Tranexamic acid-containing topical composition

Abstract

To provide a method for inhibiting the precipitation of a solidified tranexamic acid in a tranexamic acid-containing external composition, and to provide a tranexamic acid-containing external composition in which the precipitation of a solidified tranexamic acid is inhibited.SOLUTION: An inventive method for inhibiting the precipitation of a solidified tranexamic acid includes blending a tranexamic acid-containing external composition with a heparinoid. The inventive external composition contains a tranexamic acid, a heparinoid, and at least one selected from the group consisting of sodium dilauramidoglutamide lysine, polyoxyethylene methyl glucoside and polyethylene glycol.SELECTED DRAWING: None

Description

[Technical field]

[0001] The present invention relates to a method for inhibiting precipitation of a solidified product of tranexamic acids in an external use composition containing at least one tranexamic acid selected from the group consisting of tranexamic acid and its salts (hereinafter also referred to as a "tranexamic acid-containing external use composition").The present invention also relates to an external use composition in which precipitation of a solidified product of tranexamic acids is inhibited. [Background technology]

[0002] Tranexamic acids are often used as anti-inflammatory and whitening ingredients in medicines, quasi-drugs, and cosmetics. In addition, tranexamic acids are known to be easily soluble in water, but highly crystalline, and there have been problems with the phenomenon that a solidified product of tranexamic acids precipitates over time during storage of an external use composition containing tranexamic acids, and when an external use composition containing tranexamic acids adheres to the mouth of a container in which it is filled, water evaporates over time, causing the tranexamic acids to solidify at the mouth of the container. The precipitation of solidified products of tranexamic acids and the solidification of tranexamic acids at the mouth of a container can cause the quality of the product to deteriorate and the feeling of use to be impaired. Various compositions have been provided to date that inhibit the precipitation of solidified tranexamic acids. For example, Patent Document 1 discloses that a combination of tranexamic acids with two or more water-soluble polymers selected from a carboxyvinyl polymer, xanthan gum, and an alginate salt is used to inhibit the tranexamic acids in a formulation from solidifying at the mouth of a container. [Prior art documents] [Patent documents]

[0003] [Patent Document 1] JP 2018-177763 A Summary of the Invention [Problem to be solved by the invention]

[0004] An object of the present invention is to provide a method for inhibiting the precipitation of solidified tranexamic acids in a topical composition containing tranexamic acids.Another object of the present invention is to provide a topical composition in which the precipitation of solidified tranexamic acids is inhibited. [Means for solving the problem]

[0005] As a result of intensive research to solve the above-mentioned problems, the inventors discovered that by incorporating a heparin-like substance into an external composition containing tranexamic acids, the precipitation of solidified tranexamic acids can be suppressed, and thus completed the present invention.

[0006] That is, the present invention provides: [1] A method for inhibiting precipitation of a solidified product of tranexamic acids, comprising blending a heparinoid with a composition for external use containing at least one tranexamic acid selected from the group consisting of tranexamic acid and its salts; [2] The method according to [1], wherein the mass ratio of the tranexamic acids to the heparinoid is 1:0.007 to 1:0.15. [3] A composition for external use comprising at least one tranexamic acid selected from the group consisting of tranexamic acid and its salts, a heparinoid, and at least one selected from the group consisting of sodium dilauroyl glutamate lysine, polyoxyethylene methyl glucoside, and polyethylene glycol; [4] The mass ratio of the tranexamic acids to the heparinoid is less than 1:0.007. The composition for external use according to [3], wherein the ratio of the glycerol to the total lipid is 1:0.15. [5] The composition for external use according to [3] or [4], wherein the at least one selected from the group consisting of sodium dilauroyl glutamate lysine, polyoxyethylene methyl glucoside, and polyethylene glycol is at least one selected from the group consisting of 0.001 to 0.3% by mass of sodium dilauroyl glutamate lysine, 0.1 to 10.0% by mass of polyoxyethylene methyl glucoside, and 0.1 to 10.0% by mass of polyethylene glycol, based on the total mass of the composition for external use. [6] A composition for external use comprising at least one tranexamic acid selected from the group consisting of tranexamic acid and its salts, a heparinoid, and at least one selected from the group consisting of sodium dilauroyl glutamate lysine, polyoxyethylene methyl glucoside, and polyethylene glycol, wherein precipitation of a solidified product of the tranexamic acid is inhibited. [7] The composition for external use according to [6], wherein the mass ratio of the tranexamic acids to the heparinoid is 1:0.007 to 1:0.15. [8] The topical composition according to [6] or [7], wherein the at least one selected from the group consisting of sodium dilauroyl glutamate lysine, polyoxyethylene methyl glucoside, and polyethylene glycol is at least one selected from the group consisting of 0.001 to 0.3% by mass of sodium dilauroyl glutamate lysine, 0.1 to 10.0% by mass of polyoxyethylene methyl glucoside, and 0.1 to 10.0% by mass of polyethylene glycol, based on the total mass of the topical composition. Regarding.

[0007] Another aspect of the present invention is [9] The composition for external use according to [3], wherein the amount of tranexamic acids is 0.001 to 15% by mass and the amount of heparinoids is 0.001 to 5% by mass, based on the total mass of the composition for external use.

[10] The composition for external use according to [6], wherein the amount of tranexamic acids is 0.001 to 15% by mass and the amount of heparinoids is 0.001 to 5% by mass, based on the total mass of the composition for external use.

[11] A method for inhibiting precipitation of a solidified product of tranexamic acids according to [1] or [2], further comprising blending one or more selected from the group consisting of a moisturizing component, a surfactant, a chelating agent, an antioxidant and a pH adjuster.

[12] The method according to [1], [2] or

[11] , further comprising blending a moisturizing component.

[13] The composition for external use according to any one of [3] to [5] or [9], further comprising one or more selected from the group consisting of moisturizing ingredients, surfactants, chelating agents, antioxidants and pH adjusters.

[14] The composition for external use according to any one of [6] to [8] or

[10] , further comprising one or more selected from the group consisting of moisturizing ingredients, surfactants, chelating agents, antioxidants and pH adjusters.

[15] The composition for external use according to

[13] or

[14] , wherein the moisturizing component comprises one or more selected from the group consisting of hyaluronic acid, chondroitin sulfate, glycerin, concentrated glycerin, propylene glycol, dipropylene glycol, and 1,3-butylene glycol. Regarding. Effect of the Invention

[0008] According to the present invention, it is possible to inhibit the precipitation of solidified tranexamic acids in a topical composition containing tranexamic acids. Therefore, by using the method of the present invention, it is possible to suppress the precipitation of solidified tranexamic acids, and thus it is possible to obtain tranexamic acids that are less likely to deteriorate in quality and less likely to have a poor usability. It is possible to provide products containing acids.

[0009] According to the present invention, it is possible to provide a composition for external use in which the precipitation of a solidified product of tranexamic acids is inhibited. The method or composition of the present invention has any one or more of the effects described above. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0010] The present invention will now be described in further detail. [Method for inhibiting precipitation of solidified tranexamic acids] The present invention relates to a method for inhibiting the precipitation of solidified tranexamic acids, which comprises incorporating a heparinoid into an external composition containing at least one tranexamic acid selected from the group consisting of tranexamic acid and its salts.

[0011] In the present invention, the tranexamic acid compound is at least one selected from the group consisting of tranexamic acid and its salts. Tranexamic acid is the abbreviation for trans-(4-aminomethyl)cyclohexanecarboxylic acid. Furthermore, examples of salts of tranexamic acid include, but are not limited to, metal salts such as sodium salt, potassium salt, magnesium salt, etc., hydrochloride salt, amino acid salts such as arginine salt, phosphate salt, sulfate salt, triethanolamine salt, etc. In the present invention, the tranexamic acid is preferably tranexamic acid in the form of a free acid. The solidified tranexamic acids of the present invention refers to a solid containing solidified tranexamic acids, and the form of the solidified tranexamic acids is not particularly limited, and may be either crystalline or amorphous.

[0012] The amount of tranexamic acids to be incorporated is not particularly limited as long as it is an amount sufficient to exert its medicinal effect, and is preferably 0.001 to 15% by mass, more preferably 0.01 to 10% by mass, and even more preferably 0.1 to 3% by mass, based on the total mass of the topical composition containing tranexamic acids. In the present invention, the blend amount and mass ratio of the tranexamic acids are the blend amount and mass ratio converted into tranexamic acid in the form of a free acid.

[0013] In the present invention, the heparinoid has the effect of suppressing the precipitation of solidified tranexamic acids, and may also act as a moisturizing component depending on the amount of the heparinoid. In the present invention, the heparinoid is a general term for polysulfated mucopolysaccharides such as chondroitin polysulfate. Examples of heparinoids include those obtained by sulfated mucopolysaccharides, and heparinoids described in the Japanese Pharmacopoeia Non-Prescription Drugs are preferred. The amount of heparinoid to be incorporated is not particularly limited as long as it is an amount sufficient to inhibit the precipitation of solidified tranexamic acids, and is preferably 0.001 to 5 mass%, more preferably 0.01 to 3 mass%, and even more preferably 0.05 to 1 mass%, based on the total mass of the topical composition containing tranexamic acids. In the present invention, the blending ratio of tranexamic acids to heparinoids is preferably 1:0.007 to 1:0.15 by mass, in order to sufficiently suppress the precipitation of solidified tranexamic acids, and more preferably 1:0.007 to 1:0.05, in order to obtain a colorless, transparent solution in addition to sufficiently suppressing the precipitation of solidified tranexamic acids.

[0014] In this specification, the effect of inhibiting the precipitation of solidified tranexamic acids refers to the effect of inhibiting the precipitation of solidified tranexamic acids and maintaining the stability of a solution containing tranexamic acids for a certain period of time. More specifically, the presence or absence of the effect of inhibiting the precipitation can be determined by, for example, dissolving tranexamic acids in water at room temperature (about 23°C) to the maximum extent that they can be dissolved, preparing a high-concentration tranexamic acids solution (saturated solution), placing it in a sealed container, and leaving it at 40°C for 5 days, and observing the presence or absence of precipitation of solidified matter. The presence or absence of precipitation of solidified matter can usually be easily determined by visual inspection.

[0015] In the present invention, in addition to the above-mentioned components, the tranexamic acid-containing topical composition may contain one or more of various components, such as whitening components, moisturizing components, anti-inflammatory components, UV absorbers, antioxidants, antibacterial and preservative agents, thickeners, chelating agents, pH adjusters, solubilizers, dissolution aids, stabilizers, surfactants (nonionic surfactants, anionic surfactants, cationic surfactants, amphoteric surfactants), hydrocarbons, esters, higher alcohols, fatty acids, fragrances, and colorants, in combination, within the scope of the object of the present invention. Each of these components is not particularly limited as long as it can be used in the fields of pharmaceuticals, quasi-drugs, and / or cosmetics, and any component may be appropriately selected and used.

[0016] Examples of the whitening ingredient include arbutin, placenta, kojic acid, ascorbic acid, niacinamide, chamomile ET, linoleic acid, hydroquinone, pantothenic acid, and vitamins such as derivatives thereof.

[0017] Examples of the moisturizing component include chondroitin sulfate, sodium chondroitin sulfate, hyaluronic acid, sodium hyaluronate, collagen, glycerin, concentrated glycerin, dipropylene glycol, propylene glycol, 1,3-butylene glycol, polyethylene glycol, polyoxyethylene methyl glucoside, xylitol, sorbitol, maltitol, urea, sodium pyrrolidone carboxylate solution, ceramide, trimethylglycine, plant extract, and sodium dilauroyl glutamate lysine. When a moisturizing ingredient is incorporated, the amount of the moisturizing ingredient may be within a range in which its effect is observed, and the amount of the moisturizing ingredient is preferably 0.001 to 60% by mass, and more preferably 0.1 to 45% by mass, based on the total mass of the topical composition containing tranexamic acids.

[0018] Examples of the anti-inflammatory components include salicylic acid, isopropylmethylphenol, allantoin, dipotassium glycyrrhizinate, zinc oxide, tocopherol acetate, and menthol.

[0019] Examples of the ultraviolet absorbing agent include salicylic acid ultraviolet absorbing agents, cinnamic acid ultraviolet absorbing agents, benzoylmethane ultraviolet absorbing agents, and benzoic acid ester derivative ultraviolet absorbing agents.

[0020] Examples of the antioxidant components include hydroquinone, astaxanthin, niacinamide, γ-oryzanol, DL-α-tocopherol acetate, natural vitamin E, placenta extract, sodium dl-α-tocopheryl phosphate, and the like.

[0021] Examples of the antioxidant include dibutylhydroxytoluene, ascorbic acid, isopropyl gallate, and sodium pyrosulfite. When an antioxidant is added, the amount of the antioxidant added may be within a range in which its effect is observed, and the amount of the antioxidant added is preferably 0.0001 to 10% by mass, and more preferably 0.0001 to 5% by mass, based on the total mass of the topical composition containing tranexamic acids.

[0022] Examples of the antibacterial and antiseptic agents include methyl paraoxybenzoate, Examples of such benzoate include ethyl parahydroxybenzoate, propyl parahydroxybenzoate, butyl parahydroxybenzoate, isopropyl parahydroxybenzoate, phenoxyethanol, benzoic acid, and chlorhexidine gluconate. When an antibacterial or preservative is added, the amount of the antibacterial or preservative may be within a range in which its effect is observed, and the amount of the antibacterial or preservative is preferably 0 to 3.0% by mass, and more preferably 0 to 1.0% by mass, based on the total mass of the topical composition containing tranexamic acids.

[0023] Examples of the thickener include alginic acid, carboxyvinyl polymer, guar gum, xanthan gum, methyl cellulose, ethyl cellulose, hydroxyethyl cellulose, hydroxypropyl cellulose, carboxymethyl cellulose, polyvinyl alcohol, bentonite, acrylate / alkyl methacrylate copolymer, and (hydroxyethyl acrylate / sodium acryloyldimethyltaurate) copolymer. When a thickening agent is added, the amount of the thickening agent may be within a range in which its effect is observed, and the amount of the thickening agent is preferably 0.001 to 3.0 mass%, more preferably 0.01 to 1.0 mass%, and even more preferably 0.01 to 0.8 mass%, based on the total mass of the topical composition containing tranexamic acids.

[0024] Examples of the chelating agent include edetate, hydroxyethanediphosphonic acid, etidronic acid, and trisodium ethylenediaminehydroxyethyltriacetate. When a chelating agent is incorporated, the amount of the chelating agent may be within a range in which its effect is observed, and the amount of the chelating agent is preferably 0.001 to 5.0% by mass, and more preferably 0.01 to 3.0% by mass, based on the total mass of the topical composition containing tranexamic acids.

[0025] Examples of the pH adjuster include citric acid, sodium citrate, anhydrous citric acid, succinic acid, sodium succinate, disodium succinate, phosphoric acid, sodium dihydrogen phosphate, anhydrous disodium hydrogen phosphate, lactic acid, sodium lactate, sodium hydroxide, and potassium hydroxide.

[0026] Examples of surfactants include polyoxyethylene hydrogenated castor oil, polyoxyethylene sterol / hydrogenated sterol, polyoxyethylene alkyl ether, polyoxyethylene polyoxypropylene alkyl ether, sorbitan fatty acid ester, polyoxyethylene sorbitan fatty acid ester, glycerin fatty acid ester, polyglycerin fatty acid ester, polyoxyethylene glycerin fatty acid ester, etc. When a surfactant is added, the amount of the surfactant added may be within a range in which its effect is observed, and the amount of the surfactant added is preferably 0.01 to 15% by mass, and more preferably 0.05 to 10% by mass, based on the total mass of the topical composition containing tranexamic acids.

[0027] Furthermore, in the present invention, the topical composition containing tranexamic acids contains water as a solvent in addition to the above-mentioned components. As the water, purified water can be used. The amount of water contained in the topical composition containing tranexamic acids is usually the remainder obtained by subtracting the total amount of each of the above-mentioned components from 100% by mass. In the present invention, the amount of water contained in the topical composition containing tranexamic acids is typically 30 to 99.9 mass%, preferably 40 to 99.9 mass%, and more preferably 50 to 99 mass%, based on the total mass of the topical composition containing tranexamic acids. As described later, the composition for external use of the present invention can have various properties and formulations, so the amount of water can be adjusted according to the purpose. For example, when it is desired to give fluidity to the composition for external use, the amount of water may be 50 to 99% by mass, or 60 to 99% by mass, based on the total mass of the composition for external use.

[0028] In the present invention, the topical composition containing tranexamic acids is preferably prepared by dissolving in, for example, purified water, deionized water, etc. The composition can be prepared by mixing the tranexamic acids and the above-mentioned optional components in water, and dissolving each component by heating, stirring, or the like, as necessary. The resulting solution can be adjusted to a desired pH by adding a pH adjuster as necessary. The pH of the solution in the present invention is not particularly limited, but since it is used as a tranexamic acid-containing external composition, it is preferably pH 3 or more, more preferably pH 4 to 8, and even more preferably pH 4.5 to 7.

[0029] In the present invention, the method of incorporating a heparinoid into a topical composition containing tranexamic acids is not particularly limited, and examples include a method of directly incorporating the heparinoid into a topical composition containing tranexamic acids, or a method of dissolving the heparinoid in a solvent such as water and then incorporating it into a topical composition containing tranexamic acids.

[0030] [External composition] The present invention relates to a composition for external use containing at least one tranexamic acid selected from the group consisting of tranexamic acid and its salts, a heparinoid, and at least one selected from the group consisting of sodium dilauroyl glutamate lysine, polyoxyethylene methyl glucoside, and polyethylene glycol.

[0031] The types, contents, and content ratios of the tranexamic acids and heparinoids in the topical composition are as explained in the topical composition containing tranexamic acids. The amount of sodium dilauroyl glutamate lysine is preferably 0.001 to 0.3% by mass, more preferably 0.01 to 0.3% by mass, and even more preferably 0.01 to 0.1% by mass, based on the total mass of the composition for external use. The amount of polyoxyethylene methyl glucoside blended is preferably 0.1 to 10.0% by mass, more preferably 0.1 to 5.0% by mass, and even more preferably 1.0 to 5.0% by mass, based on the total mass of the composition for external use. The amount of polyethylene glycol is preferably 0.1 to 10.0% by mass, more preferably 0.1 to 5.0% by mass, and even more preferably 1.0 to 5.0% by mass, based on the total mass of the composition for external use.

[0032] In addition, in the present invention, in addition to the above-mentioned components, the topical composition may contain one or more of the various components exemplified in paragraph

[0015] in combination, provided that the purpose of the present invention is not impaired. Furthermore, in the present invention, the topical composition contains water as a solvent in addition to the above-mentioned components. The content of water is as described above for the topical composition containing tranexamic acids.

[0033] In the present invention, the method for producing the composition for external use is not limited thereto, but may be exemplified by a method in which each of the components, tranexamic acids, heparinoids, and at least one selected from the group consisting of sodium dilauroyl glutamate lysine, polyoxyethylene methyl glucoside, and polyethylene glycol, and any optional components, is separately added to water such as purified water or deionized water to prepare each composition, and the compositions are mixed and stirred so that each component is 100% by mass in total.Another example is a method in which all components are combined together and dissolved in water to prepare the composition. The obtained solution can be adjusted to a desired pH by adding a pH adjuster as necessary. The pH of the solution in the present invention is not particularly limited, but since it is used as a composition for external use, it is preferably pH 3 or more, more preferably pH 4 to 8, and even more preferably pH 4.5 to 7.

[0034] The external composition of the present invention may be in the form of a liquid, gel, cream, etc., and is preferably in the form of a liquid. The formulation of the present invention may be in the form of a liquid, lotion, emulsion, gel, cream, etc. Examples of the formulation include creams, aerosols, foams, etc., and preferably include solutions, lotions, and emulsions. These formulations can be prepared by the above-mentioned methods.

[0035] Since the topical composition of the present invention is inhibited from depositing solidified tranexamic acids, it can be used in the fields of medicines, quasi-drugs, and cosmetics as a skin lotion, lotion, emulsion, beauty essence, etc. In particular, the topical composition of the present invention is preferably used as a skin lotion, lotion, emulsion, beauty essence, etc. for quasi-drugs. EXAMPLES

[0036] The present invention will be described in more detail below with reference to examples, but the present invention is not limited to the following examples. In the following test examples and preparation examples, a heparinoid (compliant with the Japanese Pharmacopoeia non-prescription drug standards) was used.

[0037] Test Example 1: Effect of heparinoids on the inhibition of precipitation of solidified tranexamic acids Each component was weighed out so that the total mass was 100% in the amounts shown in Table 1, and the components were mixed and stirred to prepare a composition for external use. After confirming that the composition had completely dissolved, the topical composition to be used in the evaluation test was transferred to a sealed glass container, and the sealed container was left in an environment of 40°C for a specified period of time to observe whether any precipitation of solidified tranexamic acids was observed. The presence or absence of precipitation of solidified tranexamic acids was judged according to the following criteria. ◯: No tranexamic acids solidified were precipitated. Δ: No tranexamic acids solidified were precipitated, but coloring of the solution was observed. ×: A solidified product of tranexamic acids was precipitated. The amount of each component in Table 1 represents mass % based on the total mass of the topical composition.

[0038] [Table 1]

[0039] Results: The heparinoid was able to suppress the precipitation of the solidified tranexamic acids. On the other hand, Comparative Example 2, in which sodium dilauroyl glutamate lysine and 1,3-butylene glycol were added instead of the heparinoid, was unable to suppress the precipitation of the solidified tranexamic acids. It was revealed that the addition of sodium dilauroyl glutamate lysine and 1,3-butylene glycol to the heparinoid did not affect the suppression of the precipitation of the solidified tranexamic acids.

[0040] Test Example 2: Effect of the amount of heparinoid According to the method of Test Example 1, etc., an external composition having the composition shown in Table 2 was prepared, and the presence or absence of precipitation of solidified tranexamic acids in the external composition was observed for a specified period of time, and judged in the same manner as in Test Example 1. The amount of each component in Table 2 represents the mass % based on the total mass of the topical composition.

[0041] [Table 2]

[0042] Results: Even when the mass ratio of the heparinoid to the tranexamic acids was tranexamic acids:heparinoid = 1:0.007, the precipitation of solidified tranexamic acid was suppressed.

[0043] Test Example 3: Moisturizing effect of a topical composition in which the precipitation of solidified tranexamic acids is suppressed According to the method of Test Example 1, etc., compositions for external use having the compositions shown in Table 3 were prepared (the numbers in Table 3 represent mass %). A subject with dry, sensitive skin, suffering from dryness including flaking and peeling of the skin on his face, was given an appropriate amount of the topical composition shown in Table 3, which was applied to the face twice a day after washing his face, removing his makeup, and applying his usual lotion. Before application, and two and four weeks after the start of application, the moisture content of the stratum corneum was measured on the skin above the right cheekbone using a MoistureMeter SC Compact (registered trademark) (Delphin Technologies, Inc.). The measurement results are shown in Table 4. The results are calculated as a relative value (AU) by measuring the capacitance, which is proportional to the moisture content of the surface layer (stratum corneum), which has low conductivity.

[0044] [Table 3]

[0045] [Table 4] Results: Compared to before application, the moisture content of the stratum corneum was significantly increased four weeks after application (one-tailed t-test: p<0.001).

[0046] [Formulation example] The topical compositions of the present invention were prepared based on the formulations shown in Tables 5 to 8 below. The values ​​in each table indicate mass %. The preparation method was similar to that of Test Example 1. The topical compositions of the present invention are not limited to the method of Test Example 1, and can be prepared by methods generally used for pharmaceuticals, quasi-drugs, or cosmetics.

[0047] [Table 5]

[0048] [Table 6]

[0049] [Table 7]

[0050] [Table 8] [Table 9]

Claims

1. A method for inhibiting the precipitation of a solidified product of tranexamic acids, comprising blending a heparinoid and at least one selected from the group consisting of sodium dilauroyl glutamate lysine, polyoxyethylene methyl glucoside, and polyethylene glycol into an external composition containing at least one tranexamic acid selected from the group consisting of tranexamic acid and its salts.

2. The method according to claim 1, wherein the mass ratio of the tranexamic acids to the heparinoid is from 1:0.007 to 1:0.

15.

3. A composition for external use comprising at least one tranexamic acid selected from the group consisting of tranexamic acid and its salts, a heparinoid, and at least one selected from the group consisting of sodium dilauroyl glutamate lysine, polyoxyethylene methyl glucoside, and polyethylene glycol.

4. The composition for external use according to claim 3, wherein the mass ratio of the tranexamic acids to the heparinoid is 1:0.007 to 1:0.

15.

5. The topical composition according to claim 3 or 4, wherein the at least one selected from the group consisting of sodium dilauroyl glutamate lysine, polyoxyethylene methyl glucoside, and polyethylene glycol is at least one selected from the group consisting of 0.001 to 0.3% by mass of sodium dilauroyl glutamate lysine, 0.1 to 10.0% by mass of polyoxyethylene methyl glucoside, and 0.1 to 10.0% by mass of polyethylene glycol, based on the total mass of the topical composition.

6. At least one tranexamic acid selected from the group consisting of tranexamic acid and its salts, a heparinoid, and at least one compound selected from the group consisting of sodium dilauroyl glutamate lysine, polyoxyethylene methyl glucoside, and polyethylene glycol. A composition for external use containing one or more of the following: A composition for external use in which the precipitation of a solidified product of tranexamic acids is inhibited.

7. The composition for external use according to claim 6, wherein the mass ratio of the tranexamic acids to the heparinoid is 1:0.007 to 1:0.

15.

8. The topical composition according to claim 6 or 7, wherein the at least one selected from the group consisting of sodium dilauroyl glutamate lysine, polyoxyethylene methyl glucoside, and polyethylene glycol is at least one selected from the group consisting of 0.001 to 0.3% by mass of sodium dilauroyl glutamate lysine, 0.1 to 10.0% by mass of polyoxyethylene methyl glucoside, and 0.1 to 10.0% by mass of polyethylene glycol, based on the total mass of the topical composition.

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