JP7340140B2 - Water-containing compositions, patches, cosmetics or dermatological medicines comprising the water-containing compositions, and methods for producing these - Google Patents

Description

Detailed description of the invention

The present invention relates to a water-containing composition, and more particularly, a water-containing composition containing water and a functional ingredient and having antiseptic properties that can be expected to have reduced skin sensitization. The present invention relates to the constructed patch, cosmetic, or dermatological drug, and to a method for producing the same.

Various proposals have been made regarding compositions containing preservatives to impart preservative properties to compositions such as cosmetics, pharmaceuticals, and foodstuffs.
Preservative properties are determined by the type of functional ingredients contained in the water-containing composition (e.g., protein-containing ingredients, natural materials such as agar, functional ingredients, water-soluble polymer ingredients, etc.) and the form (e.g., transparent liquid, emulsified). preservatives, gel-like, gel-like), preservatives dissolved in the composition or dispersed without being dissolved, content, aqueous/oil-based composition, patch, cosmetics , the type of product such as dermatological agents, etc., and vary significantly.
Furthermore, it is said that the corrosiveness of the composition varies greatly depending on the difference in "water activity" between water and the functional component-containing composition. Water in a composition containing water includes bound water that is chemically bonded to the components contained in the composition, dissolved water that dissolves the contained components, and free water that has soaked into the surfaces and voids of the contained components. It is said that this water activity is closely related to the preservative properties of the composition.

In general, water-containing compositions containing functional ingredients dissolved in water tend to be susceptible to bacterial spoilage over time during storage, etc., and in order to prevent quality deterioration due to spoilage, paraoxygen is used as a preservative. Water-containing compositions containing parabens such as methyl benzoate (methylparaben) and probyl paraoxybenzoate (propylparaben) have been proposed.

For example, as a cooling patch, Japanese Patent Laid-Open No. 2000-107219 (Patent Document 1) discloses a water-retaining patch containing a water-soluble polymer such as polyacrylic acid, polyvinyl alcohol, or carboxymethyl cellulose, and a water-retaining patch containing 40% by weight or more of water. A cooling/moisturizing material comprising a water-retaining matrix and fibers having at least a hydrophilic surface dispersed within the water-retaining matrix, at least a part of which is exposed on the surface of the water-retaining matrix. Gels have been proposed, and they can retain a large amount of water within the water-retaining matrix and have excellent moisturizing ability.Moreover, the fibers make it easy for water to move within the matrix, and these fibers also allow water to move from the water-retaining matrix to the outside. It has been disclosed that moisture evaporates easily and has excellent cold storage ability. In particular, Example 1 in paragraph 0048 discloses a water-retentive matrix containing 0.1 g (0.1% by weight) of paraben.

JP-A No. 2010-13470 (Patent Document 2) proposes a thin aqueous patch containing water, polyacrylic acid or sodium polyacrylate, carboxymethyl cellulose, and a sparingly soluble metal salt on a support. A patch has been disclosed that maintains a moisture protection effect on the skin and has excellent usability. In particular, Example 4 in Table 2 discloses an adhesive containing both parabens, 0.1% by weight of propylparaben and 0.05% by weight of methylparaben.

International Publication WO 2005/105150 (Patent Document 3) includes a support and an adhesive layer disposed on one surface of the support, the adhesive layer containing water and easily soluble agar, and further comprising polyacrylic acid. Alternatively, a patch has been proposed, which is composed of an adhesive base containing polyvinyl alcohol or polyvinylpyrrolidone, and the adhesive base further contains an analgesic and anti-inflammatory ingredient such as diclofenac, indomethacin, or loxoprofen. In particular, paragraph 0076, Tables 1 and 3 disclose an adhesive layer containing 0.2% by mass of methylparaben as a preservative.

JP 2007-145749 A (Patent Document 4) Cosmetics containing a preservative sterilizer containing 1,2-alkanediol and lysozyme as a preservative sterilizer other than parabens instead of a paraben preservative , pharmaceuticals or foodstuffs are disclosed.

Japanese Patent Application Publication No. 2000-107219 Japanese Patent Application Publication No. 2010-13470 International publication WO2005/105150 Japanese Patent Application Publication No. 2007-145749

In the above-mentioned conventional water-containing compositions, compositions containing parabens such as methyl paraoxybenzoate (methylparaben) and probyl paraoxybenzoate (propylparaben) are generally proposed as preservatives. Parabens such as methyl paraoxybenzoate and probyl paraoxybenzoate, which are contained as preservatives in water-containing compositions used in cosmetics or patches, may be used by people with particularly low (or weak) skin resistance, such as infants and the elderly. ) It has recently been reported that when used by humans, there is a skin sensitization effect on the skin that comes into contact with it, such as the occurrence of skin irritation.

A water-containing composition that contains functional ingredients dissolved in water, a composition that does not contain parabens, or a composition that contains a very small amount of parabens and exhibits sufficient antiseptic properties. There is a need for a water-containing composition that can be expected to reduce skin sensitization, as well as cosmetics, external skin preparations, and the like that include the water-containing composition.

The water-containing composition of the present invention is a water-containing composition containing (A) water, and (B) the water-soluble functional component, and at least (C) the water-soluble or compatible functional component. (E) a preservative other than parabens that is soluble in the water and/or polyhydric alcohol; It is characterized by containing at least one preservative other than parabens selected from the group consisting of phenoxyethanol, glyceryl caprylate, and polylysine, and having preservative properties.

As the polyhydric alcohol that promotes antiseptic properties, a structure containing at least one polyhydric alcohol selected from the group consisting of propylene glycol, butylene glycol, and glycerin can be preferably implemented.

A configuration in which the preservatives other than parabens include both phenoxyethanol and glyceryl caprylate and/or polylysine can be preferably implemented.

In the water-containing composition of the present invention, a structure that does not contain preservatives such as parabens or a structure that contains a small amount of parabens that does not cause skin sensitization can be preferably implemented.

A patch comprising a water-containing composition of the present invention comprises a water-containing composition and a sheet-like holding member, wherein the water-containing composition adheres to and/or impregnates the sheet-like holding member and is held therein. The functional component contained in the water-containing composition is characterized in that it contains a water-soluble polymer that can be dissolved in water, is formed to be able to be applied to human skin, and has antiseptic properties.

The method for producing a water-containing composition having preservative properties of the present invention includes: (A) water; (B) a functional component soluble in water; and (C) a water-soluble or (E) a preservative other than parabens that is soluble in the water and/or polyhydric alcohol; , phenoxyethanol, glyceryl caprylate, polylysine, and at least one preservative other than parabens selected from the group consisting of: (a) ) At least a step of mixing and dissolving a functional ingredient that is soluble in water in water to thereby prepare a functional ingredient-containing pre-prepared liquid; (c) a preservative other than parabens; A step of mixing soluble water and/or polyhydric alcohol to thereby prepare a preservative-containing preconditioned liquid containing a dissolved preservative; (e) the polyhydric alcohol and the above (a); The functional ingredient-containing pre-conditioned liquid prepared by above and the preservative-containing pre-conditioned liquid prepared by above (c) are mixed, whereby the functional ingredient and the preservative are dissolved. The method is characterized by comprising a step of preparing a water-containing composition.

The method for producing a patch containing a water-containing composition of the present invention comprises a sheet-like holding member and a water-containing composition adhered to and/or impregnated with the sheet-like holding member, and the patch is applied to human skin. A possible method for producing a patch, wherein the water-containing composition contains (A) water, and (B) a water-soluble polymer as a functional component soluble in water, and further includes at least , (C) a polyhydric alcohol that is soluble or compatible with the water and exhibits a preservative promoting effect, and (E) a preservative other than parabens that is soluble in the water and/or polyhydric alcohol. and the preservative other than parabens contains at least one preservative other than parabens selected from the group consisting of phenoxyethanol, glyceryl caprylate, and polylysine, and the temperature is about 45°C or less. It has a gel-like, non-flowable state with flexibility and adhesiveness, has antiseptic properties, and is configured to be able to be applied to human skin, and (a) is at least soluble in water. A step of mixing and dissolving a water-soluble polymer in water to thereby prepare a water-soluble polymer-containing pre-prepared solution having viscosity and fluidity; (c) preservatives other than parabens; a step of mixing water and/or polyhydric alcohol capable of dissolving the preservative, thereby preparing a preservative-containing pre-preparation liquid containing the dissolved preservative; (e) the polyhydric alcohol; The water-soluble polymer-containing pre-prepared liquid prepared in (a) and the preservative-containing pre-prepared liquid prepared in (c) are mixed, so that the preservative is dissolved and , a step of preparing a flowable water-containing polymer composition having viscosity and fluidity, wherein the flowable water-containing polymer composition is adjusted to a predetermined temperature; (f) the above (e) ) After the step, while maintaining the fluidity of the fluid water-containing polymer composition until gelation, the fluid water-containing polymer composition is attached to the sheet-like holding member at a predetermined thickness. and/or impregnation, thereby preparing a flowable water-containing polymer composition with a sheet-like holding member held by the sheet-like holding member, (g) the sheet-like holding prepared by the step (f) above; The flowable water-containing polymer composition with the component is adjusted to a predetermined temperature, thereby converting the flowable water-containing polymer composition into a gelled patch having a water-containing composition that has no fluidity. It is characterized by comprising a step of preparing.

The water-containing composition of the present invention contains functional ingredients such as water and water-soluble polymers (Effect A: water-containing composition with reduced skin sensitization and excellent antiseptic properties), and also contains parabens. In a water-containing composition containing no parabens, or a water-containing composition containing extremely small amounts of parabens, it is possible to obtain a water-containing composition that exhibits sufficient antiseptic properties and has reduced skin sensitization. In particular, when used by people with low (or weak) skin resistance, such as infants and the elderly, a water-containing composition that is expected to have reduced skin sensitization and exhibits excellent antiseptic properties can be obtained.

The patch made of the water-containing composition of the present invention (Effect E - Patch: Patch with reduced skin sensitization and excellent antiseptic properties) can be used by people with low (or weak) skin resistance. When applied as a patch, it is expected to reduce skin sensitization such as irritation on the skin that comes into contact with it, and it is possible to obtain a patch that has excellent antiseptic properties, and also has the adhesiveness and preservation required for a patch. A patch having basic patch properties such as shapeability, flexibility, easy-to-peel adhesiveness, and ability to suppress residual peeling is obtained. In particular, when used by people with low skin resistance such as infants and the elderly, a patch is expected to have reduced skin sensitization and exhibit excellent antiseptic properties.

According to the method for producing a water-containing composition of the present invention, preservatives other than parabens can be dissolved in water and/or polyhydric alcohol in which functional ingredients are dissolved, and can exhibit sufficient antiseptic properties, as well as A water-containing composition with reduced sensitization is obtained.

By the method for producing a patch comprising the water-containing composition of the present invention, (Effect O: method for producing a patch that has the basic performance required for a patch, reduced skin sensitization, and excellent antiseptic properties) ) Other preservatives other than parabens can be dissolved in the water-containing composition, which makes it easier for people with low (or weak) skin resistance to use the patch on their skin. It is expected to reduce skin sensitization such as skin irritation, and has excellent antiseptic properties, especially the adhesiveness, shape retention, flexibility, easy-peel adhesion, and peel-resistance required for patches. A patch having basic patch performance such as suppressive properties can be manufactured.

BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a schematic process explanatory diagram illustrating a manufacturing process of a patch comprising a water-containing composition according to an example of the present invention. FIG. 3 is a diagram illustrating an example of determining the effect of antiseptic properties caused by blending two types of preservatives.

The water-containing composition of the present invention is a water-containing composition containing (A) water, and (B) the water-soluble functional component, and at least (C) the water-soluble or compatible functional component. (E) a preservative other than parabens that is soluble in the water and/or polyhydric alcohol; It is characterized by containing at least one preservative other than parabens selected from the group consisting of phenoxyethanol, glyceryl caprylate, and polylysine, and having preservative properties.

<About the preservative promoting effect of polyhydric alcohol in aqueous compositions containing preservatives other than parabens>
The aqueous composition of the present invention contains at least one polyhydric alcohol selected from propylene glycol, butylene glycol, and glycerin as the polyhydric alcohol, and at least phenoxyethanol, glyceryl caprylate, and as preservatives. It is possible to implement a configuration in which the composition contains at least one preservative selected from the group consisting of polylysine, and by containing the polyhydric alcohol and the preservative, the polyhydric alcohol has a preservative promoting effect of promoting the preservative property of the preservative. It is.
With this configuration, it has the above-mentioned (effect A), and (effect B: antiseptic promoting effect due to the inclusion of polyhydric alcohol and other preservatives) propylene glycol, butylene glycol and/or glycerin as the polyhydric alcohol. By containing these parabens, it exhibits a preservative-promoting action that promotes the preservative action of preservatives other than parabens. In other words, by using these polyhydric alcohols together with preservatives other than parabens such as phenoxyethanol, glyceryl caprylate, and polylysine, it is possible to reduce the minimum preservative concentration of preservatives other than parabens. can get.
This effect was discovered during this experiment, and it is presumed that when the preservatives phenoxyethanol, glyceryl caprylate, or polylysine are added, these polyhydric alcohols have some kind of antiseptic promoting effect. Ru.

From the viewpoint of preservative properties, propylene glycol contains 3% by weight or more based on the total content, or butylene glycol contains 3% by weight or more based on the total content, or glycerin contains 3% or more by weight based on the total content. A composition containing 5% by weight or more is desirable and practicable, and exhibits a preservative promoting effect. As a polyhydric alcohol, if the content of propylene glycol alone or butylene glycol alone is less than 3% by weight, or if the content of glycerin alone is less than 5% by weight, there is a tendency that a sufficient antiseptic promoting effect will not be exhibited. be.
Note that when the polyhydric alcohol content exceeds 50% by weight, particularly when used as a patch, shape retention and post-peeling residue suppression tend to be poor.
A structure containing both propylene glycol and butylene glycol and a total amount of 3% by weight or more is also possible, and exhibits a preservative promoting effect. A composition containing two or more of propylene glycol, butylene glycol, and glycerin and a total amount of 3% by weight or more of these polyhydric alcohols is also possible, and exhibits a preservative promoting effect.

Note that a water-containing composition that does not contain parabens, but contains propylene glycol, butylene glycol, and/or glycerin, and also contains a preservative other than the above-mentioned parabens also exhibits excellent antiseptic properties.
In addition, even if the water-containing composition contains parabens in an amount of 0.05% by weight or less based on the total amount, and also contains the above-mentioned polyhydric alcohol and a preservative other than parabens, the preservative It can be expected to have a good effect on skin sensitization and reduce skin sensitization.

According to known literature, the above polyhydric alcohol has the following properties.
Propylene glycol has a melting point of -59°C and a boiling point of 188.2°C, and has a slightly viscous liquid state at room temperature, is easily miscible and compatible with water, and is easily miscible and compatible with ethanol. Dipropylene glycol has a melting point. It has a boiling point of -39°C and a boiling point of 232.2°C, is a viscous liquid at room temperature, is easily miscible and compatible with water, and is easily miscible and compatible with ethanol. Butylene glycol is also known as 1,3-butylene glycol, 1,3-butanediol, or 1,3-dihydroxybutane, and has a viscous liquid state at room temperature and is easily miscible and compatible with water. It is easily miscible and compatible with ethanol. Glycerin, also known as glycerol, has a melting point of approximately 18°C, but it is easily supercooled and difficult to crystallize. It is a highly viscous liquid at room temperature, is easily miscible and compatible with water, and is compatible with ethanol. They are easily miscible and compatible.

<About water-containing compositions containing preservatives other than parabens>
In the aqueous composition of the present invention, the preservative other than parabens is a group consisting of phenoxyethanol soluble in polyhydric alcohol, glyceryl caprylate soluble in polyhydric alcohol, and polylysine soluble in water. A configuration containing at least one preservative other than parabens selected from the following can be implemented.

With this structure, the structure contains at least one preservative selected from the group consisting of phenoxyethanol, glyceryl caprylate, and polylysine. When used by people with low skin resistance, it is expected to reduce skin sensitization such as irritation on the skin that comes into contact with it, and it also contains functional ingredients dissolved in water that have excellent antiseptic properties. A water-containing composition and a cosmetic product or patch comprising the water-containing composition can be obtained.

Further, the preservatives other than the parabens may be phenoxyethanol, which is soluble in the water and/or the polyhydric alcohol, or phenoxyethanol, which is sparingly soluble in the water but soluble in the polyhydric alcohol, without containing a paraben preservative. A configuration containing at least one preservative selected from the group consisting of soluble glyceryl caprylate and the water-soluble polylysine preservative is also possible. As a result, a water-containing composition can be obtained which exhibits the above-mentioned effect of reducing skin sensitization (effect I-abd: reduced skin sensitization and excellent antiseptic properties) even more markedly.

Table 1 shows the known physical properties of the preservative contained in the aqueous composition of the present invention. Known literature discloses the solubility of these preservatives in water, ethanol, propylene glycol, etc., but no data on solubility in other polyhydric alcohols could be found.

<About the water-containing composition containing phenoxyethanol>
In the aqueous composition of the present invention, it is preferable that the preservative other than parabens contains phenoxyethanol in an amount of 0.2 to 1.0% by weight based on the total content. More preferably, phenoxyethanol is dissolved or mixed in a water-containing composition.
With this composition, (Effect A-a: Contains phenoxyethanol, reduced skin sensitization, excellent antiseptic properties) Due to the composition containing dissolved or mixed phenoxyethanol, it can be used by people with low skin resistance. A water-containing composition containing a functional ingredient dissolved in water is expected to reduce skin sensitization such as irritation on the skin that comes into contact with it, and also exhibits excellent antiseptic properties.

Further, it is also possible to implement a configuration in which the preservative other than the parabens contains a phenoxyethanol preservative without containing a paraben preservative. As a result, a water-containing composition can be obtained which exhibits the above-mentioned effect of reducing skin sensitization (effect A-a: reduced skin sensitization and excellent antiseptic properties) even more markedly.

Phenoxyethanol is a colorless, transparent, slightly viscous liquid with a boiling point of about 245° C. and a freezing point of about 13° C., and a slight aroma, and is widely used as an excellent solvent for various organic substances. It is also used as a preservative in the cosmetics field to prevent oxidation of contained ingredients. The solubility in water is approximately 2.8% by weight at 20°C.
On the other hand, according to known literature, parabens are difficult to dissolve in water, and the solubility in water is approximately 0.25% by weight for methylparaben, 0.17% by weight for ethylparaben, and 0.04% by weight for propylparaben. %, butylparaben is 0.02% by weight. That is, phenoxyethanol has a property of being more easily soluble in water than parabens.
Generally, according to known literature, phenoxyethanol is said to be safer for human health than parabens; however, it is desirable to keep the content as low as possible. Furthermore, when a preservative such as phenoxyethanol is contained as a preservative in a cosmetic product, the preservative effect differs significantly depending on the types of other ingredients contained in the cosmetic product. Furthermore, experiments conducted by the inventors have confirmed that phenoxyethanol dissolves in propylene glycol at room temperature, and dissolves in butylene glycol or glycerin by increasing the temperature. Even when this dissolved phenoxyethanol solution was mixed with a large amount of water, no separation or precipitation of phenoxyethanol was observed, and it was confirmed that the dissolved state in the mixed solvent of water and polyhydric alcohol was maintained. . That is, it was confirmed that phenoxyethanol is soluble in water and/or polyhydric alcohol at a predetermined ratio.

In the water-containing composition of the present invention, as a result of various experiments conducted by the inventor, the content of phenoxyethanol is preferably in the range of 0.2% to 1.0% by weight based on the total amount of the composition, and It was discovered that phenoxyethanol maintains a dissolved state in a water-containing composition without separating, and exhibits excellent antiseptic properties. More desirably, the phenoxyethanol content is in the range of 0.3% to 0.8% by weight, and it has been found that sufficient antiseptic properties can be achieved even within this range. When the phenoxyethanol content is less than 0.2% by weight, sufficient antiseptic properties cannot be obtained. If the phenoxyethanol content exceeds 1.0% by weight, it is presumed that there is a tendency for inconvenience to human health to occur.

Furthermore, at room temperature, phenoxyethanol dissolves and is compatible with water at a concentration of approximately 2% by weight, and also dissolves and is compatible with water at a concentration of approximately 3% by weight when the temperature is raised to approximately 50°C, for example. It was confirmed. Furthermore, phenoxyethanol is easily dissolved and compatible with polyhydric alcohols such as propylene glycol, dipropylene glycol, and butylene glycol, and for highly viscous glycerin, it can be heated to reduce the viscosity of glycerin. It was confirmed that they were easily dissolved in the same state and were compatible. In particular, it was confirmed that phenoxyethanol is easily soluble and compatible even at room temperature in the presence of both water and polyhydric alcohol solvents.
Further, in a water-containing composition containing a crosslinkable water-soluble polymer and/or a non-crosslinkable water-soluble polymer dissolved in water and a polyhydric alcohol, and also containing about 1.0% by weight of phenoxyethanol, It was confirmed that the phenoxyethanol was maintained in a dissolved state without separating or precipitating even at a low temperature of about 10°C.

<About the water-containing composition containing glyceryl caprylate>
In the aqueous composition of the present invention, it is preferable that the preservative other than parabens is glyceryl caprylate in an amount of 0.01 to 0.8% by weight based on the total content. More preferably, glyceryl caprylate is dissolved or mixed in a water-containing composition containing a polyhydric alcohol.
With this composition, (Effect A-B: Glyceryl caprylate, reduced skin sensitization, excellent antiseptic properties) Due to the composition containing glyceryl caprylate dissolved in polyhydric alcohol or mixed without separation, the skin A water-containing composition containing functional ingredients dissolved in water, which is expected to reduce skin sensitization such as skin irritation when used by people with low resistance, and has excellent antiseptic properties. is obtained.

In particular, it is also possible to implement a configuration in which glyceryl caprylate is contained as a preservative other than parabens without containing a paraben preservative. Thereby, a water-containing composition can be obtained which exhibits the above-mentioned effect of reducing skin sensitization (effect E-b: reduced skin sensitization and excellent antiseptic properties) even more markedly.

According to known literature, glyceryl caprylate is a waxy semi-solid at room temperature, becomes liquid at elevated temperatures, is insoluble in water, and easily dissolves in ethanol. It has both bactericidal and emulsifying properties and is widely used in cosmetics.
Although no known data on the solubility of glyceryl caprylate in polyhydric alcohols was found, the inventor conducted various experiments and found that glyceryl caprylate was insoluble in water but easily soluble in propylene glycol. However, it was confirmed that these polyhydric alcohols or glyceryl caprylate dissolve in high-viscosity polyhydric alcohols such as dipropylene glycol, butylene glycol, and glycerin when heated, and have compatibility and miscibility. That is, it was confirmed that glyceryl caprylate can be dissolved in polyhydric alcohol. Furthermore, even when glyceryl caprylate dissolved in these polyhydric alcohols is mixed into a composition containing water and a water-soluble polymer dissolved in water, the glyceryl caprylate phase such as clouding and separation may occur. No phenomenon of poor miscibility such as poor solubility was observed, and it was confirmed that a well-dissolved or mixed state was maintained in the produced water-containing composition. Additionally, it was separately confirmed that glyceryl caprylate is soluble in, compatible with, and miscible with ethanol.

As a result of various experiments conducted by the inventor, the content of glyceryl caprylate is desirably in the range of 0.01 to 0.8% by weight based on the total amount of the composition, and within this range, glyceryl caprylate is added to the water-containing composition. It has been found that it maintains a dissolved state without separating in products, and exhibits excellent antiseptic properties. More desirably, the content of glyceryl caprylate is in the range of 0.02% to 0.5% by weight, and it has been found that sufficient antiseptic properties can be achieved even within this range. When the glyceryl caprylate content is less than 0.01% by weight, sufficient antiseptic properties cannot be obtained. If the glyceryl caprylate content exceeds 0.8% by weight, it is presumed that there is a tendency for inconvenience to human health to occur.

<About the water-containing composition containing polylysine>
In the water-containing composition of the present invention, it is preferable that the composition contains polylysine in an amount of 0.01 to 0.8% by weight based on the total content as a preservative other than parabens. More preferably, polylysine is dissolved or mixed in a water-containing composition.
With this composition, (Effect I-d: paraben-free, polylysine, reduced skin sensitization, excellent antiseptic properties) polylysine is dissolved in water and/or polyhydric alcohol or mixed without separation. Due to its composition, when used by people with low skin resistance, it is expected to reduce skin sensitization such as irritation on the skin that comes into contact with it, and also has a water-containing composition containing water and functional ingredients that has excellent antiseptic properties. You can get things.

Further, it is also possible to implement a configuration in which the preservative other than parabens contains a polylysine preservative without containing a paraben preservative. Thereby, a water-containing composition can be obtained which exhibits the above-mentioned effect of suppressing skin sensitization (Effect I-d: reduced skin sensitization and excellent antiseptic properties) even more markedly.

Polylysine is a polyamino acid with a melting point of about 173°C, L-lysine, which is an essential amino acid, connected in a linear chain, and is soluble in water. It is widely used as a food preservative and preservative because of its stability and health safety.
As a result of various experiments conducted by the inventor, the content of polylysine is desirably in the range of 0.01 to 0.8% by weight based on the total amount of the composition, and within this range, polylysine is separated in the water-containing composition. It has been found that the dissolved state can be maintained without any oxidation, and that it exhibits excellent antiseptic properties. More desirably, the antibacterial content of polylysine is in the range of 0.02% to 0.5% by weight, and it has been found that sufficient antiseptic properties can be achieved even within this range. When the polylysine antibacterial content is less than 0.01% by weight, sufficient antiseptic properties cannot be obtained. If the polylysine antibacterial content exceeds 0.8% by weight, it is presumed that there is a tendency for inconvenience to human health to occur.

Furthermore, even when a polylysine solution dissolved in water is mixed with a polyhydric alcohol such as propylene glycol, dipropylene glycol, propanediol, butylene glycol, glycerin, or sorbitol, no precipitation of polylysine is observed. No phenomena such as precipitation or separation of polylysine were observed.
Furthermore, even when a polylysine solution dissolved in water is mixed with a composition containing water, a functional component dissolved in water, and a polyhydric alcohol, phenomena such as precipitation and separation of polylysine such as clouding are observed. It was confirmed that the solution remained well dissolved in the resulting water-containing composition.

<Aqueous composition containing both phenoxyethanol and other preservatives>
In the aqueous composition of the present invention, a configuration in which the preservative other than parabens contains both phenoxyethanol and a glyceryl caprylate and/or polylysine preservative can be preferably implemented.
With this composition, (effect B: preservative synergistic effect between phenoxyethanol and other preservatives, reduced skin sensitization, and excellent antiseptic properties), the preservatives of both phenoxyethanol and glyceryl caprylate and/or polylysine preservatives can be used. By having a structure containing a preservative, the content of phenoxyethanol can be further reduced, and the content of other preservatives such as glyceryl caprylate and/or polylysine used in combination can also be significantly reduced. Even in a composition with a small total content of water, a water-containing composition containing water and functional ingredients that exhibits sufficient antiseptic properties can be obtained. In other words, the composition containing both the preservatives, glyceryl caprylate and/or polylysine, in addition to phenoxyethanol, provides superior results compared to the use of these preservatives alone at the same preservative concentration. The effect of exhibiting antiseptic properties can be obtained.

FIG. 2 is a diagram illustrating an example of determining the effect of antiseptic properties caused by blending two types of preservatives.
When two types of preservatives having antiseptic properties are contained, the preservative effects caused by them are broadly classified into synergistic, additive, and antagonistic effects. Synergistic action is an action in which two types of preservatives act synergistically to further enhance their inherent preservative power. Additive effect is the effect of combining the preservative powers of each preservative. Antagonism is the effect of one preservative canceling out the preservative power of another preservative. For example, as shown in FIG. 2, the minimum preservative concentration is determined from a graph in which the respective content ratios of phenoxyethanol, glyceryl caprylate, or polylysine are measured. According to this, the minimum preservative concentration in only phenoxyethanol is 0.2% by weight (point X) according to Example 1 described below, and the minimum preservative concentration in only glyceryl caprylate or only polylysine is determined by Example 2 and According to Example 3, each preservative concentration is 0.01% by weight (point Y), and a straight line XY connecting this point X and point Y is drawn, and the minimum preservative concentration when both preservatives are used together is: If the location is on the inside (lower side) of this straight line If it is located at (e.g., point P), it is determined that there is an additive effect, and if it is outside (above) the straight line be able to.

<About water containing preservatives of both phenoxyethanol and glyceryl caprylate>
In the water-containing composition of the present invention, the minimum content of preservatives other than parabens is determined based on the total amount in the XY coordinate with the phenoxyethanol content as the X axis and the glyceryl caprylate content as the Y axis. In the XY coordinate with the amount as the X axis and the glyceryl caprylate content as the Y axis, point M where the phenoxyethanol content on the X axis is 0.17% by weight and the glyceryl caprylate content on the Y axis is 0.007 weight%. A configuration in which both phenoxyethanol and glyceryl caprylate preservatives are contained in an area above the straight line MN connecting point N, which is %, is desirable and practicable.
It is presumed that as the content of phenoxyethanol and glyceryl caprylate increases, there is a tendency for disadvantages to human health to occur.Preferably, the maximum content of phenoxyethanol is 0.9% by weight or less, and the maximum content of glyceryl caprylate is A composition in which the amount is 0.8% by weight or less is desirable, and a content as small as possible within this range is desirable.

With this structure, (low-effect: antiseptic synergistic effect of phenoxyethanol and glyceryl caprylate, reduced skin sensitization, excellent antiseptic properties), it contains both preservatives of phenoxyethanol and glyceryl caprylate. With this structure, the content of phenoxyethanol can be reduced, and the content of glyceryl caprylate used in combination can also be significantly reduced, making it possible to maintain sufficient preservative properties even in compositions with a small total content of preservatives. A water-containing composition containing water and a functional component that exhibits the following properties can be obtained. In other words, the composition containing both phenoxyethanol and glyceryl caprylate as preservatives has a more excellent preservative effect than the use of these preservatives alone at the same preservative concentration. can get.

In particular, it is also possible to implement a structure in which the preservatives of both phenoxyethanol and glyceryl caprylate are contained without containing parabens. As a result, a water-containing composition can be obtained which exhibits the above-mentioned effect of reducing skin sensitization (low-ab: preservative synergistic effect, reduced skin sensitization, excellent antiseptic properties) even more markedly.

<About the water-containing composition containing both phenoxyethanol and polylysine preservatives>
In the water-containing composition of the present invention, the minimum content of preservatives other than parabens is the phenoxyethanol content in the XY coordinate with the phenoxyethanol content as the X axis and the polylysine content as the Y axis relative to the total amount. In the XY coordinate with the X axis as the polylysine content and the Y axis as the polylysine content, point M on the X axis where the phenoxyethanol content is 0.17% by weight, and point N on the Y axis where the polylysine content is 0.007% by weight. A configuration in which both phenoxyethanol and polylysine preservatives are contained in the region above the straight line MN connecting the two is desirable and practicable.
It is presumed that as the content of phenoxyethanol and polylysine increases, there is a tendency for inconvenience to human health to occur, and it is desirable that the maximum content of phenoxyethanol is 0.9% by weight or less, and the maximum content of polylysine is 0.9% by weight or less. A composition in which the content is 8% by weight or less is desirable, and a content as small as possible within this range is desirable.

With this structure, (low effect: preservative synergistic combination of phenoxyethanol and polylysine, reduced skin sensitization, excellent antiseptic properties), phenoxyethanol This makes it possible to significantly reduce the content of polylysine that is used in combination with water and functionality, which provides sufficient preservative properties even in compositions with a small total content of preservatives. A water-containing composition comprising a water-containing composition containing the components is obtained. In other words, the composition containing both phenoxyethanol and polylysine preservatives provides a more excellent preservative effect than the use of these preservatives alone at the same preservative concentration. .
Further, it is also possible to implement a structure in which both phenoxyethanol and polylysine preservatives are contained without containing parabens. As a result, a water-containing composition that exhibits the above-mentioned (low-ad: preservative synergistic effect, reduced skin sensitization, excellent antiseptic properties) effect of reducing skin sensitization can be obtained.

<About the water-containing composition containing multiple preservatives: phenoxyethanol, glyceryl caprylate, and polylysine>
In the water-containing composition of the present invention, the minimum content of preservatives other than parabens is expressed in an XY coordinate with the phenoxyethanol content as the X axis and the total content of glyceryl caprylate and polylysine as the Y axis relative to the total amount. In the XY coordinate, where the phenoxyethanol content is the X axis and the total content of glyceryl caprylate and polylysine is the Y axis, point M where the phenoxyethanol content is 0.17% by weight on the X axis and glyceryl caprylate on the Y axis. It is desirable that the preservatives of phenoxyethanol, glyceryl caprylate, and polylysine are both contained in the region above the straight line MN connecting the point N where the total polylysine content is 0.007% by weight. It is possible to implement.
With this composition, multiple preservatives such as phenoxyethanol, glyceryl caprylate, and polylysine (low-effect synergistic antiseptic combination of phenoxyethanol, glyceryl caprylate, and polylysine, reduced skin sensitization, and excellent antiseptic properties) are used. Due to the composition containing phenoxyethanol, it is possible to reduce the content of phenoxyethanol and also to significantly reduce the content of polylysine and glyceryl caprylate used together, even in compositions with a small total content of preservatives. A water-containing composition containing water and a functional component, which exhibits sufficient antiseptic properties, can be obtained. In other words, the composition containing both the preservatives polylysine and glyceryl caprylate in addition to phenoxyethanol has the effect of exhibiting superior preservative properties compared to the use of these preservatives alone at the same preservative concentration. is obtained.

Further, desirably, a configuration can be implemented in which a plurality of preservatives including phenoxyethanol, glyceryl caprylate, and polylysine are included without containing parabens. Thereby, a water-containing composition can be obtained which exhibits the above-mentioned effect of reducing skin sensitization (low-abd: antiseptic synergistic effect, reduced skin sensitization, excellent antiseptic properties) even more markedly.

<About a water-containing composition containing a preservative other than parabens and 0.05% by weight or less of parabens>
In the aqueous composition of the present invention, the aqueous composition may further contain (F) 0.05% by weight or less of parabens based on the total amount, in addition to a preservative other than parabens. .
Parabens have the property of being sparingly soluble in water and soluble in polyhydric alcohol, but in this configuration, parabens are contained in a dissolved form in a water-containing composition containing water and polyhydric alcohol. Ru.
With this composition, (Effect C: reduced parabens, reduced skin sensitization, excellent antiseptic properties), it contains significantly less parabens, which have been reported to be skin sensitizers, than conventional products, and also contains phenoxyethanol. By using it in combination with other preservatives such as glyceryl caprylate, polylysine, etc., the content of parabens can be significantly reduced and skin sensitization can be reduced. Even when used by people with low resistance, a water-containing composition is expected to reduce skin sensitization such as irritation on the skin that comes into contact with it, and also has excellent antiseptic properties.

Since parabens have skin sensitizing properties, compositions that do not contain parabens are most desirable; however, in addition to compositions that contain preservatives other than parabens, such as phenoxyethanol, glyceryl caprylate, and polylysine. It is also possible to implement compositions containing parabens in as low a content as possible, resulting in a water-containing composition with reduced skin sensitization.
Since skin sensitization varies depending on the user, it is not possible to clearly define the permissible content of paraben preservatives, but the content of paraben preservatives should be as low as possible, 0.05% by weight or less. If the content of the paraben preservative exceeds 0.05% by weight based on the total amount, skin sensitization tends to occur.
In a composition containing 0.05% by weight or less of parabens based on the total amount to reduce skin sensitization, and containing a preservative other than the above parabens, the composition contains a preservative other than the above parabens. Excellent preservative properties can be obtained even in a composition in which the minimum content of preservatives other than the parabens is reduced compared to a composition containing the preservative alone. When the preservative other than parabens is phenoxyethanol, the minimum content of 0.2% by weight can be reduced to a minimum content of 0.1% by weight, and when it is glyceryl caprylate, the minimum content is 0.01% by weight. The minimum content of % by weight may be reduced to a minimum content of 0.005% by weight, and in the case of polylysine, the minimum content of 0.01% by weight may be reduced to a minimum content of 0.005% by weight. It is possible to obtain excellent preservative properties.

<About the dissolution state of the contained preservatives in water>
In the water-containing composition of the present invention, a structure in which the preservative is contained in a dissolved state in the water-containing composition can be preferably implemented.
With this configuration, each of the above-mentioned effects of "Effect A", "Effect B", and "Effect C" is more significantly exhibited. (Skin sensitization and excellent preservative properties) In water-containing compositions containing preservatives other than parabens, the content of preservatives can be significantly reduced by containing the preservatives in a dissolved state. Even with this composition, it is expected to reduce skin sensitization such as skin irritation when used by people with low skin resistance, and it also contains water and water-soluble polymers that have excellent antiseptic properties. A water-containing composition is obtained. In particular, when used by people with low skin resistance, such as infants and the elderly, a significant improvement in skin sensitization such as skin irritation can be expected.

<About the structure in which the functional component is a water-soluble polymer>
In the water-containing composition of the present invention, the functional component is a water-soluble polymer that can be dissolved in water, and the water-soluble polymer is dissolved in the water, and the water, water-soluble polymer, polyhydric alcohol, and Preservatives other than parabens are desirably dissolved or compatible with each other.

As the water-soluble polymer as the functional component, the following crosslinkable water-soluble polymers and/or non-crosslinkable water-soluble polymers can be used.
(a) Contains a crosslinkable water-soluble polymer that can be crosslinked into a network structure in terms of molecular structure, and at around room temperature of about 18 to about 30°C, the crosslinkable water-soluble polymer is in the presence of a crosslinking agent. , has a crosslinked gel-like state with no fluidity when dissolved in water.
(b) Contains a crosslinkable water-soluble polymer that can be crosslinked into a network structure in terms of molecular structure, and at room temperature of about 18 to about 30°C, the crosslinkable water-soluble polymer in the absence of a crosslinking agent. , has a fluid viscous form that is not crosslinked when dissolved in water.
(c) Contains a non-crosslinkable water-soluble polymer that is not crosslinked in its molecular structure, and the non-crosslinkable water-soluble polymer is not crosslinked when dissolved in water at around room temperature of about 18 to about 30°C. It has a fluid and viscous consistency.
(d) It has both a water-soluble polymer, a cross-linkable water-soluble polymer that can be cross-linked into a network structure in its molecular structure, and a non-cross-linkable water-soluble polymer that is not cross-linked in its molecular structure, and has a molecular structure of about 18 to about 30 At around room temperature of ℃, the crosslinkable water-soluble polymer has a non-flowable gel-like state that is crosslinked in the water-dissolved state in the presence of a crosslinking agent, and the non-crosslinkable water-soluble polymer The polymer has a fluid and viscous form that is not crosslinked when dissolved in water.

<About crosslinkable water-soluble polymers>
A crosslinkable water-soluble polymer is soluble in water before crosslinking and has fluidity as dissolved in water, and after crosslinking, it is in a state dissolved in water and/or in a state containing water. It has the property of becoming gel-like, which is a non-flowing state. Crosslinkable water-soluble polymers have the property of being crosslinkable into a network structure in terms of molecular structure through a chemical reaction with a crosslinking agent.
The crosslinkable water-soluble polymer is not particularly limited, but includes, for example, (i) polymerized acrylic acid monomers of at least one of acrylic acid, methacrylic acid, and monovalent metal salts thereof; The resulting crosslinked acrylic acid polymer, (ii) at least one acrylic acid monomer selected from (a) acrylic acid, methacrylic acid, and a monovalent metal salt thereof, and (b) an alkyl acrylate. and at least one alkyl acrylate monomer of alkyl methacrylate, (iii) a partially neutralized portion of polyacrylic acid; Japanese polyacrylic acid, (iv) a crosslinked carboxyvinyl polymer, and (v) a crosslinked cellulose compound of carboxyalkyl cellulose sodium and/or hydroxyalkyl cellulose sodium (as an alkyl group, for example, a methyl group, At least one crosslinkable water-soluble polymer selected from the group consisting of ethyl group, probyl group, etc.) can be used.
As the partially neutralized polyacrylic acid, partially neutralized sodium polyacrylate, which is obtained by neutralizing a portion of the carboxylic acid groups of polyacrylic acid with monovalent ions such as sodium, is used.

With this configuration, the above-mentioned (effect 1: reduced skin sensitization and excellent antiseptic properties) can be obtained, as well as (effect 2: comfortable water retention, flexibility and shape retention due to the inclusion of crosslinkable water-soluble polymer). (Skin sensitization, excellent antiseptic properties) Due to the inclusion of crosslinkable water-soluble polymers, the crosslinkable water-soluble polymers dissolved in water are crosslinked into a network structure in their molecular structure through a chemical reaction with a crosslinking agent. It has a structure that changes from a fluid state to a gel state with no fluidity, and has shape retention that can maintain its shape even against external pressure, as well as water retention that can retain a large amount of water. It has the effect of changing the state of the composition into a gel-like water-containing composition that has comfortable water-retaining flexibility and shape-retaining properties and is inhibited from running off when it adheres to human skin.

The crosslinkable water-soluble polymer is easily dissolved in water, and the crosslinkable water-soluble polymer dissolved in water becomes a water-containing crosslinkable water-soluble polymer that retains a large amount of water and has a viscous viscosity. It has the property of becoming a viscous liquid. When this water-containing crosslinkable water-soluble polymer is dissolved in water and mixed with a crosslinking agent, it chemically reacts and becomes crosslinked into a network structure in its chemical structure. It changes into a gel-like water-containing composition that has shape, water retention, and flexibility. The water-containing composition has a predetermined amount of bound water, dissolved water, and free water.
The molecular weight of the crosslinkable water-soluble polymer is not particularly limited, but a crosslinkable water-soluble polymer with a molecular weight of about 10,000 to about 10 million is used, but as the molecular weight increases, the viscosity when dissolved in water increases. The crosslinking density of the crosslinkable water-soluble polymer is not particularly limited. The water-retaining, flexible, and shape-retaining properties of water-containing compositions tend to become hard. The type of agent is selected and used.

As the content of the crosslinkable water-soluble polymer increases, the effect of maintaining the shape retention of the gel-like water-containing composition formed by the crosslinking chemical reaction increases and the water retention property also improves. If the content of the polymer is too large, the adhesive tends to become hard in terms of water retention, flexibility, and shape retention, and tends to feel uncomfortable when applied to human skin. As the content of cross-linkable water-soluble polymer decreases, the gel's shape retention ability to maintain its shape even against external pressure decreases, as well as its water-retention ability, which indicates that the content of cross-linkable water-soluble polymer is too low. In this case, the effect of changing the state of the water-containing composition into a gel-like water-containing composition that can maintain the shape-retaining properties of the gel tends to decrease.

<About crosslinking agent>
Examples of the crosslinking agent include, but are not limited to, polyvalent metal ionic compounds such as magnesium, calcium, zinc, and aluminum, aluminum hydroxide, aluminum chloride, aluminum sulfate, magnesium aluminum hydroxide, potassium aluminum hydroxide, Potassium aluminum sulfate (also known as alum), magnesium aluminate metasilicate, aluminum glycinate (also known as dihydroxyaluminum aminoacetate, aluminum glycine), magnesium aluminate metasilicate, aluminum nitrate, aluminum sulfate, aluminum acetate, etc. alone or Any combination of two or more crosslinking agents can be used.
Such polyvalent metal ionic compounds chemically react with the carboxylic acid or carboxylic acid ion of the crosslinkable water-soluble polymer dissolved in the medium, resulting in a chemical structure with a network structure and no fluidity. , has the effect of producing a gel-like water-containing composition that has shape retention, water retention, and flexibility.

The content of the crosslinking agent is not particularly limited, but is, for example, 0.001 to 1% by weight, preferably 0.005 to 0.5% by weight. If the content of the crosslinking agent is less than 0.001, the crosslinking reaction of the crosslinkable water-soluble polymer will be incomplete, and the desired gel strength and comfortable water retention flexibility and shape retention of the water-containing composition will not be obtained. Tend. When the content of the crosslinking agent exceeds 1% by weight, the unreacted crosslinking agent remains in the water-containing composition, which may result in unexpected adverse effects without obtaining any benefit.

<About non-crosslinked water-soluble polymers>
The non-crosslinkable water-soluble polymer functions to impart or control the flexibility, adhesiveness, and/or easy-peel adhesiveness of the water-containing composition when it is formed into a patch.
As the non-crosslinkable water-soluble polymer, a polymer material that is easily soluble in water is applied, and examples include, but are not limited to, polyvinyl alcohol, polyethylene glycol, polypropylene glycol, starch acrylate, alkyl polyacrylate, and polyvinyl. Pyrrolidone, a copolymer of alkyl acrylate and a submonomer, non-crosslinked cellulose, gelatin, agar, etc. can be used.
As the polyalkyl acrylate, for example, ethyl polyacrylate, butyl polyacrylate, ethylhexyl polyacrylate, octyl polyacrylate, decyl polyacrylate, etc. can be used. As the submonomer copolymerized with the alkyl acrylate, for example, vinyl acetate, methyl methacrylate, maleic anhydride, hydroxyethyl acrylate, etc. can be used. As the non-crosslinked cellulose, carboxyalkyl cellulose, hydroxyalkyl cellulose, etc. can be used.

Other water-soluble polymers include hyaluronic acid, alginic acid, sodium alginate, carrageenan, glucomannan, xanthan gum, guar gum, dulan gum, Ernest gum, locust bean gum, pectin, agarose, dextrin, glucomannan, polyglutamic acid, and polyglutamic acid. Salts, partially neutralized products of polyglutamic acid, alginic acid, salts of alginic acid, etc. can also be used.

These non-crosslinked water-soluble polymers are soluble in water or have good compatibility with water, and have the characteristics of viscosity, flexibility, tackiness, and non-stickiness characteristic of each non-crosslinked water-soluble polymer. A water-containing composition having desired viscosity, flexibility, tackiness, easy-peel tackiness, ability to control residual tackiness after peeling, etc. corresponding to the properties of the non-crosslinkable water-soluble polymer. can get things. For example, gelatin, collagen, agar, etc. have the property of suppressing adhesion, and when used as adhesives that control easy-peel adhesion and residual adhesion after removal when used as adhesives that control residual adhesion after peeling. act.

As the content of non-crosslinked water-soluble polymer increases, it becomes possible to retain a large amount of sufficient water, and the flexibility and viscosity, which increases flexibility and viscosity, also improves. If the content is too large, the flexibility tends to become hard.

With this configuration, the above-mentioned (effect A: reduced skin sensitization and excellent antiseptic properties) can be obtained, as well as (effect E: comfortable water retention, flexibility and adhesiveness due to the inclusion of non-crosslinked water-soluble polymer). Contains a non-crosslinked water-soluble polymer dissolved in a water-soluble polymer, which has water-retaining properties capable of retaining a large amount of water, and has a comfortable flexibility and adhesiveness when attached or pasted on human skin. The effects of water retention, flexibility and adhesiveness can be obtained.

In particular, in a patch comprising the water-containing composition of the present invention, (Effects: easy-peel adhesion and post-peel residue suppression properties due to the inclusion of non-crosslinkable water-soluble polymer), non-crosslinkable water-soluble polymer By selecting and containing gelatin, agar, etc. that can suppress stickiness as a molecule, an appropriate pressing force can be achieved in a composition containing at least a crosslinkable water-soluble polymer, water, and a non-crosslinkable water-soluble polymer. Due to this, there is adhesiveness or tackiness at the time of application that sticks to the human skin, persistent adhesiveness that is difficult to peel off during daily movements while using the adhesive, and damage to the skin when removed from the skin. It has an easy-to-peel adhesive property that allows it to be removed without causing significant discomfort or irritation to the skin, and when a patch containing hydrated organisms attached to the skin is removed from the skin, a part of the hydrated composition is removed. It is possible to obtain a patch that has both easy-peel adhesion and post-peel residue suppressing properties, as well as post-peel residue suppressing properties to the extent that no residual adhesion remains on the skin.

These non-crosslinkable water-soluble polymers are soluble in water and have the property of increasing the viscosity of the water-containing composition; however, the water-containing composition containing these non-crosslinkable water-soluble polymers An action that can suppress the remaining water-containing composition from adhering to the skin when a patch having the following properties is applied to the human skin and the water-containing composition applied to the skin is peeled off from the skin after a certain elapsed time. has.

<About a water-containing composition containing a crosslinkable water-soluble polymer that does not contain a crosslinking agent and is not crosslinked>
In the composition structure containing the above-mentioned crosslinkable water-soluble polymer, a structure containing no crosslinking agent is also possible. In this case, the crosslinkable water-soluble polymer is not crosslinked and has fluidity at higher temperatures than room temperature, and as the temperature decreases, it becomes a gel-like state with no fluidity, and the above "effect" is achieved. It exhibits an effect similar to that of non-crosslinked water-soluble polymers.
That is, in the water-containing composition, the water-soluble polymer contains a crosslinkable water-soluble polymer that can be crosslinked in terms of its molecular structure, and does not contain a crosslinking agent that can crosslink the crosslinkable water-soluble polymer in its molecular structure. , the crosslinkable water-soluble polymer includes the aforementioned (i) crosslinked acrylic acid polymer, (ii) crosslinked acrylic acid copolymer, (iii) crosslinked carboxyvinyl polymer, and (iv) crosslinked cellulose. At least one crosslinkable water-soluble polymer selected from the group consisting of a compound, which is contained in an uncrosslinked state, has a fluidity in a temperature range higher than about 50°C, and a fluidity at a temperature of about 45°C or less. It is also possible to implement a structure having a gel-like structure without any.

With this configuration, the above-mentioned (effect A: reduced skin sensitization and excellent antiseptic properties) can be obtained, and similar to the above-mentioned (effect E), (effect H-1: contained in an uncrosslinked state) Comfortable water retention due to the inclusion of a cross-linked water-soluble polymer that is dissolved in water (soft and adhesive properties). A water-containing composition having comfortable flexibility and tackiness and comfortable water-retaining flexibility and tackiness when adhered to or affixed to the substrate is obtained.

A crosslinkable water-soluble polymer dissolved in water has fluidity at high temperatures, but as the temperature decreases, it tends to become gel-like without fluidity, and its boundary temperature is It varies depending on the type, content, etc. of the crosslinkable water-soluble polymer, and it is not clear. A structure containing a crosslinkable water-soluble polymer is desirable.

<About changes in fluidity depending on temperature of a water-containing composition containing a water-soluble polymer>
In a water-containing composition containing water and a water-soluble polymer, whether the water-soluble polymer is a crosslinkable water-soluble polymer or a non-crosslinkable water-soluble polymer, the water-containing composition exhibits fluidity at high temperatures. It has the property of becoming gel-like with no fluidity as the temperature decreases.
In particular, when the water-soluble polymer is a crosslinkable water-soluble polymer and also contains a crosslinking agent, the crosslinkable water-soluble polymer gradually crosslinks into a network structure in its molecular structure due to a chemical reaction with the crosslinking agent. It becomes a gel-like form with no fluidity. The water-containing composition containing the crosslinked water-soluble polymer having a crosslinked network structure has a non-flowable gel state even at high temperatures, and maintains its non-flowable gel state even at low temperatures. .
On the other hand, compositions containing non-crosslinkable water-soluble polymers and/or crosslinkable water-soluble polymers that do not contain crosslinking agents have fluidity at high temperatures, but at low temperatures. As it grows, it becomes gel-like with no fluidity.

<About the efficacy-imparting functional ingredient as a functional ingredient contained in the water-containing composition>
The functional ingredients contained in the water-containing composition include the above-mentioned various water-soluble polymers and/or efficacy-imparting functional ingredients, and the efficacy-imparting functional ingredients include pharmacologically active ingredients, skin-improving ingredients, and fragrances. A configuration in which the component is at least one selected from the group consisting of the following is desirable and practicable.
The water-containing composition of the present invention contains a water-soluble polymer as the above-mentioned functional component, or further contains an efficacy-imparting functional component in addition to the water-soluble polymer contained as the functional component. It is possible to implement a water-containing composition having a structure such as a structure in which a water-containing composition is used, or a structure in which an efficacy-imparting functional component is contained without containing a water-soluble polymer.
The efficacy-imparting functional ingredient is contained in the water-containing composition in a dissolved state, in an emulsified state in the water-containing composition, or in a state in which fine particles thereof are dispersed.

Examples of pharmacologically active ingredients include, but are not limited to, indomethacin, loxoprofen, ketoprofen, diclofenac, diclofenac sodium, felbinac, piroxicam, suprofen, ibuprofen, ketorolac, lidocaine, flurbiprofen, mefenamic acid, dipotassium glycyrrhizinate, salicylic acid. Analgesic and anti-inflammatory agents such as esters, antipruritics, emollients, hair preparations, bath preparations, and other skin preparations can be used.

Skin-improving ingredients include, but are not particularly limited to, tocopherols such as tocopherol acetate, placenta extracts, hyaluronic acids, econzyme, arbutin, collagens, polyphenols, allantoin, squalane, panthenol, chamomile extract, Hamamelis extract, Lavender extract, pearl barley extract, plantain extract, rice extract, salmon ovary extract, Saccharomyces, rice fermentation liquid, vitamin C, vitamin E, other vitamins, etc. can be used. When a water-containing composition containing such skin-improving ingredients is applied, adhered, or pasted to the skin of a human body, it can whiten/beautify the face, remove spots and freckles on the skin, etc., depending on the skin-improving ingredients. It can have effects such as removing and reducing skin wrinkles, improving skin wrinkles, and moisturizing the skin.

The aromatic component that generates a fragrance is not particularly limited, but, for example, essential oil components (essential oils) commonly used in aromatherapy can be used. Examples of the aromatic components include those described in "84 Essential Oil Ingredients for Aromatherapy" by Wonder Seller, published by Fragrance Journal. For example, anise, angelica, benzoin, immortelle, chamomile, garlic, cardamom, galbanum, caraway, carrot seed, guaiac wood, grapefruit, cypress, cedarwood, star anise, sage, geranium, celery, thyme, tarragon, turpentine, frankincense, Violet, pine, parsley, fennel, black pepper, bodega, lemon, lemongrass, rosemary, laurel, meadowflower, meadowsweet, cornflower, almond, arnica, fennel, broom, watercress, gentian, camphor, plum, pear, thornweed Examples include, but are not limited to, extracts from , dandelion, chimo, chorei, chili pepper, wild rose, mentha, ash, bouquet, melissa, peach, mistletoe, eucalyptus, chinensis, lavender, forsythia, and the like.

(Efficacy) By applying, adhering or pasting a water-containing composition containing the efficacy-imparting functional ingredient to the skin of the human body, such as the forehead, armpits, neck, limbs, etc., the efficacy-imparting functionality is achieved. In response to this, it has pharmacologically active effects such as analgesic and anti-inflammatory effects, antipruritic effects, as well as efficacy-imparting effects such as whitening and beautifying the face, removing and reducing skin spots and freckles, improving skin wrinkles, moisturizing the skin, and improving skin. can be played.

<About additional components contained in the water-containing composition>
The water-containing composition of the present invention further contains an additional component, and the additional component is (K-1) an accidental ingestion prevention component that has a function of suppressing accidental ingestion by giving a bitter taste when put in the mouth; K-2) A cooling sensation-imparting component that provides a cooling sensation, (K-3) a warming sensation-imparting component that provides a warming sensation, and (K-4) a pH-adjusting component that adjusts pH. Configurations containing at least one additional component are also possible.

The ingredient to prevent accidental ingestion is disodium benzoate, the cooling sensation imparting ingredient is menthol and/or peppermint oil, the warming sensation imparting ingredient is capsaicin and/or chili pepper ingredient, and the pH adjusting ingredient is citric acid without particular limitation. , acetic acid, tartaric acid, sodium hydroxide, and other general-purpose acidic or alkaline substances can be used.
As an agent for preventing accidental ingestion, disodium benzoate is effective, and by containing a small amount of disodium benzoate, it gives a bitter taste when put in the mouth, and has the function of suppressing accidental ingestion.
Denodium benzoate is a solid powder with a melting point of about 166 to 170°C, has a property of being soluble in water and ethanol, and is contained in a dissolved state in a water-containing composition. If a composition containing a small amount of disodium benzoate is taken into the mouth, it has the property of giving a strong bitter taste. When a person mistakenly puts this water-containing composition containing disodium benzoate in his mouth, he feels a strong bitter taste. In this configuration, (effect 1) the water-containing composition containing disodium benzoate has the effect of suppressing accidental ingestion by giving a bitter taste when put in the mouth, and is particularly effective for infants, the elderly, etc. When used by people with weak health resistance, the effect of suppressing accidental ingestion can be obtained.

As the cooling sensation imparting component, for example, menthol, peppermint oil, and brains can be used.
As the warming sensation-imparting component, for example, capsaicin, capsicum extract, or capsicum powder can be used.

<About other additives contained in the water-containing composition>
In the water-containing composition of the present invention, in order to obtain the desired performance of the water-containing composition in terms of adhesiveness, flexibility, water retention, shape retention, easy-peel adhesion, ability to suppress residue after peeling, etc., the above-mentioned In addition to water, functional ingredients such as water-soluble polymers, polyhydric alcohol, and prescribed preservatives, we also add tackifiers, softeners, humectants, plasticizers, colorants, skin absorption enhancers, and antioxidants. , UV absorbers, inorganic fillers, surfactants, stabilizers, viscosity modifiers, inorganic fillers, fine powders, silicone oil, pH adjusters, and other additive aids. is also possible.

For example, tackifiers include rosin, hydrogenated rosin, rosin ester, hydrogenated rosin ester, polyterpene, terpene phenol, phenolic resin, xylene resin, coumaron indene resin, other aliphatic resins (C5 resins), petroleum type resins, alicyclic hydrocarbon resins (hydrogenated aromatic resins), etc. can be used.
Softeners and plasticizers include polybutene, polyisobutylene, dioctyl phthalate, dibutyl phthalate, diethyl phthalate, liquid rosin ester, chlorinated paraffin, process oil, lanolin, silicone, vaseline, solid paraffin, liquid paraffin, plastic tape, and beeswax. , menthol, limonene, pinene, piperitone, terpinol, carveol, almond oil, olive oil, camellia oil, persic oil, peppermint oil, sesame oil, soybean oil, mink oil, cottonseed oil, corn oil, safflower oil, grape oil, macadamia nut oil, Egg yolk oil, safflower oil, etc. can be used.

As the coloring agent, dyes and pigments commonly used in the cosmetics field can be used.
The inorganic filler, fine powder, etc. are not particularly limited, but for example, powders and fine powders of silica, kaolin, talc, titanium oxide, mica, silicone powder, charcoal powder, etc. can be used.

Examples of pH adjusters include, but are not limited to, organic acids such as citric acid, succinic acid, tartaric acid, lactic acid, malic acid, acetic acid, gluconic acid, and maleic acid; sodium salts or potassium salts of these organic acids; Hydrochloric acid, sulfuric acid, sodium hydroxide, potassium carbonate, sodium hydrogen carbonate, calcium chloride, diisopropanolamine, etc. are used.
In order to prevent the inclusion of such a pH adjusting agent from having an adverse effect on the skin, the pH of the water-containing composition is adjusted to a range of 4 to 10, preferably a range of 5 to 9, more preferably a pH of 5 to 9. , the pH is adjusted to a range of 6 to 8.

As the stabilizer, sodium pyrosulfite, magnesium aluminate metasilicate, vanillyl nonanoate, sodium edetate, etc. can be used.
As the surfactant, various polysorbates, polyoxyethylene sorbitol tetraoleate, polyoxyethylene lauryl ether, polyethylene glycol laurate, etc. can be used.

Other additives include lanolin, liquid paraffin, beeswax, limonene, pinene, piperitone, terpinol, carveol, jojoba oil, almond oil, olive oil, camellia oil, persic oil, peppermint oil, sesame oil, soybean oil, mink oil, cottonseed oil. , corn oil, safflower oil, grape oil, macadamia nut oil, egg yolk oil, safflower oil, etc. can be used. As the silicone oil, methylsiloxane, methylphenylpolysiloxane, dodecamethylpolysiloxane, etc. can be used.

In the present invention, the water-containing composition may further contain a lower alcohol such as ethanol and/or propyl alcohol, and/or a surfactant. Such lower alcohols and surfactants are used as solubilizing agents to facilitate the dissolution or uniform dispersion of functional components, additional components, preservatives, and other additives. For example, in step (d) of FIG. 1, additional components are used dissolved in water, polyhydric alcohol, lower alcohol and/or surfactant.
When pharmacologically active ingredients, skin-improving ingredients, functional ingredients that impart efficacy such as fragrance ingredients, additional ingredients such as ingredients that impart a cooling sensation, ingredients that prevent accidental ingestion, preservatives, and other additives cannot be dissolved in water or polyhydric alcohol. contains the minimum necessary lower alcohol or surfactant, and dissolves or emulsifies these efficacy-imparting functional ingredients, additional ingredients, other additives, etc. into a water-containing composition and uniformly contains them. It is possible to prepare moistened aqueous compositions. A solution of the efficacy-imparting functional ingredients, additional ingredients, preservatives, and other additives containing lower alcohols or surfactants is prepared by dissolving or uniformly dispersing them, and then, A solution of the efficacy-imparting functional ingredients and additional ingredients is mixed with a composition containing polyhydric alcohol and water, thereby preparing a water-containing composition uniformly containing the efficacy-imparting functional ingredients and additional ingredients. I can do it. The content of lower alcohols such as ethanol and propyl alcohol is preferably about 10% by weight or less based on the total weight of the water-containing composition. When the content of lower alcohols exceeds about 10% by weight, these lower alcohols tend to evaporate and vaporize when they come into contact with human skin, resulting in an unpleasant alcohol odor, or the vaporized lower alcohols tends to have a negative effect on the human body.

The surfactant to be used is not particularly limited, but for example, a liquid surfactant that is liquid at room temperature or at a slight temperature increase and has a function as a solvent can be used. For example, glycerin fatty acid ester, alkyl polyoxyethylene glycol, ponoxyethylene alkylphenyl ether (alkyl group is octyl group, etc.), alkyl glycoside (alkyl group is octyl group, decyl group, dodecyl group, etc.), sorbitan fatty acid ester ( Nonionic surfactants such as those in which the fatty acid group is monolauric acid, monostearic acid, tristearic acid, oleic acid, tetraoleic acid, etc.) can be used.

<About cosmetics and external medicines with water-containing compositions>
Possible examples include patches, cosmetics, and external medicines containing a water-containing composition.
Examples of the patch include a cooling sheet for cooling the forehead of the human body, which has a structure in which the water-containing composition of the present invention is held in a sheet-like holding member, an analgesic and anti-inflammatory patch, and a skin-improving patch that improves the skin condition of the face and other areas. Pack sheets or face masks can be used.
Cosmetics or external medicines include, for example, a water-containing composition having the structure of the present invention, and have a liquid, spray, cream, emulsified, gel, etc. form, and can be applied, adhered to, or pasted on the skin. It is possible to apply this method to cosmetics and skin medicines.

<About the patch with a water-containing composition>
A water-containing composition containing a water-soluble polymer as a functional component contained in the water-containing composition is adhered to and/or impregnated into a sheet-like holding member, and is retained, and the functionality contained in the water-containing composition is The component contains a water-soluble polymer that can be dissolved in water, and is formed into a patch that can be applied to human skin and has antiseptic properties.

A patch containing a water-containing composition held in a sheet-like holding member is used by being applied to the human skin, exhibits a desired effect during use, and is peeled off from the human skin after use.
A patch that is applied to the human skin for the purpose of cooling effect, warming effect, cooling effect, analgesic effect, anti-inflammatory effect, skin whitening effect, skin wrinkle improvement effect, or other pharmacological effect. It is desired that the adhesive agent exhibit the excellent antiseptic properties described in (a) below, as well as the desired performance as a patch agent as described in (b) to (f) below, in an optimal balance.
(a) Preservative properties that prevent spoilage due to bacteria, etc. during storage.
(b) Soft and supple flexibility that suppresses discomfort such as a hard sensation and easily adheres to human skin.
(c) Shape retention in which the water-containing composition adhered or applied to the skin maintains its shape without flowing or being damaged.
(d-1) Adhesiveness or tackiness at the time of application that sticks to the human skin with appropriate pressure, (d-2) Adhesiveness that is difficult to peel off during daily movements while using the adhesive. and (d-3) easy-to-peel adhesion that can be removed without damaging the skin or causing significant discomfort or irritation to the skin when removed from the skin.
(e) Post-peel residue suppression properties to such an extent that when the water-containing composition adhered or applied to the skin is peeled off from the skin, no part of the water-containing composition remains attached to the skin.
(f) A water-containing composition having a water-retaining flexibility and shape-retaining property, which has a water-retaining property that makes it difficult for water to evaporate in addition to flexibility and shape-retaining property, and a patch comprising the water-containing composition.

In such a patch, in order to obtain the desired basic performance as a patch, the functional ingredients contained in the water-containing composition include a crosslinkable water-soluble polymer and molecules that can be crosslinked into a network structure in terms of molecular structure. A patch containing both a water-soluble polymer and a non-crosslinkable water-soluble polymer that is not structurally cross-linked, which has flexibility and adhesiveness and is non-flowable at a temperature of about 45°C or lower. A patch that has gel-like shape retention and antiseptic properties and is used by being applied to human skin can be implemented.
A crosslinkable water-soluble polymer has fluidity until it is crosslinked by a chemical reaction in the presence of a crosslinking agent, and is in a non-fluid state after being crosslinked by a chemical reaction with the crosslinking agent. The gel-like, non-crosslinkable water-soluble polymer has a fluid and viscous state that is dissolved in water and is not cross-linked.

The water-containing composition included in the patch has fluidity before it is adhered to and/or impregnated with a sheet-like holding member and held at a temperature of about 45°C or less after being attached and held on the sheet-like holding member. A composition having a gel-like state, which is a non-flowable state having flexibility and tackiness at a temperature of Also, non-crosslinkable water-soluble polymers that cannot be crosslinked are used.

In the case of a composition containing a crosslinkable water-soluble polymer and a crosslinking agent, a method for producing a patch having a structure in which a water-containing composition is held in a sheet-like holding member includes a method in which the crosslinkable water-soluble polymer is When in a non-crosslinked, fluid state, this fluid water-containing polymer composition is adhered to and/or impregnated into a sheet-like holding member in a predetermined shape, and then, over time, a cross-linkable water-soluble polymer composition is formed. The molecules are crosslinked, and the flowable water-containing polymer composition becomes a non-flowable gel state. In this way, a patch is produced in which the gel-like water-containing composition is adhered to and/or impregnated into the gauze-shaped holding member. In this case, the temperature of the fluid water-containing polymer composition is not particularly limited, and may be any temperature such as low temperature, room temperature, and high temperature.
For example, a fluid water-containing polymer composition is adhered to and/or impregnated into a sheet-like holding member at a low temperature, and then the crosslinkable water-soluble polymer is It is possible to carry out a method of changing the liquid into a gel state with no fluidity.
In addition, a fluid water-containing polymer composition having fluidity is adhered to and/or impregnated into a sheet-like holding member at a low temperature or room temperature, and then heated to a predetermined temperature to form a crosslinkable water-soluble polymer. It is possible to carry out a method of changing the liquid into a gel state with no fluidity.

In the case of a composition containing a crosslinkable water-soluble polymer that does not contain a crosslinking agent or a non-crosslinkable water-soluble polymer, it flows at temperatures higher than about 50°C and at temperatures below about 45°C. The types, contents, etc. of water, water-soluble polymer, and polyhydric alcohol are adjusted as desired so as to have a gel-like state with no fluidity.

The crosslinkable water-soluble polymer and non-crosslinkable water-soluble polymer contained in the water-containing composition of the patch include the same cross-linkable water-soluble polymer as the water-soluble polymer explained in the section of the water-containing composition above. Contains a polymer and a non-crosslinkable water-soluble polymer.
That is, the crosslinkable water-soluble polymer includes (i) a crosslinked acrylic acid polymer, (ii) (a) an acrylic acid monomer, (b) a crosslinked acrylic acid copolymer, and (iii) a moiety. It contains at least one crosslinkable water-soluble polymer selected from the group consisting of neutralized polyacrylic acid, (iv) crosslinked carboxyvinyl polymer, and/or (v) crosslinked cellulose compound. Non-crosslinkable water-soluble polymers include polyvinyl alcohol, polyethylene glycol, polypropylene glycol, starch acrylate, polyalkyl acrylate, polyvinylpyrrolidone, carboxyalkyl cellulose, hydroxyalkyl cellulose, copolymer of alkyl acrylate and submonomer, Contains at least one non-crosslinkable water-soluble polymer selected from the group consisting of gelatin and agar.
Such a water-containing composition has flexibility and stickiness at a temperature of about 45° C. or lower, has gel-like shape retention in a non-flowable state, and has antiseptic properties.

The water-containing composition comprised in the patch of the present invention includes (A) water in an amount of 20 to 95% by weight based on the total content of the water-containing composition, and (B) a water-soluble polymer in the water-containing composition. (C) is contained in an amount of 3 to 40% by weight based on the total content of the water-containing composition, and (C) a polyhydric alcohol is contained in an amount of 5 to 50% by weight based on the total content of the water-containing composition.

In the water-containing composition included in the patch, the water content is preferably in the range of about 20 to about 95% by weight, more preferably in the range of about 25 to about 90% by weight. . Aqueous compositions containing water in this range will form a form with optimal flexibility and gel-like properties at temperatures below about 45°C.
A water-containing composition with a water content of less than about 20% by weight may be in a state in which it is impossible to completely dissolve all of the water-soluble polymers contained therein, leaving undissolved powder, or in a state where the water-soluble polymers contained therein remain undissolved. Even if it does, it will be in a state where it has no fluidity even at high temperatures, or a state where flexibility is reduced at room temperature. Furthermore, when a patch containing a water-containing composition is attached or pasted on human skin, it tends to have a slightly hard and uncomfortable feeling, resulting in a poor feeling of use when applied to human skin.
A water-containing composition with a water content of more than about 95% by weight will have fluidity even at temperatures below about 45°C, making it difficult to obtain a gel-like state without fluidity, and causing damage to the human body. Adhesiveness to the skin also tends to decrease, which tends to cause problems in terms of application to human skin.

In the water-containing composition included in the patch, the content of the water-soluble polymer is preferably in the range of about 3 to about 40% by weight, more preferably the content of the water-soluble polymer is in the range of about 3 to about 30% by weight. % by weight. Aqueous compositions containing water in this range will form a form with optimal flexibility and gel-like properties at temperatures below about 45°C.
A water-containing composition containing less than about 3% by weight of water-soluble polymer has fluidity at a temperature of about 20 to 45°C and tends to have poor shape retention.
In a water-containing composition in which the water-soluble polymer content exceeds about 40% by weight, it becomes impossible to completely dissolve all the water-soluble polymers contained therein, and undissolved powder remains. Even if the water-soluble polymer is dissolved, it will be in a non-fluid state even at high temperatures. Furthermore, the flexibility of water-containing compositions decreases at room temperature, and when a patch containing a water-containing composition is attached to or pasted on human skin, it may feel a little hard and uncomfortable when used as a patch on human skin. There is a tendency for the feeling of use to deteriorate.

The patch comprising the water-containing composition of the present invention can be applied to the skin by people with low skin resistance. In some cases, it is expected to reduce skin sensitization such as irritation on the skin that comes into contact with it, and it is possible to obtain a patch that exhibits excellent antiseptic properties, as well as the adhesiveness, shape retention, and flexibility required for a patch. A patch having the basic properties of a patch such as , easy-peel adhesion, and ability to suppress peeling residue can be obtained. In particular, when used by people with low skin resistance such as infants and the elderly, a patch is expected to have reduced skin sensitization and exhibit excellent antiseptic properties.
In particular, it contains a cross-linkable water-soluble polymer that is cross-linked into a network structure and has a gel-like state with no fluidity, and is a water-containing water-containing polymer that has a predetermined amount of bound water, dissolved water, and free water. A patch comprising the composition also has the basic performance as a patch as described in (a) to (f) above, and also exhibits reduced skin sensitization and excellent antiseptic properties.
Furthermore, depending on the type of water-soluble polymer contained, we have added the above-mentioned (Effect 2: Comfortable water retention, flexibility and shape retention, reduced skin sensitization, and excellent antiseptic properties due to the inclusion of crosslinkable water-soluble polymers.) (Effect E: Comfortable water-retaining flexibility and adhesiveness due to the inclusion of non-crosslinking water-soluble polymer), (Effect E: Comfortable water-retention flexibility and adhesiveness due to the inclusion of non-crosslinking water-soluble polymer). A patch with effective performance can be obtained.

<About the polyhydric alcohol contained in the water-containing composition comprised in the patch>
The polyhydric alcohol contained in the water-containing composition of the adhesive patch of the present invention is preferably a polyhydric alcohol that is soluble in water or has a property of being compatible with water.
As polyhydric alcohols, glycerin, propylene glycol, dipropylene glycol, propanediol, butylene glycol, octanediol, polyethylene glycol, polypropylene glycol, sorbitol, crotamiton, etc. can be used. Sorbitol liquid is a viscous liquid made by dissolving sorbitol in a solvent such as water.
Among these polyhydric alcohols, propylene glycol, butylene glycol, and glycerin are especially effective when used in combination with preservatives other than parabens such as phenoxyethanol, glyceryl caprylate, and polylysine. It has the effect of promoting antiseptic properties.

Polyhydric alcohol has a higher viscosity than water, is soluble in water or has good compatibility with water, and has the property of forming a uniform liquid without separation when mixed with water in any proportion. In addition, it is possible to obtain a water-containing composition having desired flexibility, adhesiveness, water retention, and moisturizing properties corresponding to the properties of the polyhydric alcohol. Furthermore, in the case of a water-containing composition containing a water-insoluble preservative or other water-insoluble pharmacologically active ingredients, these preservatives and/or pharmacologically active ingredients can be dissolved to form a water-containing composition. The efficacy of these preservatives or pharmacologically active ingredients can be efficiently exhibited by incorporating them into

That is, the above-mentioned (Effect I - patch: a patch that exhibits reduced skin sensitization and excellent antiseptic properties) can be obtained, and (Effect I) the patch has a water-containing composition due to the inclusion of polyhydric alcohol. When the patch is applied to the human skin, it is adjusted to have an optimal balance in all performances such as adhesion, flexibility, water retention, shape retention, easy-to-peel adhesion, and ability to suppress residue after peeling. In addition, (effect A) it also acts as a solvent for dissolving preservatives that are hardly soluble in water, and has efficacy-imparting functionality for pharmacologically active ingredients, etc. When the ingredients and preservatives are sparingly water-soluble, these ingredients can be dissolved and contained to achieve the effect of efficiently exerting the efficacy of the preservative or efficacy-imparting functional ingredient.

The optimal content of polyhydric alcohol contained in the water-containing composition that constitutes the patch varies depending on the type of polyhydric alcohol and the content of non-crosslinkable water-soluble polymer, and for example, 5 to 50% by weight. The amount is preferably 5 to 40% by weight, particularly preferably 5 to 40% by weight. In this range, the above effect (effect (g)) can be optimally obtained. If the polyhydric alcohol content is less than 5% by weight, the adhesiveness, flexibility, and water retention properties tend to be poor, and optimal physical properties cannot be obtained. It tends to be inferior in substance suppression.

In addition, the polyhydric alcohol contained in the water-containing composition that constitutes the patch has adhesiveness, flexibility, water retention, shape retention, easy-peel adhesion, It has the effect of adjusting the optimal balance performance in all performances such as the ability to suppress residues after peeling, and in particular, glycerin, dipropylene glycol, sorbitol, etc. have the function of increasing the moisturizing properties of the water-containing composition. In addition, propylene glycol, butylene glycol, and the like have the function of imparting softening properties and tackiness to the water-containing composition, and also function as a solvent for preservatives that are sparingly soluble in water.
These polyhydric alcohols are used as solvents to dissolve and uniformly contain additional ingredients, such as pain-relieving and anti-inflammatory ingredients, skin-improving ingredients, cooling sensation-imparting ingredients, and preservatives, which are poorly soluble in water, in water-containing compositions. It can also perform the functions of In the case of polyhydric alcohols such as glycerin, which have high viscosity at room temperature, the viscosity can be lowered by raising the temperature to make it easier to dissolve additional ingredients, or the above-mentioned methods can be used in combination with lower alcohols such as ethanol or propyl alcohol. Additional ingredients can be dissolved and used.

<About the sheet-like holding member>
The sheet-like holding member included in the adhesive patch of the present invention is not particularly limited, but may be any material that can sufficiently hold the water-containing composition without being peeled off from the sheet-like holding member. Use sheet-like holding members such as fiber aggregates such as non-woven fabrics or woven fabrics using synthetic fibers and natural fibers, fiber aggregates such as paper, stretchable materials containing stretchable rubber materials, plastic film materials, etc. be able to.
It is particularly desirable that the sheet-like holding member be made of a porous material having a finely uneven surface through which at least one of air, moisture, and humidity can pass, and the water-containing composition is preferably made of a porous material that allows passage of at least one of air, water, and humidity. The water-containing composition is adhered to or impregnated into the unevenness of the uneven surface and is retained, thereby achieving the effect that the water-containing composition is fixed without being peeled off from the sheet-like holding member.
In addition, the sheet-like holding member was configured to be expandable and contractible in the plane direction, and the water-containing composition adhered and held on the sheet-like holding member was also configured to be expandable and contractible in response to the expansion and contraction of the sheet-like holding member. configuration is preferred. In the case of a stretchable sheet-like holding member, when a patch in which a water-containing composition is laminated on the sheet-like holding member is used by applying it to the human body, the patch can be applied to the human body in a flexible manner, and after being applied. The adhesive patch expands and contracts freely in response to the movements of the human body, and can be used stably without causing boundary separation between the sheet-like holding member and the water-containing polymer gel composition, and without peeling off the adhesive adhesive from the human body. becomes.

With this configuration, (Effect No.) The water-containing composition is adhered to and/or impregnated onto the surface of the sheet-like holding member, and the above-mentioned (Effect No. - Patch: reduced skin sensitization and excellent In addition to achieving the effects of a patch that exhibits antiseptic properties, it can be applied particularly well to the desired skin of the human body, and furthermore, the back side of the sheet-like holding member to which the water-containing composition is not attached has no adhesive properties. A patch having non-adhesive properties that does not adhere to human hands or clothing can be obtained without having to adhere to the skin.

<About the release sheet>
In the adhesive patch of the present invention, it is also possible to implement a configuration in which a release sheet is further provided that covers the water-containing composition adhered and held on the sheet-like holding member and is laminated on the surface of the water-containing composition. When this release sheet is used, it is peeled off from the patch and the side of the water-containing composition adhered to and held on the surface of the sheet-like holding member is applied to the human skin. The release sheet is not particularly limited, and may be a sheet made of a plastic film having releasability that allows the water-containing composition to be released from the water-containing composition without damage. For example, a film-like sheet made of polyethylene, polypropylene, polyamide, polyethylene terephthalate, etc. can be used.

<About the method for producing a patch containing a water-containing composition>
The method for producing a patch containing a water-containing composition of the present invention comprises a sheet-like holding member and a water-containing composition adhered to and/or impregnated with the sheet-like holding member, and the patch is applied to human skin. A possible method for producing a patch, wherein the water-containing composition contains (A) water, and (B) a water-soluble polymer as a functional component that can be dissolved in water, and further includes at least: (C) a polyhydric alcohol that is soluble or compatible with the water and has a preservative promoting effect; and (E) a preservative other than parabens that is soluble in the water and/or the polyhydric alcohol. , the preservative other than parabens contains at least one preservative other than parabens selected from the group consisting of phenoxyethanol, glyceryl caprylate, and polylysine, and at a temperature of about 45°C or less It has a gel-like state with flexibility and adhesiveness and no fluidity, has antiseptic properties, and is configured to be able to be applied to human skin.
The method for manufacturing such a patch includes the following steps.
(a) A step of mixing and dissolving at least a water-soluble polymer in water, thereby preparing a water-soluble polymer-containing preconditioned liquid having viscosity and fluidity.
(c) Preservatives other than parabens are mixed with water and/or polyhydric alcohol that can dissolve the preservatives, thereby preparing a preservative-containing pre-preparation liquid containing dissolved preservatives. The process of doing.
(e) mixing a polyhydric alcohol, the water-soluble polymer-containing preconditioned liquid prepared in the above (a), and the preservative-containing preconditioned liquid prepared in the above (c); thereby, A step of preparing a flowable water-containing polymer composition in which the preservative is dissolved and has viscosity and fluidity, wherein the flowable water-containing polymer composition is adjusted to a predetermined temperature. It will be done.
(f) After the step (e), when the fluidity of the fluid water-containing polymer composition is maintained until it gels, the fluid water-containing polymer composition is applied to a sheet-like holding member with a predetermined thickness. A step of adhering and/or impregnating the composition, thereby preparing a fluid water-containing polymer composition with a sheet-like holding member held by the sheet-like holding member.
(g) Adjusting the flowable water-containing polymer composition with a sheet-like holding member prepared in step (f) to a predetermined temperature, thereby making the flowable water-containing polymer composition non-flowable. A step of preparing a gelled water-containing composition in a gel state.

In the method for manufacturing the patch described above, a manufacturing method preferably having the following configuration can be implemented. A schematic process explanatory diagram of a manufacturing process showing a method for manufacturing a patch comprising this water-containing composition is shown in FIG. However, FIG. 1 shows a step in which the water-containing composition further contains additional components described below.
In the above (B), the water-soluble polymer includes (B-1) a crosslinkable water-soluble polymer that can be crosslinked in terms of molecular structure, and (B-2) a non-crosslinkable water-soluble polymer that cannot be crosslinked in terms of molecular structure. The water-containing composition further contains (D) a crosslinking agent capable of molecularly crosslinking the crosslinkable water-soluble polymer, and includes the following steps.
(a-1) A step of mixing and dissolving at least a crosslinkable water-soluble polymer in water, thereby preparing a crosslinkable water-soluble polymer-containing preconditioned liquid having viscosity and fluidity.
(a-2) At least a step of mixing and dissolving a non-crosslinkable water-soluble polymer in water, thereby preparing a preconditioned liquid containing a non-crosslinkable water-soluble polymer that has viscosity and fluidity;
(b) A step of mixing and dissolving at least a crosslinking agent capable of molecularly crosslinking a crosslinkable water-soluble polymer in water, thereby preparing a crosslinking agent-containing preconditioned liquid.
(c) Preservatives other than parabens are mixed with water and/or polyhydric alcohol that can dissolve the preservatives, thereby preparing a preservative-containing pre-preparation liquid containing dissolved preservatives. The process of doing.
(e) A polyhydric alcohol, the crosslinkable water-soluble polymer-containing preconditioned liquid prepared by (a-1) above, and the non-crosslinkable water-soluble polymer-containing liquid prepared by (a-2) above. The pre-conditioned liquid, the cross-linking agent-containing pre-conditioned liquid prepared according to (b) above, and the preservative-contained pre-conditioned liquid prepared according to (c) above are mixed, whereby the preservative is dissolved. A step of preparing a flowable water-containing polymer composition having a viscosity and flowability.
(f) After the step (e), when the fluidity of the fluid water-containing polymer composition is maintained until it gels, the fluid water-containing polymer composition is applied to a sheet-like holding member with a predetermined thickness. A step of adhering and/or impregnating the composition, thereby preparing a fluid water-containing polymer composition with a sheet-like holding member held by the sheet-like holding member.
(g) After the step (f), the crosslinkable water-soluble polymer contained in the flowable water-containing polymer composition with a sheet-like holding member is crosslinked into a network structure by a chemical reaction with the crosslinking agent. A step of preparing a gelled water-containing composition in a gel state having no fluidity.
In addition, in step (d) of Figure 1, if the additional components cannot be dissolved in water and/or polyhydric alcohol, the additional components can be dissolved in lower alcohols such as ethanol and propyl alcohol, and/or surfactants. A step of dissolving and mixing the agent into the agent can be carried out.

In the above steps (a-1), (a-2), (b), and (c), any of the temperature state where the temperature is lowered to a predetermined temperature, the temperature state where the temperature is raised to a predetermined temperature, or the normal temperature state. It is possible to mix in this state. Further, in the above step (e), it is possible to mix in any one of a temperature state where the temperature is lowered to a predetermined temperature, a temperature state where the temperature is raised to a predetermined temperature, or a room temperature state. As a result, a fluid water-containing polymer composition containing a mixed crosslinkable water-soluble polymer and a non-crosslinkable water-soluble polymer and having desired fluidity is prepared. In the step (g), the mixture can be mixed either at a temperature adjusted by lowering or increasing the temperature to a predetermined temperature, or at room temperature. As a result, the crosslinkable water-soluble polymer contained in the flowable water-containing polymer composition with a sheet-like holding member is crosslinked into a network structure through a chemical reaction with the crosslinking agent, resulting in a gel state with no fluidity. A patch is prepared with the hydrated composition. Note that normal temperature means a temperature range in which the temperature does not rise or fall in particular, and is, for example, room temperature, which is a normal working environment, or about 18°C to about 30°C.

In this manufacturing method, the following steps can be desirably implemented in the steps (e), (f), and (g).
A manufacturing method in which in step (e) above, the mixture is heated to a predetermined temperature, and in step (g) above, the crosslinkable water-soluble polymer is crosslinked in a temperature range from elevated temperature to room temperature. is possible. In this case, in step (f), the crosslinking reaction of the crosslinkable water-soluble polymer is promoted by the temperature rise, and the sheet-like holding member tends to have a fluidized water content. It is desirable to use a crosslinking agent that has properties such that the crosslinking reaction does not proceed during deposition and/or impregnation of the molecular composition.

In this manufacturing method, in the step (e) above, the mixture is cooled to a predetermined temperature, and in the step (g) above, the crosslinkable water-soluble polymer is crosslinked in a temperature range from cooled to room temperature. Other manufacturing methods are also possible. That is, in the above step (e), a polyhydric alcohol, a crosslinkable water-soluble polymer-containing preconditioning liquid, a non-crosslinking water-soluble polymer containing preconditioning liquid, a crosslinking agent-containing preconditioning liquid, and a preservative containing The preconditioned liquid is adjusted to a temperature below room temperature and mixed, and by controlling the temperature to this low temperature, the progress of the crosslinking reaction is controlled in a direction that retards the flowable water-containing polymer composition in step (f). Adhering and/or impregnating the fluid water-containing polymer composition to a predetermined thickness on the sheet-like holding member while ensuring a long period of time during which fluidity is maintained until it gels. In step (g) above, the crosslinkable water-soluble polymer contained in the flowable water-containing polymer composition with a sheet-like holding member interacts with the crosslinking agent at room temperature or an ambient temperature higher than room temperature. It is also possible to carry out a method of preparing a water-containing composition that is crosslinked into a network structure by a chemical reaction and gelled into a gel state without fluidity. In this case, it is desirable to use a crosslinking agent that has the property of causing a crosslinking reaction in a temperature range of room temperature.

In the above manufacturing method, it is possible to implement a configuration that does not contain a paraben preservative as a preservative, or a configuration in which the paraben content is reduced to 0.05% by weight or less.

With this configuration, (Effect E) adhesiveness, flexibility, water retention, shape retention, easy-peel adhesion, and residual strength after peeling are achieved in patches equipped with a water-containing composition containing preservatives other than parabens. It is possible to produce a patch that is adjusted to have an optimal balance performance in all performances such as anti-inflammatory properties, and in particular, it is possible to produce a patch in which a preservative is dissolved in a water-containing composition. Accordingly, it is possible to produce a patch that can efficiently exhibit antiseptic performance even when containing a smaller amount of preservative.
In other words, it has no fluidity, has shape retention properties that allow it to maintain its shape even against external pressure, has water retention properties that can retain a large amount of moisture, and is hard to apply when applied to human skin. A method for producing a patch comprising a water-containing composition that has comfortable flexibility without discomfort and comfortable water-retaining, flexible, and shape-retaining properties is obtained. When this patch is used by people with weak skin resistance, it is expected to reduce skin sensitization such as rashes on the skin that comes into contact with it. A method for producing a patch comprising a water-containing composition containing molecules is obtained. In particular, when used by people with low skin resistance, such as infants and the elderly, a significant improvement in skin sensitization such as skin irritation can be expected.
Furthermore, the composition contains at least one preservative selected from the group consisting of phenoxyethanol (effect E-ABD: reduced skin sensitization and excellent antiseptic properties), glyceryl caprylate, and polylysine. When used by people with low skin resistance, a method for producing a patch is expected to reduce skin sensitization such as irritation on the skin that comes into contact with it, and also exhibits excellent antiseptic properties.

In the method for producing a patch comprising the water-containing composition of the present invention, the above-mentioned (B-1) crosslinkable water-soluble polymer, (B-2) non-crosslinkable water-soluble polymer, and the above-mentioned (C) Polyhydric alcohols can be used.
(B-1) As the crosslinkable water-soluble polymer, (i) crosslinked acrylic acid polymer, (ii) crosslinked acrylic acid copolymer, (iii) crosslinked acrylic acid polymer, (iv) crosslinked at least one crosslinkable water-soluble polymer selected from a crosslinked type carboxyvinyl polymer and (v) a crosslinked water-soluble polymer of a crosslinked cellulose compound, and the crosslinked water-soluble polymer undergoes a chemical reaction with the crosslinking agent. A crosslinkable water-soluble polymer having the property of being crosslinked into a network structure can be used.
(B-2) Non-crosslinked water-soluble polymers include polyvinyl alcohol, polyethylene glycol, starch acrylate, polyalkyl acrylate, polyvinylpyrrolidone, copolymer of alkyl acrylate and secondary monomer, non-crosslinked cellulose, At least one non-crosslinkable water-soluble polymer selected from the group consisting of gelatin and agar can be used.
(C) As the polyhydric alcohol, at least one polyhydric alcohol selected from the group consisting of propylene glycol, dipropylene glycol, butylene glycol, propanediol, glycerin, and sorbitol liquid can be used.

With this configuration, the above-mentioned (Effect I - patch: a patch exhibiting reduced skin sensitization and excellent antiseptic properties) can be obtained, and the above-mentioned (Effect) can also be obtained.
Furthermore, polyhydric alcohols have the above-mentioned "effects", and in particular, glycerin, dipropylene glycol, sorbitol, etc. have the function of increasing the moisturizing properties of water-containing compositions, and propylene glycol, butylene Glycol and the like have both the effect of imparting softening properties and the effect of acting as a solvent for preservatives that are sparingly soluble in water.

In the method for producing a water-containing composition of the present invention and the method for producing a patch comprising the water-containing composition of the present invention, the water-containing composition further includes an efficacy-imparting functional ingredient as a functional ingredient, and/or , the efficacy-imparting functional ingredient is at least one efficacy-imparting functional ingredient selected from the group consisting of pharmacologically active ingredients, skin-improving ingredients, and aromatic ingredients, and the additional ingredient is: (K-1) An ingredient that prevents accidental ingestion by giving a bitter taste when put in the mouth, (K-2) A cooling sensation imparting ingredient that provides a cooling sensation, (K-3) A warming sensation. at least one additional component selected from the group consisting of (K-4) a pH-adjusting component that adjusts the pH; At least one component selected from the group consisting of an anti-food ingredient, the cooling sensation imparting ingredient, the warming sensation imparting ingredient, and a pH adjusting ingredient is dissolved or mixed in water and/or polyhydric alcohol to improve efficacy. a step of preparing a pre-conditioned solution containing a functional component/additional component; A step of mixing a pre-prepared liquid containing the components and additional components, thereby preparing a fluid water-containing polymer composition in which the preservative is dissolved and which has viscosity and fluidity. A method for manufacturing a patch is practicable.

As a result, the preservative is dissolved, and the efficacy-imparting functional ingredients and additional ingredients are dissolved in the water-containing composition, or contained in the water-containing composition in an emulsified state, or These fine particles are contained in a dispersed state.
With this configuration, (effect-li) the water-containing composition or patch containing the efficacy-imparting functional ingredient or additional ingredient can achieve the effect of exhibiting the efficacy corresponding to the efficacy-imparting functional ingredient or additional ingredient it contains. It will be done.

<About the method for producing a patch comprising a water-containing composition containing a preservative>
In the method for producing a patch of the present invention, a water-containing composition containing the following various preservatives can be constituted as a preservative.
In the method for producing a patch of the present invention, the preservatives include phenoxyethanol in an amount of 0.2 to 1.0% by weight based on the total amount, glyceryl caprylate in an amount of 0.01 to 0.8% by weight based on the total amount, and Contains at least one preservative other than parabens selected from the group consisting of polylysine in an amount of 0.01 to 0.8% by weight based on the total amount, and in the step (c), (ca) water and /or selected from the group consisting of a step of dissolving phenoxyethanol in a polyhydric alcohol, (c-b) a step of dissolving glyceryl caprylate in a polyhydric alcohol, and (c-d) a step of dissolving polylysine in water. At least one pre-preparation solution containing a preservative is prepared, and in the step (e), the preservative is dissolved in the flowable water-containing polymer composition.

Further, as a preservative, a water-containing composition containing the following various preservatives can be constituted.
In (E) above, the minimum content of preservatives other than the parabens is determined by an XY coordinate in which the phenoxyethanol content is the X-axis and the glyceryl caprylate and/or polylysine content is the Y-axis relative to the total amount. , above the straight line MN connecting point M where the phenoxyethanol content is 0.17% by weight on the X axis and point N where the content of glyceryl caprylate and/or polylysine on the Y axis is 0.007% by weight. As shown in the section, phenoxyethanol and glyceryl caprylate and/or polylysine are both included as preservatives, and in step (c), phenoxyethanol is added to water and/or polyhydric alcohol (ca). Prepare a pre-preparation solution containing a preservative for the step of dissolving, (c-b) dissolving glyceryl caprylate in polyhydric alcohol and/or (c-d) dissolving polylysine in water, In step ), the preservative is dissolved in the fluid water-containing polymer composition.
In addition, in this structure, a structure containing phenoxyethanol and glyceryl caprylate, phenoxyethanol and polylysine, or phenoxyethanol, glyceryl caprylate and polylysine as preservatives can be implemented.

That is, phenoxyethanol has the property of being slightly soluble in water and easily soluble in polyhydric alcohol, and glyceryl caprylate has the property of being slightly soluble in water but easily soluble in polyhydric alcohol. Polylysine is easily soluble in water but poorly soluble in polyhydric alcohol.
When containing preservatives with different solubility, in step (c), depending on the type of preservative used, water, polyhydric alcohol, or water and polyhydric alcohol can be used as a solvent for dissolving the preservative. A preservative-containing pre-preparation liquid in which a preservative is dissolved is prepared by selectively using a mixed solvent with a alcohol.
In step (e), when the non-crosslinkable water-soluble polymer-containing pre-conditioned liquid, the cross-linking agent-containing pre-conditioned liquid, and the preservative-containing pre-conditioned liquid are mixed, water and/or polyhydric Contains a crosslinking agent in which the preservative dissolved in alcohol does not become particulate or suspended, precipitated, dispersed, or phase separated, and the preservative is dissolved in the fluid water-containing polymer composition. Prepare the preconditioning solution.

This composition (low-efficacy patch: contains phenoxyethanol and other preservatives, reduced skin sensitization, and excellent antiseptic properties), especially the antiseptic properties of both phenoxyethanol and glyceryl caprylate and/or polylysine. Due to the composition containing the preservative, the content of phenoxyethanol can be significantly reduced, and the content of other preservatives used in combination can also be significantly reduced, resulting in a composition with a small total content of preservatives. A method for producing a water-containing polymer gel patch that exhibits sufficient antiseptic properties even in a patch having the above-mentioned properties can be obtained. In addition, in addition to phenoxyethanol, the composition contains both glyceryl caprylate and/or polylysine preservatives, which provides superior preservative properties compared to the use of these preservatives alone at the same preservative concentration. is obtained.

In the method for producing a patch of the present invention, the water-containing composition contains at least one polyhydric alcohol selected from the group consisting of propylene glycol, butylene glycol, and glycerin, as a polyhydric alcohol that promotes antiseptic properties. In addition, the preservative contains at least one preservative selected from the group consisting of phenoxyethanol, glyceryl caprylate, and polylysine, and by containing the polyhydric alcohol and the preservative, the polyhydric alcohol has the effect of promoting the preservative properties of the preservative, and in the step (c), a preservative other than parabens and a polyhydric alcohol capable of dissolving the preservative are mixed, whereby the preservative is dissolved. A configuration is desirable and practicable that includes the step of preparing a preconditioned solution containing a dissolved preservative.
With this configuration, it is possible to efficiently produce a patch that exhibits (effective patch: antiseptic promoting effect due to the inclusion of polyhydric alcohol and other preservatives).

In the method for producing a water-containing composition and the method for producing a patch of the present invention, the water-containing composition does not contain parabens, or contains parabens in an amount of 0.05% by weight or less that does not affect skin sensitization. A configuration containing the following is desirable and practicable.

Regarding the functional components, preservatives, polyhydric alcohols, and other components contained in the method for manufacturing the water-containing composition and the patch manufacturing method of the present invention, the types, contents, and properties of these components are as follows. , are the same as those explained for the above water-containing composition and patch.

Examples of the present invention will be described below.
In Examples, the preservative properties and the like of each of the prepared water-containing compositions or patches provided with the water-containing compositions were compared and studied.
[Preservative test and measurement method]:
(a) One test sample was prepared for each of the prepared water-containing compositions or patches.
(b) Two types of test bacteria are prepared: a standard bacterial mixture (Escherichia coli, Pseudomonas aeruginosa, and Staphylococcus aureus) and a standard fungal mixture (Aspergillus niger and Candida).
(c) Using sterile phosphate-buffered saline, prepare a test bacterial solution of each of the above test bacteria at a concentration of 1 x 1,000,000 cells/mL to 30 x 1,000,000 cells/mL.
(d) Place a test sample of each water-containing composition or patch containing the water-containing composition into a sterilized vial, and inoculate with 0.1 ml of the test bacterial solution. In this case, if the test sample is a water-containing composition, the test sample is a petri dish containing the water-containing composition. When the test sample is a patch, the test sample is a patch in which a water-containing composition is attached to a 20 mm x 20 mm sheet-like holding member.
(e) A sterilized vial containing a water-containing composition inoculated with the above-mentioned bacterial mixture and fungal mixture or a patch containing the water-containing composition is stored at 25-37°C and 95% humidity.
(f) Test pieces of each water-containing composition or patch inoculated with the test bacterial solution were taken out on the 7th, 14th, 21st, and 28th days, and the number of viable bacteria was measured.
(g) In the measurement results on the 28th day, if the bacterial mixture is 0.01% or less of the number of inoculated bacteria, and the fungal mixture is 0.1% or less of the number of inoculated fungi, the preservative It was judged as good (◯), and when the number of bacteria exceeded these, it was judged as poor antiseptic property (×).

[Test and measurement method for adhesiveness of patch]:
It was measured using the inclined ball tack test method listed in the Pharmaceutical Manufacturing and Sales Guidelines.
Various patch samples were applied to the skin of the human forehead and kept in a vertical position for 30 minutes, and the presence or absence of the patch falling off was observed. It was selected as the most suitable adhesive patch. Then, using the optimal adhesive patch as a test sample, it was measured by the inclined ball tack test method, and the basic measurement values by the inclined ball tack test method were defined.
That is, using the prepared patch containing the water-containing composition as a test sample, the test sample was placed on a 30-degree inclined plate with the water-containing composition of the patch facing toward the surface, and the test sample was placed on the surface of the water-containing composition. Adhesive strength was measured by rolling iron balls of different sizes and determining whether they stopped for a certain period of time. Then, by comparing the optimal adhesive patch with the basic measurement value by the inclined ball tack test method using the test sample, cases where the adhesive force is felt to be good are judged as good (○), and cases where the adhesive force is felt to be poor. The case was judged as (×).
[Testing and measuring method of shape retention of patch]:
The sheet-like holding member side of the patch was attached to a plate and tilted at an angle of about 45 degrees, and after 3 minutes, the water-containing composition attached to the surface side was observed to see if it could flow or not, and the shape was determined without flow or deformation. A good case where the properties were maintained was judged as good (◯), and a case where the shape was changed due to flow was judged as poor (x).
[Method for testing flexibility of patch]:
When the prepared patch was applied to the forehead of a human body, it was judged as good (◯) if a comfortable soft feeling was felt, and bad (x) if an unpleasant hard feeling was felt.
[Test and measurement method for easy peel adhesion of patch]:
The prepared patch was applied to the forehead of a human body, and after 3 minutes, the end of the patch applied to the forehead was gradually peeled off, so that the skin of the forehead could be easily removed without feeling any discomfort. A case in which the adhesive was successfully removed was judged as good (◯), and a case in which the adhesive force was so strong that the skin of the forehead felt uncomfortable and could not be easily removed was judged as unacceptable (x).
[Test and measurement method for post-peeling residue suppression property (peeling residue suppression property)]:
The prepared patch was applied to the forehead of a human body, and after 3 minutes, it was gradually peeled off from the edge of the patch applied to the forehead. If the patch could be removed without any abnormality, it was evaluated as good (○). ), and cases where a part of the water-containing composition of the patch was damaged and remained attached to the human forehead were judged as unacceptable (x).

A water-containing composition containing water, a water-soluble polymer as a functional component, 1,3-butylene glycol, propylene glycol, and glycerin as a polyhydric alcohol, and phenoxyethanol as a preservative is prepared, and the water-containing composition thereof We prepared patches containing these ingredients, and compared and examined the antiseptic properties, etc. of each of the prepared patches.
FIG. 1 shows a schematic process diagram illustrating a method for producing a patch according to an embodiment of the present invention. A water-containing composition and a patch comprising the water-containing composition were prepared through the following steps in accordance with the schematic process diagram of FIG. 1.

(a-1) 10 g of a crosslinkable water-soluble polymer such as sodium polyacrylate, partially neutralized polyacrylic acid, or crosslinked carboxyvinyl polymer as a functional component is mixed and dissolved in water to obtain viscosity and A preconditioned liquid containing a crosslinkable water-soluble polymer having fluidity is prepared.
(a-2) 6 g of non-crosslinked water-soluble polymers such as polyvinyl alcohol, non-crosslinked carboxymethyl cellulose, and alkyl polyacrylate as functional ingredients are mixed and dissolved in water to have viscosity and fluidity. A preconditioned solution containing a non-crosslinkable water-soluble polymer is prepared.
(b) A crosslinking agent-containing preconditioning solution is prepared by mixing and dissolving 0.5 g or less of a crosslinking agent capable of crosslinking a crosslinkable water-soluble polymer in water.
(c) Mix and dissolve a predetermined amount of phenoxyethanol as a preservative in propylene glycol to prepare a preservative-containing pre-preparation liquid containing the dissolved preservative.
(d-1) A preconditioned liquid d1 containing an additional component is prepared by mixing and dissolving acids (0.1 g or less) as a pH adjusting component in water.
(d-3) Preparation liquid d3 containing additional components is prepared by mixing and dissolving Vitrex raw material (0.01 g or less, also known as disodium benzoate) as an accidental ingestion prevention agent in water.
(e) A mixed polyhydric alcohol of 5 g of 1,3-butylene glycol, 5 g of propylene glycol, and 8 g of glycerin as a polyhydric alcohol, a preconditioned solution containing a crosslinkable water-soluble polymer prepared by the above (a-1), the above A pre-conditioned liquid containing a non-crosslinkable water-soluble polymer prepared by (a-2), a pre-conditioned liquid containing a cross-linking agent prepared by the above-mentioned (b), a pre-conditioned liquid containing a preservative prepared by the above-mentioned (c) , the additional component-containing pre-conditioned liquid d1 prepared by the above (d-1), and the additional component-containing pre-conditioned liquid d3 prepared by the above (d-3) are mixed. In this case, mixing is performed at a predetermined temperature. In this way, a fluid water-containing polymer composition in which the preservative is dissolved and which has viscosity and fluidity is prepared.
In this way, a fluid water-containing polymer composition in which the preservative is dissolved and has viscosity and fluidity is prepared as a water-containing composition.

(f) After the above step (e), when the flowable water-containing polymer composition maintains its fluidity to the point of gelatinization, the sheet-like holding member is coated with a sheet having a thickness of about 0.5 mm in the above (e) step. The flowable water-containing polymer composition prepared by the method is applied, spread and/or impregnated. In this way, a fluid water-containing polymer composition with a sheet-like holding member held by the sheet-like holding member is prepared. The sheet-like holding member is a rectangular sheet with a vertical width of 50 mm and a horizontal width of about 130 mm, and a thickness of about 1 mm, and is made of a nonwoven fabric made of synthetic fiber that has bending flexibility that can be expanded and contracted in a plane direction, and air humidity permeability. Use a shape retaining member.
(g) Adjust the flowable water-containing polymer composition with a sheet-like holding member prepared in the above step (f) to a predetermined temperature, and thereby, over time, the flowable water-containing polymer composition with a sheet-like holding member The crosslinkable water-soluble polymer contained in the polymer composition is crosslinked into a network structure through a chemical reaction with the crosslinking agent, and the flowable water-containing polymer composition is gelled into a non-flowable gel state. A water-containing composition is prepared.
In addition, in the above (e), the content of water contained in the water-containing composition is added and mixed so that the total amount of the water-containing composition is 100 g.

In this way, water, a water-soluble polymer having a cross-linkable water-soluble polymer (10 g) and a non-cross-linkable water-soluble polymer (6 g), a polyhydric alcohol (18 g), and a cross-linking agent (0.5 g) Samples 1 to 7 patches were prepared with a water-containing composition containing the following), a pH adjusting component and an accidental ingestion prevention agent (total of 0.2 g or less), and a phenoxyethanol preservative at various content ratios. did. Note that samples 1 to 7 of this example do not contain parabens as preservatives.
In addition, as a comparative example of the preservative, in step (c) above, preservative-containing pre-prepared liquid p was prepared by dissolving paraben preservatives such as methylparaben and propylparaben in ethanol without containing phenoxyethanol. A patch containing the preservative-containing preparative solution P was prepared (Sample 8).

It was confirmed that the water-containing compositions included in each of the prepared patches had flexibility and tackiness at a temperature of about 45° C. or lower, and had a gel-like state with no fluidity. In addition, the water-containing composition had a transparent state, and it was confirmed that the preservative and other additional components contained therein were uniformly contained in the water-containing composition. Table 2 shows the measurement results of the physical properties of the patch for each of the prepared patches. In Table 2, the content of each component is shown in weight% (wt%).

In Table 2, patches with a phenoxyethanol content of 0.2% by weight or more (Samples 4 to 7) exhibited good antiseptic properties, while patches with a phenoxyethanol content of less than 0.2% by weight (Samples 1 to 3) exhibited good antiseptic properties. It can be seen that the preservative properties are inferior in some cases.
On the other hand, as a comparative example (prior art), it was confirmed that when the content of parabens was 0.1% by weight (sample 8), good antiseptic properties were exhibited.

A patch containing a water-containing composition containing glyceryl caprylate as a preservative was prepared, and the antiseptic properties of each of the prepared patches were compared and examined.
A patch containing a water-containing composition containing glyceryl caprylate in place of phenoxyethanol in Example 1 was prepared. In this example, step (c) includes mixing and dissolving a predetermined amount of glyceryl caprylate as a preservative in propylene glycol to prepare a preservative-containing pre-preparation solution containing the dissolved preservative. do. In this case, glyceryl caprylate, which has a waxy state at room temperature, is heated to mix and dissolve the liquid glyceryl caprylate and propylene glycol. The other steps are the same as in Example 1 described above. Table 3 shows the measurement results of the physical properties of the patch for each of the prepared patches. Note that samples 9 to 14 of this example do not contain parabens as preservatives.

In Table 3, patches with glyceryl caprylate content of 0.01% by weight or more (Samples 11 to 14) exhibited good antiseptic properties, and patches with glyceryl caprylate content of less than 0.01% by weight (Sample 9). , 10), it can be seen that the antiseptic properties are inferior.

A patch containing a water-containing composition containing polylysine as a preservative was prepared, and the antiseptic properties of each of the prepared patches were compared and examined.
A patch containing a water-containing composition containing polylysine instead of phenoxyethanol in Example 1 was prepared.
In this example, in step (c), a predetermined amount of polylysine as a preservative (c) is mixed and dissolved in water to prepare a preservative-containing pre-preparation liquid containing the dissolved preservative. The other steps are the same as in Example 1 described above.
Table 4 shows the measurement results of the physical properties of the patch for each of the prepared patches. Note that samples 15 to 20 of this example do not contain parabens as preservatives.

In Table 4, patches with a polylysine content of 0.01% by weight or more (Samples 17 to 20) exhibited good antiseptic properties, while patches with a polylysine content of less than 0.01% by weight (Samples 15 and 16) exhibited good antiseptic properties. It can be seen that the preservative properties are inferior in some cases.

A patch containing a water-containing composition containing both phenoxyethanol and other preservatives as a preservative was prepared, and the preservative properties of each of the prepared patches were comparatively examined. .
In this example, it was prepared by a method similar to Example 1. However, instead of the step (c) of Example 1, the step (c) includes the following steps, which vary depending on the type of preservative.
(c) Mix and dissolve a predetermined amount of phenoxyethanol as a preservative in propylene glycol to prepare a phenoxyethanol-containing preconditioning liquid containing the dissolved preservative.
(c) Mix and dissolve a predetermined amount of glyceryl caprylate as a preservative in propylene glycol to prepare a preconditioned solution containing glyceryl caprylate in which the preservative is dissolved.
(c) Mix and dissolve a predetermined amount of polylysine as a preservative in water to prepare a polylysine-containing preconditioned solution containing the dissolved preservative.
(c) As a preservative, a predetermined amount of a chlorinated preservative is mixed and dissolved in water to prepare a chlorinated preservative-containing preconditioning liquid containing the dissolved preservative.
Then, the phenoxyethanol-containing preconditioning liquid and another desired preservative-containing preconditioning liquid are mixed to prepare a preservative-containing preconditioning liquid.
The other steps are the same as in Example 1 described above.
Tables 5 and 6 show the measurement results of the physical properties of each patch prepared. In addition, in this example, parabens as a preservative are not contained.

In Table 5, sample 30 containing only 0.2% by weight of phenoxyethanol exhibits antiseptic properties, but sample 31 containing only 0.17% by weight of reduced phenoxyethanol does not have antiseptic properties.
In addition, sample 37 containing only 0.01% by weight of glyceryl caprylate exhibits antiseptic properties, but sample 34 containing only 0.007% by weight of reduced glyceryl caprylate does not have antiseptic properties. 0.1% by weight of phenoxyethanol and caprylic acid Sample 32 (point Q in FIG. 2) containing both 0.003% by weight of glyceryl does not have preservative properties, but sample 33 containing both 0.1% by weight of phenoxyethanol and 0.005% by weight of glyceryl caprylate (Point S in FIG. 2) has antiseptic properties.
Sample 35 (point T in Figure 2) containing both 0.05% by weight of phenoxyethanol and 0.007% by weight of glyceryl caprylate has antiseptic properties, and also contains 0.15% by weight of phenoxyethanol and glyceryl caprylate. Sample 36 (point U in FIG. 2), which contains both 0.003% by weight and 0.003% by weight, has antiseptic properties.
That is, in FIG. 2, the patch containing the preservative-containing composition in the area surrounded by the line XY connecting point X and Y point and the line MN connecting point M and N points is It can be seen that the synergistic action of the preservatives makes it possible to reduce the minimum preservative content of each preservative.
In other words, the composition containing both phenoxyethanol and glyceryl caprylate preservatives provides superior preservative properties compared to the use of these preservatives alone at the same preservative concentration. You can get the effect of playing.

In Table 6, sample 40 containing only 0.2% by weight of phenoxyethanol exhibits antiseptic properties, but sample 41 containing only 0.17% by weight of reduced phenoxyethanol does not have antiseptic properties.
In addition, sample 47 containing only 0.01% by weight of polylysine has antiseptic properties, but sample 44 containing only 0.007% by weight of reduced polylysine does not have antiseptic properties. Phenoxyethanol 0.1% by weight and polylysine 0.003% by weight Sample 42 (point Q in Figure 2), which contains both 0.1% by weight of phenoxyethanol and 0.005% by weight of polylysine, has no antiseptic properties, but sample 43 (point S in Figure 2), which contains both 0.1% by weight of phenoxyethanol and 0.005% by weight of polylysine, has no antiseptic properties. It has antiseptic properties.
Sample 45 (point T in FIG. 2) containing both 0.05% by weight of phenoxyethanol and 0.007% by weight of polylysine has antiseptic properties, and also contains 0.15% by weight of phenoxyethanol and 0.003% by weight of polylysine. Sample 46 (point U in FIG. 2) containing both % and % has antiseptic properties.
That is, in FIG. 2, the patch containing the preservative-containing composition in the area surrounded by the line XY connecting point X and Y point and the line MN connecting point M and N points is It can be seen that the synergistic action of the preservatives makes it possible to reduce the minimum preservative content of each preservative.
In other words, the composition containing both phenoxyethanol and polylysine preservatives provides superior preservative properties compared to the use of these preservatives alone at the same preservative concentration. is obtained.

This example is a composition containing phenoxyethanol, glyceryl caprylate, and polylysine as preservatives, glycerin, propylene glycol, or 1,3-butylene glycol as a polyhydric alcohol, and a functional component. An example of a patch comprising a water-containing composition containing a water-soluble polymer, and a comparative example in which the content of a water-soluble polymer was increased in place of polyhydric alcohol without containing polyhydric alcohol. .

By the same method as in Example 1, a composition containing a crosslinking agent and varying the content of glycerin, propylene glycol, and butylene glycol as polyhydric alcohols was prepared, and a water-containing composition containing various preservatives was prepared. Prepare a patch.
In this example, the step (c) includes mixing and dissolving a predetermined amount of preservative in glycerin, propylene glycol and/or butylene glycol at elevated temperature to dissolve and contain the preservative. Prepare a pre-prepared solution containing a preservative.
The step (e) includes (e) a polyhydric alcohol such as glycerin, 1,3-butylene glycol, or propylene glycol, and a crosslinkable water-soluble polymer prepared by the above (a-1). A preconditioning liquid, a non-crosslinking water-soluble polymer-containing preconditioning liquid prepared according to (a-2) above, a crosslinking agent containing preconditioning liquid prepared according to (b) above, and a preconditioning liquid prepared according to (c) above. pre-conditioned liquid containing preservative prepared by the above, pre-conditioned liquid d1 containing additional ingredients prepared by above (d-1), pre-conditioned liquid d2 containing additional ingredients prepared by above (d-2), above (d-3). ) is mixed with the preconditioned liquid d3 containing additional components. In this case, mixing is performed at a predetermined temperature. As a result, a fluid water-containing polymer composition in which the preservative is dissolved and has viscosity and fluidity is prepared.
Other steps are similar to Example 1. Tables 7, 8, and 9 show the measurement results of the physical properties of the patches for the patches containing each of the prepared water-containing compositions. In addition, in this example, parabens as a preservative are not contained.

As is clear from Table 7, in the samples containing 0.2% by weight of phenoxyethanol (samples 70 to 79), the samples containing 18% by weight of polyhydric alcohols such as glycerin, propylene glycol, butylene glycol (samples 70, 71, No. 72) has excellent antiseptic properties, and a sample containing no polyhydric alcohol (sample 73) has poor antiseptic properties.
The sample containing 5% by weight of glycerin (sample 75) has antiseptic properties, but the sample containing 3% by weight of glycerin (sample 74) has poor antiseptic properties.
The sample containing 3% by weight of propylene glycol (sample 77) has antiseptic properties, but the sample containing 1% by weight of propylene glycol (sample 76) has poor antiseptic properties.
The sample containing 3% by weight of butylene glycol (sample 79) has antiseptic properties, but the sample containing 1% by weight of butylene glycol (sample 78) has poor antiseptic properties.
In other words, a patch comprising a composition containing 0.2% by weight of phenoxyethanol, a composition containing about 5% by weight of glycerin, a composition containing about 3% by weight or more of propylene glycol or butylene glycol, is a preservative. It is understood that it has a sex-promoting effect.

As is clear from Table 8, in the samples containing 0.01% by weight of glyceryl caprylate (samples 80 to 89), the samples containing 18% by weight of polyhydric alcohols such as glycerin, propylene glycol, butylene glycol (sample 80, 81, 82) have excellent antiseptic properties, and the sample containing no polyhydric alcohol (sample 83) has poor antiseptic properties.
The sample containing 5% by weight of glycerin (sample 85) has antiseptic properties, but the sample containing 3% by weight of glycerin (sample 84) has poor antiseptic properties.
The sample containing 3% by weight of propylene glycol (sample 87) has antiseptic properties, but the sample containing 1% by weight of propylene glycol (sample 86) has poor antiseptic properties.
The sample containing 3% by weight of butylene glycol (sample 89) has antiseptic properties, but the sample containing 1% by weight of butylene glycol (sample 88) has poor antiseptic properties.
That is, a patch comprising a composition containing 0.01% by weight of glyceryl caprylate, a composition containing 5% by weight of glycerin, and a composition containing about 3% by weight or more of propylene glycol or butylene glycol. It can be seen that it has a preservative promoting effect.

In addition, in the step (c) of mixing a preservative, in the preparation of a sample (sample 83) that does not contain polyhydric alcohol, a sample containing a preservative with a preservative concentration of 10% by dissolving glyceryl caprylate in about 10 times the volume of ethanol is used. Prepare and use the preconditioning solution. In addition, in samples with low polyhydric alcohol content (samples 84 to 87), when the temperature of the polyhydric alcohol was raised to 50°C or higher, the preservative dissolved or was compatible with the polyhydric alcohol and became transparent. Prepare pre-preparation solution containing preservative.

As Comparative Example 85, in relation to the sample 85 containing 5% by weight of glycerin and 0.01% by weight of glyceryl caprylate, (e In step (a), glyceryl caprylate is mixed with the water-soluble polymer-containing preconditioned liquid prepared in step (a) and forcedly mixed to disperse the glyceryl caprylate, so that the glyceryl caprylate is completely hydrated. A fluid water-containing polymer composition is prepared which is not dissolved but dispersed in the form of fine particles in a water-containing polymer pre-preparation solution containing the following. As a result of measuring the antiseptic properties of the patch thus prepared, the antiseptic properties were (x).
That is, when the preservative is contained in a completely dissolved state in the water-containing composition, the preservative properties are slightly better than when the preservative is not completely dissolved in the water-containing composition.

As is clear from Table 9, in the samples containing 0.01% by weight of polylysine (samples 90 to 99), the samples containing 18% by weight of polyhydric alcohols such as glycerin, propylene glycol, butylene glycol (samples 90, 91, Sample No. 92) has excellent antiseptic properties, while the sample containing no polyhydric alcohol (Sample 93) has poor antiseptic properties.
The sample containing 5% by weight of glycerin (sample 95) has antiseptic properties, but the sample containing 3% by weight of glycerin (sample 94) has poor antiseptic properties.
The sample containing 3% by weight of propylene glycol (Sample 97) has antiseptic properties, but the sample containing 1% by weight of propylene glycol (Sample 96) has poor antiseptic properties.
The sample containing 3% by weight of butylene glycol (sample 99) has antiseptic properties, but the sample containing 1% by weight of butylene glycol (sample 98) has poor antiseptic properties.
That is, in a composition containing 0.01% by weight of polylysine, a patch comprising a composition containing 5% by weight of glycerin, a composition containing about 3% by weight or more of propylene glycol or butylene glycol, has antiseptic properties. I understand that it is effective.

This example is intended to compare and study the influence of polyhydric alcohol content on preservative properties. This study demonstrates that a composition containing 5% by weight of glycerin and about 3% by weight or more of propylene glycol or butylene glycol exhibits the effect of promoting the antiseptic properties of a preservative, and is suitable for use as other adhesive patches. The characteristics are considered for reference only.
Therefore, in this example, all samples with a polyhydric alcohol content of less than 5% by weight tend to have poor adhesiveness and flexibility as a patch, and are inappropriate as a patch. As the patch, a patch comprising a water-containing composition containing 5% by weight of polyhydric alcohol is preferably practicable.

Water, water-soluble polymers as functional ingredients, efficacy-imparting functional ingredients (pharmacologically active ingredients, skin-improving ingredients, aromatic ingredients, antiseptic properties, etc.), polyhydric alcohols that have a promoting effect, preservatives, and additional ingredients ( various water-containing compositions containing a component that prevents accidental ingestion, a component that imparts a cooling sensation, a component that imparts a warm sensation, a pH-adjusting component, etc.), and various patches in which the water-containing composition is adhered and retained on a sheet-like holding member. was prepared.
A water-containing polymer gel patch was prepared by the following steps in accordance with the schematic process diagram shown in FIG.
(a-1) Crosslinking property that has viscosity and fluidity by mixing and dissolving crosslinkable water-soluble polymers such as sodium polyacrylate, partially neutralized polyacrylic acid, and crosslinked carboxyvinyl polymer in water. Prepare a preconditioned solution containing a water-soluble polymer.
(a-2) Non-crosslinking property that has viscosity and fluidity by mixing and dissolving a predetermined amount of non-crosslinking water-soluble polymer such as polyvinyl alcohol, non-crosslinking carboxymethylcellulose, or alkyl polyacrylate in water. Prepare a preconditioned solution containing a water-soluble polymer.
(b) A crosslinking agent-containing preconditioning solution is prepared by mixing and dissolving 0.5 g or less of a crosslinking agent capable of crosslinking a crosslinkable water-soluble polymer in water.
(c) Mix and dissolve a predetermined amount of preservative in propylene glycol to prepare a preservative-containing preconditioning liquid containing the dissolved preservative.
(d-1) A preconditioned liquid d1 containing an additional component is prepared by mixing and dissolving acids (0.1 g or less) as a pH adjusting component in water.
(d-2) Dissolve a predetermined additional component in ethanol to prepare additional component-containing preconditioned liquid d2.
(d-3) Preparation liquid d3 containing additional components is prepared by mixing and dissolving Vitrex raw material (0.01 g or less, also known as disodium benzoate) as an accidental ingestion prevention agent in water.
(e) A mixed polyhydric alcohol of glycerin and propylene glycol as a polyhydric alcohol, a crosslinkable water-soluble polymer-containing preconditioning liquid prepared according to (a-1) above, and a preconditioning liquid prepared according to (a-2) above. The non-crosslinkable water-soluble polymer-containing pre-conditioned liquid prepared by the above-mentioned method, the cross-linking agent-containing pre-conditioned liquid prepared by the above (b), the preservative-containing pre-conditioned liquid prepared by the above-mentioned (c), and the above-mentioned (d) Pre-conditioned liquid d1 containing an additional component prepared by -1), pre-conditioned liquid d2 containing an additional component prepared by (d-2), and pre-conditioned liquid d2 containing an additional component prepared by (d-3) above. Mix with liquid d3. In this case, mixing is performed at a predetermined temperature. In this way, a fluid water-containing polymer composition in which the preservative is dissolved and which has viscosity and fluidity is prepared.
(f) After the above step (e), when the flowable water-containing polymer composition maintains its fluidity to the point where it gels, a sheet-shaped holding member is coated with the fluidized water-containing polymer composition with a thickness of about 0.5 mm. The molecular composition is applied and/or impregnated into the sheet-like holding member. In this way, a fluid water-containing polymer composition with a sheet-like holding member held by the sheet-like holding member is prepared. The sheet-like holding member is rectangular with a vertical width of 50 mm and a horizontal width of about 130 mm, and a thickness of about 1.5 mm, and is made of a nonwoven fabric made of synthetic fibers that has bending flexibility that can be stretched in the plane direction and air humidity permeability. A sheet-like holding member is used.
(g) The fluid water-containing polymer composition with a sheet-like holding member prepared in the step (f) is adjusted to a predetermined temperature, thereby increasing the fluidity with the sheet-like holding member over time. The crosslinkable water-soluble polymer contained in the water-containing polymer composition is cross-linked into a network structure through a chemical reaction with the cross-linking agent, and the flowable water-containing polymer composition is transformed into a non-flowable gel state. A patch comprising a gelled water-containing composition is prepared.
In addition, in the above (e), the content of water contained in the water-containing composition is added and mixed so that the total amount of the water-containing composition is 100 g.

In this way, water, a crosslinkable water-soluble polymer, a non-crosslinkable water-soluble polymer, a polyhydric alcohol, ethanol, a crosslinking agent, a pH adjusting component, a cooling sensation imparting component, an accidental ingestion prevention agent, etc. A patch was prepared with a water-containing composition containing an additional ingredient and a preservative. The water content was adjusted so that the total amount of the water-containing composition was 100 g.
It was confirmed that the water-containing compositions included in each of the prepared patches had flexibility and tackiness at a temperature of about 45° C. or lower, and had a gel-like state with no fluidity. In addition, the water-containing composition had a transparent state, and it was confirmed that the preservative and other additional components contained therein were uniformly contained in the water-containing composition. Table 10 shows the measurement results of the physical properties of the patch for each of the prepared patches. In addition, in this example, parabens as a preservative are not contained.

As is clear from Table 10, all of the patches Samples 51 to 57 exhibit excellent antiseptic properties.
Samples 51 and 52 are adhesive patches in which a water-containing composition is attached to one side of a sheet-like holding member, and are cooling sheets that are used by being applied to the forehead or the like of a human body to be cooled.
Sample 53 is a patch in which a water-containing composition is adhered to one side of a sheet-like holding member, and is a cold-warm sensation imparting sheet that is used by being applied to the skin of a region of the human body that is desired to be warmed.
Samples 54 and 55 are adhesive patches in which a water-containing composition is adhered to one side of a sheet-like holding member, and are analgesic and anti-inflammatory sheets that are applied to inflamed or painful skin of the human body.
Samples 56 and 57 are patches in which a water-containing composition is attached to one or both sides of a sheet-like holding member, or is impregnated into a nonwoven fabric sheet having microscopic voids, and is applied to the skin of the face or the like. It is a skin improvement sheet used for the purpose of beautifying the skin by moisturizing or improving rough skin, spots, and freckles, and is used, for example, as a skin improvement pack sheet or a skin improvement face mask. .
As a face mask for skin improvement, for example, a sheet-like elastic sheet having holes for ear hooks, holes corresponding to the human mouth, eyes, and nostrils is used. A holding member is impregnated with a water-containing composition, and a skin improvement pack sheet constituted by impregnating the water-containing composition is used to cover the human face, excluding the mouth, eyes, and nostrils, the forehead, cheeks, and chin. At the same time, it is pasted over both ears of the human body like a mask, and by pasting, the skin-improving ingredients contained in the water-containing composition come into contact with the human skin and/or penetrate into the skin through the skin. As a result, human skin can be improved in accordance with the skin-improving ingredients contained therein.

(Comparative example of Example 6)
In Example 5, patches were prepared in which each water-containing composition contained a small amount of preservative and the other ingredients were the same, and the preservative properties were measured. Table 11 shows the results. Note that in Comparative Samples 51 to 57 of this Comparative Example, parabens as a preservative were not contained.

As is clear from Table 11, among the comparative samples of Comparative Samples 51 to 57, the samples with lower preservative content tended to have inferior antiseptic properties.

In this example, the physical properties of adhesive patches comprising water-containing compositions with different content ratios of water-soluble polymer and polyhydric alcohol were investigated.
A patch containing a water-containing composition was prepared by the following steps.
(a-1) Mix and dissolve a predetermined amount of a crosslinkable water-soluble polymer such as sodium polyacrylate, partially neutralized polyacrylic acid, or crosslinked carboxyvinyl polymer in water to obtain viscosity and fluidity. A pre-prepared solution containing a crosslinkable water-soluble polymer is prepared.
(a-2) Non-crosslinking property that has viscosity and fluidity by mixing and dissolving a predetermined amount of non-crosslinking water-soluble polymer such as polyvinyl alcohol, non-crosslinking carboxymethylcellulose, or alkyl polyacrylate in water. Prepare a preconditioned solution containing a water-soluble polymer.
(b) A crosslinking agent-containing preconditioning solution is prepared by mixing and dissolving 0.5 g or less of a crosslinking agent capable of crosslinking a crosslinkable water-soluble polymer in water.
(c) Mix and dissolve predetermined amounts of phenoxyethanol and polylysine as preservatives in propylene glycol to prepare a preservative-containing pre-preparation liquid containing the dissolved preservatives.
(d-1) A preconditioned liquid d1 containing an additional component is prepared by mixing and dissolving acids (0.1 g or less) as a pH adjusting component in water.
(e) a predetermined amount of a mixed polyhydric alcohol of 1,3-butylene glycol, propylene glycol, and glycerin as polyhydric alcohols, and a crosslinkable water-soluble polymer-containing preconditioning liquid prepared according to (a-1) above. , a non-crosslinkable water-soluble polymer-containing preconditioning liquid prepared by (a-2) above, a crosslinking agent-containing preconditioning liquid prepared by above (b), and a preservative prepared by (c) above. The containing preconditioned liquid and the additional component-containing preconditioned liquid d1 prepared in the above (d-1) are mixed. In this case, mixing is performed at a predetermined temperature. In this way, a fluid water-containing polymer composition in which the preservative is dissolved and which has viscosity and fluidity is prepared.
(f) After the above step (e), when the flowable water-containing polymer composition maintains its fluidity to the point where it gels, a sheet-shaped holding member is coated with the fluidized water-containing polymer composition with a thickness of about 0.5 mm. Depositing and/or impregnating the molecular composition. In this way, a fluid water-containing polymer composition with a sheet-like holding member held by the sheet-like holding member is prepared. The sheet-like holding member is a rectangular sheet with a vertical width of 50 mm and a horizontal width of about 130 mm, and a thickness of about 1 mm, and is made of a non-woven fabric made of synthetic fibers that have bending flexibility that can be expanded and contracted in a plane direction, and air humidity permeability. Use a shape retaining member.
(g) The fluid water-containing polymer composition with a sheet-like holding member prepared in the step (f) is adjusted to a predetermined temperature, thereby increasing the fluidity with the sheet-like holding member over time. The crosslinkable water-soluble polymer contained in the water-containing polymer composition is cross-linked into a network structure by a chemical reaction with the cross-linking agent, and the flowable water-containing polymer composition is transformed into a non-flowable gel state. A formulation comprising a gelled aqueous composition is prepared.
In addition, in the above (e), the content of water contained in the water-containing composition is added and mixed so that the total amount of the water-containing composition is 100 g.

In this way, it contains water, a crosslinkable water-soluble polymer, a non-crosslinkable water-soluble polymer, a polyhydric alcohol, a crosslinking agent, and a pH adjusting component, and also contains phenoxyethanol and polylysine as preservatives. A patch containing a water-containing composition was prepared. The water content was adjusted so that the total amount of the water-containing composition was 100 g.
Table 12 shows the results of the prepared patches.
In addition, in this example, parabens as a preservative are not contained.

The following can be seen from Table 12.
In the case of a composition with a water content of less than 20% by weight (Sample 108), all the water-soluble polymers are not dissolved in the water-containing composition, and a transparent water-containing composition cannot be obtained. In the case of a composition in which the water content exceeds 95% by weight (sample 100), it is difficult to obtain a gel-like water-containing composition that has fluidity at 45°C and has no fluidity, and tends to have poor shape retention. .
In the case of compositions with a water-soluble polymer content of 3 to 40% by weight and a polyhydric alcohol content of 5 to 50% by weight (Samples 103 and 105), adhesiveness, shape retention, and easy-to-peel adhesiveness All physical properties such as peeling residue suppression, transparency, etc. are good. In the case of compositions in which the water-soluble polymer content exceeds 40% by weight (Samples 107 and 108), a transparent water-containing composition can be obtained without all of the water-soluble polymer being dissolved in the water-containing composition. I can't do it. Compositions containing less than 3% by weight of water-soluble polymer (samples 100 and 102) tend to have fluidity at 45° C. and have poor shape retention.
In the case of compositions with a polyhydric alcohol content exceeding 50% by weight (Samples 104 and 106), residues of the water-containing composition may remain on the skin when the patch is removed after being applied to the skin. However, there is a tendency for the inhibition of residual peeling to be poor. In the case of a composition containing less than 5% by weight of polyhydric alcohol (sample 101), the adhesiveness of the patch when applied to the skin tends to be poor.

In this example, in addition to (E) a preservative other than the parabens mentioned above, the preservative properties of patches were comparatively investigated, including (F) a water-containing composition containing parabens as a preservative. .
The step (c) of the method for producing a patch in Example 1 includes (c-p) dissolving parabens in water and/or polyhydric alcohol, and (c-a) dissolving parabens in water or polyhydric alcohol. or (c-b) dissolving glyceryl caprylate in polyhydric alcohol, or (c-d) dissolving polylysine in water. The method includes a step of preparing a pre-conditioned liquid, and prepares a pre-conditioned liquid containing a preservative in which a preservative is dissolved. The other steps are the same as in Example 1 described above. As the parabens, a mixture of equal amounts of both methylparaben and propylparaben was used. Table 13 shows the measurement results of the physical properties of the patch for each of the prepared patches.

The following can be seen from Table 13.
A sample containing 0.05% by weight of parabens and no preservatives other than parabens (sample 117), a sample containing 0.05% by weight of phenoxyethanol (sample 111), and 0.003% by weight of glyceryl caprylate. The sample containing polylysine (sample 113) and the sample containing 0.003% by weight of polylysine (sample 115) have poor antiseptic properties.
On the other hand, when containing 0.05% by weight of parabens and 0.1% by weight of phenoxyethanol (sample 112), when containing 0.05% by weight of parabens and 0.005% by weight of glyceryl caprylate (Sample 114) and 0.05% by weight of parabens and 0.005% by weight of polylysine (Sample 116), both have excellent antiseptic properties.
In other words, when the minimum content of preservatives other than parabens is reduced by using the above preservatives other than parabens in combination with 0.05% by weight or less of parabens based on the total amount. It also has excellent antiseptic properties.

A cream-like water-containing product that is homogeneously mixed with polyhydric alcohol that promotes antiseptic properties, preservatives other than parabens, ibuprofen piconol as a functional ingredient that imparts efficacy, other additional ingredients, and water. A composition was prepared. That is, (a) a functional ingredient is mixed with water to prepare a functional ingredient-containing pre-prepared liquid, and (c) a preservative other than parabens and water and water that can dissolve the preservative are mixed. and/or a polyhydric alcohol, thereby preparing a preservative-containing pre-prepared liquid containing a dissolved preservative; (e) polyhydric alcohol and the function prepared by (a) above; The functional ingredient-containing preconditioned liquid and the preservative-containing preconditioned liquid prepared in (c) above were mixed, thereby preparing a water-containing composition in which the functional ingredient and the preservative were dissolved. . Table 14 shows the measurement results of antiseptic properties and the like for each of the prepared water-containing compositions.
In addition, in this example, parabens as a preservative are not contained. Further, as for the content ratio of propylene glycol and butylene glycol as the polyhydric alcohol, a mixed polyhydric alcohol is used in an equal weight ratio of 1:1.
The water-containing composition of this example has a cream state and is a dermatological drug that is used by applying it to the human face to improve the skin condition of the face.

The following can be seen from Table 14.
The sample containing 0.1% by weight of phenoxyethanol (Sample 120) and the sample containing 0.005% by weight of glyceryl caprylate (Sample 122) were inferior in antiseptic properties. On the other hand, the sample containing 0.3% by weight of phenoxyethanol (sample 121) and the sample containing 0.01% by weight of glyceryl caprylate (sample 123) have excellent antiseptic properties. That is, a water-containing composition containing less than 0.3% by weight of phenoxyethanol has poor preservative properties, and a water-containing composition containing 0.3% by weight or more of phenoxyethanol has excellent preservative properties.
Sample 124 (point Q in FIG. 2), which contains both 0.1% by weight of phenoxyethanol and 0.003% by weight of glyceryl caprylate, has no antiseptic properties, but contains 0.1% by weight of phenoxyethanol and 0.005% by weight of glyceryl caprylate. Sample 125 (point S in FIG. 2) containing both % and % by weight has antiseptic properties. That is, in FIG. 2, a patch comprising a composition containing a preservative in an area surrounded by a line XY connecting points X and Y, and a line MN connecting points M and N, It can be seen that the synergistic action of both preservatives makes it possible to reduce the minimum preservative content of each preservative and the total content of both preservatives. In other words, the composition containing both phenoxyethanol and glyceryl caprylate preservatives provides superior preservative properties compared to the use of these preservatives alone at the same preservative concentration. You can get the effect of playing.

In addition, a sample containing 0.3% by weight of phenoxyethanol and 10% by weight of polyhydric alcohol (sample 121) exhibits excellent antiseptic properties; The sample containing 4% by weight of glycerin as a polyhydric alcohol (sample 126) has poor antiseptic properties.
A sample containing 0.01% by weight of glyceryl caprylate and 10% by weight of polyhydric alcohol (Sample 123) exhibited excellent antiseptic properties; The sample (sample 127) containing 2% by weight of propylene glycol and butylene glycol as polyhydric alcohols has poor antiseptic properties.
A sample containing both phenoxyethanol and glyceryl caprylate as preservatives and 10% by weight of polyhydric alcohol (sample 125) exhibits excellent preservative properties; The sample containing both preservatives and 4% by weight of glycerin as a polyhydric alcohol (sample 128) has poor preservative properties.

That is, in a water-containing composition containing phenoxyethanol and/or glyceryl caprylate, a composition containing 5% by weight or more of glycerin as a polyhydric alcohol, or a composition containing 3% by weight or more of polyhydric alcohol and/or butylene glycol. It can be seen that compositions containing alcohols exhibit excellent antiseptic properties, and these polyhydric alcohols promote the antiseptic properties of phenoxyethanol and/or glyceryl caprylate.

(Example 10 and comparative example)
The present Examples and Comparative Examples are water-containing compositions containing water-soluble polymers such as cross-linked water-soluble polymers and non-cross-linked water-soluble polymers as functional ingredients, and water-containing compositions containing no water-soluble polymers. The antiseptic properties of the obtained patches were compared and examined regarding the patches provided with the substance.
A water-containing composition and a patch comprising the water-containing composition were prepared through the following steps.
(a-1) Mix and dissolve a predetermined amount of a crosslinkable water-soluble polymer such as sodium polyacrylate, partially neutralized polyacrylic acid, or crosslinked carboxyvinyl polymer in water to obtain viscosity and fluidity. A preconditioned solution containing a crosslinkable water-soluble polymer is prepared.
(a-2) Contains a non-cross-linked water-soluble polymer that has viscosity and fluidity by mixing and dissolving a predetermined amount of non-cross-linked water-soluble polymer such as polyvinyl alcohol or non-cross-linked carboxymethyl cellulose in water. Prepare the preconditioning solution.
(b) A crosslinking agent-containing preconditioning solution is prepared by mixing and dissolving 0.5 g or less of a crosslinking agent capable of crosslinking a crosslinkable water-soluble polymer in water.
(c) Mix and dissolve predetermined amounts of phenoxyethanol and polylysine as preservatives in propylene glycol to prepare a preservative-containing pre-preparation liquid containing the dissolved preservatives.
(d-1) A preconditioned liquid d1 containing an additional component is prepared by mixing and dissolving acids (0.1 g or less) as a pH adjusting component in water.
(e) a predetermined amount of a mixed polyhydric alcohol of 1,3-butylene glycol, propylene glycol, and glycerin as polyhydric alcohols, and a crosslinkable water-soluble polymer-containing preconditioning liquid prepared according to (a-1) above. , a non-crosslinkable water-soluble polymer-containing preconditioning liquid prepared by (a-2) above, a crosslinking agent-containing preconditioning liquid prepared by above (b), and a preservative prepared by (c) above. The containing preconditioned liquid and the additional component-containing preconditioned liquid d1 prepared in the above (d-1) are mixed. In this case, mixing is performed at a predetermined temperature. In this way, a fluid water-containing polymer composition in which the preservative is dissolved and which has viscosity and fluidity is prepared.
(f) After the above step (e), when the flowable water-containing polymer composition maintains its fluidity to the point where it gels, a sheet-shaped holding member is coated with the fluidized water-containing polymer composition with a thickness of about 0.5 mm. Depositing and/or impregnating the molecular composition. In this way, a fluid water-containing polymer composition with a sheet-like holding member held by the sheet-like holding member is prepared. The sheet-like holding member is a rectangular sheet with a vertical width of 50 mm and a horizontal width of about 130 mm, and a thickness of about 1 mm, and is made of a non-woven fabric made of synthetic fibers that have bending flexibility that can be expanded and contracted in a plane direction, and air humidity permeability. Use a shape retaining member.
(g) The fluid water-containing polymer composition with a sheet-like holding member prepared in the step (f) is adjusted to a predetermined temperature, thereby increasing the fluidity with the sheet-like holding member over time. The crosslinkable water-soluble polymer contained in the water-containing polymer composition is cross-linked into a network structure by a chemical reaction with the cross-linking agent, and the flowable water-containing polymer composition is transformed into a non-flowable gel state. A patch comprising a gelled water-containing composition is prepared.
In addition, in the above (e), the water content contained in the water-containing composition is added and mixed so that the total amount of the water-containing composition is 100 g.

In this way, it contains water, a crosslinkable water-soluble polymer, a non-crosslinkable water-soluble polymer, a polyhydric alcohol, a crosslinking agent, and a pH adjusting component, and also contains phenoxyethanol and polylysine as preservatives. A patch containing a water-containing composition was prepared. The water content was adjusted so that the total amount of the water-containing composition was 100 g.
In addition, for samples that do not contain the crosslinkable water-soluble polymer in step (a-1) above and/or the non-crosslinkable water-soluble polymer in step (a-2), these (a-1) step or (a-2) step.
Table 15 shows the results of each patch prepared. In addition, in the present example and comparative example, parabens as a preservative are not contained.
In addition, in the case of samples (samples 131, 133, 135, 137) that do not contain a crosslinkable water-soluble polymer, in the step (g), the water-containing composition that has fluidity without being gelled is added to the sheet-like holding member. A patch was prepared that was impregnated with and retained by

The following can be seen from Table 15.
Patch (Sample 130) with a water-containing composition containing 0.2% by weight of phenoxyethanol and 3% by weight of a water-soluble polymer, 0.01% by weight of polylysine and 3% by weight of a water-soluble polymer (sample 132), and a patch (sample 132) comprising a water-containing composition containing 0.1% by weight of phenoxyethanol and 0.005% by weight of polylysine, and 3% by weight of a water-soluble polymer. The patch (Sample 134) with a water-containing composition containing 0.2% by weight of phenoxyethanol and no water-soluble polymer (Sample 131) exhibited excellent antiseptic properties. ), a patch comprising a water-containing composition containing 0.01% by weight of polylysine and no water-soluble polymer (sample 133), a patch containing 0.1% by weight of phenoxyethanol and 0.005% by weight of polylysine and a water-soluble The adhesive patch (Sample 135) comprising a water-containing composition that does not contain 3% by weight of a synthetic polymer has poor antiseptic properties. That is, among compositions containing preservatives of phenoxyethanol and polylysine at the same content ratio, patches (samples 130, 132, 134, 136, 137) with a water-containing composition containing 3% by weight of water-soluble polymer , has excellent antiseptic properties, but on the other hand, patches (samples 131, 133, and 135) equipped with water-containing compositions that do not contain water-soluble polymers tend to have poor antiseptic properties.

Note that this example is a comparative study of antiseptic properties depending on the presence or absence of water-soluble polymer content, and also includes samples that are not suitable for use as a patch.

According to the present invention, a water-containing composition containing water and a functional component such as a water-soluble polymer can exhibit sufficient antiseptic properties and has reduced skin sensitization, and a water-containing composition thereof. A patch, a cosmetic product, a medicinal product for the skin, and the like are obtained.

Claims (6)

(A) Water;
(B) a water-containing composition containing the water-soluble functional component,
at least,
(C) a polyhydric alcohol that is soluble or compatible with the water and has a preservative promoting effect;
(E) a preservative other than parabens that is soluble in the water and/or the polyhydric alcohol that promotes antiseptic properties;
Contains
(E) Regarding the total amount of preservatives other than the parabens,
Contains 0.6% by weight or more of phenoxyethanol,
(C) The polyhydric alcohol that exhibits the antiseptic promoting effect is
Propylene glycol,
butylene glycol, and
glycerin,
at least one polyhydric alcohol selected from the group consisting of,
Contains 18% by weight or more based on the total amount,
(B) The functional component is at least based on the total amount,
Contains 16% by weight or more of a water-soluble polymer,
The water-soluble polymer is dissolved in the water, and
Preservatives other than the water, the water-soluble polymer, the polyhydric alcohol, and the parabens are:
They are in a mutually dissolved or compatible state,
The water-soluble polymer contains at least one water-soluble polymer selected from the group consisting of polyacrylic acid, sodium polyacrylate, partially neutralized polyacrylic acid, carboxyvinyl polymer, and carboxyalkyl cellulose. ,
A water-containing composition having antiseptic properties. (A) Water;
(B) a water-containing composition containing the water-soluble functional component,
at least,
(C) a polyhydric alcohol that is soluble or compatible with the water and has a preservative promoting effect;
(E) a preservative other than parabens that is soluble in the water and/or the polyhydric alcohol that promotes antiseptic properties;
Contains
(E) Regarding the total amount of preservatives other than the parabens,
Contains 0.01% by weight or more of glyceryl caprylate,
(C) The polyhydric alcohol that exhibits the antiseptic promoting effect is based on the total amount:
5% by weight or more of propylene glycol and butylene glycol,
5% by weight or more of glycerin;
Contains
(B) the water-soluble functional ingredient contains ibuprofen piconol and/or sodium hyaluronate;
A water-containing composition having antiseptic properties. (A) Water;
(B) a water-containing composition containing the water-soluble functional component,
at least,
(C) a polyhydric alcohol that is soluble or compatible with the water and has a preservative promoting effect;
(E) a preservative other than parabens that is soluble in the water and/or the polyhydric alcohol that promotes antiseptic properties;
Contains
(E) Regarding the total amount of preservatives other than the parabens,
0.1% by weight or more phenoxyethanol;
0.005% by weight or more of glyceryl caprylate;
Contains both preservatives,
(C) The polyhydric alcohol that exhibits the antiseptic promoting effect is based on the total amount:
5% by weight or more of propylene glycol and butylene glycol,
5% by weight or more of glycerin;
Contains
(B) the water-soluble functional ingredient contains ibuprofen piconol and/or sodium hyaluronate;
A water-containing composition having antiseptic properties. (B) the functional ingredient contains an efficacy-imparting functional ingredient,
The efficacy-imparting functional ingredients include pharmacologically active ingredients, skin-improving ingredients, and aromatic ingredients.
At least one selected from the group consisting of
The water-containing composition having antiseptic properties according to any one of claims 1 to 3. (B) The pharmacologically active ingredients include indomethacin, loxoprofen, ketoprofen, diclofenac, diclofenac sodium, felbinac, piroxicam, suprofen, ibuprofen, ibuprofen piconol, ketorolac, lidocaine,
Contains at least one pharmacologically active ingredient selected from the group consisting of flurbiprofen, mefenamic acid, dipotassium glycyrrhizinate, and salicylic acid esters,
The skin-improving ingredients include tocopherols, placenta extracts, hyaluronic acids, econzymes, arbutin, collagens, polyphenols, allantoin, squalane, panthenol, chamomile extract, hamamelis extract, lavender extract, pearl barley extract, plantain extract, and rice. Contains at least one skin-improving ingredient selected from the group consisting of extracts, salmon ovary extracts, Saccharomyces, fermented rice liquid, vitamin C, vitamin E, and vitamins,
The aromatic component contains an essential oil component that generates a fragrance.
The water-containing composition having antiseptic properties according to claim 4. A patch, cosmetic, or dermatological drug comprising at least the water-containing composition having preservative properties according to any one of claims 1 to 5.

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