WO2023112664A1 - Pharmaceutical composition for external application which contains benzoyl peroxide - Google Patents
Pharmaceutical composition for external application which contains benzoyl peroxide Download PDFInfo
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- WO2023112664A1 WO2023112664A1 PCT/JP2022/044017 JP2022044017W WO2023112664A1 WO 2023112664 A1 WO2023112664 A1 WO 2023112664A1 JP 2022044017 W JP2022044017 W JP 2022044017W WO 2023112664 A1 WO2023112664 A1 WO 2023112664A1
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- WIPO (PCT)
- Prior art keywords
- mass
- acid
- parts
- oil
- benzoyl peroxide
- Prior art date
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- 239000004342 Benzoyl peroxide Substances 0.000 title claims abstract description 49
- OMPJBNCRMGITSC-UHFFFAOYSA-N Benzoylperoxide Chemical compound C=1C=CC=CC=1C(=O)OOC(=O)C1=CC=CC=C1 OMPJBNCRMGITSC-UHFFFAOYSA-N 0.000 title claims abstract description 49
- 235000019400 benzoyl peroxide Nutrition 0.000 title claims abstract description 49
- 239000008194 pharmaceutical composition Substances 0.000 title claims abstract description 23
- POJWUDADGALRAB-UHFFFAOYSA-N allantoin Chemical compound NC(=O)NC1NC(=O)NC1=O POJWUDADGALRAB-UHFFFAOYSA-N 0.000 claims abstract description 103
- POJWUDADGALRAB-PVQJCKRUSA-N Allantoin Natural products NC(=O)N[C@@H]1NC(=O)NC1=O POJWUDADGALRAB-PVQJCKRUSA-N 0.000 claims abstract description 49
- 229960000458 allantoin Drugs 0.000 claims abstract description 49
- MPDGHEJMBKOTSU-YKLVYJNSSA-N 18beta-glycyrrhetic acid Chemical compound C([C@H]1C2=CC(=O)[C@H]34)[C@@](C)(C(O)=O)CC[C@]1(C)CC[C@@]2(C)[C@]4(C)CC[C@@H]1[C@]3(C)CC[C@H](O)C1(C)C MPDGHEJMBKOTSU-YKLVYJNSSA-N 0.000 claims abstract description 41
- 230000007423 decrease Effects 0.000 claims abstract description 32
- 150000003839 salts Chemical class 0.000 claims abstract description 26
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- KYMBYSLLVAOCFI-UHFFFAOYSA-N thiamine Chemical compound CC1=C(CCO)SCN1CC1=CN=C(C)N=C1N KYMBYSLLVAOCFI-UHFFFAOYSA-N 0.000 description 1
- 229960003495 thiamine Drugs 0.000 description 1
- DPJRMOMPQZCRJU-UHFFFAOYSA-M thiamine hydrochloride Chemical compound Cl.[Cl-].CC1=C(CCO)SC=[N+]1CC1=CN=C(C)N=C1N DPJRMOMPQZCRJU-UHFFFAOYSA-M 0.000 description 1
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- 239000011678 thiamine pyrophosphate Substances 0.000 description 1
- YXVCLPJQTZXJLH-UHFFFAOYSA-N thiamine(1+) diphosphate chloride Chemical compound [Cl-].CC1=C(CCOP(O)(=O)OP(O)(O)=O)SC=[N+]1CC1=CN=C(C)N=C1N YXVCLPJQTZXJLH-UHFFFAOYSA-N 0.000 description 1
- 239000010678 thyme oil Substances 0.000 description 1
- 235000010384 tocopherol Nutrition 0.000 description 1
- 229960001295 tocopherol Drugs 0.000 description 1
- 229930003799 tocopherol Natural products 0.000 description 1
- 239000011732 tocopherol Substances 0.000 description 1
- 229940042585 tocopherol acetate Drugs 0.000 description 1
- 150000003611 tocopherol derivatives Chemical class 0.000 description 1
- 229960001727 tretinoin Drugs 0.000 description 1
- 229960005294 triamcinolone Drugs 0.000 description 1
- GFNANZIMVAIWHM-OBYCQNJPSA-N triamcinolone Chemical compound O=C1C=C[C@]2(C)[C@@]3(F)[C@@H](O)C[C@](C)([C@@]([C@H](O)C4)(O)C(=O)CO)[C@@H]4[C@@H]3CCC2=C1 GFNANZIMVAIWHM-OBYCQNJPSA-N 0.000 description 1
- 229960002117 triamcinolone acetonide Drugs 0.000 description 1
- YNDXUCZADRHECN-JNQJZLCISA-N triamcinolone acetonide Chemical compound C1CC2=CC(=O)C=C[C@]2(C)[C@]2(F)[C@@H]1[C@@H]1C[C@H]3OC(C)(C)O[C@@]3(C(=O)CO)[C@@]1(C)C[C@@H]2O YNDXUCZADRHECN-JNQJZLCISA-N 0.000 description 1
- LADGBHLMCUINGV-UHFFFAOYSA-N tricaprin Chemical compound CCCCCCCCCC(=O)OCC(OC(=O)CCCCCCCCC)COC(=O)CCCCCCCCC LADGBHLMCUINGV-UHFFFAOYSA-N 0.000 description 1
- 229960003500 triclosan Drugs 0.000 description 1
- 239000001069 triethyl citrate Substances 0.000 description 1
- VMYFZRTXGLUXMZ-UHFFFAOYSA-N triethyl citrate Natural products CCOC(=O)C(O)(C(=O)OCC)C(=O)OCC VMYFZRTXGLUXMZ-UHFFFAOYSA-N 0.000 description 1
- 235000013769 triethyl citrate Nutrition 0.000 description 1
- UFTFJSFQGQCHQW-UHFFFAOYSA-N triformin Chemical compound O=COCC(OC=O)COC=O UFTFJSFQGQCHQW-UHFFFAOYSA-N 0.000 description 1
- SCRSFLUHMDMRFP-UHFFFAOYSA-N trimethyl-(methyl-octyl-trimethylsilyloxysilyl)oxysilane Chemical compound CCCCCCCC[Si](C)(O[Si](C)(C)C)O[Si](C)(C)C SCRSFLUHMDMRFP-UHFFFAOYSA-N 0.000 description 1
- 235000011178 triphosphate Nutrition 0.000 description 1
- 239000001226 triphosphate Substances 0.000 description 1
- UNXRWKVEANCORM-UHFFFAOYSA-N triphosphoric acid Chemical compound OP(O)(=O)OP(O)(=O)OP(O)(O)=O UNXRWKVEANCORM-UHFFFAOYSA-N 0.000 description 1
- SMYKBXMWXCZOLU-UHFFFAOYSA-N tris-decyl benzene-1,2,4-tricarboxylate Chemical compound CCCCCCCCCCOC(=O)C1=CC=C(C(=O)OCCCCCCCCCC)C(C(=O)OCCCCCCCCCC)=C1 SMYKBXMWXCZOLU-UHFFFAOYSA-N 0.000 description 1
- HRXKRNGNAMMEHJ-UHFFFAOYSA-K trisodium citrate Chemical compound [Na+].[Na+].[Na+].[O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O HRXKRNGNAMMEHJ-UHFFFAOYSA-K 0.000 description 1
- 235000019801 trisodium phosphate Nutrition 0.000 description 1
- 229910000406 trisodium phosphate Inorganic materials 0.000 description 1
- CCXAYLQLOLXXKE-DWJAGBRCSA-K trisodium;(2s,3s,4s,5r,6r)-6-[(2s,3r,4s,5s,6s)-2-[[(3s,4ar,6ar,6bs,8as,11s,12ar,14ar,14bs)-11-carboxylato-4,4,6a,6b,8a,11,14b-heptamethyl-14-oxo-2,3,4a,5,6,7,8,9,10,12,12a,14a-dodecahydro-1h-picen-3-yl]oxy]-6-carboxylato-4,5-dihydroxyoxan-3-yl]oxy-3,4,5-t Chemical compound [Na+].[Na+].[Na+].O([C@@H]1[C@@H](O)[C@H](O)[C@H](O[C@@H]1O[C@H]1CC[C@]2(C)[C@H]3C(=O)C=C4[C@@H]5C[C@](C)(CC[C@@]5(CC[C@@]4(C)[C@]3(C)CC[C@H]2C1(C)C)C)C([O-])=O)C([O-])=O)[C@@H]1O[C@H](C([O-])=O)[C@@H](O)[C@H](O)[C@H]1O CCXAYLQLOLXXKE-DWJAGBRCSA-K 0.000 description 1
- SOBHUZYZLFQYFK-UHFFFAOYSA-K trisodium;hydroxy-[[phosphonatomethyl(phosphonomethyl)amino]methyl]phosphinate Chemical class [Na+].[Na+].[Na+].OP(O)(=O)CN(CP(O)([O-])=O)CP([O-])([O-])=O SOBHUZYZLFQYFK-UHFFFAOYSA-K 0.000 description 1
- 229940035936 ubiquinone Drugs 0.000 description 1
- 229950010121 ufenamate Drugs 0.000 description 1
- 229920000785 ultra high molecular weight polyethylene Polymers 0.000 description 1
- 235000021122 unsaturated fatty acids Nutrition 0.000 description 1
- 150000004670 unsaturated fatty acids Chemical class 0.000 description 1
- 229940099259 vaseline Drugs 0.000 description 1
- 125000000391 vinyl group Chemical group [H]C([*])=C([H])[H] 0.000 description 1
- 229920002554 vinyl polymer Polymers 0.000 description 1
- 235000019163 vitamin B12 Nutrition 0.000 description 1
- 239000011715 vitamin B12 Substances 0.000 description 1
- 235000019154 vitamin C Nutrition 0.000 description 1
- 239000011718 vitamin C Substances 0.000 description 1
- 235000001892 vitamin D2 Nutrition 0.000 description 1
- 239000011653 vitamin D2 Substances 0.000 description 1
- MECHNRXZTMCUDQ-RKHKHRCZSA-N vitamin D2 Chemical compound C1(/[C@@H]2CC[C@@H]([C@]2(CCC1)C)[C@H](C)/C=C/[C@H](C)C(C)C)=C\C=C1\C[C@@H](O)CCC1=C MECHNRXZTMCUDQ-RKHKHRCZSA-N 0.000 description 1
- 235000005282 vitamin D3 Nutrition 0.000 description 1
- 239000011647 vitamin D3 Substances 0.000 description 1
- QYSXJUFSXHHAJI-YRZJJWOYSA-N vitamin D3 Chemical compound C1(/[C@@H]2CC[C@@H]([C@]2(CCC1)C)[C@H](C)CCCC(C)C)=C\C=C1\C[C@@H](O)CCC1=C QYSXJUFSXHHAJI-YRZJJWOYSA-N 0.000 description 1
- 229940021056 vitamin d3 Drugs 0.000 description 1
- 239000010497 wheat germ oil Substances 0.000 description 1
- 229920001221 xylan Polymers 0.000 description 1
- 150000004823 xylans Chemical class 0.000 description 1
- UHVMMEOXYDMDKI-JKYCWFKZSA-L zinc;1-(5-cyanopyridin-2-yl)-3-[(1s,2s)-2-(6-fluoro-2-hydroxy-3-propanoylphenyl)cyclopropyl]urea;diacetate Chemical compound [Zn+2].CC([O-])=O.CC([O-])=O.CCC(=O)C1=CC=C(F)C([C@H]2[C@H](C2)NC(=O)NC=2N=CC(=CC=2)C#N)=C1O UHVMMEOXYDMDKI-JKYCWFKZSA-L 0.000 description 1
- ZNVKGUVDRSSWHV-UHFFFAOYSA-L zinc;4-hydroxybenzenesulfonate Chemical compound [Zn+2].OC1=CC=C(S([O-])(=O)=O)C=C1.OC1=CC=C(S([O-])(=O)=O)C=C1 ZNVKGUVDRSSWHV-UHFFFAOYSA-L 0.000 description 1
- 239000004711 α-olefin Substances 0.000 description 1
- GVJHHUAWPYXKBD-IEOSBIPESA-N α-tocopherol Chemical compound OC1=C(C)C(C)=C2O[C@@](CCC[C@H](C)CCC[C@H](C)CCCC(C)C)(C)CCC2=C1C GVJHHUAWPYXKBD-IEOSBIPESA-N 0.000 description 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
- A61K31/19—Carboxylic acids, e.g. valproic acid
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/327—Peroxy compounds, e.g. hydroperoxides, peroxides, peroxyacids
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
- A61K31/4164—1,3-Diazoles
- A61K31/4166—1,3-Diazoles having oxo groups directly attached to the heterocyclic ring, e.g. phenytoin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
- A61K31/7028—Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages
- A61K31/7034—Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages attached to a carbocyclic compound, e.g. phloridzin
- A61K31/704—Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages attached to a carbocyclic compound, e.g. phloridzin attached to a condensed carbocyclic ring system, e.g. sennosides, thiocolchicosides, escin, daunorubicin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/28—Steroids, e.g. cholesterol, bile acids or glycyrrhetinic acid
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/06—Ointments; Bases therefor; Other semi-solid forms, e.g. creams, sticks, gels
Definitions
- B1 benzoyl peroxide
- B1 glycyrrhetinic acid, its derivatives and/or salts thereof
- B2 allantoin External composition.
- the present inventors found that when benzoyl peroxide is added to the base of the composition for external use, the viscosity decreases over time.
- the decrease in viscosity due to the addition of benzoyl peroxide is suppressed.
- a decrease in viscosity affects the amount of drug released from the formulation, so it should be avoided in order to ensure the quality of the drug. Since the external pharmaceutical composition of the present invention has a reduced decrease in viscosity over time, it can be applied in a predetermined amount without particular consideration.
- the external pharmaceutical composition of the present invention contains a component selected from glycyrrhetinic acids and allantoin in addition to benzoyl peroxide, so that it can be spread smoothly when applied to the skin. There is If it cannot be applied smoothly, it cannot be used comfortably. Since the purpose of topical pharmaceutical preparations is to treat a target disease, QOL deterioration such as discomfort during or after use tends to be neglected compared to topical cosmetic preparations and the like. However, if the feeling of use of the external pharmaceutical preparation is bad, it becomes a psychological hurdle to continuous use, and compliance or adherence decreases. Since the topical pharmaceutical composition of the present invention can be spread smoothly with little friction between the skin when applied, it has a good feeling in use and can avoid a decrease in compliance or adherence.
- the external pharmaceutical composition of the present invention contains at least one component selected from (A) benzoyl peroxide, (B) (B1) glycyrrhetinic acid, derivatives thereof, and/or salts thereof, and (B2) allantoin.
- the content of benzoyl peroxide relative to the total amount of the composition is 0.05-10% by mass, 0.05-7% by mass, 0.05-5% by mass, 0.05-3.5% by mass, 0.05-3.5% by mass, and 0.05-3.5% by mass.
- the total concentration of at least one component selected from component (B) glycyrrhetinic acids and allantoin is preferably 0.05% by mass or more, more preferably 0.1% by mass or more, and 0.1% by mass or more, based on the total amount of the composition. 5% by mass or more is more preferable. Also, it is preferably 1.5% by mass or less, more preferably 1% by mass or less, and even more preferably 0.7% by mass or less. Within this range, a sufficient anti-inflammatory action can be obtained, a decrease in viscosity over time can be suppressed, and smooth application can be achieved.
- Glycyrrhetinic acid which is a glycoside of glycyrrhetinic acid, and glycyrrhizic acid esters such as methyl glycyrrhizinate and stearyl glycyrrhizinate are also examples of derivatives of glycyrrhetinic acid.
- Glycyrrhizin can also be formulated in the form of licorice or licorice extract.
- Salts of glycyrrhetic acid or glycyrrhetic acid derivatives are preferably ammonium salts and alkali metal salts, more preferably ammonium salts, potassium salts and sodium salts, and particularly preferably monoammonium salts, dipotassium salts and trisodium salts.
- glycyrrhetinic acids glycyrrhetinic acid, stearyl glycyrrhetinate, glycyrrhizic acid, and salts thereof are preferred, and glycyrrhizic acid and glycyrrhizinate are more preferred.
- Preferred glycyrrhizinates are monoammonium glycyrrhizinate, dipotassium glycyrrhizinate, and trisodium glycyrrhizinate.
- Glycyrrhetinic acids can be used alone or in combination of two or more.
- the concentration of glycyrrhetinic acids is preferably 0.05% by mass or more, more preferably 0.1% by mass or more, more preferably 0.2% by mass, relative to the total amount of the composition. % by mass or more is more preferable. Moreover, 1 mass % or less is preferable, 0.75 mass % or less is preferable, and 0.5 mass % or less is more preferable. Within this range, a sufficient anti-inflammatory action can be obtained, a decrease in viscosity over time can be suppressed, and smooth application can be achieved.
- the concentration of glycyrrhetinic acids relative to the total amount of the composition is 0.05 to 1% by mass, 0.05 to 0.75% by mass, 0.05 to 0.5% by mass, 0.1 to 1% by mass, 0.05% to 0.75% by mass, 0.05% to 0.5% by mass, 0.1% to 1% by mass. 1 to 0.75% by mass, 0.1 to 0.5% by mass, 0.2 to 1% by mass, 0.2 to 0.75% by mass, and 0.2 to 0.5% by mass.
- the concentration of allantoin is preferably 0.05% by mass or more, more preferably 0.1% by mass or more, relative to the total amount of the composition. Also, it is preferably 5% by mass or less, more preferably 2% by mass or less, more preferably 1% by mass or less, more preferably 0.5% by mass or less, and more preferably 0.2% by mass or less. Within this range, a sufficient anti-inflammatory action can be obtained, a decrease in viscosity over time can be suppressed, and smooth application can be achieved.
- the content of allantoin is preferably 0.005 parts by mass or more, more preferably 0.01 parts by mass or more with respect to 1 part by mass of the content of benzoyl peroxide. is more preferable, 0.02 parts by mass or more is preferable, and 0.03 parts by mass or more is more preferable.
- 0.8 mass part or less is preferable, 0.4 mass part or less is more preferable, 0.2 mass part or less is preferable, and 0.08 mass part or less is more preferable.
- the ratio of the allantoin content to 1 part by mass of the benzoyl peroxide content is 0.005 to 0.8 parts by mass, 0.005 to 0.4 parts by mass, 0.005 to 0.2 parts by mass, 0.01 to 0.8 parts by mass, 0.01 to 0.4 parts by mass, 0.01 to 0.2 parts by mass, 0.02 to 0.8 parts by mass, 0.02 to 0.4 parts by mass, 0.02 to 0.2 parts by mass, 0.03 to 0.8 parts by mass, 0.03 to 0.4 parts by mass, and 0.03 to 0.2 parts by mass.
- component (B1) and component (B2) are blended include glycyrrhetinic acid and allantoin, stearyl glycyrrhetinate and allantoin, glycyrrhizic acid and allantoin, monoammonium glycyrrhizinate and allantoin, dipotassium glycyrrhizinate and allantoin, and glycyrrhizin. acid trisodium salt and allantoin.
- the composition of the present invention desirably contains water.
- the concentration of water is preferably 25% by mass or more, more preferably 28% by mass or more, and even more preferably 40% by mass or more, relative to the total amount of the composition.
- 90 mass % or less is preferable, and 80 mass % or less is more preferable. Within this range, destabilization of the composition due to benzoyl peroxide can be avoided, and the effects of the present invention can be sufficiently obtained.
- the concentration of water relative to the total amount of the composition includes 25 to 90% by mass, 25 to 80% by mass, 28 to 90% by mass, 28 to 80% by mass, 40 to 90% by mass, and 40 to 80% by mass.
- Higher alcohols include higher alcohols with 12 to 22 carbon atoms.
- linear saturated alcohols such as lauryl alcohol, myristyl alcohol, cetanol, cetostearyl alcohol, stearyl alcohol, arachyl alcohol, behenyl alcohol; unsaturated alcohols such as oleyl alcohol, selachyl alcohol; hexyldecanol, isostearyl alcohol, octyldodeca decyltetradecanol, lanolin alcohol, branched alcohols such as isostearyl glyceryl ether, and the like.
- sterols examples include animal sterols such as cholesterol, ergosterol and lanosterol; plant sterols (phytosterols) such as sitosterol, campesterol, stigmasterol, spinasterol and brassicasterol; and sterol derivatives such as phytosteryl hydroxystearate. .
- animal sterols such as cholesterol, ergosterol and lanosterol
- plant sterols such as sitosterol, campesterol, stigmasterol, spinasterol and brassicasterol
- sterol derivatives such as phytosteryl hydroxystearate.
- silicone oils include methylpolysiloxane, dimethylpolysiloxane, methylphenylpolysiloxane, decamethyltetrasiloxane, methylcyclopentasiloxane, highly polymerized methylpolysiloxane, octamethylcyclotetrasiloxane, decamethylcyclopentasiloxane, and methylhydrogenpolysiloxane.
- the base used in the present invention is preferably a combination of water and a polyhydric alcohol and/or an oil agent. 1 type selected from the group consisting of linear saturated or unsaturated alcohols of number 12 to 22, etc.) and ester oils (esters of fatty acids with 12 to 22 carbon atoms such as isopropyl myristate and fatty alcohols, etc.) A combination of the above is preferred.
- sorbitan fatty acid esters propylene glycol fatty acid esters such as propylene glycol monostearate; polyoxyethylene hydrogenated castor oil 40 (HCO-40), polyoxyethylene hydrogenated castor oil 50 (HCO-50), polyoxyethylene hydrogenated castor Hydrogenated castor oil derivatives such as oil 60 (HCO-60), polyoxyethylene hydrogenated castor oil 80; polyoxyethylene (20) sorbitan monolaurate (polysorbate 20), polyoxyethylene (20) sorbitan monostearate (polysorbate 60) ), polyoxyethylene sorbitan fatty acid esters such as polyoxyethylene (20) sorbitan monooleate (polysorbate 80), polyoxyethylene (20) sorbitan isostearate; polyoxyethylene monococonut oil fatty acid glyceryl; glycerin alkyl ether; stearin Glycerin fatty acid esters such as glyceryl acid, glyceryl myristate, glyceryl oleate,
- Moisturizing agents include, for example, hyaluronic acid, salts thereof, or derivatives thereof (e.g., sodium hyaluronate, zinc hyaluronate, low-molecular-weight hyaluronic acid, acetylated hyaluronic acid, crosslinked hyaluronic acid derivatives, cationized hyaluronic acid, etc.); chondroitin; Sulfuric acid or its salts; Amino acids such as heparinoids, alanine, serine, aspartic acid, glycine, arginine and derivatives thereof; Polyhydric alcohols such as glycerin, dipropylene glycol and 1,3-butanediol; Sorbitol, xylitol, erythritol, Sugar alcohols such as maltose/sucrose condensate (glucooligosaccharide), hydrolyzed xylan (xylo-
- Antioxidants include dibutylhydroxytoluene, butylhydroxyanisole, p-hydroxyanisole, sorbic acid, sodium sulfite, ascorbic acid, ascorbic acid derivatives (ascorbyl stearate, ascorbyl palmitate, ascorbyl dipalmitate, ascorbyl acid monophosphate, ascorbyl diphosphate, ascorbate triphosphate, ascorbate sulfate, etc.), tocopherol, tocopherol derivatives (tocopherol acetate, tocopherol succinate, tocopherol calcium succinate, etc.), erythorbic acid, L-cysteine hydrochloride etc.
- thickeners examples include polyvinyl alcohol, polyvinyl pyrrolidone, polyvinyl methyl ether, carboxyvinyl polymer, alkyl acrylate copolymer, alkyl acrylate methacrylate copolymer, and vinyl-based thickeners such as sodium polyacrylate.
- Thickeners such as methyl cellulose, ethyl cellulose, hydroxyethyl cellulose, hydroxymethyl cellulose, hydroxypropyl cellulose, hydroxypropyl methyl cellulose, carboxymethyl cellulose, carboxyethyl cellulose, hydrophobized hydroxypropyl methyl cellulose, polyvinyl alcohol, polyvinyl pyrrolidone, polyvinyl methyl ether , guar gum, sclerotium gum, tamarind gum, xanthan gum, dextran, pectin, pullulan, gelatin, locust bean gum, carrageenan, agar, biosaccharide gum, alkyl acrylate methacrylate copolymer, sodium polyacrylate, bentonite, dextrin Fatty acid ester, dimethyldistearylammonium hectorite, sodium alginate, propylene glycol alginate, polyethylene glycol, macrogol, trimethylammonium
- carboxyvinyl polymer is preferable from the viewpoint of exhibiting remarkable effects of the invention.
- concentration of the total amount of thickening agent relative to the total amount of the composition may be 0.01 to 0.8% by mass, 0.05 to 0.5% by mass, and 0.1 to 0.2% by mass.
- Antiseptics or preservatives include benzoic acid, sodium benzoate, dehydroacetic acid, sodium dehydroacetate, isobutyl parahydroxybenzoate, isopropyl parahydroxybenzoate, butyl parahydroxybenzoate, ethyl parahydroxybenzoate, propyl parahydroxybenzoate, parahydroxybenzoic acid.
- pH adjusters examples include inorganic acids (hydrochloric acid, sulfuric acid, etc.), organic acids (lactic acid, sodium lactate, citric acid, sodium citrate, succinic acid, sodium succinate, etc.), inorganic bases (potassium hydroxide, sodium hydroxide, etc.). ), organic bases (triethanolamine, diisopropanolamine, triisopropanolamine, arginine, glycine, etc.), and the like.
- inorganic acids hydroochloric acid, sulfuric acid, etc.
- organic acids lactic acid, sodium lactate, citric acid, sodium citrate, succinic acid, sodium succinate, etc.
- inorganic bases potassium hydroxide, sodium hydroxide, etc.
- organic bases triethanolamine, diisopropanolamine, triisopropanolamine, arginine, glycine, etc.
- Chelating agents include ethylenediaminetetraacetic acid (edetic acid), ethylenediaminetetraacetate (sodium salt (edetate sodium: Japanese Pharmacopoeia, EDTA-2Na, etc.), potassium salt, etc.), phytic acid, gluconic acid, polyphosphoric acid, metalin acids and the like.
- coloring agents examples include pigments listed in the legal pigment handbook (edited by the Japan Cosmetic Industry Association (2004)).
- Bioactive or pharmacologically active ingredient Biologically active or pharmacologically active ingredients other than benzoyl peroxide, glycyrrhetinic acids, and allantoin include anti-inflammatory agents (other than glycyrrhetinic acids and allantoin), antipruritic agents (including antihistamines), local anesthetics, and disinfectants (other than benzoyl peroxide). , cooling agents, vitamins, keratin softening ingredients (chemical peeling ingredients), astringent ingredients, and the like. Among them, anti-inflammatory agents, anti-allergic agents, antibacterial agents, keratin softening ingredients, and vitamins are ingredients that are recommended to be used in combination with benzoyl peroxide.
- Steroidal anti-inflammatory agents include prednisolone, hydrocortisone, cortisone, dexamethasone, triamcinolone, triamcinolone acetonide, difluprednate, mometasone, diflucortolone, fluocinonide, beclomethasone, deprodone, alclomethasone, flumethasone, amcinonide, clobetasone, diflorazone, and derivatives thereof.
- Antihistamines include diphenhydramine, diphenhydramine hydrochloride, bromodiphenhydramine hydrochloride, clemastine fumarate, chlorphenoxamine hydrochloride, chlorpheniramine, chlorpheniramine maleate, promethazine hydrochloride, cetirizine hydrochloride, meclizine hydrochloride, ketotifen fumarate, olopatadine hydrochloride, fexofenadine hydrochloride, antazoline hydrochloride, azatadine dimaleate, epinastine hydrochloride and the like.
- Antipruritic agents include crotamiton, ictamol, and moktar.
- Local anesthetics include lidocaine, lidocaine hydrochloride, dibucaine hydrochloride, benzocaine, bupivacaine hydrochloride, tetracaine hydrochloride, and the like.
- Bactericides other than benzoyl peroxide include isopropylmethylphenol, phenoxyethanol, benzalkonium chloride, benzethonium chloride, chlorhexidine hydrochloride, chlorhexidine gluconate, cetylpyridinium chloride, sodium benzoate, ethanol, chlorobutanol, sorbic acid, sorbin potassium salt, sodium dehydroacetate, methyl parahydroxybenzoate, ethyl parahydroxybenzoate, propyl parahydroxybenzoate, butyl parahydroxybenzoate, oxyquinoline sulfate, phenethyl alcohol, benzyl alcohol, salicylic acid, cresol, triclosan and the like.
- Vitamins include retinol, retinol acetate, retinol palmitate, retinol propionate, retinol derivatives such as retinol linoleate, retinal, retinoic acid, methyl retinoate, ethyl retinoate, retinol retinoate, d- ⁇ -tocopheryl retino Vitamin A such as ate, ⁇ -tocopheryl retinoate, ⁇ -tocopheryl retinoate; , Vitamin E such as (ascorbyl/tocopheryl) potassium phosphate; riboflavin, flavin mononucleotide, flavin adenine dinucleotide, riboflavin butyrate, riboflavin tetrabutyrate, riboflavin 5'-phosphate sodium, riboflavin tetranicotinate, etc.
- Keratin softening ingredients include salicylic acid, salicylic acid derivatives (macrogol salicylate, ethanol salicylate, etc.), glycolic acid, fruit acid, phytic acid, sulfur, urea, resorcinol, phytic acid, lactic acid, lactate, sodium hydroxide, potassium hydroxide. etc.
- Astringent components include zinc paraphenolsulfonate, zinc oxide, menthol, and ethanol.
- the formulation form of the composition for external use of the present invention is not particularly limited. Examples include spray agents, aerosol agents, pump foam agents, sheet agents obtained by impregnating a sheet such as nonwoven fabric with a chemical liquid, and stick agents.
- gel formulations gel formulations
- emulsion formulations emulsion formulations
- cream formulations are preferable because they are easy to spread on the skin and have a good feeling in use.
- the composition of the present invention is smooth, it can be easily spread over a wide area even in the form of a bulky preparation such as a stick type.
- a stick-type formulation is preferable because the formulation does not stick to the hands.
- emulsified formulations such as emulsions, creams and emulsion ointments
- oil-in-water type water-in-oil type may be used. oil-in-water type is preferred.
- the pH of the pharmaceutical composition of the present invention can be pH 3 to 7.5, preferably pH 3 to 7, more preferably pH 3 to 6.5, and pH 3.5 to 6. is even more preferred, and pH 3.8 to 5.5 is particularly preferred.
- This pH can be adjusted, for example, by using a pH adjuster. However, this does not apply to formulation forms for which pH measurement is impossible or difficult.
- the external pharmaceutical composition of the present invention can be used for treating or improving acne and pimples.
- acnes acne vulgaris is preferred.
- an anti-inflammatory agent selected from glycyrrhetinic acids and allantoin, it can be used to treat or improve acne and pimples while suppressing irritation caused by benzoyl peroxide.
- the external pharmaceutical composition of the present invention may be applied to the affected area 1 to 3 times, 1 to 2 times, or once a day.
- about 0.5 g may be applied to the entire face.
- the external pharmaceutical composition of the present invention is preferably applied to the skin, and more preferably the skin of the face (especially forehead, chin, cheeks, around the mouth, nose), neck and back.
- the container for containing the external pharmaceutical composition of the present invention includes bottle type, tube type, jar type, roll-on type, dropper type, spray type, dispenser type, stick type, pouch bag, chia pack and the like.
- Roll-on type, dropper type, spray type, and dispenser type containers tend to leave part of the contents in the container or clog the discharge port, but the composition of the present invention is smooth, Even relatively hard or highly viscous formulations can flow smoothly from such containers.
- the material of the container containing the external pharmaceutical composition of the present invention is not particularly limited as long as it can be used as a container for external pharmaceutical preparations.
- container materials include polyolefin resins, acrylic acid resins, polyesters, polycarbonates, fluororesins, polyvinyl chloride, polyamides, and ABS, which are partially or entirely, preferably entirely, in contact with the external pharmaceutical composition for skin.
- a container made of at least one material selected from the group consisting of resin, AS resin, polyacetal, modified polyphenylene ether, polyarylate, polysulfone, polyimide, cellulose acetate, aluminum, and glass.
- polyethylene high density polyethylene (HDPE), low density polyethylene (LDPE), ultra-low density polyethylene, linear low-density polyethylene (LLDPE), ultra-high molecular weight polyethylene, etc.
- polypropylene PP
- polyolefin resins such as ethylene/propylene copolymer, polymethylpentene, polybutene-1,1,2-polybutadiene, polyester resins such as polyethylene terephthalate, polybutylene terephthalate, and polyethylene naphthalate are preferred, and polyethylene, polypropylene, and polyethylene terephthalate are preferred.
- PE polyethylene
- HDPE high density polyethylene
- LDPE low density Polyethylene
- LLDPE linear low density polyethylene
- polypropylene aluminum
- container materials can be used. When two or more materials are used, when two or more materials are mixed, when layers containing two or more different materials are laminated, different parts of the container (receiving part, lid, nozzle, etc.) This includes cases where different materials are included.
- a topical pharmaceutical composition containing benzoyl peroxide is selected from (B) (B1) glycyrrhetinic acid, derivatives thereof, and/or salts thereof, and (B2) allantoin. It includes a method for suppressing a decrease in viscosity over time of a composition for external use, comprising at least one component of the composition for external use. The type and content of each component, the properties of the composition, etc. are as described for the topical pharmaceutical composition of the present invention.
- the present invention provides (A) a topical pharmaceutical composition containing benzoyl peroxide, (B) (B1) glycyrrhetinic acid, derivatives thereof, and/or salts thereof, and (B2) allantoin.
- the type and content of each component, the properties of the composition, etc. are as described for the topical pharmaceutical composition of the present invention.
- the topical pharmaceutical composition of the present invention has little friction with the skin during application and can be spread smoothly, thus avoiding situations such as unapplied or excessive application.
- Ability to spread smoothly includes less squeaking, less snagging, or less stickiness.
- composition for external use was prepared so as to have the composition shown in Table 1.
- the carboxyvinyl polymer was dispersed in water.
- dipotassium glycyrrhizinate or allantoin was added, it was added in advance.
- An aqueous solution of triethanolamine was added to this to neutralize it.
- This mixture was dispersed in 1,3-propylene glycol and finally benzoyl peroxide hydrate was added.
- the dosage form of the resulting composition is a gel.
- Table 1 shows the results.
- benzoyl peroxide Comparative Example 1
- a composition containing only a base that does not contain benzoyl peroxide Reference Example 1
- the viscosity ratio decreased.
- allantoin Comparative Example 1
- dipotassium glycyrrhizinate Comparative Example 2
- recovery of the viscosity ratio was observed.
- both allantoin and dipotassium glycyrrhizinate were blended (Example 3)
- the viscosity ratio was remarkably recovered.
- composition for external use of the present invention contains benzoyl peroxide, the decrease in viscosity during storage is suppressed, so no special consideration is required for distribution and storage.
- external pharmaceutical composition of the present invention can be applied smoothly, it is easy to apply a predetermined amount, and therefore, a predetermined medicinal effect can be obtained. In addition, since it can be applied smoothly, it can be used comfortably.
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Abstract
A pharmaceutical composition for external application which comprises (A) benzoyl peroxide and (B) at least one component selected from (B1) glycyrrhetinic acid and derivatives and salts thereof and (B2) allantoin does not undergo the decrease in viscosity over time and can be applied and spread smoothly on the skin.
Description
本発明は、過酸化ベンゾイルを含有する実用的な医薬外用組成物に関する。
The present invention relates to a practical external pharmaceutical composition containing benzoyl peroxide.
ニキビは、ホルモンバランスの変化などにより過剰分泌された皮脂が毛包内に溜まって皮膚表面に盛り上がったものである。毛包内に、アクネ菌やブドウ球菌などの細菌類が増殖すると、炎症を起こし赤く腫れた状態になる。さらに、角化異常を生じることもある。ニキビは、患者のOQLを低下させ、また放置すると瘢痕が残ることもあるため、早期治療が必要である。
ニキビの治療薬は、当初、抗菌剤が主流であったが、薬剤耐性が問題となったため、現在では、アダパレンや過酸化ベンゾイルが外用剤の成分として汎用されている。過酸化ベンゾイルは、薬剤耐性が出現し難い抗菌作用と、角質堆積の改善作用を有する。 Acne is caused by sebum that is excessively secreted due to a change in hormonal balance or the like, and accumulates in hair follicles to swell on the surface of the skin. When bacteria such as P. acnes and Staphylococcus proliferate in the hair follicle, it becomes inflamed and becomes red and swollen. In addition, dyskeratosis may occur. Acne lowers the patient's OQL and may leave scars if left untreated, so early treatment is necessary.
Initially, antibacterial agents were the mainstream of acne therapeutic agents, but due to the problem of drug resistance, adapalene and benzoyl peroxide are now widely used as components of topical preparations. Benzoyl peroxide has an antibacterial action that makes it difficult for drug resistance to develop, and an action to improve keratin deposition.
ニキビの治療薬は、当初、抗菌剤が主流であったが、薬剤耐性が問題となったため、現在では、アダパレンや過酸化ベンゾイルが外用剤の成分として汎用されている。過酸化ベンゾイルは、薬剤耐性が出現し難い抗菌作用と、角質堆積の改善作用を有する。 Acne is caused by sebum that is excessively secreted due to a change in hormonal balance or the like, and accumulates in hair follicles to swell on the surface of the skin. When bacteria such as P. acnes and Staphylococcus proliferate in the hair follicle, it becomes inflamed and becomes red and swollen. In addition, dyskeratosis may occur. Acne lowers the patient's OQL and may leave scars if left untreated, so early treatment is necessary.
Initially, antibacterial agents were the mainstream of acne therapeutic agents, but due to the problem of drug resistance, adapalene and benzoyl peroxide are now widely used as components of topical preparations. Benzoyl peroxide has an antibacterial action that makes it difficult for drug resistance to develop, and an action to improve keratin deposition.
ここで、医薬外用剤は、塗布した製剤中に予定される薬剤量が正確に含まれることが求められる。このため、製剤中の薬剤が分解しないことはもちろんのこと、塗布量が変化しないことも必要である。外用剤は、塗り広げ易い粘度に調整されているため、その粘度が経時的に変化すると、塗布量や製剤から放出される薬剤量が変わり易く、ひいては投与する薬剤量が変わり易い。外用剤は、成分の分解や他成分との反応により粘度が低下し易いため、経時的な粘度の低下がないことが求められる。
Here, for external pharmaceutical preparations, it is required that the expected amount of drug is accurately contained in the applied formulation. Therefore, it is necessary not only that the drug in the formulation does not decompose, but also that the application amount does not change. Since the external preparation is adjusted to have a viscosity that is easy to spread, if the viscosity changes over time, the applied amount and the amount of the drug released from the formulation are likely to change, and the amount of the drug to be administered is likely to change. Since the viscosity of external preparations tends to decrease due to decomposition of components or reactions with other components, it is required that the viscosity does not decrease over time.
また、医薬外用剤は、塗布した製剤中に予定される薬剤量が正確に含まれることが求められるため、粘度だけでなく、皮膚上に滑らかに延ばすことができることが必要である。滑らかさに欠けると、塗り残しが生じたり、延び難いために必要以上に多量の製剤を皮膚に塗布してしまったりするからである。また、滑らかさに欠けると、継続的な使用に対する心理的ハードルとなり、コンプライアンス又はアドヒアランスが低下し易い。医薬外用剤は対象疾患の治療が目的であるから、化粧品外用剤などと比べて、滑らかさといった使用感は軽視される傾向にあるが、重要な特性である。
In addition, since topical pharmaceutical preparations are required to contain the expected amount of drug accurately in the applied preparation, it is necessary not only to have viscosity but also to be able to spread smoothly on the skin. This is because if the smoothness is lacking, an unapplied portion may occur, or an unnecessarily large amount of the preparation may be applied to the skin due to difficulty in spreading. Moreover, lack of smoothness becomes a psychological hurdle to continuous use, and compliance or adherence tends to decrease. Since the purpose of topical pharmaceutical preparations is to treat a target disease, the feeling of use such as smoothness tends to be neglected compared to topical cosmetics, but it is an important characteristic.
本発明は、過酸化ベンゾイルを含有する医薬外用組成物であって、経時的な粘度低下が抑えられており、かつ皮膚に滑らかに塗り広げることができるものを提供することを課題とする。
An object of the present invention is to provide a topical pharmaceutical composition containing benzoyl peroxide, which suppresses a decrease in viscosity over time and can be smoothly spread on the skin.
本発明者は、上記課題を解決するために研究を重ね、以下の知見を得た。
(1) 外用組成物の基剤に過酸化ベンゾイルを配合すると、経時的に粘度が低下するようになる。
(2) 過酸化ベンゾイルに加えて、グリチルレチン酸、その誘導体、及び/若しくはそれらの塩(以下、「グリチルレチン酸類」と称することもある)、又はアラントインを配合することにより、過酸化ベンゾイルの配合による粘度低下が少なくなり、また、グリチルレチン酸類とアラントインの両方を配合することにより、過酸化ベンゾイルの配合による粘度低下が顕著に少なくなる。
(3) 外用組成物に、過酸化ベンゾイルに加えて、グリチルレチン酸類又はアラントインを配合することにより、皮膚に塗り広げる際の摩擦が小さくなり、また、グリチルレチン酸類とアラントインの両方を配合することにより、皮膚に塗り広げる際の摩擦が顕著に小さくなる。 The present inventor has made extensive research to solve the above problems, and has obtained the following knowledge.
(1) When benzoyl peroxide is added to the base of the composition for external use, the viscosity decreases over time.
(2) In addition to benzoyl peroxide, by blending glycyrrhetinic acid, derivatives thereof, and/or salts thereof (hereinafter sometimes referred to as "glycyrrhetinic acids"), or allantoin, by blending benzoyl peroxide The decrease in viscosity is reduced, and by blending both glycyrrhetinic acids and allantoin, the decrease in viscosity caused by blending benzoyl peroxide is remarkably reduced.
(3) By blending glycyrrhetinic acids or allantoin in addition to benzoyl peroxide to the composition for external use, friction when spreading on the skin is reduced. Friction when spreading on the skin is remarkably reduced.
(1) 外用組成物の基剤に過酸化ベンゾイルを配合すると、経時的に粘度が低下するようになる。
(2) 過酸化ベンゾイルに加えて、グリチルレチン酸、その誘導体、及び/若しくはそれらの塩(以下、「グリチルレチン酸類」と称することもある)、又はアラントインを配合することにより、過酸化ベンゾイルの配合による粘度低下が少なくなり、また、グリチルレチン酸類とアラントインの両方を配合することにより、過酸化ベンゾイルの配合による粘度低下が顕著に少なくなる。
(3) 外用組成物に、過酸化ベンゾイルに加えて、グリチルレチン酸類又はアラントインを配合することにより、皮膚に塗り広げる際の摩擦が小さくなり、また、グリチルレチン酸類とアラントインの両方を配合することにより、皮膚に塗り広げる際の摩擦が顕著に小さくなる。 The present inventor has made extensive research to solve the above problems, and has obtained the following knowledge.
(1) When benzoyl peroxide is added to the base of the composition for external use, the viscosity decreases over time.
(2) In addition to benzoyl peroxide, by blending glycyrrhetinic acid, derivatives thereof, and/or salts thereof (hereinafter sometimes referred to as "glycyrrhetinic acids"), or allantoin, by blending benzoyl peroxide The decrease in viscosity is reduced, and by blending both glycyrrhetinic acids and allantoin, the decrease in viscosity caused by blending benzoyl peroxide is remarkably reduced.
(3) By blending glycyrrhetinic acids or allantoin in addition to benzoyl peroxide to the composition for external use, friction when spreading on the skin is reduced. Friction when spreading on the skin is remarkably reduced.
本発明は、上記知見に基づき完成されたものであり、下記の〔1〕~〔6〕を提供する。
〔1〕 (A)過酸化ベンゾイル、並びに(B)(B1)グリチルレチン酸、その誘導体、及び/若しくはそれらの塩、及び(B2)アラントインからなる群より選ばれる少なくとも1種の成分を含有する医薬外用組成物。
〔2〕 (B)成分の含有量が、(A)成分の1質量部に対して、0.015~0.6質量部である、〔1〕に記載の組成物。
〔3〕 (B1)成分、及び(B2)成分を含有する、〔1〕又は〔2〕の何れかに記載の組成物。
〔4〕 (B1)成分が、グリチルリチン酸、グリチルレチン酸、及びそれらの塩からなる群より選ばれる少なくとも1種である、〔1〕~〔3〕の何れかに記載の組成物。
〔5〕 組成物の全量に対して、25質量%以上の水を含む、〔1〕~〔4〕の何れかに記載の組成物。
〔6〕 (A)過酸化ベンゾイルを含有する医薬外用組成物に、(B)(B1)グリチルレチン酸、その誘導体、及び/若しくはそれらの塩、及び(B2)アラントインからなる群より選ばれる少なくとも1種の成分を含ませる、医薬外用組成物の経時的粘度低下の抑制方法。 The present invention has been completed based on the above findings, and provides the following [1] to [6].
[1] A medicament containing at least one component selected from the group consisting of (A) benzoyl peroxide and (B) (B1) glycyrrhetinic acid, its derivatives and/or salts thereof, and (B2) allantoin External composition.
[2] The composition according to [1], wherein the content of component (B) is 0.015 to 0.6 parts by mass per 1 part by mass of component (A).
[3] The composition according to any one of [1] or [2], which contains component (B1) and component (B2).
[4] The composition according to any one of [1] to [3], wherein component (B1) is at least one selected from the group consisting of glycyrrhizic acid, glycyrrhetinic acid, and salts thereof.
[5] The composition according to any one of [1] to [4], which contains water in an amount of 25% by mass or more relative to the total amount of the composition.
[6] At least one selected from the group consisting of (B) (B1) glycyrrhetinic acid, derivatives thereof, and/or salts thereof, and (B2) allantoin, in (A) a topical pharmaceutical composition containing benzoyl peroxide A method for suppressing a decrease in viscosity over time of an external pharmaceutical composition, comprising containing a seed component.
〔1〕 (A)過酸化ベンゾイル、並びに(B)(B1)グリチルレチン酸、その誘導体、及び/若しくはそれらの塩、及び(B2)アラントインからなる群より選ばれる少なくとも1種の成分を含有する医薬外用組成物。
〔2〕 (B)成分の含有量が、(A)成分の1質量部に対して、0.015~0.6質量部である、〔1〕に記載の組成物。
〔3〕 (B1)成分、及び(B2)成分を含有する、〔1〕又は〔2〕の何れかに記載の組成物。
〔4〕 (B1)成分が、グリチルリチン酸、グリチルレチン酸、及びそれらの塩からなる群より選ばれる少なくとも1種である、〔1〕~〔3〕の何れかに記載の組成物。
〔5〕 組成物の全量に対して、25質量%以上の水を含む、〔1〕~〔4〕の何れかに記載の組成物。
〔6〕 (A)過酸化ベンゾイルを含有する医薬外用組成物に、(B)(B1)グリチルレチン酸、その誘導体、及び/若しくはそれらの塩、及び(B2)アラントインからなる群より選ばれる少なくとも1種の成分を含ませる、医薬外用組成物の経時的粘度低下の抑制方法。 The present invention has been completed based on the above findings, and provides the following [1] to [6].
[1] A medicament containing at least one component selected from the group consisting of (A) benzoyl peroxide and (B) (B1) glycyrrhetinic acid, its derivatives and/or salts thereof, and (B2) allantoin External composition.
[2] The composition according to [1], wherein the content of component (B) is 0.015 to 0.6 parts by mass per 1 part by mass of component (A).
[3] The composition according to any one of [1] or [2], which contains component (B1) and component (B2).
[4] The composition according to any one of [1] to [3], wherein component (B1) is at least one selected from the group consisting of glycyrrhizic acid, glycyrrhetinic acid, and salts thereof.
[5] The composition according to any one of [1] to [4], which contains water in an amount of 25% by mass or more relative to the total amount of the composition.
[6] At least one selected from the group consisting of (B) (B1) glycyrrhetinic acid, derivatives thereof, and/or salts thereof, and (B2) allantoin, in (A) a topical pharmaceutical composition containing benzoyl peroxide A method for suppressing a decrease in viscosity over time of an external pharmaceutical composition, comprising containing a seed component.
上記の通り、本発明者は、外用組成物の基剤に過酸化ベンゾイルを配合すると、経時的に粘度低下するようになることを見出したが、本発明の医薬外用組成物は、過酸化ベンゾイルに加えて、グリチルレチン酸類及びアラントインから選ばれる成分を含有することにより、過酸化ベンゾイルの配合による粘度低下が抑えられている。
粘度の低下は、製剤から放出される薬剤の量に影響を及ぼすことから、医薬品の品質を担保するうえでは避けるべきである。本発明の医薬外用組成物は、経時的な粘度低下が抑えられているため、特に配慮することなく決められた量の製剤を塗布することができる。 As described above, the present inventors found that when benzoyl peroxide is added to the base of the composition for external use, the viscosity decreases over time. In addition, by containing a component selected from glycyrrhetinic acids and allantoin, the decrease in viscosity due to the addition of benzoyl peroxide is suppressed.
A decrease in viscosity affects the amount of drug released from the formulation, so it should be avoided in order to ensure the quality of the drug. Since the external pharmaceutical composition of the present invention has a reduced decrease in viscosity over time, it can be applied in a predetermined amount without particular consideration.
粘度の低下は、製剤から放出される薬剤の量に影響を及ぼすことから、医薬品の品質を担保するうえでは避けるべきである。本発明の医薬外用組成物は、経時的な粘度低下が抑えられているため、特に配慮することなく決められた量の製剤を塗布することができる。 As described above, the present inventors found that when benzoyl peroxide is added to the base of the composition for external use, the viscosity decreases over time. In addition, by containing a component selected from glycyrrhetinic acids and allantoin, the decrease in viscosity due to the addition of benzoyl peroxide is suppressed.
A decrease in viscosity affects the amount of drug released from the formulation, so it should be avoided in order to ensure the quality of the drug. Since the external pharmaceutical composition of the present invention has a reduced decrease in viscosity over time, it can be applied in a predetermined amount without particular consideration.
また、本発明の医薬外用組成物は、過酸化ベンゾイルに加えて、グリチルレチン酸類及びアラントインから選ばれる成分を含有することにより、皮膚に塗布する際に、滑らかに塗り広げることができるものとなっている。滑らかに塗り広げることができない場合、気持ちよく使用できない。医薬外用剤は対象疾患の治療が目的であるため、化粧品外用剤などと比べて、使用時又は使用後の不快感といったQOLの低下が軽視される傾向にある。しかし、医薬外用剤の使用感が悪いと、継続的に使用することに対する心理的ハードルとなり、コンプライアンス又はアドヒアランスが低下する。本発明の医薬外用組成物は、皮膚との間の塗布時の摩擦が小さく、滑らかに塗り広げることができるため、使用感が良く、コンプライアンス又はアドヒアランスの低下を回避することができる。
Further, the external pharmaceutical composition of the present invention contains a component selected from glycyrrhetinic acids and allantoin in addition to benzoyl peroxide, so that it can be spread smoothly when applied to the skin. there is If it cannot be applied smoothly, it cannot be used comfortably. Since the purpose of topical pharmaceutical preparations is to treat a target disease, QOL deterioration such as discomfort during or after use tends to be neglected compared to topical cosmetic preparations and the like. However, if the feeling of use of the external pharmaceutical preparation is bad, it becomes a psychological hurdle to continuous use, and compliance or adherence decreases. Since the topical pharmaceutical composition of the present invention can be spread smoothly with little friction between the skin when applied, it has a good feeling in use and can avoid a decrease in compliance or adherence.
従って、本発明の医薬外用組成物は、過酸化ベンゾイルの配合による経時的な粘度低下を抑制でき、また、塗り広げ易くなり、使用感も良好になるという効果を奏する。
Therefore, the topical pharmaceutical composition of the present invention has the effects of being able to suppress the decrease in viscosity over time due to the addition of benzoyl peroxide, and also being easy to spread and having a good feel during use.
以下、本発明を詳細に説明する。
本発明の医薬外用組成物は、(A)過酸化ベンゾイルと、(B)(B1)グリチルレチン酸、その誘導体、及び/又はそれらの塩、並びに(B2)アラントインから選ばれる少なくとも1種の成分を含有する組成物である。 The present invention will be described in detail below.
The external pharmaceutical composition of the present invention contains at least one component selected from (A) benzoyl peroxide, (B) (B1) glycyrrhetinic acid, derivatives thereof, and/or salts thereof, and (B2) allantoin. The composition containing
本発明の医薬外用組成物は、(A)過酸化ベンゾイルと、(B)(B1)グリチルレチン酸、その誘導体、及び/又はそれらの塩、並びに(B2)アラントインから選ばれる少なくとも1種の成分を含有する組成物である。 The present invention will be described in detail below.
The external pharmaceutical composition of the present invention contains at least one component selected from (A) benzoyl peroxide, (B) (B1) glycyrrhetinic acid, derivatives thereof, and/or salts thereof, and (B2) allantoin. The composition containing
(A)過酸化ベンゾイル
過酸化ベンゾイルの含有量は、組成物の全量に対して、0.05質量%以上が好ましく、0.1質量%以上がより好ましく、1質量%以上がさらに好ましい。2質量%以上とすることもできる。また、10質量%以下が好ましく、7質量%以下がより好ましく、5質量%以下がより好ましく、3.5質量%以下がより好ましく、3質量%以下がより好ましく、2.6質量%以下がより好ましい。この範囲であれば、十分なニキビの治療効果が得られる。また、経時的な粘度低下が抑えられると共に、滑らかに塗布できるものとなる。
組成物の全量に対する過酸化ベンゾイルの含有量としては、0.05~10質量%、0.05~7質量%、0.05~5質量%、0.05~3.5質量%、0.05~3質量%、0.05~2.6質量%、0.1~10質量%、0.1~7質量%、0.1~5質量%、0.1~3.5質量%、0.1~3質量%、0.1~2.6質量%、1~10質量%、1~7質量%、1~5質量%、1~3.5質量%、1~3質量%、1~2.6質量%、2~10質量%、2~7質量%、2~5質量%、2~3.5質量%、2~3質量%、2~2.6質量%が挙げられる。 (A) Benzoyl peroxide The content of benzoyl peroxide is preferably 0.05% by mass or more, more preferably 0.1% by mass or more, and even more preferably 1% by mass or more, relative to the total amount of the composition. It can also be 2% by mass or more. Further, it is preferably 10% by mass or less, more preferably 7% by mass or less, more preferably 5% by mass or less, more preferably 3.5% by mass or less, more preferably 3% by mass or less, and 2.6% by mass or less. more preferred. Within this range, a sufficient therapeutic effect for acne can be obtained. In addition, the decrease in viscosity over time can be suppressed, and smooth application can be achieved.
The content of benzoyl peroxide relative to the total amount of the composition is 0.05-10% by mass, 0.05-7% by mass, 0.05-5% by mass, 0.05-3.5% by mass, 0.05-3.5% by mass, and 0.05-3.5% by mass. 05 to 3% by mass, 0.05 to 2.6% by mass, 0.1 to 10% by mass, 0.1 to 7% by mass, 0.1 to 5% by mass, 0.1 to 3.5% by mass, 0.1 to 3% by mass, 0.1 to 2.6% by mass, 1 to 10% by mass, 1 to 7% by mass, 1 to 5% by mass, 1 to 3.5% by mass, 1 to 3% by mass, 1 to 2.6% by mass, 2 to 10% by mass, 2 to 7% by mass, 2 to 5% by mass, 2 to 3.5% by mass, 2 to 3% by mass, and 2 to 2.6% by mass. .
過酸化ベンゾイルの含有量は、組成物の全量に対して、0.05質量%以上が好ましく、0.1質量%以上がより好ましく、1質量%以上がさらに好ましい。2質量%以上とすることもできる。また、10質量%以下が好ましく、7質量%以下がより好ましく、5質量%以下がより好ましく、3.5質量%以下がより好ましく、3質量%以下がより好ましく、2.6質量%以下がより好ましい。この範囲であれば、十分なニキビの治療効果が得られる。また、経時的な粘度低下が抑えられると共に、滑らかに塗布できるものとなる。
組成物の全量に対する過酸化ベンゾイルの含有量としては、0.05~10質量%、0.05~7質量%、0.05~5質量%、0.05~3.5質量%、0.05~3質量%、0.05~2.6質量%、0.1~10質量%、0.1~7質量%、0.1~5質量%、0.1~3.5質量%、0.1~3質量%、0.1~2.6質量%、1~10質量%、1~7質量%、1~5質量%、1~3.5質量%、1~3質量%、1~2.6質量%、2~10質量%、2~7質量%、2~5質量%、2~3.5質量%、2~3質量%、2~2.6質量%が挙げられる。 (A) Benzoyl peroxide The content of benzoyl peroxide is preferably 0.05% by mass or more, more preferably 0.1% by mass or more, and even more preferably 1% by mass or more, relative to the total amount of the composition. It can also be 2% by mass or more. Further, it is preferably 10% by mass or less, more preferably 7% by mass or less, more preferably 5% by mass or less, more preferably 3.5% by mass or less, more preferably 3% by mass or less, and 2.6% by mass or less. more preferred. Within this range, a sufficient therapeutic effect for acne can be obtained. In addition, the decrease in viscosity over time can be suppressed, and smooth application can be achieved.
The content of benzoyl peroxide relative to the total amount of the composition is 0.05-10% by mass, 0.05-7% by mass, 0.05-5% by mass, 0.05-3.5% by mass, 0.05-3.5% by mass, and 0.05-3.5% by mass. 05 to 3% by mass, 0.05 to 2.6% by mass, 0.1 to 10% by mass, 0.1 to 7% by mass, 0.1 to 5% by mass, 0.1 to 3.5% by mass, 0.1 to 3% by mass, 0.1 to 2.6% by mass, 1 to 10% by mass, 1 to 7% by mass, 1 to 5% by mass, 1 to 3.5% by mass, 1 to 3% by mass, 1 to 2.6% by mass, 2 to 10% by mass, 2 to 7% by mass, 2 to 5% by mass, 2 to 3.5% by mass, 2 to 3% by mass, and 2 to 2.6% by mass. .
(B)成分
グリチルレチン酸類及びアラントインから選ばれる少なくとも1種の成分の合計濃度は、組成物の全量に対して、0.05質量%以上が好ましく、0.1質量%以上がより好ましく、0.5質量%以上がさらに好ましい。また、1.5質量%以下が好ましく、1質量%以下がより好ましく、0.7質量%以下がさらに好ましい。この範囲であれば、十分な抗炎症作用が得られると共に、経時的な粘度低下が抑えられ、また滑らかに塗布できるものとなる。
組成物の全量に対するグリチルレチン酸類及びアラントインから選ばれる少なくとも1種の成分の合計濃度としては、0.05~1.5質量%、0.05~1質量%、0.05~0.7質量%、0.1~1.5質量%、0.1~1質量%、0.1~0.7質量%、0.5~1.5質量%、0.5~1質量%、0.5~0.7質量%が挙げられる。 The total concentration of at least one component selected from component (B) glycyrrhetinic acids and allantoin is preferably 0.05% by mass or more, more preferably 0.1% by mass or more, and 0.1% by mass or more, based on the total amount of the composition. 5% by mass or more is more preferable. Also, it is preferably 1.5% by mass or less, more preferably 1% by mass or less, and even more preferably 0.7% by mass or less. Within this range, a sufficient anti-inflammatory action can be obtained, a decrease in viscosity over time can be suppressed, and smooth application can be achieved.
The total concentration of at least one component selected from glycyrrhetinic acids and allantoin relative to the total amount of the composition is 0.05 to 1.5% by mass, 0.05 to 1% by mass, and 0.05 to 0.7% by mass. , 0.1 to 1.5% by mass, 0.1 to 1% by mass, 0.1 to 0.7% by mass, 0.5 to 1.5% by mass, 0.5 to 1% by mass, 0.5 ~0.7% by mass.
グリチルレチン酸類及びアラントインから選ばれる少なくとも1種の成分の合計濃度は、組成物の全量に対して、0.05質量%以上が好ましく、0.1質量%以上がより好ましく、0.5質量%以上がさらに好ましい。また、1.5質量%以下が好ましく、1質量%以下がより好ましく、0.7質量%以下がさらに好ましい。この範囲であれば、十分な抗炎症作用が得られると共に、経時的な粘度低下が抑えられ、また滑らかに塗布できるものとなる。
組成物の全量に対するグリチルレチン酸類及びアラントインから選ばれる少なくとも1種の成分の合計濃度としては、0.05~1.5質量%、0.05~1質量%、0.05~0.7質量%、0.1~1.5質量%、0.1~1質量%、0.1~0.7質量%、0.5~1.5質量%、0.5~1質量%、0.5~0.7質量%が挙げられる。 The total concentration of at least one component selected from component (B) glycyrrhetinic acids and allantoin is preferably 0.05% by mass or more, more preferably 0.1% by mass or more, and 0.1% by mass or more, based on the total amount of the composition. 5% by mass or more is more preferable. Also, it is preferably 1.5% by mass or less, more preferably 1% by mass or less, and even more preferably 0.7% by mass or less. Within this range, a sufficient anti-inflammatory action can be obtained, a decrease in viscosity over time can be suppressed, and smooth application can be achieved.
The total concentration of at least one component selected from glycyrrhetinic acids and allantoin relative to the total amount of the composition is 0.05 to 1.5% by mass, 0.05 to 1% by mass, and 0.05 to 0.7% by mass. , 0.1 to 1.5% by mass, 0.1 to 1% by mass, 0.1 to 0.7% by mass, 0.5 to 1.5% by mass, 0.5 to 1% by mass, 0.5 ~0.7% by mass.
また、グリチルレチン酸類及びアラントインから選ばれる少なくとも1種の成分の合計含有量は、過酸化ベンゾイルの含有量の1質量部に対して、0.005質量部以上が好ましく、0.01質量部以上がより好ましく、0.015質量部以上が更に好ましく、0.03質量部以上が更により好ましく、0.15質量部以上が特に好ましい。また、0.8質量部以下が好ましく、0.6質量部以下がより好ましく、0.4質量部以下が更に好ましく、0.3質量部以下が特に好ましい。この範囲であれば、十分な抗炎症作用が得られると共に、経時的な粘度低下が抑えられ、また滑らかに塗布できるものとなる。
過酸化ベンゾイルの含有量の1質量部に対するグリチルレチン酸類及びアラントインから選ばれる少なくとも1種の成分の合計含有量の比率としては、0.005~0.8質量部、0.005~0.6質量部、0.005~0.4質量部、0.005~0.3質量部、0.01~0.8質量部、0.01~0.6質量部、0.01~0.4質量部、0.01~0.3質量部、0.015~0.8質量部、0.015~0.6質量部、0.015~0.4質量部、0.015~0.3質量部、0.03~0.8質量部、0.03~0.6質量部、0.03~0.4質量部、0.03~0.3質量部、0.15~0.8質量部、0.15~0.6質量部、0.15~0.4質量部、0.15~0.3質量部が挙げられる。 In addition, the total content of at least one component selected from glycyrrhetinic acids and allantoin is preferably 0.005 parts by mass or more, and preferably 0.01 parts by mass or more, relative to 1 part by mass of the content of benzoyl peroxide. It is more preferably 0.015 parts by mass or more, even more preferably 0.03 parts by mass or more, and particularly preferably 0.15 parts by mass or more. Also, it is preferably 0.8 parts by mass or less, more preferably 0.6 parts by mass or less, still more preferably 0.4 parts by mass or less, and particularly preferably 0.3 parts by mass or less. Within this range, a sufficient anti-inflammatory action can be obtained, a decrease in viscosity over time can be suppressed, and smooth application can be achieved.
The ratio of the total content of at least one component selected from glycyrrhetinic acids and allantoin to 1 part by mass of the content of benzoyl peroxide is 0.005 to 0.8 parts by mass, 0.005 to 0.6 parts by mass. parts, 0.005 to 0.4 parts by mass, 0.005 to 0.3 parts by mass, 0.01 to 0.8 parts by mass, 0.01 to 0.6 parts by mass, 0.01 to 0.4 parts by mass parts, 0.01 to 0.3 parts by mass, 0.015 to 0.8 parts by mass, 0.015 to 0.6 parts by mass, 0.015 to 0.4 parts by mass, 0.015 to 0.3 parts by mass parts, 0.03 to 0.8 parts by mass, 0.03 to 0.6 parts by mass, 0.03 to 0.4 parts by mass, 0.03 to 0.3 parts by mass, 0.15 to 0.8 parts by mass parts, 0.15 to 0.6 parts by mass, 0.15 to 0.4 parts by mass, and 0.15 to 0.3 parts by mass.
過酸化ベンゾイルの含有量の1質量部に対するグリチルレチン酸類及びアラントインから選ばれる少なくとも1種の成分の合計含有量の比率としては、0.005~0.8質量部、0.005~0.6質量部、0.005~0.4質量部、0.005~0.3質量部、0.01~0.8質量部、0.01~0.6質量部、0.01~0.4質量部、0.01~0.3質量部、0.015~0.8質量部、0.015~0.6質量部、0.015~0.4質量部、0.015~0.3質量部、0.03~0.8質量部、0.03~0.6質量部、0.03~0.4質量部、0.03~0.3質量部、0.15~0.8質量部、0.15~0.6質量部、0.15~0.4質量部、0.15~0.3質量部が挙げられる。 In addition, the total content of at least one component selected from glycyrrhetinic acids and allantoin is preferably 0.005 parts by mass or more, and preferably 0.01 parts by mass or more, relative to 1 part by mass of the content of benzoyl peroxide. It is more preferably 0.015 parts by mass or more, even more preferably 0.03 parts by mass or more, and particularly preferably 0.15 parts by mass or more. Also, it is preferably 0.8 parts by mass or less, more preferably 0.6 parts by mass or less, still more preferably 0.4 parts by mass or less, and particularly preferably 0.3 parts by mass or less. Within this range, a sufficient anti-inflammatory action can be obtained, a decrease in viscosity over time can be suppressed, and smooth application can be achieved.
The ratio of the total content of at least one component selected from glycyrrhetinic acids and allantoin to 1 part by mass of the content of benzoyl peroxide is 0.005 to 0.8 parts by mass, 0.005 to 0.6 parts by mass. parts, 0.005 to 0.4 parts by mass, 0.005 to 0.3 parts by mass, 0.01 to 0.8 parts by mass, 0.01 to 0.6 parts by mass, 0.01 to 0.4 parts by mass parts, 0.01 to 0.3 parts by mass, 0.015 to 0.8 parts by mass, 0.015 to 0.6 parts by mass, 0.015 to 0.4 parts by mass, 0.015 to 0.3 parts by mass parts, 0.03 to 0.8 parts by mass, 0.03 to 0.6 parts by mass, 0.03 to 0.4 parts by mass, 0.03 to 0.3 parts by mass, 0.15 to 0.8 parts by mass parts, 0.15 to 0.6 parts by mass, 0.15 to 0.4 parts by mass, and 0.15 to 0.3 parts by mass.
(B1)グリチルレチン酸・誘導体・塩
グリチルレチン酸の誘導体としては、グリチルレチン酸ピリドキシン、グリチルレチン酸ステアリル、グリチルレチン酸グリセリル、グリチルレチン酸モノグルクロニド等が挙げられる。また、グリチルレチン酸の配糖体であるグリチルリチン酸や、グリチルリチン酸メチル、グリチルリチン酸ステアリルのようなグリチルリチン酸エステルも、グリチルレチン酸の誘導体として挙げられる。グリチルリチンは甘草又は甘草抽出物の形で配合することもできる。 (B1) Glycyrrhetinic Acid Derivatives Salts Derivatives of glycyrrhetinic acid include pyridoxine glycyrrhetinate, stearyl glycyrrhetinate, glyceryl glycyrrhetinate, monoglucuronide glycyrrhetinate and the like. Glycyrrhetinic acid, which is a glycoside of glycyrrhetinic acid, and glycyrrhizic acid esters such as methyl glycyrrhizinate and stearyl glycyrrhizinate are also examples of derivatives of glycyrrhetinic acid. Glycyrrhizin can also be formulated in the form of licorice or licorice extract.
グリチルレチン酸の誘導体としては、グリチルレチン酸ピリドキシン、グリチルレチン酸ステアリル、グリチルレチン酸グリセリル、グリチルレチン酸モノグルクロニド等が挙げられる。また、グリチルレチン酸の配糖体であるグリチルリチン酸や、グリチルリチン酸メチル、グリチルリチン酸ステアリルのようなグリチルリチン酸エステルも、グリチルレチン酸の誘導体として挙げられる。グリチルリチンは甘草又は甘草抽出物の形で配合することもできる。 (B1) Glycyrrhetinic Acid Derivatives Salts Derivatives of glycyrrhetinic acid include pyridoxine glycyrrhetinate, stearyl glycyrrhetinate, glyceryl glycyrrhetinate, monoglucuronide glycyrrhetinate and the like. Glycyrrhetinic acid, which is a glycoside of glycyrrhetinic acid, and glycyrrhizic acid esters such as methyl glycyrrhizinate and stearyl glycyrrhizinate are also examples of derivatives of glycyrrhetinic acid. Glycyrrhizin can also be formulated in the form of licorice or licorice extract.
グリチルレチン酸又はグリチルレチン酸誘導体の塩は、薬学的に許容される塩であればよく、アンモニウム塩、アルカリ金属塩(ナトリウム塩、カリウム塩など)、アルカリ土類金属塩(カルシウム塩、マグネシウム塩など)、金属塩(アルミニウム塩など)、アンモニウム塩のような無機塩基との塩;有機アミン塩(メチルアミン塩、トリエチルアミン塩、トリエタノールアミン塩、アルギニン塩、グリシン塩など)のような有機塩基との塩などが挙げられる。
グリチルレチン酸又はグリチルレチン酸誘導体の塩は、中でも、アンモニウム塩、アルカリ金属塩が好ましく、アンモニウム塩、カリウム塩、ナトリウム塩がより好ましく、モノアンモニウム塩、ジカリウム塩、トリナトリウム塩が特に好ましい。 Salts of glycyrrhetinic acid or glycyrrhetinic acid derivatives may be pharmaceutically acceptable salts, such as ammonium salts, alkali metal salts (sodium salts, potassium salts, etc.), alkaline earth metal salts (calcium salts, magnesium salts, etc.). , metal salts (aluminum salts, etc.), salts with inorganic bases such as ammonium salts; organic amine salts (methylamine salts, triethylamine salts, triethanolamine salts, arginine salts, glycine salts, etc.). Examples include salt.
Salts of glycyrrhetic acid or glycyrrhetic acid derivatives are preferably ammonium salts and alkali metal salts, more preferably ammonium salts, potassium salts and sodium salts, and particularly preferably monoammonium salts, dipotassium salts and trisodium salts.
グリチルレチン酸又はグリチルレチン酸誘導体の塩は、中でも、アンモニウム塩、アルカリ金属塩が好ましく、アンモニウム塩、カリウム塩、ナトリウム塩がより好ましく、モノアンモニウム塩、ジカリウム塩、トリナトリウム塩が特に好ましい。 Salts of glycyrrhetinic acid or glycyrrhetinic acid derivatives may be pharmaceutically acceptable salts, such as ammonium salts, alkali metal salts (sodium salts, potassium salts, etc.), alkaline earth metal salts (calcium salts, magnesium salts, etc.). , metal salts (aluminum salts, etc.), salts with inorganic bases such as ammonium salts; organic amine salts (methylamine salts, triethylamine salts, triethanolamine salts, arginine salts, glycine salts, etc.). Examples include salt.
Salts of glycyrrhetic acid or glycyrrhetic acid derivatives are preferably ammonium salts and alkali metal salts, more preferably ammonium salts, potassium salts and sodium salts, and particularly preferably monoammonium salts, dipotassium salts and trisodium salts.
グリチルレチン酸類の中では、グリチルレチン酸、グリチルレチン酸ステアリル、グリチルリチン酸、それらの塩が好ましく、グリチルリチン酸、グリチルリチン酸塩がより好ましい。グリチルリチン酸塩では、グリチルリチン酸モノアンモニウム、グリチルリチン酸ジカリウム、グリチルリチン酸トリナトリウム塩が好ましい。
グリチルレチン酸類は、1種又は2種以上を使用できる。 Among the glycyrrhetinic acids, glycyrrhetinic acid, stearyl glycyrrhetinate, glycyrrhizic acid, and salts thereof are preferred, and glycyrrhizic acid and glycyrrhizinate are more preferred. Preferred glycyrrhizinates are monoammonium glycyrrhizinate, dipotassium glycyrrhizinate, and trisodium glycyrrhizinate.
Glycyrrhetinic acids can be used alone or in combination of two or more.
グリチルレチン酸類は、1種又は2種以上を使用できる。 Among the glycyrrhetinic acids, glycyrrhetinic acid, stearyl glycyrrhetinate, glycyrrhizic acid, and salts thereof are preferred, and glycyrrhizic acid and glycyrrhizinate are more preferred. Preferred glycyrrhizinates are monoammonium glycyrrhizinate, dipotassium glycyrrhizinate, and trisodium glycyrrhizinate.
Glycyrrhetinic acids can be used alone or in combination of two or more.
本発明の医薬外用組成物がグリチルレチン酸類を含む場合、グリチルレチン酸類の濃度は、組成物の全量に対して、0.05質量%以上が好ましく、0.1質量%以上がより好ましく、0.2質量%以上がさらに好ましい。また、1質量%以下が好ましく、0.75質量%以下が好ましく、0.5質量%以下がさらに好ましい。この範囲であれば、十分な抗炎症作用が得られると共に、経時的な粘度低下が抑えられ、また滑らかに塗布できるものとなる。
組成物の全量に対するグリチルレチン酸類の濃度としては、0.05~1質量%、0.05~0.75質量%、0.05~0.5質量%、0.1~1質量%、0.1~0.75質量%、0.1~0.5質量%、0.2~1質量%、0.2~0.75質量%、0.2~0.5質量%が挙げられる。 When the topical pharmaceutical composition of the present invention contains glycyrrhetinic acids, the concentration of glycyrrhetinic acids is preferably 0.05% by mass or more, more preferably 0.1% by mass or more, more preferably 0.2% by mass, relative to the total amount of the composition. % by mass or more is more preferable. Moreover, 1 mass % or less is preferable, 0.75 mass % or less is preferable, and 0.5 mass % or less is more preferable. Within this range, a sufficient anti-inflammatory action can be obtained, a decrease in viscosity over time can be suppressed, and smooth application can be achieved.
The concentration of glycyrrhetinic acids relative to the total amount of the composition is 0.05 to 1% by mass, 0.05 to 0.75% by mass, 0.05 to 0.5% by mass, 0.1 to 1% by mass, 0.05% to 0.75% by mass, 0.05% to 0.5% by mass, 0.1% to 1% by mass. 1 to 0.75% by mass, 0.1 to 0.5% by mass, 0.2 to 1% by mass, 0.2 to 0.75% by mass, and 0.2 to 0.5% by mass.
組成物の全量に対するグリチルレチン酸類の濃度としては、0.05~1質量%、0.05~0.75質量%、0.05~0.5質量%、0.1~1質量%、0.1~0.75質量%、0.1~0.5質量%、0.2~1質量%、0.2~0.75質量%、0.2~0.5質量%が挙げられる。 When the topical pharmaceutical composition of the present invention contains glycyrrhetinic acids, the concentration of glycyrrhetinic acids is preferably 0.05% by mass or more, more preferably 0.1% by mass or more, more preferably 0.2% by mass, relative to the total amount of the composition. % by mass or more is more preferable. Moreover, 1 mass % or less is preferable, 0.75 mass % or less is preferable, and 0.5 mass % or less is more preferable. Within this range, a sufficient anti-inflammatory action can be obtained, a decrease in viscosity over time can be suppressed, and smooth application can be achieved.
The concentration of glycyrrhetinic acids relative to the total amount of the composition is 0.05 to 1% by mass, 0.05 to 0.75% by mass, 0.05 to 0.5% by mass, 0.1 to 1% by mass, 0.05% to 0.75% by mass, 0.05% to 0.5% by mass, 0.1% to 1% by mass. 1 to 0.75% by mass, 0.1 to 0.5% by mass, 0.2 to 1% by mass, 0.2 to 0.75% by mass, and 0.2 to 0.5% by mass.
また、本発明の医薬外用組成物がグリチルレチン酸類を含む場合、グリチルレチン酸類の含有量は、過酸化ベンゾイルの含有量の1質量部に対して、0.005質量部以上が好ましく、0.01質量部以上がより好ましく、0.02質量部以上が更に好ましく、0.04質量部以上が更により好ましく、0.08質量部以上が特に好ましい。また、0.8質量部以下が好ましく、0.4質量部以下がより好ましく、0.32質量部以下が更に好ましく、0.2質量部以下が特に好ましい。この範囲であれば、十分な抗炎症作用が得られると共に、経時的な粘度低下が抑えられ、また滑らかに塗布できるものとなる。
過酸化ベンゾイルの含有量の1質量部に対するグリチルレチン酸類の含有量の比率としては、0.005~0.8質量部、0.005~0.4質量部、0.005~0.32質量部、0.005~0.2質量部、0.01~0.8質量部、0.01~0.4質量部、0.01~0.32質量部、0.01~0.2質量部、0.02~0.8質量部、0.02~0.4質量部、0.02~0.32質量部、0.02~0.2質量部、0.04~0.8質量部、0.04~0.4質量部、0.04~0.32質量部、0.04~0.2質量部、0.08~0.8質量部、0.08~0.4質量部、0.08~0.32質量部、0.08~0.2質量部が挙げられる。 In addition, when the external pharmaceutical composition of the present invention contains glycyrrhetinic acids, the content of glycyrrhetinic acids is preferably 0.005 parts by mass or more, and preferably 0.01 part by mass, with respect to 1 part by mass of the content of benzoyl peroxide. Part or more is more preferable, 0.02 mass part or more is still more preferable, 0.04 mass part or more is even more preferable, and 0.08 mass part or more is particularly preferable. Also, it is preferably 0.8 parts by mass or less, more preferably 0.4 parts by mass or less, still more preferably 0.32 parts by mass or less, and particularly preferably 0.2 parts by mass or less. Within this range, a sufficient anti-inflammatory action can be obtained, a decrease in viscosity over time can be suppressed, and smooth application can be achieved.
The ratio of the glycyrrhetic acid content to 1 part by mass of the benzoyl peroxide content is 0.005 to 0.8 parts by mass, 0.005 to 0.4 parts by mass, and 0.005 to 0.32 parts by mass. , 0.005 to 0.2 parts by weight, 0.01 to 0.8 parts by weight, 0.01 to 0.4 parts by weight, 0.01 to 0.32 parts by weight, 0.01 to 0.2 parts by weight , 0.02 to 0.8 parts by weight, 0.02 to 0.4 parts by weight, 0.02 to 0.32 parts by weight, 0.02 to 0.2 parts by weight, 0.04 to 0.8 parts by weight , 0.04 to 0.4 parts by weight, 0.04 to 0.32 parts by weight, 0.04 to 0.2 parts by weight, 0.08 to 0.8 parts by weight, 0.08 to 0.4 parts by weight , 0.08 to 0.32 parts by mass, and 0.08 to 0.2 parts by mass.
過酸化ベンゾイルの含有量の1質量部に対するグリチルレチン酸類の含有量の比率としては、0.005~0.8質量部、0.005~0.4質量部、0.005~0.32質量部、0.005~0.2質量部、0.01~0.8質量部、0.01~0.4質量部、0.01~0.32質量部、0.01~0.2質量部、0.02~0.8質量部、0.02~0.4質量部、0.02~0.32質量部、0.02~0.2質量部、0.04~0.8質量部、0.04~0.4質量部、0.04~0.32質量部、0.04~0.2質量部、0.08~0.8質量部、0.08~0.4質量部、0.08~0.32質量部、0.08~0.2質量部が挙げられる。 In addition, when the external pharmaceutical composition of the present invention contains glycyrrhetinic acids, the content of glycyrrhetinic acids is preferably 0.005 parts by mass or more, and preferably 0.01 part by mass, with respect to 1 part by mass of the content of benzoyl peroxide. Part or more is more preferable, 0.02 mass part or more is still more preferable, 0.04 mass part or more is even more preferable, and 0.08 mass part or more is particularly preferable. Also, it is preferably 0.8 parts by mass or less, more preferably 0.4 parts by mass or less, still more preferably 0.32 parts by mass or less, and particularly preferably 0.2 parts by mass or less. Within this range, a sufficient anti-inflammatory action can be obtained, a decrease in viscosity over time can be suppressed, and smooth application can be achieved.
The ratio of the glycyrrhetic acid content to 1 part by mass of the benzoyl peroxide content is 0.005 to 0.8 parts by mass, 0.005 to 0.4 parts by mass, and 0.005 to 0.32 parts by mass. , 0.005 to 0.2 parts by weight, 0.01 to 0.8 parts by weight, 0.01 to 0.4 parts by weight, 0.01 to 0.32 parts by weight, 0.01 to 0.2 parts by weight , 0.02 to 0.8 parts by weight, 0.02 to 0.4 parts by weight, 0.02 to 0.32 parts by weight, 0.02 to 0.2 parts by weight, 0.04 to 0.8 parts by weight , 0.04 to 0.4 parts by weight, 0.04 to 0.32 parts by weight, 0.04 to 0.2 parts by weight, 0.08 to 0.8 parts by weight, 0.08 to 0.4 parts by weight , 0.08 to 0.32 parts by mass, and 0.08 to 0.2 parts by mass.
(B2)アラントイン
本発明の医薬外用組成物がアラントインを含む場合、アラントインの濃度は、組成物の全量に対して、0.05質量%以上が好ましく、0.1質量%以上がより好ましい。また、5質量%以下が好ましく、2質量%以下がより好ましく、1質量%以下がより好ましく、0.5質量%以下がより好ましく、0.2質量%以下がより好ましい。この範囲であれば、十分な抗炎症作用が得られると共に、経時的な粘度低下が抑えられ、また滑らかに塗布できるものとなる。
組成物の全量に対するアラントインの濃度としては、0.05~5質量%、0.05~2質量%、0.05~1質量%、0.05~0.5質量%、0.05~0.2質量%、0.1~5質量%、0.1~2質量%、0.1~1質量%、0.1~0.5質量%、0.1~0.2質量%が挙げられる。 (B2) Allantoin When the external pharmaceutical composition of the present invention contains allantoin, the concentration of allantoin is preferably 0.05% by mass or more, more preferably 0.1% by mass or more, relative to the total amount of the composition. Also, it is preferably 5% by mass or less, more preferably 2% by mass or less, more preferably 1% by mass or less, more preferably 0.5% by mass or less, and more preferably 0.2% by mass or less. Within this range, a sufficient anti-inflammatory action can be obtained, a decrease in viscosity over time can be suppressed, and smooth application can be achieved.
The concentration of allantoin with respect to the total amount of the composition is 0.05 to 5% by mass, 0.05 to 2% by mass, 0.05 to 1% by mass, 0.05 to 0.5% by mass, 0.05 to 0.05% by mass. .2% by mass, 0.1 to 5% by mass, 0.1 to 2% by mass, 0.1 to 1% by mass, 0.1 to 0.5% by mass, and 0.1 to 0.2% by mass. be done.
本発明の医薬外用組成物がアラントインを含む場合、アラントインの濃度は、組成物の全量に対して、0.05質量%以上が好ましく、0.1質量%以上がより好ましい。また、5質量%以下が好ましく、2質量%以下がより好ましく、1質量%以下がより好ましく、0.5質量%以下がより好ましく、0.2質量%以下がより好ましい。この範囲であれば、十分な抗炎症作用が得られると共に、経時的な粘度低下が抑えられ、また滑らかに塗布できるものとなる。
組成物の全量に対するアラントインの濃度としては、0.05~5質量%、0.05~2質量%、0.05~1質量%、0.05~0.5質量%、0.05~0.2質量%、0.1~5質量%、0.1~2質量%、0.1~1質量%、0.1~0.5質量%、0.1~0.2質量%が挙げられる。 (B2) Allantoin When the external pharmaceutical composition of the present invention contains allantoin, the concentration of allantoin is preferably 0.05% by mass or more, more preferably 0.1% by mass or more, relative to the total amount of the composition. Also, it is preferably 5% by mass or less, more preferably 2% by mass or less, more preferably 1% by mass or less, more preferably 0.5% by mass or less, and more preferably 0.2% by mass or less. Within this range, a sufficient anti-inflammatory action can be obtained, a decrease in viscosity over time can be suppressed, and smooth application can be achieved.
The concentration of allantoin with respect to the total amount of the composition is 0.05 to 5% by mass, 0.05 to 2% by mass, 0.05 to 1% by mass, 0.05 to 0.5% by mass, 0.05 to 0.05% by mass. .2% by mass, 0.1 to 5% by mass, 0.1 to 2% by mass, 0.1 to 1% by mass, 0.1 to 0.5% by mass, and 0.1 to 0.2% by mass. be done.
また、本発明の医薬外用組成物がアラントインを含む場合、アラントインの含有量は、過酸化ベンゾイルの含有量の1質量部に対して、0.005質量部以上が好ましく、0.01質量部以上がより好ましく、0.02質量部以上が好ましく、0.03質量部以上がより好ましい。また、0.8質量部以下が好ましく、0.4質量部以下がより好ましく、0.2質量部以下が好ましく、0.08質量部以下がより好ましい。この範囲であれば、十分な抗炎症作用が得られると共に、経時的な粘度低下が抑えられ、また滑らかに塗布できるものとなる。
過酸化ベンゾイルの含有量の1質量部に対するアラントインの含有量の比率としては、0.005~0.8質量部、0.005~0.4質量部、0.005~0.2質量部、0.01~0.8質量部、0.01~0.4質量部、0.01~0.2質量部、0.02~0.8質量部、0.02~0.4質量部、0.02~0.2質量部、0.03~0.8質量部、0.03~0.4質量部、0.03~0.2質量部質量部が挙げられる。 In addition, when the external pharmaceutical composition of the present invention contains allantoin, the content of allantoin is preferably 0.005 parts by mass or more, more preferably 0.01 parts by mass or more with respect to 1 part by mass of the content of benzoyl peroxide. is more preferable, 0.02 parts by mass or more is preferable, and 0.03 parts by mass or more is more preferable. Moreover, 0.8 mass part or less is preferable, 0.4 mass part or less is more preferable, 0.2 mass part or less is preferable, and 0.08 mass part or less is more preferable. Within this range, a sufficient anti-inflammatory action can be obtained, a decrease in viscosity over time can be suppressed, and smooth application can be achieved.
The ratio of the allantoin content to 1 part by mass of the benzoyl peroxide content is 0.005 to 0.8 parts by mass, 0.005 to 0.4 parts by mass, 0.005 to 0.2 parts by mass, 0.01 to 0.8 parts by mass, 0.01 to 0.4 parts by mass, 0.01 to 0.2 parts by mass, 0.02 to 0.8 parts by mass, 0.02 to 0.4 parts by mass, 0.02 to 0.2 parts by mass, 0.03 to 0.8 parts by mass, 0.03 to 0.4 parts by mass, and 0.03 to 0.2 parts by mass.
過酸化ベンゾイルの含有量の1質量部に対するアラントインの含有量の比率としては、0.005~0.8質量部、0.005~0.4質量部、0.005~0.2質量部、0.01~0.8質量部、0.01~0.4質量部、0.01~0.2質量部、0.02~0.8質量部、0.02~0.4質量部、0.02~0.2質量部、0.03~0.8質量部、0.03~0.4質量部、0.03~0.2質量部質量部が挙げられる。 In addition, when the external pharmaceutical composition of the present invention contains allantoin, the content of allantoin is preferably 0.005 parts by mass or more, more preferably 0.01 parts by mass or more with respect to 1 part by mass of the content of benzoyl peroxide. is more preferable, 0.02 parts by mass or more is preferable, and 0.03 parts by mass or more is more preferable. Moreover, 0.8 mass part or less is preferable, 0.4 mass part or less is more preferable, 0.2 mass part or less is preferable, and 0.08 mass part or less is more preferable. Within this range, a sufficient anti-inflammatory action can be obtained, a decrease in viscosity over time can be suppressed, and smooth application can be achieved.
The ratio of the allantoin content to 1 part by mass of the benzoyl peroxide content is 0.005 to 0.8 parts by mass, 0.005 to 0.4 parts by mass, 0.005 to 0.2 parts by mass, 0.01 to 0.8 parts by mass, 0.01 to 0.4 parts by mass, 0.01 to 0.2 parts by mass, 0.02 to 0.8 parts by mass, 0.02 to 0.4 parts by mass, 0.02 to 0.2 parts by mass, 0.03 to 0.8 parts by mass, 0.03 to 0.4 parts by mass, and 0.03 to 0.2 parts by mass.
(B1)成分と(B2)成分の双方を配合する場合の好ましい組み合わせとして、グリチルレチン酸とアラントイン、グリチルレチン酸ステアリルとアラントイン、グリチルリチン酸とアラントイン、グリチルリチン酸モノアンモニウムとアラントイン、グリチルリチン酸ジカリウムとアラントイン、グリチルリチン酸トリナトリウム塩とアラントインが挙げられる。
Preferred combinations when both component (B1) and component (B2) are blended include glycyrrhetinic acid and allantoin, stearyl glycyrrhetinate and allantoin, glycyrrhizic acid and allantoin, monoammonium glycyrrhizinate and allantoin, dipotassium glycyrrhizinate and allantoin, and glycyrrhizin. acid trisodium salt and allantoin.
その他の成分
本発明の医薬外用組成物は、上記(A)成分及び(B)成分を、医薬外用剤に使用される添加剤や、その他の生理活性又は薬理活性成分と混合して調製することができる。添加剤としては、油剤、界面活性剤、保湿剤、多価アルコール、酸化防止剤、増粘剤、防腐剤又は保存剤、pH調整剤、キレート剤、着色剤、香料等が挙げられる。添加剤は、1種又は2種以上を使用できる。また、添加剤は、本発明の効果を損なわない範囲で使用することができる。 Other Components The topical pharmaceutical composition of the present invention can be prepared by mixing the above components (A) and (B) with additives used in topical preparations and other physiologically active or pharmacologically active ingredients. can be done. Additives include oils, surfactants, humectants, polyhydric alcohols, antioxidants, thickeners, antiseptics or preservatives, pH adjusters, chelating agents, coloring agents, perfumes, and the like. 1 type, or 2 or more types can be used for an additive. In addition, additives can be used within a range that does not impair the effects of the present invention.
本発明の医薬外用組成物は、上記(A)成分及び(B)成分を、医薬外用剤に使用される添加剤や、その他の生理活性又は薬理活性成分と混合して調製することができる。添加剤としては、油剤、界面活性剤、保湿剤、多価アルコール、酸化防止剤、増粘剤、防腐剤又は保存剤、pH調整剤、キレート剤、着色剤、香料等が挙げられる。添加剤は、1種又は2種以上を使用できる。また、添加剤は、本発明の効果を損なわない範囲で使用することができる。 Other Components The topical pharmaceutical composition of the present invention can be prepared by mixing the above components (A) and (B) with additives used in topical preparations and other physiologically active or pharmacologically active ingredients. can be done. Additives include oils, surfactants, humectants, polyhydric alcohols, antioxidants, thickeners, antiseptics or preservatives, pH adjusters, chelating agents, coloring agents, perfumes, and the like. 1 type, or 2 or more types can be used for an additive. In addition, additives can be used within a range that does not impair the effects of the present invention.
過酸化ベンゾイルは、反応性が高い物質であるため、本発明の組成物は、水を含むことが望ましい。水の濃度は、組成物の全量に対して、25質量%以上が好ましく、28質量%以上がより好ましく、40質量%以上がさらに好ましい。また、90質量%以下が好ましく、80質量%以下がより好ましい。この範囲であれば、過酸化ベンゾイルによる組成物の不安定化を回避でき、また、本発明の効果を十分に得ることができる。
組成物の全量に対する水の濃度としては、25~90質量%、25~80質量%、28~90質量%、28~80質量%、40~90質量%、40~80質量%が挙げられる。 Since benzoyl peroxide is a highly reactive substance, the composition of the present invention desirably contains water. The concentration of water is preferably 25% by mass or more, more preferably 28% by mass or more, and even more preferably 40% by mass or more, relative to the total amount of the composition. Moreover, 90 mass % or less is preferable, and 80 mass % or less is more preferable. Within this range, destabilization of the composition due to benzoyl peroxide can be avoided, and the effects of the present invention can be sufficiently obtained.
The concentration of water relative to the total amount of the composition includes 25 to 90% by mass, 25 to 80% by mass, 28 to 90% by mass, 28 to 80% by mass, 40 to 90% by mass, and 40 to 80% by mass.
組成物の全量に対する水の濃度としては、25~90質量%、25~80質量%、28~90質量%、28~80質量%、40~90質量%、40~80質量%が挙げられる。 Since benzoyl peroxide is a highly reactive substance, the composition of the present invention desirably contains water. The concentration of water is preferably 25% by mass or more, more preferably 28% by mass or more, and even more preferably 40% by mass or more, relative to the total amount of the composition. Moreover, 90 mass % or less is preferable, and 80 mass % or less is more preferable. Within this range, destabilization of the composition due to benzoyl peroxide can be avoided, and the effects of the present invention can be sufficiently obtained.
The concentration of water relative to the total amount of the composition includes 25 to 90% by mass, 25 to 80% by mass, 28 to 90% by mass, 28 to 80% by mass, 40 to 90% by mass, and 40 to 80% by mass.
油剤としては、エステル油、油脂類、ロウ類、高級脂肪酸、高級アルコール、ステロール類、炭化水素、シリコーン油等が挙げられる。
Examples of oils include ester oils, fats and oils, waxes, higher fatty acids, higher alcohols, sterols, hydrocarbons, and silicone oils.
エステル油としては、ミリスチン酸イソプロピル、ミリスチン酸ブチル、ミリスチン酸デシル、ミリスチン酸ミリスチル、ミリスチン酸セチル、パルミチン酸イソプロピル、パルミチン酸セチル、ステアリン酸エチル、ステアリン酸ブチル、ステアリン酸ステアリル、ステアリン酸イソセチル、ラウリン酸ヘキシル、オレイン酸エチル、リノール酸エチル、リノール酸イソプロピル、カプリル酸セチル、オレイン酸デシル、オレイン酸オレイル、オレイン酸イソデシル、オクタン酸セチル、ミリスチン酸2-オクチルドデシル、ジメチルオクタン酸2-オクチルドデシル、ジメチルオクタン酸ヘキシルデシル、セバシン酸ジエチル、セバシン酸ジイソプロピル、セバシン酸ジ-2-エチルヘキシル、ミリスチン酸2-ヘキシルデシル、パルミチン酸2-ヘキシルデシル、アジピン酸ジイソプロピル、アジピン酸ジイソブチル、アジピン酸ジ-2-ヘプチルウンデシル、アジピン酸2-ヘキシルデシル、イソステアリン酸イソセチル、イソステアリン酸イソステアリル、イソノナン酸イソノニル、イソノナン酸イソトリデシルのような、炭素数8~22の脂肪酸と脂肪族アルコールとのエステル、12-ヒドロキシステアリル酸コレステリル、ステアリン酸コレステリル、オレイン酸コレステリル、マカデミアナッツ脂肪酸フィトステリル、オレイン酸フィトステリル、ステアリン酸イヌリン、ジ-2-エチルヘキシル酸エチレングリコール、2-エチルヘキサン酸セチル、モノイソステアリン酸N-アルキルグリコール、ジカプリン酸ネオペンチルグリコール、ジ-2-ヘプチルウンデカン酸グリセリン、トリメリト酸トリ2-エチルヘキシル、トリメリト酸トリトリデシル、トリ-2-エチルヘキシル酸トリメチロールプロパン、トリイソステアリン酸トリメチロールプロパン、テトラ-2-エチルヘキサン酸ペンタエリスリトール、トリ-2-エチルヘキサン酸グリセリン、トリイソステアリン酸トリメチロールプロパン、セチル2-エチルヘキサノエート、トリミリスチン酸グリセリン、トリ(カプリル酸/カプリン酸)グリセリル、トリ(カプリル酸/カプリン酸/ミリスチン酸/ステアリン酸)グリセリル、中鎖脂肪酸トリグリセリド、ヒマシ油脂肪酸メチルエステル、ラウロイルグルタミン酸ジ(フィトステリル/オクチルドデシル)、ラウロイルグルタミン酸ジ(オクチルドデシル/フィトステリル/ベヘニル)、リンゴ酸ジイソステアリル、乳酸セチル、乳酸ミリスチル、コハク酸ジエトキシエチル、コハク酸ジエチルヘキシル、シクロヘキサン-1,4-ジカルボン酸ビスエトキシジグリコール、酢酸ラノリン、酢酸エチル、酢酸ブチル、酢酸アミル、クエン酸トリエチル、ダイマージリノール酸(フィトステリル/イソステアリル/セチル/ステアリル/ベヘニル)、ダイマージリノール酸ダイマージリノレイル、トリポリヒドロキシステアリン酸ジペンタエリスリチル、トリ(ベヘン酸/イソステアリン酸/エイコサン二酸)グリセリル等が挙げられる。
Ester oils include isopropyl myristate, butyl myristate, decyl myristate, myristyl myristate, cetyl myristate, isopropyl palmitate, cetyl palmitate, ethyl stearate, butyl stearate, stearyl stearate, isocetyl stearate, laurin hexyl acid, ethyl oleate, ethyl linoleate, isopropyl linoleate, cetyl caprylate, decyl oleate, oleyl oleate, isodecyl oleate, cetyl octanoate, 2-octyldodecyl myristate, 2-octyldodecyl dimethyloctanoate, Hexyldecyl dimethyloctanoate, diethyl sebacate, diisopropyl sebacate, di-2-ethylhexyl sebacate, 2-hexyldecyl myristate, 2-hexyldecyl palmitate, diisopropyl adipate, diisobutyl adipate, di-2-adipate Esters of C8-C22 fatty acids with fatty alcohols, such as heptylundecyl, 2-hexyldecyl adipate, isocetyl isostearate, isostearyl isostearate, isononyl isononanoate, isotridecyl isononanoate, 12-hydroxystearyl cholesteryl acid, cholesteryl stearate, cholesteryl oleate, macadamia nut fatty acid phytosteryl, phytosteryl oleate, inulin stearate, ethylene glycol di-2-ethylhexylate, cetyl 2-ethylhexanoate, N-alkyl glycol monoisostearate, neo dicaprate Pentyl glycol, glyceryl di-2-heptylundecanoate, tri-2-ethylhexyl trimellitate, tridecyl trimellitate, trimethylolpropane tri-2-ethylhexylate, trimethylolpropane triisostearate, pentaerythritol tetra-2-ethylhexanoate , glyceryl tri-2-ethylhexanoate, trimethylolpropane triisostearate, cetyl 2-ethylhexanoate, glyceryl trimyristate, caprylic/capric triglyceride, tri(caprylic/capric/myristate) / stearic acid) glyceryl, medium chain fatty acid triglyceride, castor oil fatty acid methyl ester, di (phytosteryl/octyldodecyl) lauroyl glutamate, di (octyldodecyl/phytosteryl/behenyl) lauroyl glutamate, diisostearyl malate, cetyl lactate, myristyl lactate , diethoxyethyl succinate, diethylhexyl succinate, bisethoxydiglycol cyclohexane-1,4-dicarboxylate, lanolin acetate, ethyl acetate, butyl acetate, amyl acetate, triethyl citrate, dimer dilinoleic acid (phytosteryl/isostearyl /cetyl/stearyl/behenyl), dimer dilinoleyl dimer dilinoleate, dipentaerythrityl tripolyhydroxystearate, and glyceryl tri(behenate/isostearate/eicosanedioate).
油脂類としては、アボガド油、アマニ油、ツバキ油、マカデミアナッツ油、トウモロコシ油、オリーブ油、サフラワー油、キョウニン油、ホホバ油、ブドウ種子油、ヒマワリ油、アーモンド油、サザンカ油、ナタネ油、ゴマ油、ヒマシ油、カカオ脂、ヤシ油、硬化ヤシ油、パーム油、パーム核油、モクロウ核油、モクロウ、小麦胚芽油、米胚芽油、米ヌカ油、綿実油、大豆油、落花生油、茶実油、月見草油、ククイナッツ油、ヘーゼルナッツ油、シア脂、オレンジ油、カミツレ油等が挙げられる。
Fats and oils include avocado oil, linseed oil, camellia oil, macadamia nut oil, corn oil, olive oil, safflower oil, Chinese nut oil, jojoba oil, grape seed oil, sunflower oil, almond oil, sasanqua oil, rapeseed oil, sesame oil, Castor oil, cocoa butter, coconut oil, hydrogenated coconut oil, palm oil, palm kernel oil, Japanese magnolia kernel oil, Japanese magnolia, wheat germ oil, rice germ oil, rice bran oil, cottonseed oil, soybean oil, peanut oil, teaseed oil, Evening primrose oil, kukui nut oil, hazelnut oil, shea butter, orange oil, chamomile oil and the like.
ロウ類としては、キャンデリラロウ、コメヌカロウ、綿ロウ、カルナウバロウ、ラノリン、ラノリン脂肪酸イソプロピル、POEラノリンアルコールエーテル、POEラノリンアルコールアセテート、ラノリン脂肪酸ポリエチレングリコール、POE水素添加ラノリンアルコールエーテル、セラックロウ、ミツロウ等が挙げられる。
Waxes include candelilla wax, rice bran wax, cotton wax, carnauba wax, lanolin, lanolin fatty acid isopropyl, POE lanolin alcohol ether, POE lanolin alcohol acetate, lanolin fatty acid polyethylene glycol, POE hydrogenated lanolin alcohol ether, shellac wax, beeswax, and the like. be done.
高級脂肪酸としては、例えば、飽和又は不飽和の直鎖もしくは分岐鎖の炭素数12~22の脂肪酸を用いることができ、好ましくは、ラウリン酸、ミリスチン酸、パルミチン酸、ステアリン酸、ベヘン酸などの直鎖飽和脂肪酸(常温で固体);オレイン酸、リノール酸、リノレン酸、パルミトレイン酸、エイコサペンタエン酸、パクセン酸、ドコサヘキサエン酸などの不飽和脂肪酸(常温で液体);イソステアリン酸、ラノリン脂肪酸などの分岐脂肪酸;12-ヒドロキシステアリン酸等が挙げられる。
As higher fatty acids, for example, saturated or unsaturated linear or branched fatty acids having 12 to 22 carbon atoms can be used, preferably lauric acid, myristic acid, palmitic acid, stearic acid, behenic acid, and the like. Straight-chain saturated fatty acids (solid at room temperature); unsaturated fatty acids (liquid at room temperature) such as oleic acid, linoleic acid, linolenic acid, palmitoleic acid, eicosapentaenoic acid, paxenoic acid, and docosahexaenoic acid; branched fatty acids such as isostearic acid and lanolin fatty acid Fatty acids; 12-hydroxystearic acid and the like.
高級アルコールとしては、炭素数12~22の高級アルコールなどが挙げられる。好ましくは、ラウリルアルコール、ミリスチルアルコール、セタノール、セトステアリルアルコール、ステアリルアルコール、アラキルアルコール、ベヘニルアルコールなどの直鎖飽和アルコール;オレイルアルコール、セラキルアルコールなどの不飽和アルコール;ヘキシルデカノール、イソステアリルアルコール、オクチルドデカノール、デシルテトラデカノール、ラノリンアルコール、イソステアリルグリセリルエーテルなどの分岐アルコール等が挙げられる。
Higher alcohols include higher alcohols with 12 to 22 carbon atoms. Preferably, linear saturated alcohols such as lauryl alcohol, myristyl alcohol, cetanol, cetostearyl alcohol, stearyl alcohol, arachyl alcohol, behenyl alcohol; unsaturated alcohols such as oleyl alcohol, selachyl alcohol; hexyldecanol, isostearyl alcohol, octyldodeca decyltetradecanol, lanolin alcohol, branched alcohols such as isostearyl glyceryl ether, and the like.
ステロール類としては、コレステロール、エルゴステロール、ラノステロールなどの動物ステロール;シトステロール、カンペステロール、スチグマステロール、スピナステロール、ブラシカステロールなどの植物ステロール(フィトステロール)、ヒドロキシステアリン酸フィトステリルなどのステロール誘導体などが挙げられる。
Examples of sterols include animal sterols such as cholesterol, ergosterol and lanosterol; plant sterols (phytosterols) such as sitosterol, campesterol, stigmasterol, spinasterol and brassicasterol; and sterol derivatives such as phytosteryl hydroxystearate. .
炭化水素としては、パラフィン、セレシン、イソパラフィン、ハードファット、マイクロクリスタリンワックス、ポリブテン、ポリエチレン末、流動パラフィン、スクワラン、ワセリン、ゲル化炭化水素(プラスチベースなど)、オゾケライト、α-オレフィンオリゴマー、軽質流動パラフィン、軽質流動パラフィン等が挙げられる。
Hydrocarbons include paraffin, ceresin, isoparaffin, hard fat, microcrystalline wax, polybutene, polyethylene powder, liquid paraffin, squalane, vaseline, gelling hydrocarbons (plastibase, etc.), ozokerite, α-olefin oligomer, light liquid paraffin, and light liquid paraffin.
シリコーン油としては、メチルポリシロキサン、ジメチルポリシロキサン、メチルフェニルポリシロキサン、デカメチルテトラシロキサン、メチルシクロペンタシロキサン、高重合メチルポリシロキサン、オクタメチルシクロテトラシロキサン、デカメチルシクロペンタシロキサン、メチルハイドロジェンポリシロキサン、メチルトリメチコン、ジメチコノール、ジメチコノールクロスポリマーなどのシロキサン;カプリリルメチコンなどのアルキル変性シリコーン;アミノプロピルジメチコン、アモジメチコンなどのアミノ変性シリコーン;架橋型メチルポリシロキサン、架橋型アルキル変性シリコーン、アミノ変性シリコーン、ポリエーテル変性シリコーン、ポリグリセリン変性シリコーン、架橋型ポリエーテル変性シリコーン、架橋型アルキルポリエーテル変性シリコーン、シリコーン・アルキル鎖共変性ポリエーテル変性シリコーン、シリコーン・アルキル鎖共変性ポリグリセリン変性シリコーン、ポリエーテル変性分岐シリコーン、ポリグリセリン変性分岐シリコーン、アクリルシリコン、フェニル変性シリコーン、シリコーンレジン等が挙げられる。
Examples of silicone oils include methylpolysiloxane, dimethylpolysiloxane, methylphenylpolysiloxane, decamethyltetrasiloxane, methylcyclopentasiloxane, highly polymerized methylpolysiloxane, octamethylcyclotetrasiloxane, decamethylcyclopentasiloxane, and methylhydrogenpolysiloxane. Siloxane such as siloxane, methyltrimethicone, dimethiconol, dimethiconol crosspolymer; alkyl-modified silicone such as caprylyl methicone; amino-modified silicone such as aminopropyl dimethicone and amodimethicone; crosslinked methylpolysiloxane, crosslinked alkyl-modified silicone, amino-modified Silicone, polyether-modified silicone, polyglycerin-modified silicone, cross-linked polyether-modified silicone, cross-linked alkyl polyether-modified silicone, silicone/alkyl chain co-modified polyether-modified silicone, silicone/alkyl chain co-modified polyglycerin-modified silicone, poly Ether-modified branched silicone, polyglycerin-modified branched silicone, acrylic silicone, phenyl-modified silicone, silicone resin, and the like.
本発明で使用する基剤としては、水と多価アルコール及び/又は油剤との組み合わせが好ましく、中でも、水と、多価アルコール(プロピレングリコール、グリセリンなど)、高級アルコール(ステアリルアルコールのような炭素数12~22の直鎖の飽和又は不飽和アルコールなど)、及びエステル油(ミリスチン酸イソプロピルのような炭素数12~22の脂肪酸と脂肪族アルコールとのエステルなど)からなる群より選ばれる1種以上との組み合わせが好ましい。
The base used in the present invention is preferably a combination of water and a polyhydric alcohol and/or an oil agent. 1 type selected from the group consisting of linear saturated or unsaturated alcohols of number 12 to 22, etc.) and ester oils (esters of fatty acids with 12 to 22 carbon atoms such as isopropyl myristate and fatty alcohols, etc.) A combination of the above is preferred.
界面活性剤は、非イオン性界面活性剤、陽イオン性界面活性剤、陰イオン性界面活性剤、両性界面活性剤等のいずれでもよい。
非イオン性界面活性剤としては、ソルビタンモノイソステアレート、ソルビタンモノラウレート、ソルビタンモノパルミテート、ソルビタンモノステアレート、ペンタ-2-エチルヘキシル酸ジグリセロールソルビタン、テトラ-2-エチルヘキシル酸ジグリセロールソルビタンなどのソルビタン脂肪酸エステル類;モノステアリン酸プロピレングリコールなどのプロピレングリコール脂肪酸エステル類;ポリオキシエチレン硬化ヒマシ油40(HCO-40)、ポリオキシエチレン硬化ヒマシ油50(HCO-50)、ポリオキシエチレン硬化ヒマシ油60(HCO-60)、ポリオキシエチレン硬化ヒマシ油80などの硬化ヒマシ油誘導体;モノラウリル酸ポリオキシエチレン(20)ソルビタン(ポリソルベート20)、モノステアリン酸ポリオキシエチレン(20)ソルビタン(ポリソルベート60)、モノオレイン酸ポリオキシエチレン(20)ソルビタン(ポリソルベート80)、イソステアリン酸ポリオキシエチレン(20)ソルビタンなどのポリオキシエチレンソルビタン脂肪酸エステル類;ポリオキシエチレンモノヤシ油脂肪酸グリセリル;グリセリンアルキルエーテル;ステアリン酸グリセリル、ミリスチン酸グリセリル、オレイン酸グリセリル、イソステアリン酸グリセリル、ステアリン酸グリセリンなどのグリセリン脂肪酸エステル;オレイン酸ポリグリセリル-2、ステアリン酸ポリグリセリル-2、オレイン酸ポリグリセリル-10、ステアリン酸ポリグリセリル-10、ラウリン酸ポリグリセリル-10、ジステアリン酸ポリグリセリル-10、トリオレイン酸ポリグリセリル-10、ペンタオレイン酸ポリグリセリル-10、ペンタステアリン酸ポリグリセリル-10などのポリグリセリン脂肪酸エステル;アルキルグルコシド;ポリオキシエチレンステアリルエーテル、ポリオキシエチレンラウリルエーテル、ポリオキシエチレンセチルエーテル、ポリオキシエチレンベヘニルエーテル、ポリオキシエチレンセチルエーテルなどのポリオキシアルキレンアルキルエーテル;モノステアリン酸ポリエチレングリコールなどのポリエチレングリコール脂肪酸エステル;ステアリルアミン、オレイルアミンなどのアミン類;ポリオキシエチレン・メチルポリシロキサン共重合体、ラウリルPEG-9ポリジメチルシロキシエチルジメチコン、PEG-9ポリジメチルシロキシエチルジメチコンなどのシリコーン系界面活性剤等が挙げられる。 Surfactants may be nonionic surfactants, cationic surfactants, anionic surfactants, amphoteric surfactants, or the like.
Nonionic surfactants include sorbitan monoisostearate, sorbitan monolaurate, sorbitan monopalmitate, sorbitan monostearate, diglycerol sorbitan penta-2-ethylhexylate, diglycerol sorbitan tetra-2-ethylhexylate, and the like. sorbitan fatty acid esters; propylene glycol fatty acid esters such as propylene glycol monostearate; polyoxyethylene hydrogenated castor oil 40 (HCO-40), polyoxyethylene hydrogenated castor oil 50 (HCO-50), polyoxyethylene hydrogenated castor Hydrogenated castor oil derivatives such as oil 60 (HCO-60), polyoxyethylene hydrogenated castor oil 80; polyoxyethylene (20) sorbitan monolaurate (polysorbate 20), polyoxyethylene (20) sorbitan monostearate (polysorbate 60) ), polyoxyethylene sorbitan fatty acid esters such as polyoxyethylene (20) sorbitan monooleate (polysorbate 80), polyoxyethylene (20) sorbitan isostearate; polyoxyethylene monococonut oil fatty acid glyceryl; glycerin alkyl ether; stearin Glycerin fatty acid esters such as glyceryl acid, glyceryl myristate, glyceryl oleate, glyceryl isostearate, glyceryl stearate; polyglyceryl-2 oleate, polyglyceryl-2 stearate, polyglyceryl-10 oleate, polyglyceryl-10 stearate, lauric acid Polyglycerol fatty acid esters such as polyglyceryl-10, polyglyceryl-10 distearate, polyglyceryl-10 trioleate, polyglyceryl-10 pentaoleate, polyglyceryl-10 pentastearate; alkyl glucoside; polyoxyethylene stearyl ether, polyoxyethylene lauryl polyoxyalkylene alkyl ethers such as ethers, polyoxyethylene cetyl ethers, polyoxyethylene behenyl ethers and polyoxyethylene cetyl ethers; polyethylene glycol fatty acid esters such as polyethylene glycol monostearate; amines such as stearylamine and oleylamine; Silicone-based surfactants such as ethylene/methylpolysiloxane copolymer, lauryl PEG-9 polydimethylsiloxyethyl dimethicone, PEG-9 polydimethylsiloxyethyl dimethicone, and the like.
非イオン性界面活性剤としては、ソルビタンモノイソステアレート、ソルビタンモノラウレート、ソルビタンモノパルミテート、ソルビタンモノステアレート、ペンタ-2-エチルヘキシル酸ジグリセロールソルビタン、テトラ-2-エチルヘキシル酸ジグリセロールソルビタンなどのソルビタン脂肪酸エステル類;モノステアリン酸プロピレングリコールなどのプロピレングリコール脂肪酸エステル類;ポリオキシエチレン硬化ヒマシ油40(HCO-40)、ポリオキシエチレン硬化ヒマシ油50(HCO-50)、ポリオキシエチレン硬化ヒマシ油60(HCO-60)、ポリオキシエチレン硬化ヒマシ油80などの硬化ヒマシ油誘導体;モノラウリル酸ポリオキシエチレン(20)ソルビタン(ポリソルベート20)、モノステアリン酸ポリオキシエチレン(20)ソルビタン(ポリソルベート60)、モノオレイン酸ポリオキシエチレン(20)ソルビタン(ポリソルベート80)、イソステアリン酸ポリオキシエチレン(20)ソルビタンなどのポリオキシエチレンソルビタン脂肪酸エステル類;ポリオキシエチレンモノヤシ油脂肪酸グリセリル;グリセリンアルキルエーテル;ステアリン酸グリセリル、ミリスチン酸グリセリル、オレイン酸グリセリル、イソステアリン酸グリセリル、ステアリン酸グリセリンなどのグリセリン脂肪酸エステル;オレイン酸ポリグリセリル-2、ステアリン酸ポリグリセリル-2、オレイン酸ポリグリセリル-10、ステアリン酸ポリグリセリル-10、ラウリン酸ポリグリセリル-10、ジステアリン酸ポリグリセリル-10、トリオレイン酸ポリグリセリル-10、ペンタオレイン酸ポリグリセリル-10、ペンタステアリン酸ポリグリセリル-10などのポリグリセリン脂肪酸エステル;アルキルグルコシド;ポリオキシエチレンステアリルエーテル、ポリオキシエチレンラウリルエーテル、ポリオキシエチレンセチルエーテル、ポリオキシエチレンベヘニルエーテル、ポリオキシエチレンセチルエーテルなどのポリオキシアルキレンアルキルエーテル;モノステアリン酸ポリエチレングリコールなどのポリエチレングリコール脂肪酸エステル;ステアリルアミン、オレイルアミンなどのアミン類;ポリオキシエチレン・メチルポリシロキサン共重合体、ラウリルPEG-9ポリジメチルシロキシエチルジメチコン、PEG-9ポリジメチルシロキシエチルジメチコンなどのシリコーン系界面活性剤等が挙げられる。 Surfactants may be nonionic surfactants, cationic surfactants, anionic surfactants, amphoteric surfactants, or the like.
Nonionic surfactants include sorbitan monoisostearate, sorbitan monolaurate, sorbitan monopalmitate, sorbitan monostearate, diglycerol sorbitan penta-2-ethylhexylate, diglycerol sorbitan tetra-2-ethylhexylate, and the like. sorbitan fatty acid esters; propylene glycol fatty acid esters such as propylene glycol monostearate; polyoxyethylene hydrogenated castor oil 40 (HCO-40), polyoxyethylene hydrogenated castor oil 50 (HCO-50), polyoxyethylene hydrogenated castor Hydrogenated castor oil derivatives such as oil 60 (HCO-60), polyoxyethylene hydrogenated castor oil 80; polyoxyethylene (20) sorbitan monolaurate (polysorbate 20), polyoxyethylene (20) sorbitan monostearate (polysorbate 60) ), polyoxyethylene sorbitan fatty acid esters such as polyoxyethylene (20) sorbitan monooleate (polysorbate 80), polyoxyethylene (20) sorbitan isostearate; polyoxyethylene monococonut oil fatty acid glyceryl; glycerin alkyl ether; stearin Glycerin fatty acid esters such as glyceryl acid, glyceryl myristate, glyceryl oleate, glyceryl isostearate, glyceryl stearate; polyglyceryl-2 oleate, polyglyceryl-2 stearate, polyglyceryl-10 oleate, polyglyceryl-10 stearate, lauric acid Polyglycerol fatty acid esters such as polyglyceryl-10, polyglyceryl-10 distearate, polyglyceryl-10 trioleate, polyglyceryl-10 pentaoleate, polyglyceryl-10 pentastearate; alkyl glucoside; polyoxyethylene stearyl ether, polyoxyethylene lauryl polyoxyalkylene alkyl ethers such as ethers, polyoxyethylene cetyl ethers, polyoxyethylene behenyl ethers and polyoxyethylene cetyl ethers; polyethylene glycol fatty acid esters such as polyethylene glycol monostearate; amines such as stearylamine and oleylamine; Silicone-based surfactants such as ethylene/methylpolysiloxane copolymer, lauryl PEG-9 polydimethylsiloxyethyl dimethicone, PEG-9 polydimethylsiloxyethyl dimethicone, and the like.
保湿剤としては、例えば、ヒアルロン酸又はその塩又はその誘導体(例えば、ヒアルロン酸ナトリウム、ヒアルロン酸亜鉛、低分子ヒアルロン酸、アセチル化ヒアルロン酸、架橋型ヒアルロン酸誘導体、カチオン化ヒアルロン酸等);コンドロイチン硫酸又はその塩;ヘパリン類似物質、アラニン、セリン、アスパラギン酸、グリシン、アルギニンなどのアミノ酸及びその誘導体;グリセリン、ジプロピレングリコール、1,3-ブタンジオールなどの多価アルコール;ソルビトール、キシリトール、エリスリトール、マルトース・ショ糖縮合物(グルコオリゴ糖)、加水分解キシラン(キシロオリゴ糖)などの糖アルコール;PPG-17ブテス-17、PPG-25ソルビトール、ポリオキシアルキレンアルキルグルコシド、PEG/PPG/ポリブチレングリコール-8/5/3グリセリン、ポリオキシアルキレンジグリセリルなどのアルキレンオキシド;グリコシルトレハロース、トレハロース;セラミド、グルコシルセラミド、コレステロール、フィトステロール、コレステロール誘導体、フィトステロール誘導体、;リン脂質類;MPCポリマー;乳酸、乳酸ナトリウム、ピロリドンカルボン酸ナトリウム、尿素などのNMF由来成分;コラーゲン、エラスチン、ケラチン、キチン、キトサン等とそれらの加水分解物;ヒドロキシエチルウレア;植物(たとえば、アロエ、海藻、カッコン、クロレラ、レモングラス、カミツレ、ハマメリス、チャ、シソ、グレープフルーツ、アマチャヅルなど)に由来する成分等が挙げられる。
Moisturizing agents include, for example, hyaluronic acid, salts thereof, or derivatives thereof (e.g., sodium hyaluronate, zinc hyaluronate, low-molecular-weight hyaluronic acid, acetylated hyaluronic acid, crosslinked hyaluronic acid derivatives, cationized hyaluronic acid, etc.); chondroitin; Sulfuric acid or its salts; Amino acids such as heparinoids, alanine, serine, aspartic acid, glycine, arginine and derivatives thereof; Polyhydric alcohols such as glycerin, dipropylene glycol and 1,3-butanediol; Sorbitol, xylitol, erythritol, Sugar alcohols such as maltose/sucrose condensate (glucooligosaccharide), hydrolyzed xylan (xylo-oligosaccharide); /5/3 glycerin, alkylene oxides such as polyoxyalkylene diglyceryl; glycosyltrehalose, trehalose; ceramide, glucosylceramide, cholesterol, phytosterol, cholesterol derivatives, phytosterol derivatives; phospholipids; MPC polymers; lactic acid, sodium lactate, pyrrolidone NMF-derived components such as sodium carboxylate and urea; collagen, elastin, keratin, chitin, chitosan, etc. and their hydrolysates; hydroxyethyl urea; , tea, perilla, grapefruit, Gynostemma pentaphyllum, etc.).
多価アルコールとしては、ヒドロキシ基を2個以上有する低分子が挙げられ、例えば、グリセリン、ジグリセリン、トリグリセリン、1,3-プロピレングリコール、ジプロピレングリコール、1,4-ブタンジオール、エチレングリコール、ジエチレングリコール、イソプレングリコール、1、3-ブチレングリコール、1,4-プロパンジオール、1,2-ペンタンジオール、1,2-ヘキサンジオール、1,2-オクタンジオール、デカンジオール、ネオペンチルグリコール、ソルビトール、キシリトール、エリスリトール、マンニトール等が挙げられる。中でも顕著な発明の効果を奏する観点から1,3-プロピレングリコールが好ましい。組成物の全量に対する多価アルコール総量の濃度としては、5~50質量%、10~30質量%、15~20質量%が挙げられる。
Examples of polyhydric alcohols include low molecules having two or more hydroxy groups, such as glycerin, diglycerin, triglycerin, 1,3-propylene glycol, dipropylene glycol, 1,4-butanediol, ethylene glycol, Diethylene glycol, isoprene glycol, 1,3-butylene glycol, 1,4-propanediol, 1,2-pentanediol, 1,2-hexanediol, 1,2-octanediol, decanediol, neopentyl glycol, sorbitol, xylitol , erythritol, mannitol and the like. Among them, 1,3-propylene glycol is preferable from the viewpoint of exhibiting remarkable effects of the invention. The concentration of the total amount of polyhydric alcohol relative to the total amount of the composition includes 5 to 50% by mass, 10 to 30% by mass, and 15 to 20% by mass.
酸化防止剤としては、ジブチルヒドロキシトルエン、ブチルヒドロキシアニソール、p-ヒドロキシアニソール、ソルビン酸、亜硫酸ナトリウム、アスコルビン酸、アスコルビン酸誘導体(アスコルビン酸ステアリン酸エステル、アスコルビン酸パルミチン酸エステル、ジパルミチン酸アスコルビル、アスコルビン酸モノリン酸エステル、アスコルビン酸ジリン酸エステル、アスコルビン酸トリリン酸エステル、アスコルビン酸硫酸エステルなど)、トコフェロール、トコフェロール誘導体(酢酸トコフェロール、コハク酸トコフェロール、コハク酸トコフェロールカルシウムなど)、エリソルビン酸、L-システイン塩酸等が挙げられる。
Antioxidants include dibutylhydroxytoluene, butylhydroxyanisole, p-hydroxyanisole, sorbic acid, sodium sulfite, ascorbic acid, ascorbic acid derivatives (ascorbyl stearate, ascorbyl palmitate, ascorbyl dipalmitate, ascorbyl acid monophosphate, ascorbyl diphosphate, ascorbate triphosphate, ascorbate sulfate, etc.), tocopherol, tocopherol derivatives (tocopherol acetate, tocopherol succinate, tocopherol calcium succinate, etc.), erythorbic acid, L-cysteine hydrochloride etc.
増粘剤としては、ポリビニルアルコール、ポリビニルピロリドン、ポリビニルメチルエーテル、カルボキシビニルポリマー、アクリル酸アルキルコポリマー、アクリル酸メタクリル酸アルキル共重合体、ポリアクリル酸ナトリウム等のアクリル酸系増粘剤などのビニル系増粘剤、メチルセルロース、エチルセルロース、ヒドロキシエチルセルロース、ヒドロキシメチルセルロース、ヒドロキシプロピルセルロース、ヒドロキシプロピルメチルセルロース、カルボキシメチルセルロース、カルボキシエチルセルロース、疎水化ヒドロキシプロピルメチルセルロースなどのセルロース系増粘剤、ポリビニルアルコール、ポリビニルピロリドン、ポリビニルメチルエーテル、グァーガム、スクレロチウムガム、タマリンドガム、キサンタンガム、デキストラン、ペクチン、プルラン、ゼラチン、ローカストビーンガム、カラギーナン、寒天、ビオサッカリドガム、アクリル酸メタクリル酸アルキル共重合体、ポリアクリル酸ナトリウム、ベントナイト、デキストリン脂肪酸エステル、ジメチルジステアリルアンモニウムヘクトライト、アルギン酸ナトリウム、アルギン酸プロピレングリコールエステル、ポリエチレングリコール、マクロゴール、塩化トリメチルアンモニウムヒドロキシプロピルグァーガム、塩化トリメチルアンモニオヒドロキシプロピルヒドロキシエチルセルロース、(アクリル酸ヒドロキシエチル/アクリロイルジメチルタウリンNa)コポリマー、(アクリロイルジメチルタウリンアンモニウム/ビニルピロリドン)コポリマー等が挙げられる。中でも顕著な発明の効果を奏する観点からカルボキシビニルポリマーが好ましい。組成物の全量に対する増粘剤総量の濃度としては、0.01~0.8質量%、0.05~0.5質量%、0.1~0.2質量%が挙げられる。
Examples of thickeners include polyvinyl alcohol, polyvinyl pyrrolidone, polyvinyl methyl ether, carboxyvinyl polymer, alkyl acrylate copolymer, alkyl acrylate methacrylate copolymer, and vinyl-based thickeners such as sodium polyacrylate. Thickeners, cellulosic thickeners such as methyl cellulose, ethyl cellulose, hydroxyethyl cellulose, hydroxymethyl cellulose, hydroxypropyl cellulose, hydroxypropyl methyl cellulose, carboxymethyl cellulose, carboxyethyl cellulose, hydrophobized hydroxypropyl methyl cellulose, polyvinyl alcohol, polyvinyl pyrrolidone, polyvinyl methyl ether , guar gum, sclerotium gum, tamarind gum, xanthan gum, dextran, pectin, pullulan, gelatin, locust bean gum, carrageenan, agar, biosaccharide gum, alkyl acrylate methacrylate copolymer, sodium polyacrylate, bentonite, dextrin Fatty acid ester, dimethyldistearylammonium hectorite, sodium alginate, propylene glycol alginate, polyethylene glycol, macrogol, trimethylammonium chloride hydroxypropyl guar gum, trimethylammonio hydroxypropyl hydroxyethylcellulose chloride, (hydroxyethyl acrylate/acryloyldimethyltaurate Na ) copolymer, (acryloyldimethyltaurate ammonium/vinylpyrrolidone) copolymer, and the like. Among them, carboxyvinyl polymer is preferable from the viewpoint of exhibiting remarkable effects of the invention. The concentration of the total amount of thickening agent relative to the total amount of the composition may be 0.01 to 0.8% by mass, 0.05 to 0.5% by mass, and 0.1 to 0.2% by mass.
防腐剤又は保存剤としては、安息香酸、安息香酸ナトリウム、デヒドロ酢酸、デヒドロ酢酸ナトリウム、パラオキシ安息香酸イソブチル、パラオキシ安息香酸イソプロピル、パラオキシ安息香酸ブチル、パラオキシ安息香酸エチル、パラオキシ安息香酸プロピル、パラオキシ安息香酸ベンジル、パラオキシ安息香酸メチル、フェノキシエタノール、ベンジルアルコール、クロロブタノール、ソルビン酸及びその塩、グルコン酸クロルヘキシジン、アルカンジオール、グリセリン脂肪酸エステル等が挙げられる。
Antiseptics or preservatives include benzoic acid, sodium benzoate, dehydroacetic acid, sodium dehydroacetate, isobutyl parahydroxybenzoate, isopropyl parahydroxybenzoate, butyl parahydroxybenzoate, ethyl parahydroxybenzoate, propyl parahydroxybenzoate, parahydroxybenzoic acid. benzyl, methyl p-oxybenzoate, phenoxyethanol, benzyl alcohol, chlorobutanol, sorbic acid and its salts, chlorhexidine gluconate, alkanediols, glycerin fatty acid esters, and the like.
pH調整剤としては、無機酸(塩酸、硫酸など)、有機酸(乳酸、乳酸ナトリウム、クエン酸、クエン酸ナトリウム、コハク酸、コハク酸ナトリウムなど)、無機塩基(水酸化カリウム、水酸化ナトリウムなど)、有機塩基(トリエタノールアミン、ジイソプロパノールアミン、トリイソプロパノールアミン、アルギニン、グリシンなど)等が挙げられる。
Examples of pH adjusters include inorganic acids (hydrochloric acid, sulfuric acid, etc.), organic acids (lactic acid, sodium lactate, citric acid, sodium citrate, succinic acid, sodium succinate, etc.), inorganic bases (potassium hydroxide, sodium hydroxide, etc.). ), organic bases (triethanolamine, diisopropanolamine, triisopropanolamine, arginine, glycine, etc.), and the like.
キレート剤としては、エチレンジアミン4酢酸(エデト酸)、エチレンジアミン4酢酸塩(ナトリウム塩(エデト酸ナトリウム:日本薬局方、EDTA-2Naなど)、カリウム塩など)、フィチン酸、グルコン酸、ポリリン酸、メタリン酸等が挙げられる。
Chelating agents include ethylenediaminetetraacetic acid (edetic acid), ethylenediaminetetraacetate (sodium salt (edetate sodium: Japanese Pharmacopoeia, EDTA-2Na, etc.), potassium salt, etc.), phytic acid, gluconic acid, polyphosphoric acid, metalin acids and the like.
着色料としては、法定色素ハンドブック(日本化粧品工業連合会編(2004))に記載された色素等が挙げられる。
Examples of coloring agents include pigments listed in the legal pigment handbook (edited by the Japan Cosmetic Industry Association (2004)).
香料としては、ラベンダー油、ローズマリー油、クラリセージ油、タイム油、ベルガモット油、ユーカリ油等のハーブ系精油、ペパーミント油、スペアミント油、ハッカ油等のミント系精油、オレンジ油、レモン油、グレープフルーツ油などの柑橘系精油のような各種精油、調合香料等が挙げられる。
Fragrances include herbal essential oils such as lavender oil, rosemary oil, clary sage oil, thyme oil, bergamot oil, and eucalyptus oil; mint essential oils such as peppermint oil, spearmint oil, and peppermint oil; orange oil, lemon oil, and grapefruit oil. Various essential oils such as citrus essential oils such as, and compounded fragrances.
(生理活性又は薬理活性成分)
過酸化ベンゾイル、グリチルレチン酸類、アラントイン以外の生理活性又は薬理活性成分としては、抗炎症剤(グリチルレチン酸類、アラントイン以外)、鎮痒剤(抗ヒスタミン剤を含む)、局所麻酔剤、殺菌剤(過酸化ベンゾイル以外)、清涼化剤、ビタミン類、角質軟化成分(ケミカルピーリング成分)、収斂成分等が挙げられる。
中でも、抗炎症剤、抗アレルギー剤、抗菌剤、角質軟化成分、ビタミン類は、過酸化ベンゾイルとの併用が推奨される成分である。
過酸化ベンゾイル、グリチルレチン酸類、アラントイン以外の生理活性又は薬理活性成分は、1種又は2種以上を使用することができる。また、本発明の効果を損なわない範囲で使用できる。 (Bioactive or pharmacologically active ingredient)
Biologically active or pharmacologically active ingredients other than benzoyl peroxide, glycyrrhetinic acids, and allantoin include anti-inflammatory agents (other than glycyrrhetinic acids and allantoin), antipruritic agents (including antihistamines), local anesthetics, and disinfectants (other than benzoyl peroxide). , cooling agents, vitamins, keratin softening ingredients (chemical peeling ingredients), astringent ingredients, and the like.
Among them, anti-inflammatory agents, anti-allergic agents, antibacterial agents, keratin softening ingredients, and vitamins are ingredients that are recommended to be used in combination with benzoyl peroxide.
One or two or more physiologically active or pharmacologically active ingredients other than benzoyl peroxide, glycyrrhetinic acids, and allantoin can be used. Moreover, it can be used within a range that does not impair the effects of the present invention.
過酸化ベンゾイル、グリチルレチン酸類、アラントイン以外の生理活性又は薬理活性成分としては、抗炎症剤(グリチルレチン酸類、アラントイン以外)、鎮痒剤(抗ヒスタミン剤を含む)、局所麻酔剤、殺菌剤(過酸化ベンゾイル以外)、清涼化剤、ビタミン類、角質軟化成分(ケミカルピーリング成分)、収斂成分等が挙げられる。
中でも、抗炎症剤、抗アレルギー剤、抗菌剤、角質軟化成分、ビタミン類は、過酸化ベンゾイルとの併用が推奨される成分である。
過酸化ベンゾイル、グリチルレチン酸類、アラントイン以外の生理活性又は薬理活性成分は、1種又は2種以上を使用することができる。また、本発明の効果を損なわない範囲で使用できる。 (Bioactive or pharmacologically active ingredient)
Biologically active or pharmacologically active ingredients other than benzoyl peroxide, glycyrrhetinic acids, and allantoin include anti-inflammatory agents (other than glycyrrhetinic acids and allantoin), antipruritic agents (including antihistamines), local anesthetics, and disinfectants (other than benzoyl peroxide). , cooling agents, vitamins, keratin softening ingredients (chemical peeling ingredients), astringent ingredients, and the like.
Among them, anti-inflammatory agents, anti-allergic agents, antibacterial agents, keratin softening ingredients, and vitamins are ingredients that are recommended to be used in combination with benzoyl peroxide.
One or two or more physiologically active or pharmacologically active ingredients other than benzoyl peroxide, glycyrrhetinic acids, and allantoin can be used. Moreover, it can be used within a range that does not impair the effects of the present invention.
グリチルレチン酸類(グリチルレチン酸、その誘導体、それらの塩)、アラントイン以外の非ステロイド系抗炎症剤としては、ウフェナマート、ヘパリン類似物質、イプシロン-アミノカプロン酸、ベルベリン、アズレン、ブロメライン、酸化亜鉛;リゾチーム、セラペプターゼ、セミアルカリプロティナーゼなどの酵素系抗炎症剤イブプロフェンピコノール等が挙げられる。これらは塩であってもよい。
Glycyrrhetinic acids (glycyrrhetinic acid, derivatives thereof, salts thereof), non-steroidal anti-inflammatory agents other than allantoin, ufenamate, heparinoids, epsilon-aminocaproic acid, berberine, azulene, bromelain, zinc oxide; lysozyme, serrapeptase, Enzymatic anti-inflammatory agents such as semi-alkaline proteinase, ibuprofen piconol, and the like. These may be salts.
また、ステロイド系抗炎症剤としては、プレドニゾロン、ヒドロコルチゾン、コルチゾン、デキサメタゾン、トリアムシノロン、トリアムシノロンアセトニド、ジフルプレドナート、モメタゾン、ジフルコルトロン、フルオシノニド、ベクロメタゾン、デプロドン、アルクロメタゾン、フルメタゾン、アムシノニド、クロベタゾン、ジフロラゾン、及びこれらの誘導体等が挙げられる。
Steroidal anti-inflammatory agents include prednisolone, hydrocortisone, cortisone, dexamethasone, triamcinolone, triamcinolone acetonide, difluprednate, mometasone, diflucortolone, fluocinonide, beclomethasone, deprodone, alclomethasone, flumethasone, amcinonide, clobetasone, diflorazone, and derivatives thereof.
抗ヒスタミン剤としては、ジフェンヒドラミン、ジフェンヒドラミン塩酸塩、ブロモジフェンヒドラミン塩酸塩、クレマスチンフマル酸塩、クロルフェノキサミン塩酸塩、クロルフェニラミン、クロルフェニラミンマレイン酸塩、プロメタジン塩酸塩、セチリジン塩酸塩、メクリジン塩酸塩、ケトチフェンフマル酸塩、オロパタジン塩酸塩、フェキソフェナジン塩酸塩、アンタゾリン塩酸塩、アザタジンジマレイン酸塩、エピナスチン塩酸塩等が挙げられる。
Antihistamines include diphenhydramine, diphenhydramine hydrochloride, bromodiphenhydramine hydrochloride, clemastine fumarate, chlorphenoxamine hydrochloride, chlorpheniramine, chlorpheniramine maleate, promethazine hydrochloride, cetirizine hydrochloride, meclizine hydrochloride, ketotifen fumarate, olopatadine hydrochloride, fexofenadine hydrochloride, antazoline hydrochloride, azatadine dimaleate, epinastine hydrochloride and the like.
鎮痒剤としては、クロタミトン、イクタモール、モクタール等が挙げられる。
Antipruritic agents include crotamiton, ictamol, and moktar.
局所麻酔剤としては、リドカイン、リドカイン塩酸塩、ジブカイン塩酸塩、ベンゾカイン、ブピバカイン塩酸塩テトラカイン塩酸塩などが挙げられる。
Local anesthetics include lidocaine, lidocaine hydrochloride, dibucaine hydrochloride, benzocaine, bupivacaine hydrochloride, tetracaine hydrochloride, and the like.
過酸化ベンゾイル以外の殺菌剤としては、イソプロピルメチルフェノール、フェノキシエタノール、塩化ベンザルコニウム、塩化ベンゼトニウム、塩酸クロルへキシジン、グルコン酸クロルヘキシジン、塩化セチルピリジニウム、安息香酸ナトリウム、エタノール、クロロブタノール、ソルビン酸、ソルビン酸カリウム、デヒドロ酢酸ナトリウム、パラオキシ安息香酸メチル、パラオキシ安息香酸エチル、パラオキシ安息香酸プロピル、パラオキシ安息香酸ブチル、硫酸オキシキノリン、フェネチルアルコール、ベンジルアルコール、サリチル酸、クレゾール、トリクロサン等が挙げられる。
Bactericides other than benzoyl peroxide include isopropylmethylphenol, phenoxyethanol, benzalkonium chloride, benzethonium chloride, chlorhexidine hydrochloride, chlorhexidine gluconate, cetylpyridinium chloride, sodium benzoate, ethanol, chlorobutanol, sorbic acid, sorbin potassium salt, sodium dehydroacetate, methyl parahydroxybenzoate, ethyl parahydroxybenzoate, propyl parahydroxybenzoate, butyl parahydroxybenzoate, oxyquinoline sulfate, phenethyl alcohol, benzyl alcohol, salicylic acid, cresol, triclosan and the like.
清涼化剤としては、メントール、カンフル、ボルネオール、ゲラニオール、シネオール、アネトール、リモネン、オイゲノールのようなテルペン類(これらはd体、l体又はdl体のいずれでもよい。);ユーカリ油、ベルガモット油、ペパーミント油、クールミント油、スペアミント油、ウイキョウ油、ハッカ油、ケイヒ油、ローズ油、テレビン油などの精油等が挙げられる。
Cooling agents include terpenes such as menthol, camphor, borneol, geraniol, cineole, anethole, limonene, and eugenol (these may be d-, l-, or dl-forms); eucalyptus oil, bergamot oil, Essential oils such as peppermint oil, cool mint oil, spearmint oil, fennel oil, peppermint oil, cinnamon oil, rose oil and turpentine oil.
ビタミン類としては、レチノール、酢酸レチノール、パルミチン酸レチノール、プロピオン酸レチノール、リノール酸レチノールなどのレチノール誘導体、レチナール、レチノイン酸、レチノイン酸メチル、レチノイン酸エチル、レチノイン酸レチノール、d-δ-トコフェリルレチノエート、α-トコフェリルレチノエート、β-トコフェリルレチノエートなどのビタミンA類;β、δ-トコフェロール、ニコチン酸トコフェロール、酢酸dl-α-トコフェロール、リノール酸トコフェロール、(リノール酸/オレイン酸)トコフェロール、(アスコルビル/トコフェリル)リン酸カリウムなどのビタミンE類;リボフラビン、フラビンモノヌクレオチド、フラビンアデニンジヌクレオチド、リボフラビン酪酸エステル、リボフラビンテトラ酪酸エステル、リボフラビン5’-リン酸エステルナトリウム、リボフラビンテトラニコチン酸エステルなどのビタミンB2類;ニコチン酸メチル、ニコチン酸、ニコチン酸ベンジル、ニコチン酸アミドなどのニコチン酸類;ステアリン酸アスコルビル、イソステアリルアスコルビルリン酸2ナトリウム、ジパルミチン酸L-アスコルビル、テトライソパルミチン酸アスコルビル(テトラ2-ヘキシルデカン酸アスコルビル)、パルミチン酸アスコルビルリン酸3ナトリウム、アスコルビン酸、アスコルビン酸ナトリウム、デヒドロアスコルビン酸、アスコルビン酸リン酸エステルナトリウム、アスコルビン酸リン酸エステルマグネシウム、アスコルビン酸グルコシド、2-O-エチルアスコルビン酸、3-O-エチルアスコルビン酸、グリセリルアスコルビン酸、ビスグリセリルアスコルビン酸、アルキルグリセリルアスコルビン酸などのビタミンC類;メチルヘスペリジン、エルゴカルシフェロール、コレカルシフェロールなどのビタミンD類;フィロキノン、ファルノキノンなどのビタミンK類;チアミン、及びそれらの塩(例えば、ジベンゾイルチアミン塩酸塩、チアミン塩酸塩、チアミンニリン酸塩)などのビタミンB1類;塩酸ピリドキシン、酢酸ピリドキシン、塩酸ピリドキサール、5’-リン酸ピリドキサール、塩酸ピリドキサミンなどのビタミンB6類、シアノコバラミン、ヒドロキソコバラミン、デオキシアデノシルコバラミン等のビタミンB12類;葉酸、プテロイルグルタミン酸などの葉酸類;パントテン酸、パントテン酸カルシウム、パントテニルアルコール(パンテノール)、D-パンテテイン、D-パンテチン、補酵素A、パントテニルエチルエーテル、パンテテインスルホン酸カルシウムなどのパントテン酸類;ビオチン、ビオシチン等のビオチン類;その他、カルニチン、フェルラ酸、α-リポ酸、オロット酸、γ-オリザノール、ピロロキノリンキノン、ヘスペリジン、グルコシルヘルペリジン、ユビキノン、及びこれらの塩等のビタミン様作用因子等が挙げられる。
Vitamins include retinol, retinol acetate, retinol palmitate, retinol propionate, retinol derivatives such as retinol linoleate, retinal, retinoic acid, methyl retinoate, ethyl retinoate, retinol retinoate, d-δ-tocopheryl retino Vitamin A such as ate, α-tocopheryl retinoate, β-tocopheryl retinoate; , Vitamin E such as (ascorbyl/tocopheryl) potassium phosphate; riboflavin, flavin mononucleotide, flavin adenine dinucleotide, riboflavin butyrate, riboflavin tetrabutyrate, riboflavin 5'-phosphate sodium, riboflavin tetranicotinate, etc. of vitamin B2; nicotinic acids such as methyl nicotinate, nicotinic acid, benzyl nicotinate, and nicotinamide; Ascorbyl 2-hexyldecanoate), ascorbyl palmitate trisodium phosphate, ascorbic acid, sodium ascorbate, dehydroascorbic acid, sodium ascorbate phosphate, magnesium ascorbate phosphate, ascorbate glucoside, 2-O-ethyl ascorbine acid, 3-O-ethylascorbic acid, glyceryl ascorbic acid, bisglyceryl ascorbic acid, alkylglyceryl ascorbic acid and other vitamin Cs; methylhesperidin, ergocalciferol, cholecalciferol and other vitamin Ds; phylloquinone, farnoquinone and the like vitamin Ks; vitamin B1s such as thiamine and their salts (e.g., dibenzoylthiamine hydrochloride, thiamine hydrochloride, thiamine diphosphate); pyridoxine hydrochloride, pyridoxine acetate, pyridoxal hydrochloride, 5′-pyridoxal phosphate, vitamin B6 such as pyridoxamine hydrochloride; vitamin B12 such as cyanocobalamin, hydroxocobalamin, deoxyadenosylcobalamin; folic acid such as folic acid and pteroylglutamic acid; pantothenic acids such as pantethein, D-pantethine, coenzyme A, pantothenyl ethyl ether, calcium pantetheine sulfonate; biotins such as biotin and biocytin; vitamin-like agents such as oryzanol, pyrroloquinoline quinone, hesperidin, glucosylhelperidin, ubiquinone, and salts thereof;
中でも、ビタミンC類は抗酸化作用により炎症と炎症後の紅斑を抑えるため好ましく、ビタミンA類は角質化を防ぐため好ましく、ビタミンB2類、B6類は皮脂分泌を抑えるため好ましく、ビタミンE類は過酸化脂質の生成を抑え、血行を促進するため好ましい。
Among them, vitamin C is preferable because it suppresses inflammation and post-inflammatory erythema by its antioxidant effect, vitamin A is preferable because it prevents keratinization, vitamin B2 and B6 are preferable because it suppresses sebum secretion, and vitamin E is preferable. It is preferable because it suppresses the production of lipid peroxide and promotes blood circulation.
角質軟化成分としては、サリチル酸、サリチル酸誘導体(サリチル酸マクロゴール、サリチル酸エタノールなど)、グリコール酸、フルーツ酸、フィチン酸、イオウ、尿素、レゾルシン、フィチン酸、乳酸、乳酸塩、水酸化ナトリウム、水酸化カリウム等が挙げられる。
Keratin softening ingredients include salicylic acid, salicylic acid derivatives (macrogol salicylate, ethanol salicylate, etc.), glycolic acid, fruit acid, phytic acid, sulfur, urea, resorcinol, phytic acid, lactic acid, lactate, sodium hydroxide, potassium hydroxide. etc.
収斂成分としては、パラフェノールスルホン酸亜鉛、酸化亜鉛、メントール、及びエタノール等が挙げられる。
Astringent components include zinc paraphenolsulfonate, zinc oxide, menthol, and ethanol.
製剤形態
本発明の医薬外用組成物の製剤形態は特に限定されず、液剤、懸濁剤、乳剤、クリーム剤、乳剤性軟膏剤、ジェル剤(ゲル剤)、リニメント剤、ローション剤、フォーム剤、スプレー剤、エアゾール剤、ポンプフォーム剤、不織布等のシートに薬液を含浸させたシート剤、スティック剤などが挙げられる。
中でも、皮膚に塗り伸ばし易く、使用感が良い点で、ジェル剤(ゲル剤)、乳剤、クリーム剤が好ましい。
また、本発明の組成物は、滑らかであるため、スティックタイプのような塊状の製剤としても、スーッと延びて広い範囲に簡単に広げることができる。製剤が手に付かない点でスティックタイプの製剤は好ましい。
乳剤、クリーム剤、乳剤性軟膏剤などの乳化状態の剤型である場合は、水中油型又は油中水型の何れでも良いが、過剰な皮脂による毛包の閉塞がニキビの原因となっていることを考慮すると、水中油型が好ましい。 FORMULATION FORM The formulation form of the composition for external use of the present invention is not particularly limited. Examples include spray agents, aerosol agents, pump foam agents, sheet agents obtained by impregnating a sheet such as nonwoven fabric with a chemical liquid, and stick agents.
Among them, gel formulations (gel formulations), emulsion formulations, and cream formulations are preferable because they are easy to spread on the skin and have a good feeling in use.
In addition, since the composition of the present invention is smooth, it can be easily spread over a wide area even in the form of a bulky preparation such as a stick type. A stick-type formulation is preferable because the formulation does not stick to the hands.
In the case of emulsified formulations such as emulsions, creams and emulsion ointments, either oil-in-water type or water-in-oil type may be used. oil-in-water type is preferred.
本発明の医薬外用組成物の製剤形態は特に限定されず、液剤、懸濁剤、乳剤、クリーム剤、乳剤性軟膏剤、ジェル剤(ゲル剤)、リニメント剤、ローション剤、フォーム剤、スプレー剤、エアゾール剤、ポンプフォーム剤、不織布等のシートに薬液を含浸させたシート剤、スティック剤などが挙げられる。
中でも、皮膚に塗り伸ばし易く、使用感が良い点で、ジェル剤(ゲル剤)、乳剤、クリーム剤が好ましい。
また、本発明の組成物は、滑らかであるため、スティックタイプのような塊状の製剤としても、スーッと延びて広い範囲に簡単に広げることができる。製剤が手に付かない点でスティックタイプの製剤は好ましい。
乳剤、クリーム剤、乳剤性軟膏剤などの乳化状態の剤型である場合は、水中油型又は油中水型の何れでも良いが、過剰な皮脂による毛包の閉塞がニキビの原因となっていることを考慮すると、水中油型が好ましい。 FORMULATION FORM The formulation form of the composition for external use of the present invention is not particularly limited. Examples include spray agents, aerosol agents, pump foam agents, sheet agents obtained by impregnating a sheet such as nonwoven fabric with a chemical liquid, and stick agents.
Among them, gel formulations (gel formulations), emulsion formulations, and cream formulations are preferable because they are easy to spread on the skin and have a good feeling in use.
In addition, since the composition of the present invention is smooth, it can be easily spread over a wide area even in the form of a bulky preparation such as a stick type. A stick-type formulation is preferable because the formulation does not stick to the hands.
In the case of emulsified formulations such as emulsions, creams and emulsion ointments, either oil-in-water type or water-in-oil type may be used. oil-in-water type is preferred.
粘度
本発明の組成物の粘度は、10mPa・s~100Pa・sであることが好ましく、100mPa・s~100Pa・sであることがより好ましく、100mPa・s~50Pa・sであることがより好ましく、100mPa・s~10Pa・sであることがより好ましく、500mPa・s~5Pa・sであることがより好ましく、500mPa・s~3Pa・sであることがより好ましく、800mPa・s~3Pa・sであることがより好ましい。この範囲であれば、皮膚に塗布し易く、また吐出口が小さい容器からでも出し易い製剤になると共に、(B)成分の配合により経時的な粘度低下を十分に抑制することができる。
本発明において、粘度は、粘度計(TVB-15(M);東機産業)を用いて室温下で測定した値であり、具体的には実施例に記載の方法で測定した値である。 Viscosity The viscosity of the composition of the present invention is preferably 10 mPa·s to 100 Pa·s, more preferably 100 mPa·s to 100 Pa·s, and more preferably 100 mPa·s to 50 Pa·s. , more preferably 100 mPa s to 10 Pa s, more preferably 500 mPa s to 5 Pa s, more preferably 500 mPa s to 3 Pa s, and 800 mPa s to 3 Pa s. is more preferable. Within this range, the preparation can be easily applied to the skin and easily discharged from a container with a small discharge port, and the decrease in viscosity over time can be sufficiently suppressed by incorporating the component (B).
In the present invention, the viscosity is a value measured at room temperature using a viscometer (TVB-15 (M); Toki Sangyo), specifically a value measured by the method described in Examples.
本発明の組成物の粘度は、10mPa・s~100Pa・sであることが好ましく、100mPa・s~100Pa・sであることがより好ましく、100mPa・s~50Pa・sであることがより好ましく、100mPa・s~10Pa・sであることがより好ましく、500mPa・s~5Pa・sであることがより好ましく、500mPa・s~3Pa・sであることがより好ましく、800mPa・s~3Pa・sであることがより好ましい。この範囲であれば、皮膚に塗布し易く、また吐出口が小さい容器からでも出し易い製剤になると共に、(B)成分の配合により経時的な粘度低下を十分に抑制することができる。
本発明において、粘度は、粘度計(TVB-15(M);東機産業)を用いて室温下で測定した値であり、具体的には実施例に記載の方法で測定した値である。 Viscosity The viscosity of the composition of the present invention is preferably 10 mPa·s to 100 Pa·s, more preferably 100 mPa·s to 100 Pa·s, and more preferably 100 mPa·s to 50 Pa·s. , more preferably 100 mPa s to 10 Pa s, more preferably 500 mPa s to 5 Pa s, more preferably 500 mPa s to 3 Pa s, and 800 mPa s to 3 Pa s. is more preferable. Within this range, the preparation can be easily applied to the skin and easily discharged from a container with a small discharge port, and the decrease in viscosity over time can be sufficiently suppressed by incorporating the component (B).
In the present invention, the viscosity is a value measured at room temperature using a viscometer (TVB-15 (M); Toki Sangyo), specifically a value measured by the method described in Examples.
pH
本発明の医薬組成物のpHは、pH3~7.5とすることができ、pH3~7であることが好ましく、pH3~6.5であることがさらに好ましく、pH3.5~6であることがさらにより好ましく、pH3.8~5.5であることが特に好ましい。なお、このpHは、例えば、pH調整剤の使用により調整することができる。ただし、pH測定が不能又は困難な製剤形態については、この限りではない。 pH
The pH of the pharmaceutical composition of the present invention can be pH 3 to 7.5, preferably pH 3 to 7, more preferably pH 3 to 6.5, and pH 3.5 to 6. is even more preferred, and pH 3.8 to 5.5 is particularly preferred. This pH can be adjusted, for example, by using a pH adjuster. However, this does not apply to formulation forms for which pH measurement is impossible or difficult.
本発明の医薬組成物のpHは、pH3~7.5とすることができ、pH3~7であることが好ましく、pH3~6.5であることがさらに好ましく、pH3.5~6であることがさらにより好ましく、pH3.8~5.5であることが特に好ましい。なお、このpHは、例えば、pH調整剤の使用により調整することができる。ただし、pH測定が不能又は困難な製剤形態については、この限りではない。 pH
The pH of the pharmaceutical composition of the present invention can be pH 3 to 7.5, preferably pH 3 to 7, more preferably pH 3 to 6.5, and pH 3.5 to 6. is even more preferred, and pH 3.8 to 5.5 is particularly preferred. This pH can be adjusted, for example, by using a pH adjuster. However, this does not apply to formulation forms for which pH measurement is impossible or difficult.
使用方法
本発明の医薬外用組成物は、ニキビや吹き出物の治療又は改善のために使用することができる。ニキビの中でも尋常性ざ瘡が好ましい。また、グリチルレチン酸類、及びアラントインから選ばれる抗炎症剤を含むことから、過酸化ベンゾイルによる刺激を抑えながらニキビや吹き出物を治療又は改善するために使用することができる。
本発明の医薬外用組成物は、1日1~3回、1~2回、又は1回、患部に塗布すればよい。本発明の医薬外用組成物を塗布する際は、一つの目安として約0.5gを顔全体に塗布すればよい。
本発明の医薬外用組成物の適用部位としては、皮膚が好ましく、中でも顔(特に額、顎、頬、口まわり、鼻)、首元、背中の皮膚がより好ましい。 Method of use The external pharmaceutical composition of the present invention can be used for treating or improving acne and pimples. Among acnes, acne vulgaris is preferred. In addition, since it contains an anti-inflammatory agent selected from glycyrrhetinic acids and allantoin, it can be used to treat or improve acne and pimples while suppressing irritation caused by benzoyl peroxide.
The external pharmaceutical composition of the present invention may be applied to the affected area 1 to 3 times, 1 to 2 times, or once a day. When applying the topical pharmaceutical composition of the present invention, as a guideline, about 0.5 g may be applied to the entire face.
The external pharmaceutical composition of the present invention is preferably applied to the skin, and more preferably the skin of the face (especially forehead, chin, cheeks, around the mouth, nose), neck and back.
本発明の医薬外用組成物は、ニキビや吹き出物の治療又は改善のために使用することができる。ニキビの中でも尋常性ざ瘡が好ましい。また、グリチルレチン酸類、及びアラントインから選ばれる抗炎症剤を含むことから、過酸化ベンゾイルによる刺激を抑えながらニキビや吹き出物を治療又は改善するために使用することができる。
本発明の医薬外用組成物は、1日1~3回、1~2回、又は1回、患部に塗布すればよい。本発明の医薬外用組成物を塗布する際は、一つの目安として約0.5gを顔全体に塗布すればよい。
本発明の医薬外用組成物の適用部位としては、皮膚が好ましく、中でも顔(特に額、顎、頬、口まわり、鼻)、首元、背中の皮膚がより好ましい。 Method of use The external pharmaceutical composition of the present invention can be used for treating or improving acne and pimples. Among acnes, acne vulgaris is preferred. In addition, since it contains an anti-inflammatory agent selected from glycyrrhetinic acids and allantoin, it can be used to treat or improve acne and pimples while suppressing irritation caused by benzoyl peroxide.
The external pharmaceutical composition of the present invention may be applied to the affected area 1 to 3 times, 1 to 2 times, or once a day. When applying the topical pharmaceutical composition of the present invention, as a guideline, about 0.5 g may be applied to the entire face.
The external pharmaceutical composition of the present invention is preferably applied to the skin, and more preferably the skin of the face (especially forehead, chin, cheeks, around the mouth, nose), neck and back.
容器
本発明の医薬外用組成物を収容する容器としては、ボトルタイプ、チューブタイプ、ジャータイプ、ロールオンタイプ、スポイトタイプ、スプレータイプ、ディスペンサータイプ、スティックタイプ、パウチ袋、チアパックなどが挙げられる。
ロールオンタイプ、スポイトタイプ、スプレータイプ、ディスペンサータイプの容器は、内容物の一部が容器内に残ってしまったり、吐出口に詰まったりし易いが、本発明の組成物は、滑らかであるため、比較的硬い又は高粘度の製剤であっても、このような容器からスムースに出すことができる。 Container The container for containing the external pharmaceutical composition of the present invention includes bottle type, tube type, jar type, roll-on type, dropper type, spray type, dispenser type, stick type, pouch bag, chia pack and the like.
Roll-on type, dropper type, spray type, and dispenser type containers tend to leave part of the contents in the container or clog the discharge port, but the composition of the present invention is smooth, Even relatively hard or highly viscous formulations can flow smoothly from such containers.
本発明の医薬外用組成物を収容する容器としては、ボトルタイプ、チューブタイプ、ジャータイプ、ロールオンタイプ、スポイトタイプ、スプレータイプ、ディスペンサータイプ、スティックタイプ、パウチ袋、チアパックなどが挙げられる。
ロールオンタイプ、スポイトタイプ、スプレータイプ、ディスペンサータイプの容器は、内容物の一部が容器内に残ってしまったり、吐出口に詰まったりし易いが、本発明の組成物は、滑らかであるため、比較的硬い又は高粘度の製剤であっても、このような容器からスムースに出すことができる。 Container The container for containing the external pharmaceutical composition of the present invention includes bottle type, tube type, jar type, roll-on type, dropper type, spray type, dispenser type, stick type, pouch bag, chia pack and the like.
Roll-on type, dropper type, spray type, and dispenser type containers tend to leave part of the contents in the container or clog the discharge port, but the composition of the present invention is smooth, Even relatively hard or highly viscous formulations can flow smoothly from such containers.
本発明の医薬外用組成物を収容する容器の材質は特に限定されず、医薬品外用剤の容器として用いられるものであればよい。このような容器材質として、例えば、皮膚外用医薬組成物との接触面の一部又は全部、好ましくは全部が、ポリオレフィン樹脂、アクリル酸樹脂、ポリエステル、ポリカーボネート、フッ素樹脂、ポリ塩化ビニル、ポリアミド、ABS樹脂、AS樹脂、ポリアセタール、変性ポリフェニレンエーテル、ポリアリレート、ポリスルホン、ポリイミド、セルロースアセテート、アルミニウム、及びガラスからなる群より選ばれる少なくとも1種の材料で構成されている容器が挙げられる。
The material of the container containing the external pharmaceutical composition of the present invention is not particularly limited as long as it can be used as a container for external pharmaceutical preparations. Examples of such container materials include polyolefin resins, acrylic acid resins, polyesters, polycarbonates, fluororesins, polyvinyl chloride, polyamides, and ABS, which are partially or entirely, preferably entirely, in contact with the external pharmaceutical composition for skin. A container made of at least one material selected from the group consisting of resin, AS resin, polyacetal, modified polyphenylene ether, polyarylate, polysulfone, polyimide, cellulose acetate, aluminum, and glass.
製剤の扱いやすさや成型加工のしやすさの観点から、本実施形態に係る医薬外用組成物を充填する容器の材質としては、例えば、アルミニウム、ポリエチレン(PE)(高密度ポリエチレン(HDPE)、低密度ポリエチレン(LDPE)、超低密度ポリエチレン、直鎖状低密度ポリエチレン(LLDPE)、超高分子量ポリエチレン等を含む)、ポリプロピレン(PP)(アイソタクチックポリプロピレン、シンジオタクチックポリプロピレン、アタクチックポリプロピレン等を含む)、エチレン・プロピレンコポリマー、ポリメチルペンテン、ポリブテン-1、1,2-ポリブタジエン等のポリオレフィン樹脂、ポリエチレンテレフタレート、ポリブチレンテレフタレート、ポリエチレンナフタレート等のポリエステル樹脂が好ましく、ポリエチレン、ポリプロピレン、ポリエチレンテレフタレートがより好ましい。また、本実施形態に係る医薬外用医薬組成物を充填する容器の最内層(医薬外用組成物と接触する面)の材質としては、例えば、ポリエチレン(PE)(高密度ポリエチレン(HDPE)、低密度ポリエチレン(LDPE)、超低密度ポリエチレン、直鎖状低密度ポリエチレン(LLDPE)、ポリプロピレン、アルミニウムが好ましい。
容器材料は、1種又は2種以上を使用できる。2種以上を使用する場合には、2種以上の材料を混合する場合、2種以上の互いに異なる材料を含む層を積層する場合、容器の異なる部分(収容部、蓋、ノズルなど)がそれぞれ異なる材料を含む場合が含まれる。 From the viewpoint of ease of handling of the formulation and ease of molding, for example, aluminum, polyethylene (PE) (high density polyethylene (HDPE), low density polyethylene (LDPE), ultra-low density polyethylene, linear low-density polyethylene (LLDPE), ultra-high molecular weight polyethylene, etc.), polypropylene (PP) (isotactic polypropylene, syndiotactic polypropylene, atactic polypropylene, etc.) ), polyolefin resins such as ethylene/propylene copolymer, polymethylpentene, polybutene-1,1,2-polybutadiene, polyester resins such as polyethylene terephthalate, polybutylene terephthalate, and polyethylene naphthalate are preferred, and polyethylene, polypropylene, and polyethylene terephthalate are preferred. more preferred. In addition, as the material of the innermost layer (surface in contact with the external pharmaceutical composition) of the container filled with the external pharmaceutical composition according to the present embodiment, for example, polyethylene (PE) (high density polyethylene (HDPE), low density Polyethylene (LDPE), ultra low density polyethylene, linear low density polyethylene (LLDPE), polypropylene, aluminum are preferred.
One or more container materials can be used. When two or more materials are used, when two or more materials are mixed, when layers containing two or more different materials are laminated, different parts of the container (receiving part, lid, nozzle, etc.) This includes cases where different materials are included.
容器材料は、1種又は2種以上を使用できる。2種以上を使用する場合には、2種以上の材料を混合する場合、2種以上の互いに異なる材料を含む層を積層する場合、容器の異なる部分(収容部、蓋、ノズルなど)がそれぞれ異なる材料を含む場合が含まれる。 From the viewpoint of ease of handling of the formulation and ease of molding, for example, aluminum, polyethylene (PE) (high density polyethylene (HDPE), low density polyethylene (LDPE), ultra-low density polyethylene, linear low-density polyethylene (LLDPE), ultra-high molecular weight polyethylene, etc.), polypropylene (PP) (isotactic polypropylene, syndiotactic polypropylene, atactic polypropylene, etc.) ), polyolefin resins such as ethylene/propylene copolymer, polymethylpentene, polybutene-1,1,2-polybutadiene, polyester resins such as polyethylene terephthalate, polybutylene terephthalate, and polyethylene naphthalate are preferred, and polyethylene, polypropylene, and polyethylene terephthalate are preferred. more preferred. In addition, as the material of the innermost layer (surface in contact with the external pharmaceutical composition) of the container filled with the external pharmaceutical composition according to the present embodiment, for example, polyethylene (PE) (high density polyethylene (HDPE), low density Polyethylene (LDPE), ultra low density polyethylene, linear low density polyethylene (LLDPE), polypropylene, aluminum are preferred.
One or more container materials can be used. When two or more materials are used, when two or more materials are mixed, when layers containing two or more different materials are laminated, different parts of the container (receiving part, lid, nozzle, etc.) This includes cases where different materials are included.
粘度低下の抑制方法
本発明は、(A)過酸化ベンゾイルを含有する医薬外用組成物に、(B)(B1)グリチルレチン酸、その誘導体、及び/若しくはそれらの塩、及び(B2)アラントインから選ばれる少なくとも1種の成分を含ませる、医薬外用組成物の経時的粘度低下の抑制方法を包含する。
各成分の種類及び含有量、組成物の性状などは本発明の医薬外用組成物について説明した通りである。 Method for Suppressing Decrease in Viscosity In the present invention, (A) a topical pharmaceutical composition containing benzoyl peroxide is selected from (B) (B1) glycyrrhetinic acid, derivatives thereof, and/or salts thereof, and (B2) allantoin. It includes a method for suppressing a decrease in viscosity over time of a composition for external use, comprising at least one component of the composition for external use.
The type and content of each component, the properties of the composition, etc. are as described for the topical pharmaceutical composition of the present invention.
本発明は、(A)過酸化ベンゾイルを含有する医薬外用組成物に、(B)(B1)グリチルレチン酸、その誘導体、及び/若しくはそれらの塩、及び(B2)アラントインから選ばれる少なくとも1種の成分を含ませる、医薬外用組成物の経時的粘度低下の抑制方法を包含する。
各成分の種類及び含有量、組成物の性状などは本発明の医薬外用組成物について説明した通りである。 Method for Suppressing Decrease in Viscosity In the present invention, (A) a topical pharmaceutical composition containing benzoyl peroxide is selected from (B) (B1) glycyrrhetinic acid, derivatives thereof, and/or salts thereof, and (B2) allantoin. It includes a method for suppressing a decrease in viscosity over time of a composition for external use, comprising at least one component of the composition for external use.
The type and content of each component, the properties of the composition, etc. are as described for the topical pharmaceutical composition of the present invention.
動摩擦係数の低下方法
本発明は、(A)過酸化ベンゾイルを含有する医薬外用組成物に、(B)(B1)グリチルレチン酸、その誘導体、及び/若しくはそれらの塩、及び(B2)アラントインから選ばれる少なくとも1種の成分を含ませる、医薬外用組成物の動摩擦係数(特に、皮膚との間の動摩擦係数)の低下方法を包含する。
各成分の種類及び含有量、組成物の性状などは本発明の医薬外用組成物について説明した通りである。
本発明の医薬外用組成物は、塗布時の皮膚との摩擦が小さく、滑らかに塗り広げることができるため、塗り残しや必要以上の塗布といった事態を避けることができる。滑らかに塗り広げることができることは、軋みが少ない、引っ掛かりが少ない、或いはべたつきが少ないことを含む。 Method for lowering dynamic friction coefficient The present invention provides (A) a topical pharmaceutical composition containing benzoyl peroxide, (B) (B1) glycyrrhetinic acid, derivatives thereof, and/or salts thereof, and (B2) allantoin. A method for reducing the dynamic friction coefficient (particularly, the dynamic friction coefficient between the skin) of an external pharmaceutical composition containing at least one component.
The type and content of each component, the properties of the composition, etc. are as described for the topical pharmaceutical composition of the present invention.
The topical pharmaceutical composition of the present invention has little friction with the skin during application and can be spread smoothly, thus avoiding situations such as unapplied or excessive application. Ability to spread smoothly includes less squeaking, less snagging, or less stickiness.
本発明は、(A)過酸化ベンゾイルを含有する医薬外用組成物に、(B)(B1)グリチルレチン酸、その誘導体、及び/若しくはそれらの塩、及び(B2)アラントインから選ばれる少なくとも1種の成分を含ませる、医薬外用組成物の動摩擦係数(特に、皮膚との間の動摩擦係数)の低下方法を包含する。
各成分の種類及び含有量、組成物の性状などは本発明の医薬外用組成物について説明した通りである。
本発明の医薬外用組成物は、塗布時の皮膚との摩擦が小さく、滑らかに塗り広げることができるため、塗り残しや必要以上の塗布といった事態を避けることができる。滑らかに塗り広げることができることは、軋みが少ない、引っ掛かりが少ない、或いはべたつきが少ないことを含む。 Method for lowering dynamic friction coefficient The present invention provides (A) a topical pharmaceutical composition containing benzoyl peroxide, (B) (B1) glycyrrhetinic acid, derivatives thereof, and/or salts thereof, and (B2) allantoin. A method for reducing the dynamic friction coefficient (particularly, the dynamic friction coefficient between the skin) of an external pharmaceutical composition containing at least one component.
The type and content of each component, the properties of the composition, etc. are as described for the topical pharmaceutical composition of the present invention.
The topical pharmaceutical composition of the present invention has little friction with the skin during application and can be spread smoothly, thus avoiding situations such as unapplied or excessive application. Ability to spread smoothly includes less squeaking, less snagging, or less stickiness.
以下、実施例を挙げて、本発明をより詳細に説明するが、本発明はこれらに限定されない。
(1)医薬外用組成物の調製
表1の組成になるように医薬外用組成物を調製した。
先ず、カルボキシビニルポリマーを水中に分散させた。グリチルリチン酸ジカリウムやアラントインを配合する場合は、あらかじめ添加した。これにトリエタノールアミン水溶液を加え中和した。この混合液を1,3ープロピレングリコール中に分散させ、最後に過酸化ベンゾイル水和物を加えた。
得られた組成物の剤型はジェル剤である。
EXAMPLES The present invention will be described in more detail below with reference to Examples, but the present invention is not limited to these.
(1) Preparation of a composition for external use A composition for external use was prepared so as to have the composition shown in Table 1.
First, the carboxyvinyl polymer was dispersed in water. When dipotassium glycyrrhizinate or allantoin was added, it was added in advance. An aqueous solution of triethanolamine was added to this to neutralize it. This mixture was dispersed in 1,3-propylene glycol and finally benzoyl peroxide hydrate was added.
The dosage form of the resulting composition is a gel.
(1)医薬外用組成物の調製
表1の組成になるように医薬外用組成物を調製した。
先ず、カルボキシビニルポリマーを水中に分散させた。グリチルリチン酸ジカリウムやアラントインを配合する場合は、あらかじめ添加した。これにトリエタノールアミン水溶液を加え中和した。この混合液を1,3ープロピレングリコール中に分散させ、最後に過酸化ベンゾイル水和物を加えた。
得られた組成物の剤型はジェル剤である。
(1) Preparation of a composition for external use A composition for external use was prepared so as to have the composition shown in Table 1.
First, the carboxyvinyl polymer was dispersed in water. When dipotassium glycyrrhizinate or allantoin was added, it was added in advance. An aqueous solution of triethanolamine was added to this to neutralize it. This mixture was dispersed in 1,3-propylene glycol and finally benzoyl peroxide hydrate was added.
The dosage form of the resulting composition is a gel.
(2)粘度低下抑制効果の評価
各例の組成物を50ml容量のガラス製ねじ口瓶に入れ、蓋を閉めて40℃で7日間静置した。
静置前後の各組成物の粘度を、ガラス製ねじ口瓶に入れた状態で、室温下で、粘度計(TVB-15(M);東機産業)を用いて測定した。
参考例1、比較例1、2、実施例1の各組成物は、M4ローターを使用し、回転数3rpm、60秒で測定し、比較例3、4、実施例2、3の各組成物は、M2ローターを使用し、回転数12rpm、60秒で測定した。被験試料の粘度に応じて適切なローターと回転数を選択することは通常行われており、また、40℃で7日間の静置前後で同じローターと回転数を採用したため、粘度比への影響はない。
40℃で7日間静置する前の粘度に対する静置後の粘度の比率(静置後の粘度/静置前の粘度)を算出した。この値が大きいほど、経時的に粘度低下し難いことを示す。 (2) Evaluation of Viscosity Decrease Suppressing Effect The composition of each example was placed in a 50 ml glass screw-capped bottle, closed with a lid, and allowed to stand at 40° C. for 7 days.
The viscosity of each composition before and after standing was measured in a glass screw-capped bottle at room temperature using a viscometer (TVB-15 (M); Toki Sangyo).
The compositions of Reference Example 1, Comparative Examples 1 and 2, and Example 1 were measured using an M4 rotor at a rotation speed of 3 rpm for 60 seconds. was measured at 12 rpm for 60 seconds using an M2 rotor. It is normal to select an appropriate rotor and rotation speed according to the viscosity of the test sample, and the same rotor and rotation speed were adopted before and after standing at 40 ° C for 7 days, so the effect on the viscosity ratio no.
The ratio of the viscosity after standing to the viscosity before standing at 40° C. for 7 days (viscosity after standing/viscosity before standing) was calculated. A larger value indicates that the viscosity is less likely to decrease over time.
各例の組成物を50ml容量のガラス製ねじ口瓶に入れ、蓋を閉めて40℃で7日間静置した。
静置前後の各組成物の粘度を、ガラス製ねじ口瓶に入れた状態で、室温下で、粘度計(TVB-15(M);東機産業)を用いて測定した。
参考例1、比較例1、2、実施例1の各組成物は、M4ローターを使用し、回転数3rpm、60秒で測定し、比較例3、4、実施例2、3の各組成物は、M2ローターを使用し、回転数12rpm、60秒で測定した。被験試料の粘度に応じて適切なローターと回転数を選択することは通常行われており、また、40℃で7日間の静置前後で同じローターと回転数を採用したため、粘度比への影響はない。
40℃で7日間静置する前の粘度に対する静置後の粘度の比率(静置後の粘度/静置前の粘度)を算出した。この値が大きいほど、経時的に粘度低下し難いことを示す。 (2) Evaluation of Viscosity Decrease Suppressing Effect The composition of each example was placed in a 50 ml glass screw-capped bottle, closed with a lid, and allowed to stand at 40° C. for 7 days.
The viscosity of each composition before and after standing was measured in a glass screw-capped bottle at room temperature using a viscometer (TVB-15 (M); Toki Sangyo).
The compositions of Reference Example 1, Comparative Examples 1 and 2, and Example 1 were measured using an M4 rotor at a rotation speed of 3 rpm for 60 seconds. was measured at 12 rpm for 60 seconds using an M2 rotor. It is normal to select an appropriate rotor and rotation speed according to the viscosity of the test sample, and the same rotor and rotation speed were adopted before and after standing at 40 ° C for 7 days, so the effect on the viscosity ratio no.
The ratio of the viscosity after standing to the viscosity before standing at 40° C. for 7 days (viscosity after standing/viscosity before standing) was calculated. A larger value indicates that the viscosity is less likely to decrease over time.
結果を表1に示す。
過酸化ベンゾイルを含まない基剤のみの組成物(参考例1)に過酸化ベンゾイルを配合することで(比較例1)、粘度比は低下した。そこに、アラントイン(実施例1)又はグリチルリチン酸ジカリウム(実施例2)を配合することで、粘度比の回復が認められた。また、アラントインとグリチルリチン酸ジカリウムの両方を配合した場合は(実施例3)、粘度比が顕著に回復した。
一方、過酸化ベンゾイルを含まない基剤のみの組成物(参考例1)に、アラントイン(比較例2)、グリチルリチン酸ジカリウム(比較例3)、又はアラントインとグリチルリチン酸ジカリウムの両方(比較例4)を配合した場合は、粘度比はほぼ変化しなかった。アラントインとグリチルリチン酸ジカリウム自体には、粘度を増大させる作用はないことが示された。
従って、アラントインとグリチルリチン酸ジカリウムは、過酸化ベンゾイルの配合による経時的な粘度低下を抑制する作用を有すること、即ち、過酸化ベンゾイルとの組み合わせにおいて粘度低下抑制作用を有することが明らかになった。
アラントインとグリチルリチン酸ジカリウムの両方を配合することによりこの作用は一層顕著になった。
なお、実施例1、2、3の各組成物の40℃・7日静置前の粘度は、それぞれ1060mPa・s、1034mPa・s、1050mPa・sであった。 Table 1 shows the results.
By blending benzoyl peroxide (Comparative Example 1) with a composition containing only a base that does not contain benzoyl peroxide (Reference Example 1), the viscosity ratio decreased. By adding allantoin (Example 1) or dipotassium glycyrrhizinate (Example 2) there, recovery of the viscosity ratio was observed. Moreover, when both allantoin and dipotassium glycyrrhizinate were blended (Example 3), the viscosity ratio was remarkably recovered.
On the other hand, allantoin (Comparative Example 2), dipotassium glycyrrhizinate (Comparative Example 3), or both allantoin and dipotassium glycyrrhizinate (Comparative Example 4) were added to a composition containing only a base not containing benzoyl peroxide (Reference Example 1). was blended, the viscosity ratio remained almost unchanged. It was shown that allantoin and dipotassium glycyrrhizinate themselves have no effect of increasing viscosity.
Therefore, it was revealed that allantoin and dipotassium glycyrrhizinate have the effect of suppressing viscosity decrease over time due to the addition of benzoyl peroxide, that is, they have the effect of suppressing viscosity decrease in combination with benzoyl peroxide.
This effect became even more remarkable by blending both allantoin and dipotassium glycyrrhizinate.
The viscosities of the compositions of Examples 1, 2, and 3 before standing at 40° C. for 7 days were 1,060 mPa·s, 1,034 mPa·s, and 1,050 mPa·s, respectively.
過酸化ベンゾイルを含まない基剤のみの組成物(参考例1)に過酸化ベンゾイルを配合することで(比較例1)、粘度比は低下した。そこに、アラントイン(実施例1)又はグリチルリチン酸ジカリウム(実施例2)を配合することで、粘度比の回復が認められた。また、アラントインとグリチルリチン酸ジカリウムの両方を配合した場合は(実施例3)、粘度比が顕著に回復した。
一方、過酸化ベンゾイルを含まない基剤のみの組成物(参考例1)に、アラントイン(比較例2)、グリチルリチン酸ジカリウム(比較例3)、又はアラントインとグリチルリチン酸ジカリウムの両方(比較例4)を配合した場合は、粘度比はほぼ変化しなかった。アラントインとグリチルリチン酸ジカリウム自体には、粘度を増大させる作用はないことが示された。
従って、アラントインとグリチルリチン酸ジカリウムは、過酸化ベンゾイルの配合による経時的な粘度低下を抑制する作用を有すること、即ち、過酸化ベンゾイルとの組み合わせにおいて粘度低下抑制作用を有することが明らかになった。
アラントインとグリチルリチン酸ジカリウムの両方を配合することによりこの作用は一層顕著になった。
なお、実施例1、2、3の各組成物の40℃・7日静置前の粘度は、それぞれ1060mPa・s、1034mPa・s、1050mPa・sであった。 Table 1 shows the results.
By blending benzoyl peroxide (Comparative Example 1) with a composition containing only a base that does not contain benzoyl peroxide (Reference Example 1), the viscosity ratio decreased. By adding allantoin (Example 1) or dipotassium glycyrrhizinate (Example 2) there, recovery of the viscosity ratio was observed. Moreover, when both allantoin and dipotassium glycyrrhizinate were blended (Example 3), the viscosity ratio was remarkably recovered.
On the other hand, allantoin (Comparative Example 2), dipotassium glycyrrhizinate (Comparative Example 3), or both allantoin and dipotassium glycyrrhizinate (Comparative Example 4) were added to a composition containing only a base not containing benzoyl peroxide (Reference Example 1). was blended, the viscosity ratio remained almost unchanged. It was shown that allantoin and dipotassium glycyrrhizinate themselves have no effect of increasing viscosity.
Therefore, it was revealed that allantoin and dipotassium glycyrrhizinate have the effect of suppressing viscosity decrease over time due to the addition of benzoyl peroxide, that is, they have the effect of suppressing viscosity decrease in combination with benzoyl peroxide.
This effect became even more remarkable by blending both allantoin and dipotassium glycyrrhizinate.
The viscosities of the compositions of Examples 1, 2, and 3 before standing at 40° C. for 7 days were 1,060 mPa·s, 1,034 mPa·s, and 1,050 mPa·s, respectively.
(3)皮膚への塗布時の摩擦の評価
各例の組成物について、下記方法で動摩擦係数を測定した。
人工皮革を移動台の上に固定し、2cm×5cmの範囲に印をつけて測定部位とした。静・動摩擦測定機(TL201Sa;トリニティーラボ)を用いて、荷重50g、2mm/secの速さで接触子(接触面1cm×1cm)を3cm移動させた時の動的摩擦係数を測定した。続いて測定部位に各組成物を約45mg塗布し、1分放置後、同様にして動摩擦係数を測定した。
各組成物を塗布する前の動摩擦係数に対する塗布後の動摩擦係数の比率(塗布後の動摩擦係数/塗布前の動摩擦係数)を算出した。3回測定し、平均値を求めた。この値が小さいほど、組成物の塗布行為中の皮膚との間の滑りが良くなることを示す。 (3) Evaluation of friction during application to skin The dynamic friction coefficient of each composition was measured by the following method.
The artificial leather was fixed on a moving table, and a 2 cm x 5 cm area was marked as a measurement site. Using a static/dynamic friction measuring machine (TL201Sa; Trinity Lab), the dynamic friction coefficient was measured when the contactor (contact surface 1 cm x 1 cm) was moved 3 cm at a speed of 2 mm/sec under a load of 50 g. Subsequently, about 45 mg of each composition was applied to the measurement site, left for 1 minute, and then the dynamic friction coefficient was measured in the same manner.
The ratio of the dynamic friction coefficient after application to the dynamic friction coefficient before application of each composition (dynamic friction coefficient after application/dynamic friction coefficient before application) was calculated. It measured 3 times and calculated the average value. The smaller this value, the better the slip between the composition and the skin during the act of application.
各例の組成物について、下記方法で動摩擦係数を測定した。
人工皮革を移動台の上に固定し、2cm×5cmの範囲に印をつけて測定部位とした。静・動摩擦測定機(TL201Sa;トリニティーラボ)を用いて、荷重50g、2mm/secの速さで接触子(接触面1cm×1cm)を3cm移動させた時の動的摩擦係数を測定した。続いて測定部位に各組成物を約45mg塗布し、1分放置後、同様にして動摩擦係数を測定した。
各組成物を塗布する前の動摩擦係数に対する塗布後の動摩擦係数の比率(塗布後の動摩擦係数/塗布前の動摩擦係数)を算出した。3回測定し、平均値を求めた。この値が小さいほど、組成物の塗布行為中の皮膚との間の滑りが良くなることを示す。 (3) Evaluation of friction during application to skin The dynamic friction coefficient of each composition was measured by the following method.
The artificial leather was fixed on a moving table, and a 2 cm x 5 cm area was marked as a measurement site. Using a static/dynamic friction measuring machine (TL201Sa; Trinity Lab), the dynamic friction coefficient was measured when the contactor (contact surface 1 cm x 1 cm) was moved 3 cm at a speed of 2 mm/sec under a load of 50 g. Subsequently, about 45 mg of each composition was applied to the measurement site, left for 1 minute, and then the dynamic friction coefficient was measured in the same manner.
The ratio of the dynamic friction coefficient after application to the dynamic friction coefficient before application of each composition (dynamic friction coefficient after application/dynamic friction coefficient before application) was calculated. It measured 3 times and calculated the average value. The smaller this value, the better the slip between the composition and the skin during the act of application.
結果を表1に示す。
過酸化ベンゾイルと基剤を含む組成物に(比較例1)、アラントイン(実施例1)又はグリチルリチン酸ジカリウム(実施例2)を配合することで、動摩擦係数比は小さくなり、アラントインとグリチルリチン酸ジカリウムの両方を配合した場合は(実施例3)、動摩擦係数比は顕著に小さくなった。
従って、アラントイン又はグリチルリチン酸ジカリウムを過酸化ベンゾイルと組み合わせて配合することにより、皮膚との間の滑りが良くなることが明らかになった。アラントインとグリチルリチン酸ジカリウムの両方を配合することによりこの効果は一層顕著になった。 Table 1 shows the results.
By adding allantoin (Example 1) or dipotassium glycyrrhizinate (Example 2) to a composition containing benzoyl peroxide and a base (Comparative Example 1), the dynamic friction coefficient ratio was reduced, and allantoin and dipotassium glycyrrhizinate were mixed. (Example 3), the dynamic friction coefficient ratio was remarkably reduced.
Therefore, it was clarified that blending allantoin or dipotassium glycyrrhizinate in combination with benzoyl peroxide improves slipping on the skin. This effect became more pronounced by blending both allantoin and dipotassium glycyrrhizinate.
過酸化ベンゾイルと基剤を含む組成物に(比較例1)、アラントイン(実施例1)又はグリチルリチン酸ジカリウム(実施例2)を配合することで、動摩擦係数比は小さくなり、アラントインとグリチルリチン酸ジカリウムの両方を配合した場合は(実施例3)、動摩擦係数比は顕著に小さくなった。
従って、アラントイン又はグリチルリチン酸ジカリウムを過酸化ベンゾイルと組み合わせて配合することにより、皮膚との間の滑りが良くなることが明らかになった。アラントインとグリチルリチン酸ジカリウムの両方を配合することによりこの効果は一層顕著になった。 Table 1 shows the results.
By adding allantoin (Example 1) or dipotassium glycyrrhizinate (Example 2) to a composition containing benzoyl peroxide and a base (Comparative Example 1), the dynamic friction coefficient ratio was reduced, and allantoin and dipotassium glycyrrhizinate were mixed. (Example 3), the dynamic friction coefficient ratio was remarkably reduced.
Therefore, it was clarified that blending allantoin or dipotassium glycyrrhizinate in combination with benzoyl peroxide improves slipping on the skin. This effect became more pronounced by blending both allantoin and dipotassium glycyrrhizinate.
本発明の医薬外用組成物の処方例を以下に示す。単位は質量%である。
処方例1(ジェル)
過酸化ベンゾイル 5
グリチルリチン酸ジカリウム 1
アラントイン 0.1
グリセリン 5
プロピレングリコール 10
カルボキシビニルポリマー 1
EDTA二ナトリウム 0.05
香料 0.05
メチルパラベン 0.1
クエン酸ナトリウム 0.05
水酸化ナトリウム 適量
キサンタンガム 0.1
水 残量
計 100 Formulation examples of the external pharmaceutical composition of the present invention are shown below. The unit is % by mass.
Formulation example 1 (gel)
Benzoyl peroxide 5
Dipotassium glycyrrhizinate 1
Allantoin 0.1
Glycerin 5
Propylene glycol 10
Carboxyvinyl polymer 1
EDTA disodium 0.05
Perfume 0.05
Methylparaben 0.1
Sodium citrate 0.05
Sodium hydroxide appropriate amount Xanthan gum 0.1
Water remaining gauge 100
処方例1(ジェル)
過酸化ベンゾイル 5
グリチルリチン酸ジカリウム 1
アラントイン 0.1
グリセリン 5
プロピレングリコール 10
カルボキシビニルポリマー 1
EDTA二ナトリウム 0.05
香料 0.05
メチルパラベン 0.1
クエン酸ナトリウム 0.05
水酸化ナトリウム 適量
キサンタンガム 0.1
水 残量
計 100 Formulation examples of the external pharmaceutical composition of the present invention are shown below. The unit is % by mass.
Formulation example 1 (gel)
Benzoyl peroxide 5
Dipotassium glycyrrhizinate 1
Allantoin 0.1
Glycerin 5
Propylene glycol 10
Carboxyvinyl polymer 1
EDTA disodium 0.05
Perfume 0.05
Methylparaben 0.1
Sodium citrate 0.05
Sodium hydroxide appropriate amount Xanthan gum 0.1
Water remaining gauge 100
処方例2(水中油型クリーム)
過酸化ベンゾイル 2.5
グリチルリチン酸ジカリウム 0.5
アラントイン 0.2
プロピレングリコール 8
自己乳化型モノステアリン酸グリセリン 8 8
ステアリルアルコール 3
ミリスチン酸イソプロピル 5
メチルパラベン 0.1
カルボキシビニルポリマー 1
水酸化カリウム 適量
プロピルパラベン 0.05
水 残量
計 100 Formulation example 2 (oil-in-water cream)
Benzoyl peroxide 2.5
Dipotassium glycyrrhizinate 0.5
Allantoin 0.2
Propylene glycol 8
Self-emulsifying glyceryl monostearate 8 8
Stearyl alcohol 3
Isopropyl myristate 5
Methylparaben 0.1
Carboxyvinyl polymer 1
Potassium hydroxide appropriate amount Propylparaben 0.05
Water remaining gauge 100
過酸化ベンゾイル 2.5
グリチルリチン酸ジカリウム 0.5
アラントイン 0.2
プロピレングリコール 8
自己乳化型モノステアリン酸グリセリン 8 8
ステアリルアルコール 3
ミリスチン酸イソプロピル 5
メチルパラベン 0.1
カルボキシビニルポリマー 1
水酸化カリウム 適量
プロピルパラベン 0.05
水 残量
計 100 Formulation example 2 (oil-in-water cream)
Benzoyl peroxide 2.5
Dipotassium glycyrrhizinate 0.5
Allantoin 0.2
Propylene glycol 8
Self-emulsifying glyceryl monostearate 8 8
Stearyl alcohol 3
Isopropyl myristate 5
Methylparaben 0.1
Carboxyvinyl polymer 1
Potassium hydroxide appropriate amount Propylparaben 0.05
Water remaining gauge 100
本発明の医薬外用組成物は、過酸化ベンゾイルを含むことによる保存時の粘度低下が抑えられているため、流通、保管に特別の配慮を要しない。また、本発明の医薬外用組成物は、滑らかに塗布することができるため、予定した分量を塗布し易く、従って、予定した薬効を得ることができる。また、滑らかに塗布できるため気持ち良く使用することができる。
Since the composition for external use of the present invention contains benzoyl peroxide, the decrease in viscosity during storage is suppressed, so no special consideration is required for distribution and storage. In addition, since the external pharmaceutical composition of the present invention can be applied smoothly, it is easy to apply a predetermined amount, and therefore, a predetermined medicinal effect can be obtained. In addition, since it can be applied smoothly, it can be used comfortably.
Since the composition for external use of the present invention contains benzoyl peroxide, the decrease in viscosity during storage is suppressed, so no special consideration is required for distribution and storage. In addition, since the external pharmaceutical composition of the present invention can be applied smoothly, it is easy to apply a predetermined amount, and therefore, a predetermined medicinal effect can be obtained. In addition, since it can be applied smoothly, it can be used comfortably.
Claims (6)
- (A)過酸化ベンゾイル、並びに(B)(B1)グリチルレチン酸、その誘導体、それらの塩、及び(B2)アラントインからなる群より選ばれる少なくとも1種の成分を含有する医薬外用組成物。 (A) benzoyl peroxide, and (B) (B1) glycyrrhetinic acid, derivatives thereof, salts thereof, and (B2) an external pharmaceutical composition containing at least one component selected from the group consisting of allantoin.
- (B)成分の含有量が、(A)成分の1質量部に対して、0.015~0.6質量部である、請求項1に記載の組成物。 The composition according to claim 1, wherein the content of component (B) is 0.015 to 0.6 parts by mass with respect to 1 part by mass of component (A).
- (B1)成分、及び(B2)成分を含有する、請求項1又は2に記載の組成物。 The composition according to claim 1 or 2, comprising (B1) component and (B2) component.
- (B1)成分が、グリチルリチン酸、グリチルレチン酸、及びそれらの塩からなる群より選ばれる少なくとも1種である、請求項1~3の何れかに記載の組成物。 The composition according to any one of claims 1 to 3, wherein the component (B1) is at least one selected from the group consisting of glycyrrhizic acid, glycyrrhetinic acid, and salts thereof.
- 組成物の全量に対して、25質量%以上の水を含む、請求項1~4の何れかに記載の組成物。 The composition according to any one of claims 1 to 4, which contains 25% by mass or more of water relative to the total amount of the composition.
- (A)過酸化ベンゾイルを含有する医薬外用組成物に、(B)(B1)グリチルレチン酸、その誘導体、それらの塩、及び(B2)アラントインからなる群より選ばれる少なくとも1種の成分を含ませる、医薬外用組成物の経時的粘度低下の抑制方法。 (A) A topical pharmaceutical composition containing benzoyl peroxide contains at least one component selected from the group consisting of (B) (B1) glycyrrhetinic acid, derivatives thereof, salts thereof, and (B2) allantoin. , a method for suppressing a decrease in viscosity over time of a composition for external use.
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