary keratin by protein modification. On the other hand, since urea is easily hydrolyzed in the composition for external use, the composition for external use containing urea needs to be stabilized with urea. Therefore, various studies have been previously conducted on the formulation of compositions for external use that can stabilize urea. For example, Patent Document 1 discloses that urea is stabilized by blending neutral amino acids such as glycine in an external composition containing urea. In addition, Patent Document 2 discloses that excellent formulation stability can be provided by containing 10% by weight to 25% by weight of urea and retinol or a derivative thereof in the composition for external use.

On the other hand, salicylic acid-based anti-inflammatory agents such as salicylic acid, salicylic acid derivatives, and salts thereof are used in external compositions for anti-inflammatory and analgesic applications.

In addition, emulsified preparations can be formulated with water-based components and oil-based components, can respond to various formulation formulations, and are also excellent in use feeling when applied to the skin, so they are commonly used in the field of external compositions.

In recent years, consumer demand for improving the functionality of external compositions has increased, and in order to meet such consumer demands, development of an external emulsified composition containing urea and a salicylic acid-based anti-inflammatory agent has been desired. [Prior Art Literature] [Patent Literature]

[Patent Document 1] Japanese Patent Laid-Open No. 7-97326 [Patent Document 2] Japanese Patent Laid-Open No. 2008-31159

[The problem to be solved by the invention] The inventors of the present invention conducted various studies to develop an external emulsion composition containing urea and a salicylic acid-based anti-inflammatory agent. As a result, it was found that in the external emulsion composition containing urea and a salicylic acid-based anti-inflammatory agent, the During storage, phase separation and decomposition of urea occur, and there is a problem in storage stability.

Therefore, the subject of this invention is to provide the external use emulsion composition which contains urea and a salicylic acid type anti-inflammatory agent, and can suppress the phase separation and decomposition|disassembly of urea by preservation|save.

[Means of Solving Problems] The inventors of the present invention have made intensive studies in order to solve the above-mentioned problems, and as a result, have found an external emulsion composition containing sorbitan fatty acid ester and/or glycerin fatty acid ester in addition to urea and a salicylic acid-based anti-inflammatory agent Phase separation and decomposition of urea due to storage can be suppressed, and excellent storage stability can be obtained. Furthermore, the present inventors have also found that the external emulsion composition spreads well when applied around the nails and is excellent in the softening effect of the keratin around the nails. The present invention is based on the above-mentioned knowledge and has been completed by further repeated studies.

That is, this invention provides invention of the aspect disclosed below. Item 1. An external emulsion composition comprising: (A) urea, (B) a salicylic acid-based anti-inflammatory agent, and (C) sorbitan fatty acid ester and/or glycerin fatty acid ester. Item 2. The external emulsion composition according to Item 1, which does not contain glycine. Item 3. The external emulsion composition according to Item 1 or Item 2, further comprising (D) selected from the group consisting of glycyrrhizic acid (glycyrrhizic acid), glycyrrhetinic acid (glycyrrhetinic acid), derivatives of these, and salts of these at least one glycyrrhizic acid from the group consisting of. Item 4. The external emulsion composition according to any one of Items 1 to 3, further comprising (E) a saturated fatty acid having 14 or more carbon atoms and/or a salt thereof. Item 5. The emulsion composition for external use according to any one of Items 1 to 4, which is used for softening keratin around nails. [Effect of invention]

According to the external emulsion composition of the present invention, although urea and a salicylic acid-based anti-inflammatory agent are contained, phase separation and decomposition of urea due to storage can be suppressed, and excellent storage stability can be obtained. Furthermore, the emulsion composition for external use of the present invention spreads well when applied around the nails, and has an excellent softening effect on the keratin around the nails, so that it can be suitably used for the application of softening the keratin around the nails.

1. External emulsion composition

The external emulsion composition of the present invention is characterized by containing (A) urea, (B) a salicylic acid-based anti-inflammatory agent, and (C) sorbitan fatty acid ester and/or glycerin fatty acid ester. Hereinafter, the external emulsion composition of the present invention will be described in detail.

[(A) Urea] The external emulsification composition of this invention contains urea (it may be expressed as (A) component). Urea is a well-known component known to have a water retention action in keratin, an action of removing or softening unnecessary keratin, and the like.

The content of the component (A) in the emulsion composition for external use of the present invention may be appropriately set according to the medicinal effect to be imparted, the application of the emulsion composition for external use, and the like, for example, 1 to 30% by weight, Preferably it is 5 to 25 weight%, More preferably, it is 10 to 20 weight%. [(B) Salicylic acid-based anti-inflammatory agent] The external emulsion composition of the present invention contains a salicylic acid-based anti-inflammatory agent (it may also be expressed as (B) component).

Specific examples of the salicylic acid-based anti-inflammatory agent include salicylic acid, derivatives of salicylic acid, and salts thereof. Examples of derivatives of salicylic acid include acetylsalicylic acid (aspirin), salicylic acid (ethenzamide), sulfosalicylic acid, methyl salicylate, Ethyl Salicylate, Glycol Salicylate, Ethylene Glycol Salicylate, Dipropylene Glycol Salicylate, Titanium Salicylate, 2-Ethylhexyl Salicylate, Homomantyl Salicylate ( homomenthyl salicylate), phenyl salicylate, etc. Examples of salts of salicylic acid and derivatives thereof include alkali metal salts such as sodium and potassium; and alkaline earth metal salts such as magnesium. These salicylic acid-based anti-inflammatory agents may be used alone or in combination of two or more.

Among these salicylic acid-based anti-inflammatory agents, salicylic acid, salts of salicylic acid, ethyl salicylate, and methyl salicylate are preferably used, and more preferably, salicylic acid is used.

The content of the component (B) in the emulsion composition for external use of the present invention may be appropriately set according to the medicinal effect to be imparted, the application of the emulsion composition for external use, and the like. For example, the total amount of the component (B) may be used. It is calculated as 0.01 to 1% by weight, preferably 0.05 to 0.5% by weight, and more preferably 0.1 to 0.5% by weight.

In the external emulsion composition of the present invention, the ratio of the component (A) to the component (B) is not particularly limited, but for example, the ratio of the component (B) to 100 parts by weight of the total amount of the The total amount is 0.01 to 300 parts by weight, preferably 0.05 to 100 parts by weight, more preferably 0.1 to 50 parts by weight.

[(C) Sorbitan fatty acid ester and/or glycerol fatty acid ester] The external emulsion composition of this invention contains sorbitan fatty acid ester and/or glycerol fatty acid ester (it may also be expressed as (C) component). In the prior art, in the emulsion composition for external use, if the component (A) and the component (B) are allowed to coexist, phase separation due to storage or decomposition of the component (A) occurs, but in the emulsion composition for external use of the present invention By further containing sorbitan fatty acid ester and/or glycerin fatty acid ester in the product, phase separation due to storage or decomposition of the component (A) can be suppressed. Furthermore, when the external emulsion composition of the present invention contains the components (A) to (C), the stretch when applied around the nails becomes favorable, and an excellent keratin softening effect around the nails can be provided.

The so-called sorbitan fatty acid ester is an ester of sorbitan and a fatty acid, and is a known nonionic surfactant. The number of fatty acids bound to each molecule of the sorbitan fatty acid ester is not particularly limited, for example, 1 to 4, preferably 1 to 3, more preferably 1 or 2, more preferably 1. Although there is no restriction|limiting in particular as carbon number of the fatty acid which comprises sorbitan fatty acid ester, For example, it is 10-22, Preferably it is 14-22, More preferably, it is 16-20. Specific examples of sorbitan fatty acid esters include sorbitan monooleate, sorbitan monostearate, sorbitan sesquioleate, and sesquistearic acid. Sorbitan ester, coconut oil fatty acid sorbitan ester, sorbitan monopalmitate, sorbitan tristearate, sorbitan trioleate, etc. Among these sorbitan fatty acid esters, from the viewpoint of more effectively suppressing phase separation due to storage and decomposition of urea, sorbitan monostearate, sesquihard Fatty acid sorbitan ester, tristearic acid sorbitan ester, more preferably monostearic acid sorbitan ester.

The glycerol fatty acid ester is an ester of glycerol and a fatty acid, and is a known nonionic surfactant. As carbon number of the fatty acid which comprises glycerol fatty acid ester, 10-22 are mentioned, for example, Preferably it is 14-22, More preferably, it is 16-20. The number of fatty acids bound to each molecule of the glycerol fatty acid is not particularly limited, and examples thereof include 1 to 3, preferably 1 or 2, and more preferably 1. Specific examples of glycerin fatty acid esters include glyceryl monomyristate, glyceryl monostearate, glyceryl monoisostearate, glyceryl monooleate, and glyceryl dimyristate. base ester, glyceryl distearate, glyceryl diisostearate, glyceryl dioleate, etc. Among these glycerol fatty acid esters, preferred are glyceryl monostearate, glyceryl monomyristate, Glyceryl monoisostearate.

As content of the component (C) in the external emulsion composition of the present invention, for example, the total amount of the component (C) is 0.01% by weight to 20% by weight, preferably 0.05% by weight to 10% by weight, More preferably, it is 0.1 to 5 weight%.

In the external emulsion composition of the present invention, the ratio of the component (A) to the component (C) is not particularly limited. For example, the ratio of the component (C) to 100 parts by weight of the total amount of the The total amount is 0.01 to 300 parts by weight, preferably 0.05 to 100 parts by weight, more preferably 0.1 to 50 parts by weight.

[glycine] The external emulsion composition of the present invention may also contain glycine, but preferably does not contain glycine. It has been known that glycine has the effect of stabilizing urea, but in the external emulsion composition of the present invention, when glycine is not contained, phase separation and urea due to storage can be suppressed more effectively decomposition.

Moreover, as an aspect of the external emulsion composition of this invention, the aspect which does not contain a neutral amino acid (amino acid which does not contain an amino group or a carboxyl group in a side chain) is mentioned.

[(D) Glycyrrhizic Acids] The external emulsion composition of the present invention may contain, in addition to the above-mentioned components, at least one glycyrrhizic acid selected from the group consisting of glycyrrhizic acid, glycyrrhetinic acid, derivatives of these, and salts of these Also expressed as (D) component). When the composition for external use of the present invention further contains the component (D), the effect of suppressing phase separation and urea decomposition due to storage can be further improved, and at the same time, the spreading and keratin softening around the nails when applied to the nails can be further improved. Effect.

Glycyrrhizic acid and glycyrrhetic acid are known drugs known to have anti-inflammatory effects, anti-allergic effects, and the like.

Derivatives of glycyrrhizic acid are not particularly limited as long as they are pharmaceutically acceptable, and examples thereof include methyl glycyrrhizinate, stearyl glycyrrhizinate, and the like. These derivatives of glycyrrhizic acid may be used alone or in combination of two or more.

Derivatives of glycyrrhetinic acid are pharmaceutically acceptable and not particularly limited. Examples include pyridoxine glycyrrhetinate, stearyl glycyrrhetinate, glycyrrhetinic acid glyceryl ester, monoglycyrrhetinic acid glucuronide, etc. These derivatives of glycyrrhetic acid may be used alone or in combination of two or more.

Salts of glycyrrhizic acid, glycyrrhetinic acid and/or derivatives thereof are not particularly limited as long as they are pharmaceutically acceptable, and examples thereof include alkali metal salts such as sodium salts and potassium salts; ammonium salts and the like. These salts may be used alone or in combination of two or more.

In the emulsion composition for external use of the present invention, as the component (D), one may be selected from glycyrrhizic acid, glycyrrhetinic acid, derivatives of these, and salts of these and used alone, or two or more may be used together used in combination.

Among the components (D), from the viewpoints of the effect of suppressing phase separation and decomposition of urea due to storage, and further enhancing the effect of spreading around nails and keratin softening around nails, preferred More preferred examples of glycyrrhizic acid and its salts include salts of glycyrrhizic acid, and still more preferred examples include monoammonium glycyrrhizate.

When the external emulsion composition of the present invention contains the component (D), the content thereof is not particularly limited. It is preferably 0.1% by weight to 1% by weight, more preferably 0.3% by weight to 0.5% by weight.

When the external composition of the present invention contains (D) component, the ratio of (D) component with respect to (A) component is not particularly limited, and for example, (D) can be exemplified with respect to 1 part by weight of (A) component. ) component is 0.01 to 300 parts by weight in total, preferably 0.05 to 100 parts by weight, more preferably 0.1 to 50 parts by weight.

[(E) Saturated fatty acids having 14 or more carbon atoms and/or their salts] The external emulsion composition of this invention may contain C14 or more saturated fatty acid and/or its salt (it may also be expressed as (E) component) as needed. In the external emulsion composition of the present invention, when the component (E) is further contained, phase separation due to storage can be significantly suppressed, and the stretch when applied around the nails can be further improved.

Saturated fatty acids and/or their salts only need to have 14 or more carbon atoms, and from the viewpoint of more effectively suppressing phase separation due to storage and further improving the stretch when applied around the nails, the following are examples: Preferably it is carbon number 14-30, More preferably, carbon number is 14-24, More preferably, carbon number is 14-22, Especially preferably, carbon number is 18. As a saturated fatty acid, myristic acid (myristic acid), palmitic acid, stearic acid, arachidic acid (arachidic acid), behenic acid (behenic acid), lignoceric acid (lignoceric acid) are mentioned more specifically ), cerotic acid, montanic acid, melissic acid; preferably myristic acid, palmitic acid, stearic acid, eicosic acid, behenic acid , behenic acid, more preferably, myristic acid, palmitic acid, stearic acid, eicosic acid, and behenic acid, and still more preferably, stearic acid.

Examples of the salts of saturated fatty acids having 14 or more carbon atoms include alkali metal salts such as sodium salts and potassium salts.

In the composition for external use of the present invention, as the component (E), one type may be selected and used from saturated fatty acids having 14 or more carbon atoms and salts thereof, or two or more types may be used in combination.

When the external emulsion composition of the present invention contains the component (E), the content thereof is not particularly limited, but for example, the total amount of the component (E) is 0.01 to 10% by weight, and It is preferably 0.1% by weight to 6% by weight, more preferably 1% by weight to 6% by weight.

When the external emulsion composition of the present invention contains the component (E), the ratio of the component (A) to the component (E) is not particularly limited. The total amount of the component (E) is 0.1 to 1200 parts by weight, preferably 0.1 to 100 parts by weight, more preferably 0.1 to 50 parts by weight.

[Polyol] The external-use emulsion composition of this invention may contain a polyhydric alcohol as needed.

The polyol is not particularly limited as long as it is pharmaceutically acceptable, and examples thereof include 1,3-butanediol, propylene glycol, dipropylene glycol, polypropylene glycol, and glycerin. Among these polyhydric alcohols, glycerin is preferably used. These polyols may be used alone or in combination of two or more.

When the external emulsion composition of the present invention contains a polyhydric alcohol, the content thereof is not particularly limited. For example, the total amount of the polyhydric alcohol is 0.1% by weight to 30% by weight, preferably 0.5% by weight. % to 20% by weight, more preferably 1% to 10% by weight.

[Surface active agents other than (C) component] The external composition for skin of this invention may contain surfactant other than the said (C)component as needed.

As surfactants other than the said (C)component, nonionic surfactants, anionic surfactants, cationic surfactants, amphoteric surfactants, etc. other than the said (C)component are mentioned. These surfactants may be used alone or in combination of two or more. Among these surfactants, nonionic surfactants are preferably used.

The nonionic surfactant (other than the component (C)) used in the present invention is not particularly limited as long as it is pharmaceutically acceptable. For example, polyoxyethylene sorbitan fatty acid ester, polyoxyethylene Ethylene alkyl ether, polyoxyethylene hardened castor oil, etc. Among these nonionic surfactants, polyoxyethylene sorbitan fatty acid ester and polyoxyethylene alkyl ether are preferably used.

The average number of added moles of ethylene oxide (EO) constituting the polyoxyethylene sorbitan fatty acid ester is not particularly limited, and for example, 5 moles to 40 moles, preferably 10 moles. mol to 30 mol, more preferably 15 mol to 25 mol. The number of carbon atoms of the fatty acid constituting the polyoxyethylene sorbitan fatty acid ester is not particularly limited, and examples thereof include 10 to 22, preferably 14 to 22, and more preferably 16 to 20 carbon atoms. . Specific examples of polyoxyethylene sorbitan fatty acid esters include polyoxyethylene sorbitan monooleate, polyoxyethylene sorbitan trioleate, and polyoxyethylene tristearate. Sorbitan ester, polyoxyethylene sorbitan monostearate, etc. Among these polyoxyethylene sorbitan fatty acid esters, polyoxyethylene sorbitan monostearate (polysorbate (polysorbate) having an average added molar number of ethylene oxide (EO) of 20 can be used. ) 60).

The average number of added moles of ethylene oxide (EO) constituting the polyoxyethylene alkyl ether is not particularly limited, and examples thereof include 5 moles to 40 moles, preferably 10 moles to 30 moles, More preferably, it is 15 mol to 25 mol. Although it does not specifically limit as carbon number of the alkyl group which comprises a polyoxyethylene alkyl ether, For example, 10-24 pieces are mentioned, Preferably it is 14-24 pieces, More preferably, it is 16-24 pieces. Specific examples of the polyoxyethylene alkyl ether include polyoxyethylene cetyl ether, polyoxyethylene oleyl ether, polyoxyethylene stearyl ether, polyoxyethylene arachyl ether, and the like. . Among these polyoxyethylene alkyl ethers, polyoxyethylene peanut ether is preferably used.

When the external emulsion composition of the present invention contains a surfactant (other than the component (C)), the content may be appropriately set according to the formulation form, feeling in use, and the like. For example, a surfactant may be used. The total amount (other than the component (C)) is 0.5% by weight to 20% by weight, preferably 1% by weight to 15% by weight, and more preferably 1.5% by weight to 10% by weight.

[other ingredients] In addition to the above-mentioned components, the external emulsion composition of the present invention may contain other additives generally used as necessary. Examples of such additives include oily bases other than (E) component, water, monohydric lower alcohols, pH adjusters, buffers, solubilizers, preservatives, preservatives, antioxidants, stabilizers, fragrances , coloring materials, etc. When these additives are contained in the emulsion composition for external use of the present invention, the content may be appropriately set according to the type of the additive to be used, or the like.

The external-use emulsion composition of this invention may contain a pharmacological component in addition to the said component. Examples of such pharmacological components include steroids, antihistamines, local anesthetics, anti-inflammatory agents (other than component (B)), moisturizing agents (other than component (A)), bactericides, antibacterial agents, and antipruritic agents. Agents, skin protectants, blood circulation promoting ingredients, vitamins, mucopolysaccharides, etc. These pharmacological components may be used alone or in combination of two or more. In addition, when these pharmacological components are contained in the composition for external use of the present invention, the concentration thereof may be appropriately set according to the type of the pharmacological component to be used, the expected effect, and the like.

[Emulsion type, formulation form] The emulsification type of the external emulsion composition of the present invention may be either an oil-in-water type or a water-in-oil type, and preferably, an oil-in-water type can be mentioned.

The formulation form of the externally emulsified composition of the present invention is not particularly limited, and examples thereof include external pharmaceuticals such as creams, emulsions, lotions, liniments, and aerosols. Among these, creams are preferably mentioned.

[use] The use of the external emulsion composition of the present invention is not particularly limited, and the external emulsion composition of the present invention can exert the softening or exfoliating action and moisturizing action of the keratin based on the (A) component, and the anti-inflammatory action based on the (B) component. Therefore, it can be suitably used in the softening or removal of keratin, moisturizing, anti-inflammatory and other purposes. In particular, the emulsion composition for external use of the present invention can be suitably used for softening the keratin around the nails because of its good spreading when applied around the nails and the excellent effect of softening the keratin around the nails.

[Manufacturing method] The emulsified composition for external use of the present invention can be produced according to a known formulation method of an emulsified formulation, depending on the type of emulsification. For example, as a method for producing the emulsion composition for external use of the present invention, there may be mentioned a method of separating components to be contained into a water-soluble component and an oily component, and preparing an aqueous phase containing the water-soluble component and an oil phase containing the oily component, These are emulsified according to a known method. [Example]

Hereinafter, although an Example is shown and this invention is demonstrated more concretely, this invention is not limited to these Examples.

Test Example 1 External emulsion compositions (cream-like oil-in-water emulsion formulations) having the compositions shown in Tables 1 to 3 were prepared. Specifically, first, surfactants (sorbitan monostearate, sorbitan sesquistearate, sorbitan tristearate, glyceryl monoisostearate, , glyceryl monomyristate, glyceryl monostearate, polyoxyethylene hardened castor oil 10, polysorbate 60), fatty acids (stearic acid, myristic acid, palmitic acid, behenic acid, Oleic acid, linoleic acid), hydrocarbon oil (white petrolatum, liquid paraffin), cetearyl alcohol, and polyoxyethylene-stearyl alcohol mixture were mixed in predetermined amounts, and heated and dissolved at 80°C to prepare oil Phase composition. Separately, urea, salicylic acid, glycine, monoammonium glycyrrhizinate, triethanolamine, and water are mixed in predetermined amounts to prepare an aqueous phase composition. Next, the water phase composition heated to 80°C was slowly added to the oil phase composition heated to 80°C, mixed, and emulsified to obtain an external emulsion composition (a cream-like oil-in-water emulsified formulation) . The emulsified compositions for external use immediately after production were all in an emulsified form in which phase separation did not occur.

Each of the obtained emulsion compositions for external use was evaluated for the stability of the emulsified state, the stability of urea, and the stretching and keratin softening effects when applied around the nails.

<Stability of emulsified state> 16 g of each emulsified composition for external use immediately after preparation was filled into a glass bottle with a capacity of 20 ml, and stored under a light-shielding condition of 50° C. for 1 month. The appearance of each external emulsion composition after storage for 1 month was visually observed, and "phase separation was not confirmed, and the same emulsified state as immediately after preparation was maintained" was set as 15 points, and "phase separation was confirmed, and stable state was not observed." The emulsified state is maintained, and the state that does not become uniform even if shaken" is set as 1 point, and the degree of stability of the emulsified state is scored between 1 point and 15 points. In addition, for reference, the external appearance of each external emulsion composition evaluated as 1 point and 15 points is shown in FIG. 1 .

<Stable of urea> 16 g of each emulsified composition for external use immediately after preparation was filled into a glass bottle with a capacity of 20 ml, and stored under a light-shielding condition of 50° C. for 2 months. The urea concentration in each external emulsion composition before storage and after storage for 2 months was quantified by High Performance Liquid Chromatography (HPLC). The residual rate (%) of urea after 2 months is rounded off to the first decimal place. The value of the residual ratio (%) of urea after storage for 2 months was classified according to the following criteria. ·Judgment criteria ◎: The residual rate of urea is 98% to 100% ○: The residual rate of urea is 95% to 97% △: The residual rate of urea is 92% to 94% ×: The residual rate of urea is 91% or less

＜Stretching and keratin softening effect when applied around nails＞ To 10 subjects who felt the hardening of the stratum corneum around the nails, 0.1 g of each external emulsion composition was applied around the nails at a frequency of once a day for a week. The stretch around the nail and the softening effect of the keratin around the nail after 1 week of use were evaluated. As for the evaluation of the stretch when applied around the nail, there are five stages: "good stretch", "good stretch as a whole", "in between", "poor stretch as a whole", and "poor stretch" The evaluation was performed, and the total number of subjects who evaluated as "good stretch" or "good stretch as a whole" was calculated as the stretch score when applied around the nail. In addition, regarding the softening effect of the keratin around the nail, the softening effect of the keratin around the nail was classified as "satisfactory", "slightly satisfied", "in between", "slightly dissatisfied" and "dissatisfied" The evaluation was carried out in five stages, and the total number of subjects who were evaluated as "satisfactory" or "slightly satisfied" was calculated as the score of the softening effect of the keratin around the nail.

The results are shown in Tables 1 to 3. In the external emulsion composition containing urea alone, phase separation due to storage did not occur, and the decomposition of urea was suppressed, but the effect of stretching and keratin softening when applied around nails was insufficient (Reference Example 1) . On the other hand, in the external emulsion composition containing urea and salicylic acid, the phase separation due to storage was remarkably generated, the decomposition of urea was also confirmed, and the stretching and keratin softening effects when applied around the nails were also confirmed. Also insufficient (Comparative Example 1 and Comparative Example 2).

On the other hand, the external emulsion composition containing urea, salicylic acid, and sorbitan fatty acid ester and/or glycerol fatty acid ester in combination can sufficiently suppress phase separation and decomposition of urea due to storage, and further sufficiently suppress the decomposition of urea. The effect of stretching and keratin softening when applied around nails was improved (Examples 1 to 15). Furthermore, when glycine was not included, the decomposition of urea due to storage was significantly suppressed (Examples 7 to 15). In addition, when monoammonium glycyrrhizinate was included, the effect of inhibiting phase separation and decomposition of urea due to storage, and the effect of stretching and keratin softening when applied around nails were particularly improved (Examples 9 to Example 15). In addition, when a saturated fatty acid having a carbon number of 14 or more is further contained, phase separation due to storage can be suppressed remarkably, and the stretch when applied around the nails is further improved (Examples 11 to 15). . In addition, an external emulsion composition in which salicylic acid in each of the external emulsion compositions of Comparative Examples 1 to 2 was changed to ethyl salicylate or methyl salicylate was prepared, and the same method as in Test Example 1 was used. Methods The emulsification state, the stability of urea, and the stretching and keratolytic effects when applied around the nails were evaluated. As a result, phase separation and decomposition of urea occurred to the same extent as those in Comparative Examples 1 to 2 corresponding to the same, and the coating was applied. The stretch and the softening effect of the keratin when applied around the nails were also scored in the same degree. On the other hand, each external emulsified composition obtained by changing the salicylic acid in each of the external compositions of Examples 1 to 15 to ethyl salicylate or methyl salicylate was prepared, using the same method as in Test Example 1. The emulsification state, the stability of urea, and the stretching and keratolytic effects when applied around nails were evaluated in the same way, and the results showed that the phase separation and the decomposition of urea were suppressed to the same extent as the corresponding Examples 1 to 15. , and the stretch and keratin softening effect scores when applied around the nails are also at the same level.

[Table 1] Reference example Comparative example 1 1 2 (A) Urea 20 20 20 (B) Salicylic acid - 0.5 0.5 Polyoxyethylene hardened castor oil 10 1 1 1 Glycine 2 2 - Polysorbate 60 1.5 1.5 1.5 Concentrated glycerin 3 3 3 liquid paraffin 5 5 5 white vaseline 5 5 5 Cetearyl Alcohol 4 4 4 Polyoxyethylene peanut ether-stearyl alcohol blend ^#1 4 4 4 Triethanolamine 1.2 1.2 1.2 purified water The remaining part The remaining part The remaining part Total (wt%) 100 100 100 Stability of emulsified state (min) 15 1 1 Urea stability ○ △ × Stretch score when applied around nails (person) 4 2 2 Score of softening effect of keratin around nails (human) 3 4 4 In the table, the unit of content of each component is % by weight. #1 Polyoxyethylene arachidyl ether-stearyl alcohol mixture was used under the trade name "NIKKOL WAX-230" (Nikko Chemicals Co., Ltd.) (the average number of added moles of ethylene oxide was 20 And the alkyl group is a mixture of 20 to 30 parts by weight of polyoxyethylene arachidyl ether of arachidyl alcohol and 70 to 80 parts by weight of stearyl alcohol).

[Table 2] Example 1 2 3 4 5 6 7 8 (A) Urea 20 20 20 20 20 20 20 20 (B) Salicylic acid 0.5 0.5 0.5 0.5 0.5 0.5 0.5 0.5 (C) Sorbitan fatty acid ester/glycerol fatty acid ester Sorbitan Monostearate 0.7 - - - - - 0.7 - Sorbitan sesquistearate - 0.7 - - - - - - Sorbitan Tristearate - - 0.5 - - - - - Glyceryl Monostearate - - - 0.9 - - - 0.9 Glyceryl Monomyristate - - - - 0.7 - - - Glyceryl Monostearate - - - - - 0.7 - - Glycine 2 2 2 2 2 2 - - Polysorbate 60 1.5 1.5 1.5 1.5 1.5 1.5 1.5 1.5 Concentrated glycerin 3 3 3 3 3 3 3 3 liquid paraffin 5 5 5 5 5 5 5 5 white vaseline 5 5 5 5 5 5 5 5 Cetearyl Alcohol 4 4 4 4 4 4 4 4 Polyoxyethylene peanut ether-stearyl alcohol blend ^#1 4 4 4 4 4 4 4 4 Triethanolamine 1.2 1.2 1.2 1.2 1.2 1.2 1.2 1.2 purified water The remaining part The remaining part The remaining part The remaining part The remaining part The remaining part The remaining part The remaining part Total (wt%) 100 100 100 100 100 100 100 100 Stability of emulsified state (min) 10 9 9 8 8 8 10 9 Urea stability ○ ○ ○ ○ ○ ○ ◎ ◎ Stretch score when applied around nails (person) 6 6 6 7 8 7 8 7 Score of softening effect of keratin around nails (human) 6 6 6 6 6 6 6 6 In the table, the unit of content of each component is % by weight. #1 Polyoxyethylene arachidyl ether-stearyl alcohol mixture was used under the trade name "NIKKOL WAX-230" (Nikko Chemicals Co., Ltd.) (the average number of added moles of ethylene oxide was 20 And the alkyl group is a mixture of 20 to 30 parts by weight of polyoxyethylene arachidyl ether of arachidyl alcohol and 70 to 80 parts by weight of stearyl alcohol).

[table 3] Example 9 10 11 12 13 14 15 (A) Urea 20 20 20 20 20 20 20 (B) Salicylic acid 0.5 0.5 0.5 0.5 0.5 0.5 0.5 (C) Sorbitan fatty acid ester/glycerol fatty acid ester Sorbitan Monostearate 0.7 - 0.7 - 0.7 0.7 0.7 Glyceryl Monomyristate - 0.7 - 0.7 - - - (D) Monoammonium glycyrrhizinate 0.5 0.5 0.5 0.5 0.5 0.5 0.5 (E) Saturated fatty acids having 14 or more carbon atoms Stearic acid - - 2 2 - - - myristic acid - - - - 2 - - Palmitic acid - - - - - 2 - behenic acid - - - - - - 2 Polysorbate 60 1.5 1.5 1.5 1.5 1.5 1.5 1.5 Concentrated glycerin 3 3 3 3 3 3 3 liquid paraffin 5 5 5 5 5 5 5 white vaseline 5 5 5 5 5 5 5 Cetearyl Alcohol 4 4 4 4 4 4 4 Polyoxyethylene peanut ether-stearyl alcohol blend ^#1 4 4 4 4 4 4 4 Triethanolamine 1.2 1.2 1.2 1.2 1.2 1.2 1.2 purified water The remaining part The remaining part The remaining part The remaining part The remaining part The remaining part The remaining part Total (wt%) 100 100 100 100 100 100 100 Stability of emulsified state (min) 12 11 15 14 13 13 13 Urea stability ◎ ◎ ◎ ◎ ◎ ◎ ◎ Stretch score when applied around nails (person) 9 9 10 10 10 10 10 Score of softening effect of keratin around nails (human) 10 9 10 9 10 10 10 In the table, the unit of content of each component is % by weight. #1 Polyoxyethylene arachidyl ether-stearyl alcohol mixture was used under the trade name "NIKKOL WAX-230" (Nikko Chemicals Co., Ltd.) (the average number of added moles of ethylene oxide was 20 And the alkyl group is a mixture of 20 to 30 parts by weight of polyoxyethylene arachidyl ether of arachidyl alcohol and 70 to 80 parts by weight of stearyl alcohol).

Prescription example An external emulsion composition (a creamy oil-in-water emulsion formulation) having the composition shown in Table 4 was prepared. In the same manner as in Test Example 1, the emulsified state, the stability of urea, and the stretching and keratin softening effects when applied around the nails were evaluated. The external emulsion compositions of Formulation Examples 1 to 7 can sufficiently suppress phase separation and decomposition of urea due to storage, and are also excellent in stretching and keratin softening effects when applied around nails.

[Table 4] Prescription example 1 2 3 4 5 6 7 (A) Urea 20 20 20 20 20 20 20 (B) Salicylic acid 0.5 0.5 0.5 0.5 0.5 0.5 0.5 (C) Sorbitan fatty acid ester/glycerol fatty acid ester Sorbitan Monostearate 0.7 1.5 - - - 0.35 0.7 Sorbitan Monopalmitate - - 0.7 - - - - Sorbitan trioleate - - - 0.7 - - - Glyceryl Monomyristate - - - - - 0.35 - Glyceryl distearate - - - - 0.7 - - Glyceryl dioleate - - - - 0.7 - (D) Monoammonium glycyrrhizinate - - 0.5 0.5 0.5 0.5 - (D) Dipotassium glycyrrhizinate 0.5 - - - - - 0.5 (D) Glycyrrhetinic acid - 0.5 - - - - - (E) Saturated fatty acids having 14 or more carbon atoms Stearic acid 2 4 2 2 2 3 2 Polysorbate 60 1.5 1.5 1.5 1.5 1.5 1.5 1.5 Concentrated glycerin 3 3 3 3 3 3 3 liquid paraffin 5 5 5 5 5 5 5 white vaseline 5 5 5 5 5 5 5 Cetearyl Alcohol 4 4 4 4 4 4 4 Polyoxyethylene peanut ether-stearyl alcohol blend ^#1 4 4 4 4 4 4 4 Triethanolamine 1.2 1.2 1.2 1.2 1.2 1.2 1.2 purified water The remaining part The remaining part The remaining part The remaining part The remaining part The remaining part The remaining part Total (wt%) 100 100 100 100 100 100 100 In the table, the unit of content of each component is % by weight. #1 Polyoxyethylene arachidyl ether-stearyl alcohol mixture was used under the trade name "NIKKOL WAX-230" (Nikko Chemicals Co., Ltd.) (the average number of added moles of ethylene oxide was 20 and the alkyl group is a mixture of 20 to 30 parts by weight of polyoxyethylene arachidyl ether of arachidyl alcohol and 70 to 80 parts by weight of stearyl alcohol).

none

FIG. 1 is a photograph of the external appearance of the emulsion composition for external use after storage.

Claims (5)

An external emulsion composition, comprising: (A) urea, (B) a salicylic acid-based anti-inflammatory agent, and (C) sorbitan fatty acid ester and/or glycerol fatty acid ester. The external emulsion composition according to claim 1, which does not contain glycine. The external emulsion composition according to claim 1 or claim 2, further comprising (D) at least one selected from the group consisting of glycyrrhizic acid, glycyrrhetic acid, derivatives of these, and salts of these Glycyrrhizin. The external emulsion composition according to any one of Claims 1 to 3, further comprising (E) a saturated fatty acid having 14 or more carbon atoms and/or a salt thereof. The external emulsion composition according to any one of claim 1 to claim 4, which is used for softening keratin around nails.

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