JP2014214097A - Composition for external application containing minoxidil - Google Patents
Composition for external application containing minoxidil Download PDFInfo
- Publication number
- JP2014214097A JP2014214097A JP2013090919A JP2013090919A JP2014214097A JP 2014214097 A JP2014214097 A JP 2014214097A JP 2013090919 A JP2013090919 A JP 2013090919A JP 2013090919 A JP2013090919 A JP 2013090919A JP 2014214097 A JP2014214097 A JP 2014214097A
- Authority
- JP
- Japan
- Prior art keywords
- composition
- weight
- minoxidil
- external
- propylene glycol
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Granted
Links
- 239000000203 mixture Substances 0.000 title claims abstract description 89
- ZFMITUMMTDLWHR-UHFFFAOYSA-N Minoxidil Chemical compound NC1=[N+]([O-])C(N)=CC(N2CCCCC2)=N1 ZFMITUMMTDLWHR-UHFFFAOYSA-N 0.000 title claims abstract description 60
- 229960003632 minoxidil Drugs 0.000 title claims abstract description 60
- DNIAPMSPPWPWGF-UHFFFAOYSA-N Propylene glycol Chemical compound CC(O)CO DNIAPMSPPWPWGF-UHFFFAOYSA-N 0.000 claims abstract description 68
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims description 23
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 17
- 230000003779 hair growth Effects 0.000 claims description 11
- 239000011521 glass Substances 0.000 claims description 8
- 239000000463 material Substances 0.000 claims description 5
- 229920000098 polyolefin Polymers 0.000 claims description 4
- 239000013078 crystal Substances 0.000 abstract description 19
- 230000008021 deposition Effects 0.000 abstract 1
- -1 plastibase) Chemical class 0.000 description 28
- 238000004040 coloring Methods 0.000 description 21
- 238000001556 precipitation Methods 0.000 description 17
- 229920001296 polysiloxane Polymers 0.000 description 13
- 239000003795 chemical substances by application Substances 0.000 description 11
- 239000004743 Polypropylene Substances 0.000 description 9
- 239000007788 liquid Substances 0.000 description 9
- 229920001155 polypropylene Polymers 0.000 description 8
- 238000002360 preparation method Methods 0.000 description 8
- 230000002349 favourable effect Effects 0.000 description 7
- 239000004698 Polyethylene Substances 0.000 description 6
- 238000000034 method Methods 0.000 description 6
- 239000002537 cosmetic Substances 0.000 description 5
- 229940079593 drug Drugs 0.000 description 5
- 239000003814 drug Substances 0.000 description 5
- 238000011156 evaluation Methods 0.000 description 5
- 238000002156 mixing Methods 0.000 description 5
- 229920000573 polyethylene Polymers 0.000 description 5
- 210000004761 scalp Anatomy 0.000 description 5
- 239000000654 additive Substances 0.000 description 4
- 239000000443 aerosol Substances 0.000 description 4
- PUPZLCDOIYMWBV-UHFFFAOYSA-N (+/-)-1,3-Butanediol Chemical compound CC(O)CCO PUPZLCDOIYMWBV-UHFFFAOYSA-N 0.000 description 3
- LYCAIKOWRPUZTN-UHFFFAOYSA-N Ethylene glycol Chemical compound OCCO LYCAIKOWRPUZTN-UHFFFAOYSA-N 0.000 description 3
- KFZMGEQAYNKOFK-UHFFFAOYSA-N Isopropanol Chemical compound CC(C)O KFZMGEQAYNKOFK-UHFFFAOYSA-N 0.000 description 3
- OKKJLVBELUTLKV-UHFFFAOYSA-N Methanol Chemical compound OC OKKJLVBELUTLKV-UHFFFAOYSA-N 0.000 description 3
- LRHPLDYGYMQRHN-UHFFFAOYSA-N N-Butanol Chemical compound CCCCO LRHPLDYGYMQRHN-UHFFFAOYSA-N 0.000 description 3
- KWYUFKZDYYNOTN-UHFFFAOYSA-M Potassium hydroxide Chemical compound [OH-].[K+] KWYUFKZDYYNOTN-UHFFFAOYSA-M 0.000 description 3
- HEMHJVSKTPXQMS-UHFFFAOYSA-M Sodium hydroxide Chemical compound [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 description 3
- 239000004480 active ingredient Substances 0.000 description 3
- 150000001298 alcohols Chemical class 0.000 description 3
- 239000003963 antioxidant agent Substances 0.000 description 3
- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid Chemical compound OC(=O)CC(O)(C(O)=O)CC(O)=O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 description 3
- 239000012611 container material Substances 0.000 description 3
- 239000000839 emulsion Substances 0.000 description 3
- 238000009472 formulation Methods 0.000 description 3
- 239000006210 lotion Substances 0.000 description 3
- GLDOVTGHNKAZLK-UHFFFAOYSA-N octadecan-1-ol Chemical compound CCCCCCCCCCCCCCCCCCO GLDOVTGHNKAZLK-UHFFFAOYSA-N 0.000 description 3
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- 229920000139 polyethylene terephthalate Polymers 0.000 description 3
- 239000005020 polyethylene terephthalate Substances 0.000 description 3
- 150000005846 sugar alcohols Polymers 0.000 description 3
- WNWHHMBRJJOGFJ-UHFFFAOYSA-N 16-methylheptadecan-1-ol Chemical compound CC(C)CCCCCCCCCCCCCCCO WNWHHMBRJJOGFJ-UHFFFAOYSA-N 0.000 description 2
- 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 description 2
- 102100028071 Fibroblast growth factor 7 Human genes 0.000 description 2
- 108090000385 Fibroblast growth factor 7 Proteins 0.000 description 2
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 description 2
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 description 2
- 102000011782 Keratins Human genes 0.000 description 2
- 108010076876 Keratins Proteins 0.000 description 2
- NBIIXXVUZAFLBC-UHFFFAOYSA-N Phosphoric acid Chemical compound OP(O)(O)=O NBIIXXVUZAFLBC-UHFFFAOYSA-N 0.000 description 2
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- 150000001413 amino acids Chemical class 0.000 description 2
- 230000003078 antioxidant effect Effects 0.000 description 2
- BTANRVKWQNVYAZ-UHFFFAOYSA-N butan-2-ol Chemical compound CCC(C)O BTANRVKWQNVYAZ-UHFFFAOYSA-N 0.000 description 2
- HVYWMOMLDIMFJA-DPAQBDIFSA-N cholesterol Chemical compound C1C=C2C[C@@H](O)CC[C@]2(C)[C@@H]2[C@@H]1[C@@H]1CC[C@H]([C@H](C)CCCC(C)C)[C@@]1(C)CC2 HVYWMOMLDIMFJA-DPAQBDIFSA-N 0.000 description 2
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- 230000007794 irritation Effects 0.000 description 2
- ZXEKIIBDNHEJCQ-UHFFFAOYSA-N isobutanol Chemical compound CC(C)CO ZXEKIIBDNHEJCQ-UHFFFAOYSA-N 0.000 description 2
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- 125000002496 methyl group Chemical group [H]C([H])([H])* 0.000 description 2
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- 239000003755 preservative agent Substances 0.000 description 2
- 230000001737 promoting effect Effects 0.000 description 2
- PRAKJMSDJKAYCZ-UHFFFAOYSA-N squalane Chemical compound CC(C)CCCC(C)CCCC(C)CCCCC(C)CCCC(C)CCCC(C)C PRAKJMSDJKAYCZ-UHFFFAOYSA-N 0.000 description 2
- 238000003860 storage Methods 0.000 description 2
- 229920002554 vinyl polymer Polymers 0.000 description 2
- 239000001993 wax Substances 0.000 description 2
- HDTRYLNUVZCQOY-UHFFFAOYSA-N α-D-glucopyranosyl-α-D-glucopyranoside Natural products OC1C(O)C(O)C(CO)OC1OC1C(O)C(O)C(O)C(CO)O1 HDTRYLNUVZCQOY-UHFFFAOYSA-N 0.000 description 1
- DSEKYWAQQVUQTP-XEWMWGOFSA-N (2r,4r,4as,6as,6as,6br,8ar,12ar,14as,14bs)-2-hydroxy-4,4a,6a,6b,8a,11,11,14a-octamethyl-2,4,5,6,6a,7,8,9,10,12,12a,13,14,14b-tetradecahydro-1h-picen-3-one Chemical compound C([C@H]1[C@]2(C)CC[C@@]34C)C(C)(C)CC[C@]1(C)CC[C@]2(C)[C@H]4CC[C@@]1(C)[C@H]3C[C@@H](O)C(=O)[C@@H]1C DSEKYWAQQVUQTP-XEWMWGOFSA-N 0.000 description 1
- BJEPYKJPYRNKOW-REOHCLBHSA-N (S)-malic acid Chemical compound OC(=O)[C@@H](O)CC(O)=O BJEPYKJPYRNKOW-REOHCLBHSA-N 0.000 description 1
- 229940058015 1,3-butylene glycol Drugs 0.000 description 1
- RYHBNJHYFVUHQT-UHFFFAOYSA-N 1,4-Dioxane Chemical compound C1COCCO1 RYHBNJHYFVUHQT-UHFFFAOYSA-N 0.000 description 1
- QWOZZTWBWQMEPD-UHFFFAOYSA-N 1-(2-ethoxypropoxy)propan-2-ol Chemical compound CCOC(C)COCC(C)O QWOZZTWBWQMEPD-UHFFFAOYSA-N 0.000 description 1
- SPSPIUSUWPLVKD-UHFFFAOYSA-N 2,3-dibutyl-6-methylphenol Chemical compound CCCCC1=CC=C(C)C(O)=C1CCCC SPSPIUSUWPLVKD-UHFFFAOYSA-N 0.000 description 1
- SBASXUCJHJRPEV-UHFFFAOYSA-N 2-(2-methoxyethoxy)ethanol Chemical compound COCCOCCO SBASXUCJHJRPEV-UHFFFAOYSA-N 0.000 description 1
- DJCYDDALXPHSHR-UHFFFAOYSA-N 2-(2-propoxyethoxy)ethanol Chemical compound CCCOCCOCCO DJCYDDALXPHSHR-UHFFFAOYSA-N 0.000 description 1
- XYVAYAJYLWYJJN-UHFFFAOYSA-N 2-(2-propoxypropoxy)propan-1-ol Chemical compound CCCOC(C)COC(C)CO XYVAYAJYLWYJJN-UHFFFAOYSA-N 0.000 description 1
- XNWFRZJHXBZDAG-UHFFFAOYSA-N 2-METHOXYETHANOL Chemical compound COCCO XNWFRZJHXBZDAG-UHFFFAOYSA-N 0.000 description 1
- ZNQVEEAIQZEUHB-UHFFFAOYSA-N 2-ethoxyethanol Chemical compound CCOCCO ZNQVEEAIQZEUHB-UHFFFAOYSA-N 0.000 description 1
- LEACJMVNYZDSKR-UHFFFAOYSA-N 2-octyldodecan-1-ol Chemical compound CCCCCCCCCCC(CO)CCCCCCCC LEACJMVNYZDSKR-UHFFFAOYSA-N 0.000 description 1
- BGRXBNZMPMGLQI-UHFFFAOYSA-N 2-octyldodecyl tetradecanoate Chemical compound CCCCCCCCCCCCCC(=O)OCC(CCCCCCCC)CCCCCCCCCC BGRXBNZMPMGLQI-UHFFFAOYSA-N 0.000 description 1
- YEYKMVJDLWJFOA-UHFFFAOYSA-N 2-propoxyethanol Chemical compound CCCOCCO YEYKMVJDLWJFOA-UHFFFAOYSA-N 0.000 description 1
- UIVPNOBLHXUKDX-UHFFFAOYSA-N 3,5,5-trimethylhexyl 3,5,5-trimethylhexanoate Chemical compound CC(C)(C)CC(C)CCOC(=O)CC(C)CC(C)(C)C UIVPNOBLHXUKDX-UHFFFAOYSA-N 0.000 description 1
- LDMRLRNXHLPZJN-UHFFFAOYSA-N 3-propoxypropan-1-ol Chemical compound CCCOCCCO LDMRLRNXHLPZJN-UHFFFAOYSA-N 0.000 description 1
- CYDQOEWLBCCFJZ-UHFFFAOYSA-N 4-(4-fluorophenyl)oxane-4-carboxylic acid Chemical compound C=1C=C(F)C=CC=1C1(C(=O)O)CCOCC1 CYDQOEWLBCCFJZ-UHFFFAOYSA-N 0.000 description 1
- HIQIXEFWDLTDED-UHFFFAOYSA-N 4-hydroxy-1-piperidin-4-ylpyrrolidin-2-one Chemical compound O=C1CC(O)CN1C1CCNCC1 HIQIXEFWDLTDED-UHFFFAOYSA-N 0.000 description 1
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- 239000004702 low-density polyethylene Substances 0.000 description 1
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- 229940035034 maltodextrin Drugs 0.000 description 1
- 239000000594 mannitol Substances 0.000 description 1
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- 229960001855 mannitol Drugs 0.000 description 1
- HEBKCHPVOIAQTA-UHFFFAOYSA-N meso ribitol Natural products OCC(O)C(O)C(O)CO HEBKCHPVOIAQTA-UHFFFAOYSA-N 0.000 description 1
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- 230000003020 moisturizing effect Effects 0.000 description 1
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- 229940073665 octyldodecyl myristate Drugs 0.000 description 1
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- 150000007524 organic acids Chemical class 0.000 description 1
- 235000005985 organic acids Nutrition 0.000 description 1
- 150000007530 organic bases Chemical class 0.000 description 1
- JCGNDDUYTRNOFT-UHFFFAOYSA-N oxolane-2,4-dione Chemical compound O=C1COC(=O)C1 JCGNDDUYTRNOFT-UHFFFAOYSA-N 0.000 description 1
- 239000003002 pH adjusting agent Substances 0.000 description 1
- 238000010979 pH adjustment Methods 0.000 description 1
- WXZMFSXDPGVJKK-UHFFFAOYSA-N pentaerythritol Chemical compound OCC(CO)(CO)CO WXZMFSXDPGVJKK-UHFFFAOYSA-N 0.000 description 1
- 229940066842 petrolatum Drugs 0.000 description 1
- 235000019271 petrolatum Nutrition 0.000 description 1
- 125000000587 piperidin-1-yl group Chemical group [H]C1([H])N(*)C([H])([H])C([H])([H])C([H])([H])C1([H])[H] 0.000 description 1
- 229920003023 plastic Polymers 0.000 description 1
- 239000004033 plastic Substances 0.000 description 1
- 229920002492 poly(sulfone) Polymers 0.000 description 1
- 229920002647 polyamide Polymers 0.000 description 1
- 229920001230 polyarylate Polymers 0.000 description 1
- 229920000515 polycarbonate Polymers 0.000 description 1
- 239000004417 polycarbonate Substances 0.000 description 1
- 229920001721 polyimide Polymers 0.000 description 1
- 229920005862 polyol Polymers 0.000 description 1
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- 229920001282 polysaccharide Polymers 0.000 description 1
- 239000005017 polysaccharide Substances 0.000 description 1
- 229920000915 polyvinyl chloride Polymers 0.000 description 1
- 239000004800 polyvinyl chloride Substances 0.000 description 1
- 239000001267 polyvinylpyrrolidone Substances 0.000 description 1
- 229920000036 polyvinylpyrrolidone Polymers 0.000 description 1
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- 102000004196 processed proteins & peptides Human genes 0.000 description 1
- 108090000765 processed proteins & peptides Proteins 0.000 description 1
- BDERNNFJNOPAEC-UHFFFAOYSA-N propan-1-ol Chemical compound CCCO BDERNNFJNOPAEC-UHFFFAOYSA-N 0.000 description 1
- QQONPFPTGQHPMA-UHFFFAOYSA-N propylene Natural products CC=C QQONPFPTGQHPMA-UHFFFAOYSA-N 0.000 description 1
- 125000004805 propylene group Chemical group [H]C([H])([H])C([H])([*:1])C([H])([H])[*:2] 0.000 description 1
- 238000011160 research Methods 0.000 description 1
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- 239000011347 resin Substances 0.000 description 1
- 239000008165 rice bran oil Substances 0.000 description 1
- 229940057910 shea butter Drugs 0.000 description 1
- 229920002545 silicone oil Polymers 0.000 description 1
- 229920002050 silicone resin Polymers 0.000 description 1
- 235000019265 sodium DL-malate Nutrition 0.000 description 1
- HELHAJAZNSDZJO-OLXYHTOASA-L sodium L-tartrate Chemical compound [Na+].[Na+].[O-]C(=O)[C@H](O)[C@@H](O)C([O-])=O HELHAJAZNSDZJO-OLXYHTOASA-L 0.000 description 1
- 239000001509 sodium citrate Substances 0.000 description 1
- NLJMYIDDQXHKNR-UHFFFAOYSA-K sodium citrate Chemical compound O.O.[Na+].[Na+].[Na+].[O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O NLJMYIDDQXHKNR-UHFFFAOYSA-K 0.000 description 1
- 235000011083 sodium citrates Nutrition 0.000 description 1
- 239000001540 sodium lactate Substances 0.000 description 1
- 229940005581 sodium lactate Drugs 0.000 description 1
- 235000011088 sodium lactate Nutrition 0.000 description 1
- 239000001394 sodium malate Substances 0.000 description 1
- 229940074404 sodium succinate Drugs 0.000 description 1
- ZDQYSKICYIVCPN-UHFFFAOYSA-L sodium succinate (anhydrous) Chemical compound [Na+].[Na+].[O-]C(=O)CCC([O-])=O ZDQYSKICYIVCPN-UHFFFAOYSA-L 0.000 description 1
- 239000001433 sodium tartrate Substances 0.000 description 1
- 229960002167 sodium tartrate Drugs 0.000 description 1
- 235000011004 sodium tartrates Nutrition 0.000 description 1
- 239000000243 solution Substances 0.000 description 1
- 239000002904 solvent Substances 0.000 description 1
- 239000000600 sorbitol Substances 0.000 description 1
- 229960002920 sorbitol Drugs 0.000 description 1
- LXMSZDCAJNLERA-ZHYRCANASA-N spironolactone Chemical compound C([C@@H]1[C@]2(C)CC[C@@H]3[C@@]4(C)CCC(=O)C=C4C[C@H]([C@@H]13)SC(=O)C)C[C@@]21CCC(=O)O1 LXMSZDCAJNLERA-ZHYRCANASA-N 0.000 description 1
- 238000005507 spraying Methods 0.000 description 1
- 229940032094 squalane Drugs 0.000 description 1
- 239000003381 stabilizer Substances 0.000 description 1
- 229940012831 stearyl alcohol Drugs 0.000 description 1
- 230000000638 stimulation Effects 0.000 description 1
- 239000000126 substance Substances 0.000 description 1
- 239000004094 surface-active agent Substances 0.000 description 1
- 239000000375 suspending agent Substances 0.000 description 1
- 239000000725 suspension Substances 0.000 description 1
- 239000011975 tartaric acid Substances 0.000 description 1
- 235000002906 tartaric acid Nutrition 0.000 description 1
- 229960001367 tartaric acid Drugs 0.000 description 1
- 150000003505 terpenes Chemical class 0.000 description 1
- 235000007586 terpenes Nutrition 0.000 description 1
- OULAJFUGPPVRBK-UHFFFAOYSA-N tetratriacontyl alcohol Natural products CCCCCCCCCCCCCCCCCCCCCCCCCCCCCCCCCCO OULAJFUGPPVRBK-UHFFFAOYSA-N 0.000 description 1
- 239000002562 thickening agent Substances 0.000 description 1
- 229940074410 trehalose Drugs 0.000 description 1
- 229920000785 ultra high molecular weight polyethylene Polymers 0.000 description 1
- 229920001862 ultra low molecular weight polyethylene Polymers 0.000 description 1
- 229940124549 vasodilator Drugs 0.000 description 1
- 239000003071 vasodilator agent Substances 0.000 description 1
- 239000011782 vitamin Substances 0.000 description 1
- 229940088594 vitamin Drugs 0.000 description 1
- 229930003231 vitamin Natural products 0.000 description 1
- 235000013343 vitamin Nutrition 0.000 description 1
- 230000002087 whitening effect Effects 0.000 description 1
- 239000000811 xylitol Substances 0.000 description 1
- HEBKCHPVOIAQTA-SCDXWVJYSA-N xylitol Chemical compound OC[C@H](O)[C@@H](O)[C@H](O)CO HEBKCHPVOIAQTA-SCDXWVJYSA-N 0.000 description 1
- 235000010447 xylitol Nutrition 0.000 description 1
- 229960002675 xylitol Drugs 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
- 239000004711 α-olefin Substances 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
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
- A61K31/50—Pyridazines; Hydrogenated pyridazines
-
- 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
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K8/00—Cosmetics or similar toiletry preparations
- A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
- A61K8/30—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
- A61K8/33—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing oxygen
- A61K8/34—Alcohols
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K8/00—Cosmetics or similar toiletry preparations
- A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
- A61K8/30—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
- A61K8/49—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing heterocyclic compounds
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61Q—SPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
- A61Q7/00—Preparations for affecting hair growth
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Epidemiology (AREA)
- Chemical & Material Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Medicinal Chemistry (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Cosmetics (AREA)
- Birds (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Engineering & Computer Science (AREA)
- Dermatology (AREA)
- Emergency Medicine (AREA)
Abstract
Description
本発明は、医薬外用剤、医薬部外品、又は化粧品として用いられる、ミノキシジルを含有する外用組成物に関する。 The present invention relates to an external composition containing minoxidil, which is used as a pharmaceutical external preparation, a quasi-drug, or a cosmetic.
ミノキシジル（６−（１−ピペリジニル）２，４−ピリミジン−３−オキサイド）は、外用により優れた育毛、養毛効果が得られるため、脱毛症の改善薬として広く使われている。
ところが、ミノキシジルは、水やエタノールへの溶解性が悪く、特に、低温で保存すると結晶が析出し易い。また、ミノキシジルを含む液剤は、経時的に着色して、商品価値が低下する。
Minoxidil (6- (1-piperidinyl) 2,4-pyrimidine-3-oxide) is widely used as an alopecia ameliorating agent because it provides excellent hair growth and nourishing effects for external use.
However, minoxidil has poor solubility in water and ethanol, and crystals tend to precipitate particularly when stored at low temperatures. Moreover, the liquid agent containing minoxidil is colored with time and the commercial value is lowered.
ここで、特許文献１は、ミノキシジルの溶解性を向上させるために、多価アルコールを大量に配合することを提案しているが、多価アルコールを大量に配合すると、頭皮にべたつきが残ったり、髪がべたついて、いつまでも乾かないなどの使用上の問題がある。
また、特許文献２は、多価アルコールを８〜３０重量％配合しつつ、組成物のｐＨを５．５〜６．５にすることで、ミノキシジルの結晶析出を抑制することを提案している。しかし、特許文献２の方法では、ミノキシジル含有液剤の着色を抑制することはできない。
Here, Patent Document 1 proposes blending a large amount of polyhydric alcohol in order to improve the solubility of minoxidil, but when blending a large amount of polyhydric alcohol, the scalp remains sticky, There are problems in use such as hair stickiness and does not dry forever.
Patent Document 2 proposes to suppress the precipitation of minoxidil crystal by adjusting the pH of the composition to 5.5 to 6.5 while blending 8 to 30% by weight of polyhydric alcohol. . However, the method of Patent Document 2 cannot suppress the coloring of the minoxidil-containing liquid agent.
ミノキシジル含有液剤の経時的な着色を抑制する試みとして、特許文献３は、ミノキシジル含有液剤にアミノ酸を配合することを教えており、特許文献４は、ミノキシジル含有液剤に抗酸化剤を配合し、かつｐＨを５．５〜７．０にすることを教えており、特許文献５は、ミノキシジル含有液剤にジブチルヒドロキシトルエンやジブチルヒドロキシアニソールを配合し、かつｐＨを５．７〜６．４にすることを教えている。しかし、これらの文献記載の方法では、ミノキシジル含有液剤の着色を実用上十分に抑制することはできない。 As an attempt to suppress the coloration of the minoxidil-containing liquid over time, Patent Document 3 teaches that an amino acid is blended with the minoxidil-containing liquid, and Patent Document 4 blends an antioxidant with the minoxidil-containing liquid, and It teaches that the pH is adjusted to 5.5 to 7.0, and Patent Document 5 discloses that dibutylhydroxytoluene or dibutylhydroxyanisole is added to the minoxidil-containing liquid and the pH is adjusted to 5.7 to 6.4. Teaching. However, the methods described in these documents cannot sufficiently suppress coloring of the minoxidil-containing liquid agent practically.
本発明は、ミノキシジルを配合した外用組成物であって、ミノキシジルの結晶析出、及び経時的な着色が抑制されており、しかも使用感に優れた組成物を提供することを課題とする。 An object of the present invention is to provide an external composition containing minoxidil, in which the crystal precipitation of minoxidil and coloring over time are suppressed, and the composition has excellent usability.
本発明者は、上記課題を解決するために研究を重ね、ミノキシジルを３〜１０重量％含有する外用組成物に、ミノキシジル：プロピレングリコールの重量比が１：３〜１：９となるようにプロピレングリコールを配合し、かつ組成物のｐＨを６．５〜７．５とすることにより、ミノキシジルの結晶析出が抑制されており、熱や光に曝されても着色し難く、さらにベタツキが抑制された組成物になることを見出した。 The present inventor conducted researches to solve the above-mentioned problems, and in an external composition containing 3 to 10% by weight of minoxidil, propylene was added so that the weight ratio of minoxidil: propylene glycol was 1: 3 to 1: 9. By blending glycol and adjusting the pH of the composition to 6.5-7.5, crystal precipitation of minoxidil is suppressed, it is difficult to color even when exposed to heat and light, and stickiness is further suppressed. It was found to be a composition.
本発明は、上記知見に基づき完成されたものであり、以下の外用組成物を提供する。
項１． ミノキシジルを３〜１０重量％含み、ミノキシジル：プロピレングリコールの重量比が１：３〜１：９となるようにプロピレングリコールを含み、かつ組成物のｐＨが６．５〜７．５である外用組成物。
項２． さらに、水を含む項１に記載の外用組成物。
項３． 水の含有量が、組成物の全量に対して、５〜３０重量％である項２に記載の外用組成物。
項４． さらに、低級アルコールを含む項１〜３の何れかに記載の外用組成物。
項５． 低級アルコールの含有量が、組成物の全量に対して、３０〜８０重量％である項４に記載の外用組成物。
項６． 育毛、養毛、又は発毛用である項１〜５の何れかに記載の外用組成物。
項７． 外用組成物に接する面の一部又は全部が、ポリオレフィン、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に項１〜５の何れかに記載の外用組成物が収容された容器入り外用組成物。
This invention is completed based on the said knowledge, and provides the following external compositions.
Item 1. A composition for external use containing 3 to 10% by weight of minoxidil, containing propylene glycol such that the weight ratio of minoxidil: propylene glycol is 1: 3 to 1: 9, and the pH of the composition is 6.5 to 7.5 object.
Item 2. Furthermore, the external composition of claim | item 1 containing water.
Item 3. Item 3. The external composition according to Item 2, wherein the water content is 5 to 30% by weight based on the total amount of the composition.
Item 4. Furthermore, the external composition in any one of claim | item 1 -3 containing a lower alcohol.
Item 5. Item 5. The composition for external use according to Item 4, wherein the content of the lower alcohol is 30 to 80% by weight based on the total amount of the composition.
Item 6. Item 6. The composition for external use according to any one of Items 1 to 5, which is used for hair growth, hair restoration, or hair growth.
Item 7. The external composition according to any one of Items 1 to 5 is accommodated in a container in which part or all of the surface in contact with the external composition is composed of at least one material selected from the group consisting of polyolefin and glass. Containerized external composition.
本発明の外用組成物は、３〜１０重量％という比較的高濃度のミノキシジルを含みながら、ミノキシジル：プロピレングリコールの重量比が１：３〜１：９となるようにプロピレングリコールを含み、ｐＨが６．５〜７．５であることにより、ミノキシジルの結晶析出、及び経時的な着色が抑制されており、しかもベタツキが抑えられた良好な使用感のものである。
ミノキシジルは、特に、低温下で結晶析出し易いが、本発明の外用組成物は、低温保存時の結晶析出も抑制されている。従って、寒冷地への流通、冬季の保管にも耐える。また、高温下や光に曝された場合の着色も抑制されているため、必ずしも遮光容器に充填しなくてもよい。従って、極めて実用的な商品価値の高いミノキシジル含有製剤である。
The composition for external use of the present invention contains propylene glycol so that the weight ratio of minoxidil: propylene glycol is 1: 3 to 1: 9 while containing a relatively high concentration of minoxidil of 3 to 10% by weight, and the pH is By being 6.5 to 7.5, crystal precipitation of minoxidil and coloring over time are suppressed, and the material has a good feeling of use with less stickiness.
Minoxidil is particularly likely to crystallize at low temperatures, but the composition for external use of the present invention also suppresses crystal precipitation during low-temperature storage. Therefore, it can withstand distribution to cold regions and storage in winter. Further, since coloring at high temperatures or exposure to light is suppressed, the light-shielding container does not necessarily have to be filled. Accordingly, it is a minoxidil-containing preparation with extremely high commercial value.
以下、本発明を詳細に説明する。
本発明の外用組成物は、ミノキシジルを約３〜１０重量％含み、ミノキシジル：プロピレングリコールの重量比が約１：３〜１：９となるようにプロピレングリコールを含み、かつｐＨが約６．５〜７．５の組成物である。
Hereinafter, the present invention will be described in detail.
The composition for external use of the present invention contains about 3 to 10% by weight of minoxidil, contains propylene glycol so that the weight ratio of minoxidil: propylene glycol is about 1: 3 to 1: 9, and has a pH of about 6.5. -7.5 composition.
ミノキシジル
ミノキシジルは市販されており、例えば、東京化成工業社から購入できる。
ミノキシジルの含有量は、組成物の全量に対して、約３重量％以上であり、約４重量％以上が好ましく、約５重量％以上がより好ましい。一般にこの範囲でミノキシジルを含む組成物はミノキシジルの溶解性が悪く、また経時的に着色し易いので、この範囲が本発明の好適な対象である。
また、ミノキシジルの含有量は、組成物の全量に対して、約１０重量％以下であり、約９重量％以下が好ましく、約７重量％以下がより好ましい。この範囲であれば、ミノキシジルの結晶析出、及び経時的な組成物の着色が抑制される。
ミノキシジルの含有量としては、組成物の全量に対して、約３〜１０重量％、約３〜９重量％、約３〜７重量％、約４〜１０重量％、約４〜９重量％、約４〜７重量％、約５〜１０重量％、約５〜９重量％、約５〜７重量％が挙げられる。
Minoxidil Minoxidil is commercially available and can be purchased from, for example, Tokyo Chemical Industry Co., Ltd.
The content of minoxidil is about 3% by weight or more, preferably about 4% by weight or more, more preferably about 5% by weight or more based on the total amount of the composition. In general, a composition containing minoxidil within this range has poor solubility of minoxidil and is likely to be colored over time, so this range is a preferred subject of the present invention.
The content of minoxidil is about 10% by weight or less, preferably about 9% by weight or less, more preferably about 7% by weight or less based on the total amount of the composition. Within this range, minoxidil crystal precipitation and coloration of the composition over time are suppressed.
The content of minoxidil is about 3 to 10% by weight, about 3 to 9% by weight, about 3 to 7% by weight, about 4 to 10% by weight, about 4 to 9% by weight, based on the total amount of the composition, Examples include about 4 to 7% by weight, about 5 to 10% by weight, about 5 to 9% by weight, and about 5 to 7% by weight.
プロピレングリコール
プロピレングリコールの含有量は、ミノキシジルの１重量部に対して、約３重量部以上であり、約３．５重量部以上が好ましく、約４重量部以上がより好ましい。この範囲であれば、ミノキシジルの結晶析出、及び経時的な組成物の着色が十分に抑制される。
また、プロピレングリコールの含有量は、ミノキシジルの１重量部に対して、約９重量部以下であり、約８重量部以下が好ましく、約７重量部以下がより好ましい。この範囲であれば、使用感が良好な組成物となる。
プロピレングリコールの含有量としては、ミノキシジルの１重量部に対して、約３〜９重量部、約３〜８重量部、約３〜７重量部、約３．５〜９重量部、約３．５〜８重量部、約３．５〜７重量部、４〜９重量部、約４〜８重量部、約４〜７重量部が挙げられる。
Propylene glycol The content of propylene glycol is about 3 parts by weight or more, preferably about 3.5 parts by weight or more, and more preferably about 4 parts by weight or more with respect to 1 part by weight of minoxidil. Within this range, minoxidil crystal precipitation and coloration of the composition over time are sufficiently suppressed.
Further, the content of propylene glycol is about 9 parts by weight or less, preferably about 8 parts by weight or less, more preferably about 7 parts by weight or less with respect to 1 part by weight of minoxidil. If it is this range, it will become a composition with a favorable usability | use_condition.
The content of propylene glycol is about 3 to 9 parts by weight, about 3 to 8 parts by weight, about 3 to 7 parts by weight, about 3.5 to 9 parts by weight, and about 3 parts by weight with respect to 1 part by weight of minoxidil. 5-8 weight part, about 3.5-7 weight part, 4-9 weight part, about 4-8 weight part, about 4-7 weight part is mentioned.
基剤又は担体
本発明の外用組成物は、医薬外用剤、医薬部外品、化粧品用の薬学的又は生理学的に許容される基剤又は担体を含むことができる。
このような基剤又は担体としては、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、及び軽質流動パラフィンのような炭化水素；メチルポリシロキサン、高重合メチルポリシロキサン、環状シリコーン、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、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、アクリルシリコーン、フェニル変性シリコーン、及びシリコーンレジンのようなシリコーン油；ヤシ油、オリーブ油、コメヌカ油、シアバターのような油脂；ホホバ油、ミウロウ、キャンデリラロウ、及びラノリンのようなロウ類；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、ベヘニルアルコール、オクチルドデカノール、イソステアリルアルコール、フィトステロール、及びコレステロールのような高級アルコール；エチルセルロース、ヒドロキシプロピルセルロース、及びヒドロキシプロピルメチルセルロースのようなセルロース誘導体；ポリビニルピロリドン；カラギーナン；ポリビニルブチラート；ポリエチレングリコール；ジオキサン；ブチレングリコールアジピン酸ポリエステル；ミリスチン酸イソプロピル、ミリスチン酸オクチルドデシル、パルミチン酸イソプロピル、パルミチン酸セチル、イソノナン酸イソノニル、及びテトラ２−エチルヘキサン酸ペンタエリスリットのようなエステル類；デキストリン、及びマルトデキストリンのような多糖類；カルボキシビニルポリマー、及びアルキル変性カルボキシビニルポリマーのようなビニル系高分子；メタノール、エタノール、プロパノール、イソプロピルアルコール、ブタノール、イソブチルアルコール、sec−ブチルアルコール、test-ブチルアルコール等のような低級（炭素数１〜４）アルコール；並びにエチレングリコールモノメチルエーテル、エチレングリコールモノエチルエーテル、エチレングリコールモノプロピルエーテル、ジエチレングリコールモノメチルエーテル、ジエチレングリコールモノエチルエーテル、ジエチレングリコールモノプロピルエーテル、ジエチレングリコールモノブチルエーテル、プロピレングリコールモノエチルエーテル、プロピレングリコールモノプロピルエーテル、ジプロピレングリコールモノエチルエーテル、及びジプロピレングリコールモノプロピルエーテルのようなグリコールエーテル；グリセリン、ジグリセリン、ポリグリセリン、ポリエチレングリコール、ブチレングリコール、ジプロピレングリコール、ポリプロピレングリコール、ソルビトール、マンニトール、トレハロース、エリスリトール、キシリトールなどのポリオール類；水などが挙げられる。
Base or Carrier The composition for external use of the present invention can contain a pharmaceutically or physiologically acceptable base or carrier for pharmaceutical external preparations, quasi drugs, and cosmetics.
Such bases or carriers include liquid paraffin, squalane, petrolatum, gelled hydrocarbons (such as plastibase), ozokerite, α-olefin oligomers, and hydrocarbons such as light liquid paraffin; methyl polysiloxane, highly polymerized methyl Polysiloxane, cyclic silicone, alkyl-modified silicone, amino-modified silicone, polyether-modified silicone, polyglycerin-modified silicone, silicone-alkyl chain co-modified polyether-modified silicone, silicone-alkyl chain co-modified polyglycerin-modified silicone, polyether-modified branch Silicone oils such as silicones, polyglycerin-modified branched silicones, acrylic silicones, phenyl-modified silicones, and silicone resins; coconut oil, olive oil, rice bran oil, shea butter Oils and fats; waxes such as jojoba oil, miw wax, candelilla wax, and lanolin; higher alcohols such as cetanol, cetostearyl alcohol, stearyl alcohol, behenyl alcohol, octyldodecanol, isostearyl alcohol, phytosterol, and cholesterol; Cellulose derivatives such as ethyl cellulose, hydroxypropyl cellulose, and hydroxypropyl methylcellulose; polyvinyl pyrrolidone; carrageenan; polyvinyl butyrate; polyethylene glycol; dioxane; butylene glycol adipate polyester; isopropyl myristate, octyldodecyl myristate, isopropyl palmitate, palmitate Cetyl acid, isononyl isononanoate, and tetra-2-ethylhexa Esters such as pentaerythritol acid; polysaccharides such as dextrin and maltodextrin; vinyl polymers such as carboxyvinyl polymer and alkyl-modified carboxyvinyl polymer; methanol, ethanol, propanol, isopropyl alcohol, butanol , Lower (1 to 4 carbon) alcohols such as isobutyl alcohol, sec-butyl alcohol, test-butyl alcohol, etc .; and ethylene glycol monomethyl ether, ethylene glycol monoethyl ether, ethylene glycol monopropyl ether, diethylene glycol monomethyl ether, diethylene glycol Monoethyl ether, diethylene glycol monopropyl ether, diethylene glycol monobutyl ether, propylene glycol Glycol ethers such as monoethyl ether, propylene glycol monopropyl ether, dipropylene glycol monoethyl ether, and dipropylene glycol monopropyl ether; glycerin, diglycerin, polyglycerin, polyethylene glycol, butylene glycol, dipropylene glycol, polypropylene glycol , Polyols such as sorbitol, mannitol, trehalose, erythritol, xylitol; water and the like.
基剤又は担体は、１種を単独で、又は２種以上を組み合わせて使用できる。 A base or a support | carrier can be used individually by 1 type or in combination of 2 or more types.
本発明の組成物は、基剤又は担体として、水、及び低級アルコール（特に、エタノール）からなる群より選ばれる１種以上を含むことが好ましい。一般に、ミノキシジルは、水や低級アルコールに溶解し難いので、これらを含む組成物は、本発明の好適な対象となる。
水、及び低級アルコールからなる群より選ばれる１種以上を含む場合のその含有量は、組成物の全量に対して、約５重量％以上が好ましく、約１０重量％以上がより好ましく、約１５重量％以上がさらにより好ましい。この範囲であれば、使用感のよい製剤が得られる。
また、水、及び低級アルコールからなる群より選ばれる１種以上を含む場合のその含有量は、組成物の全量に対して、約９０重量％以下が好ましく、約８０重量％以下がより好ましく、約７０重量％以下がさらにより好ましい。この範囲であれば、ミノキシジルの溶解性が良好になる。
水、及び低級アルコールからなる群より選ばれる１種以上の含有量としては、組成物の全量に対して、約５〜９０重量％、約５〜８０重量％、約５〜７０重量％、約１０〜９０重量％、約１０〜８０重量％、約１０〜７０重量％、約１５〜９０重量％、約１５〜８０重量％、約１５〜７０重量％が挙げられる。
It is preferable that the composition of this invention contains 1 or more types chosen from the group which consists of water and a lower alcohol (especially ethanol) as a base or a support | carrier. In general, since minoxidil is difficult to dissolve in water or lower alcohol, a composition containing these is a suitable subject of the present invention.
The content of one or more selected from the group consisting of water and lower alcohols is preferably about 5% by weight or more, more preferably about 10% by weight or more, and more preferably about 15% by weight relative to the total amount of the composition. Even more preferred is weight percent or more. If it is this range, a formulation with a favorable feeling of use will be obtained.
In addition, the content when containing at least one selected from the group consisting of water and lower alcohol is preferably about 90% by weight or less, more preferably about 80% by weight or less, based on the total amount of the composition, Even more preferred is about 70% or less by weight. If it is this range, the solubility of minoxidil will become favorable.
The content of one or more selected from the group consisting of water and lower alcohol is about 5 to 90% by weight, about 5 to 80% by weight, about 5 to 70% by weight, about 5% by weight, based on the total amount of the composition. 10-90 wt%, about 10-80 wt%, about 10-70 wt%, about 15-90 wt%, about 15-80 wt%, about 15-70 wt%.
特に、本発明の外用組成物が水を含む場合の水の含有量は、組成物の全量に対して、約５重量％以上が好ましく、約１０重量％以上がより好ましく、約１５重量％以上がさらにより好ましい。この範囲であれば、使用感のよい製剤が得られる。
また、水を含む場合の水の含有量は、組成物の全量に対して、約３０重量％以下が好ましく、約２５重量％以下がより好ましく、約２０重量％以下がさらにより好ましい。この範囲であれば、ミノキシジルの溶解性が良好になる。
水の含有量としては、組成物の全量に対して、約５〜３０重量％、約５〜２５重量％、約５〜２０重量％、約１０〜３０重量％、約１０〜２５重量％、約１０〜２０重量％、約１５〜３０重量％、約１５〜２５重量％、約１５〜２０重量％が挙げられる。
In particular, when the external composition of the present invention contains water, the content of water is preferably about 5% by weight or more, more preferably about 10% by weight or more, and more preferably about 15% by weight or more based on the total amount of the composition. Is even more preferred. If it is this range, a formulation with a favorable feeling of use will be obtained.
In addition, when water is contained, the content of water is preferably about 30% by weight or less, more preferably about 25% by weight or less, and still more preferably about 20% by weight or less based on the total amount of the composition. If it is this range, the solubility of minoxidil will become favorable.
The water content is about 5-30% by weight, about 5-25% by weight, about 5-20% by weight, about 10-30% by weight, about 10-25% by weight, based on the total amount of the composition, Examples include about 10 to 20% by weight, about 15 to 30% by weight, about 15 to 25% by weight, and about 15 to 20% by weight.
また、特に、本発明の外用組成物が低級アルコール（特に、エタノール）を含む場合のその含有量は、組成物の全量に対して、約３０重量％以上が好ましく、約４０重量％以上がより好ましく、約５０重量％以上がさらにより好ましい。この範囲であれば、使用感のよい製剤が得られる。
また、本発明の外用組成物が低級アルコール（特に、エタノール）を含む場合のその含有量は、組成物の全量に対して、約８０重量％以下が好ましく、約７０重量％以下がより好ましく、約６０重量％以下がさらにより好ましい。この範囲であれば、ミノキシジルの溶解性が良好になる。
本発明の外用組成物が低級アルコール（特に、エタノール）を含む場合のその含有量としては、組成物の全量に対して、約３０〜８０重量％、約３０〜７０重量％、約３０〜６０重量％、約４０〜８０重量％、約４０〜７０重量％、約４０〜６０重量％、約５０〜８０重量％、約５０〜７０重量％、約５０〜６０重量％が挙げられる。
In particular, when the composition for external use of the present invention contains a lower alcohol (particularly ethanol), the content thereof is preferably about 30% by weight or more, more preferably about 40% by weight or more based on the total amount of the composition. Preferably, about 50 wt% or more is even more preferred. If it is this range, a formulation with a favorable feeling of use will be obtained.
Further, when the composition for external use of the present invention contains a lower alcohol (particularly ethanol), the content thereof is preferably about 80% by weight or less, more preferably about 70% by weight or less based on the total amount of the composition, Even more preferred is about 60 wt% or less. If it is this range, the solubility of minoxidil will become favorable.
When the composition for external use of the present invention contains a lower alcohol (particularly ethanol), the content thereof is about 30 to 80% by weight, about 30 to 70% by weight, about 30 to 60% with respect to the total amount of the composition. Weight percent, about 40-80 wt%, about 40-70 wt%, about 40-60 wt%, about 50-80 wt%, about 50-70 wt%, about 50-60 wt%.
添加剤
本発明の外用組成物は、医薬外用剤、医薬部外品、化粧品用の薬学的又は生理学的に許容される添加剤を含むことができる。このような添加剤としては、酸化防止剤、界面活性剤、増粘剤、保存剤、ｐＨ調整剤、安定化剤、刺激軽減剤、防腐剤、着色剤、香料、溶解補助剤、等が挙げられる。
添加剤は、１種を単独で、又は２種以上を組み合わせて使用できる。
Additives The external composition of the present invention may contain pharmaceutically or physiologically acceptable additives for pharmaceutical external preparations, quasi-drugs, and cosmetics. Examples of such additives include antioxidants, surfactants, thickeners, preservatives, pH adjusters, stabilizers, irritation reducers, preservatives, colorants, fragrances, solubilizers, and the like. It is done.
An additive can be used individually by 1 type or in combination of 2 or more types.
薬理活性成分・生理活性成分
本発明の外用組成物は、ミノキシジル以外の、医薬外用剤、医薬部外品、化粧品用の薬理活性成分又は生理活性成分を含むことができる。このような成分としては、血行促進成分、血管新生促進因子、保湿成分、抗炎症成分、抗菌成分、ビタミン類、ペプチド又はその誘導体、アミノ酸又はその誘導体、細胞賦活化成分、老化防止成分、角質軟化若しくは角質溶解成分、美白成分、収斂成分、血管拡張成分、抗ヒスタミン成分、抗酸化成分、代謝賦活剤、清涼化剤等が挙げられる。また、例えば、スピラノラクトン、センブリエキス、カプサイシノイド、角質増殖因子（ＫＧＦ；ＦＧＦ−７）、グリチルリチン酸塩、グリチルレチン酸、人参エキス等のミノキシジル以外の育毛成分を含むこともできる。
薬理活性成分又は生理活性成分は、１種を単独で、又は２種以上を組み合わせて使用できる。
Pharmacologically active ingredient / physiologically active ingredient The composition for external use of the present invention may contain a pharmacologically active ingredient or physiologically active ingredient for pharmaceutical external preparations, quasi drugs and cosmetics other than minoxidil. Such components include blood circulation promoting components, angiogenesis promoting factors, moisturizing components, anti-inflammatory components, antibacterial components, vitamins, peptides or derivatives thereof, amino acids or derivatives thereof, cell activation components, anti-aging components, keratin softening Alternatively, a keratolytic component, a whitening component, an astringent component, a vasodilator component, an antihistamine component, an antioxidant component, a metabolic activator, a refreshing agent and the like can be mentioned. Further, for example, hair growth ingredients other than minoxidil such as spiranolactone, assembly extract, capsaicinoid, keratin growth factor (KGF; FGF-7), glycyrrhizinate, glycyrrhetinic acid, carrot extract and the like can also be included.
A pharmacologically active ingredient or a physiologically active ingredient can be used individually by 1 type or in combination of 2 or more types.
剤型
本発明の外用組成物の形態は、特に限定されず、液剤、懸濁剤、乳剤、クリーム剤、ゲル剤、リニメント剤、ローション剤、及びエアゾール剤等が挙げられる。また、ミノキシジルを溶解させることができる程度の水を含む場合は軟膏とすることもできる。中でも、液剤、懸濁剤、乳剤、ローション剤、エアゾール剤が好ましく、液剤、ローション剤、エアゾール剤がより好ましい。
クリーム剤、乳剤、及び場合により軟膏剤、エアゾール剤等のように、油性基剤と水性基剤とを含む場合は、Ｗ／Ｏ型でもよく、Ｏ／Ｗ型でもよいが、使用感が良い点で、Ｏ／Ｗ型が好ましい。
製剤は、第１６改正日本薬局方総則に従い、又はこれに準拠して、各成分を混合することにより製造できる。
Dosage Form The form of the composition for external use of the present invention is not particularly limited, and examples thereof include solutions, suspensions, emulsions, creams, gels, liniments, lotions, and aerosols. Moreover, when it contains the water which can melt | dissolve minoxidil, it can also be set as ointment. Among these, a liquid agent, a suspension agent, an emulsion, a lotion agent, and an aerosol agent are preferable, and a liquid agent, a lotion agent, and an aerosol agent are more preferable.
When an oily base and an aqueous base are included, such as creams, emulsions, and, in some cases, ointments, aerosols, etc., they may be W / O type or O / W type, but have a good feeling of use. In this respect, the O / W type is preferable.
The preparation can be produced by mixing each component according to or in accordance with the 16th revised Japanese Pharmacopoeia General Rules.
ｐＨ
本発明の組成物のｐＨは、約６．５以上であり、約６．６以上が好ましく、約６．７以上がより好ましく、約６．８以上がさらにより好ましい。この範囲であれば、ミノキシジルの経時的な組成物の着色が十分に抑制される。
また、本発明の組成物のｐＨは、約７.５以下であり、約７．３以下が好ましく、約７．１以下がより好ましい。上記範囲であれば、高ｐＨによる頭皮への刺激を避けることができる。また、ミノキシジルが溶解し易いため、プロピレングリコールの使用量を抑えることができ、使用感が良好な組成物となる。
本発明の組成物のｐＨ範囲としては、約６．５〜７.５、約６．５〜７．３、約６．５〜７．１、約６．６〜７.５、約６．６〜７．３、約６．６〜７．１、約６．７〜７.５、約６．７〜７．３、約６．７〜７．１、約６．８〜７.５、約６．８〜７．３、約６．８〜７．１が挙げられる。
pH
The pH of the composition of the present invention is about 6.5 or higher, preferably about 6.6 or higher, more preferably about 6.7 or higher, and even more preferably about 6.8 or higher. If it is this range, coloring of the composition of Minoxidil with time will be sufficiently suppressed.
The pH of the composition of the present invention is about 7.5 or less, preferably about 7.3 or less, more preferably about 7.1 or less. If it is the said range, irritation | stimulation to the scalp by high pH can be avoided. In addition, since minoxidil is easily dissolved, the amount of propylene glycol used can be suppressed, and the composition has a good usability.
The pH range of the composition of the present invention is about 6.5 to 7.5, about 6.5 to 7.3, about 6.5 to 7.1, about 6.6 to 7.5, about 6. 6 to 7.3, about 6.6 to 7.1, about 6.7 to 7.5, about 6.7 to 7.3, about 6.7 to 7.1, about 6.8 to 7.5 About 6.8 to 7.3, about 6.8 to 7.1.
ｐＨの調整は、乳酸、乳酸ナトリウム、クエン酸、クエン酸ナトリウム、リンゴ酸、リンゴ酸ナトリウム、コハク酸、コハク酸ナトリウム、酒石酸、酒石酸ナトリウムのような有機酸；リン酸、塩酸、硫酸のような無機酸などのｐＨ調整剤を用いて行えばよい。また、必要に応じて、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のような有機塩基；水酸化カリウム、水酸化ナトリウムのような無機塩基などのｐＨ調整剤を用いて行えばよい。
ｐＨ調整剤は、１種を単独で、又は２種以上を組み合わせて使用できる。
pH adjustment is possible with organic acids such as lactic acid, sodium lactate, citric acid, sodium citrate, malic acid, sodium malate, succinic acid, sodium succinate, tartaric acid, sodium tartrate; phosphoric acid, hydrochloric acid, sulfuric acid, etc. What is necessary is just to perform using pH adjusters, such as an inorganic acid. Moreover, what is necessary is just to use pH adjusters, such as organic bases, such as a triethanolamine, diisopropanolamine, and triisopropanolamine; inorganic bases, such as potassium hydroxide and sodium hydroxide, as needed.
A pH adjuster can be used individually by 1 type or in combination of 2 or more types.
容器
本発明の外用組成物を充填する容器は特に限定されない。医薬品外用剤、医薬部外品、化粧品用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、外用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、アクリル酸樹脂、テレフタル酸エステル、２，６−ナフタレンジカルボン酸エステル、ポリカーボネート、ポリメチルテルペン、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。
Container The container for filling the composition for external use of the present invention is not particularly limited. What is necessary is just to be used as a pharmaceutical external preparation, a quasi-drug, and a container for cosmetics.
As such a container material, for example, a part or all, preferably all, of the contact surface with the composition for external use is polyolefin, acrylic acid resin, terephthalic acid ester, 2,6-naphthalenedicarboxylic acid ester, polycarbonate, polymethyl. Consists of at least one material selected from the group consisting of terpene, fluororesin, polyvinyl chloride, polyamide, ABS resin, AS resin, polyacetal, modified polyphenylene ether, polyarylate, polysulfone, polyimide, cellulose acetate, aluminum, and glass Containers that are used.
中でも、組成物の経時的な着色を一層効果的に抑制できる点で、ポリエチレン（高密度ポリエチレン、低密度ポリエチレン、超低密度ポリエチレン、直鎖状低密度ポリエチレン、超高分子量ポリエチレンなどを含む）、ポリプロピレン（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などを含む）、及びエチレン・プロピレンコポリマーのようなポリオレフィン；ガラス等が好ましく、ポリエチレン、ポリプロピレン、ガラスがより好ましい。 Among them, polyethylene (including high-density polyethylene, low-density polyethylene, ultra-low-density polyethylene, linear low-density polyethylene, ultra-high molecular weight polyethylene, etc.) in that the coloration with time of the composition can be more effectively suppressed. Polypropylene (including isotactic polypropylene, syndiotactic polypropylene, atactic polypropylene, etc.) and polyolefin such as ethylene / propylene copolymer; glass is preferred, and polyethylene, polypropylene, and glass are more preferred.
使用方法
本発明の外用組成物の使用方法は、使用対象の毛髪の状態、頭皮の状態、年齢、性別などによって異なるが、例えば以下の方法とすればよい。
即ち、１日数回（例えば、約１〜５回、好ましくは１〜３回）、適量（例えば、約０．５〜２ｇ、又は０．５〜２ｍｌ）を皮膚（例えば、頭皮）に適用すればよい。また、ミノキシジルの１日使用量が、例えば約１〜１０００ｍｇとなるように組成物を皮膚（例えば、頭皮）に適用すればよい。適用方法は、剤型に合わせて、塗布、又は噴霧等とすればよい。適用期間は、例えば約７日間以上とすればよい。また、育毛効果が十分に得られるまで適用すればよく、例えば６か月以内、少なくとも４か月以内とすればよい。
本発明の外用組成物は、育毛、養毛、又は発毛のために使用できる。
Method of Use The method of using the composition for external use of the present invention varies depending on the condition of the hair to be used, the condition of the scalp, age, sex, etc., but for example, the following method may be used.
That is, several times a day (for example, about 1 to 5 times, preferably 1 to 3 times), an appropriate amount (for example, about 0.5 to 2 g, or 0.5 to 2 ml) is applied to the skin (for example, the scalp). That's fine. Moreover, what is necessary is just to apply a composition to skin (for example, scalp) so that the daily usage-amount of minoxidil may be about 1-1000 mg. The application method may be application or spraying according to the dosage form. The application period may be, for example, about 7 days or longer. Further, it may be applied until the hair-growth effect is sufficiently obtained, for example, within 6 months, at least within 4 months.
The composition for external use of the present invention can be used for hair growth, hair growth, or hair growth.
以下、本発明を実施例を挙げてより詳細に説明するが、本発明はこれらの実施例に限定されるものではない。 EXAMPLES Hereinafter, although an Example is given and this invention is demonstrated in detail, this invention is not limited to these Examples.
結晶析出・着色・使用感の評価
後掲の表１〜５に示す組成に従い、各成分を混合溶解し、５０ｍｌ容量の容器に充填した。容器材質は、原則、ガラスとし、容器材質の影響を検討する場合は、ガラス、ポリエチレン、ポリプロピレン、又はポリエチレンテレフタレート製の容器を用いた。
Evaluation of Crystal Precipitation / Coloring / Usage Feeling Each component was mixed and dissolved in accordance with the composition shown in Tables 1 to 5 below, and filled in a 50 ml container. In principle, the container material was glass, and when the influence of the container material was examined, a container made of glass, polyethylene, polypropylene, or polyethylene terephthalate was used.
低温安定性の評価は、各組成物を４℃の恒温器で約２か月静置した後、目視で結晶析出を観察することにより行った。結晶の析出が認められなかった場合を〇、認められた場合を×とした。 Evaluation of low temperature stability was performed by observing crystal precipitation visually after leaving each composition still at a 4 degreeC thermostat for about 2 months. The case where no precipitation of crystals was observed was marked with ◯, and the case where it was recognized was marked with x.
熱安定性の評価は、各組成物を４０℃の恒温器で約２か月静置した後、目視で黄色の着色の程度を観察することにより行った。着色が認められない場合を−、僅かな着色が認められた場合を＋、着色がより強く認められるごとに、＋の数を増やして表示した。 Evaluation of thermal stability was performed by observing the degree of yellow coloring visually after each composition was allowed to stand for about 2 months in a 40 ° C. thermostat. When the coloring was not recognized,-, when the slight coloring was recognized, +, and whenever the coloring was recognized more strongly, the number of + was increased.
光安定性の評価は、ＳＵＮＴＥＳＴＥＲ ＸＬＳ＋（東洋精機社）を用いて、３０℃以下で、３５０Ｗ／ｍ2を７２時間照射し、目視で黄色の着色の程度を観察することにより行った。着色が認められない場合を−、僅かな着色が認められた場合を＋、着色がより強く認められるごとに、＋の数を増やして表示した。 Evaluation of light stability was performed by irradiating 350 W / m 2 for 72 hours at 30 ° C. or lower using SUNTESTER XLS + (Toyo Seiki Co., Ltd.) and visually observing the degree of yellow coloring. When the coloring was not recognized,-, when the slight coloring was recognized, +, and whenever the coloring was recognized more strongly, the number of + was increased.
使用感の評価は、５名の社内の男性パネリストが、毛髪のある頭部に１ｍｌ塗布し、ベタツキ、製剤の皮膚へのなじみ、臭い、及び塗布後の感触を総合的に判定することで行った。５名中３名以上が使用上の問題がないと判定した場合を〇、５名中１〜２名が使用上の問題がないと判定した場合を△、使用上の問題がないと判定したパネリストが無かった場合を×とした。
結果を、表１〜５に併せて示す。表１〜５の各成分の含有量の単位は重量％である。
Evaluation of the feeling of use was performed by 5 in-house male panelists applying 1 ml to the head with hair, and comprehensively judging stickiness, familiarity of the preparation with the skin, smell, and feel after application. It was. When 3 or more out of 5 judges that there is no problem in use, △ When 1 or 2 out of 5 judges that there is no problem in use △, it was judged that there is no problem in use When there was no panelist, it was set as x.
A result is combined with Tables 1-5 and shown. The unit of the content of each component in Tables 1 to 5 is% by weight.
ＰＥ ：ポリエチレン
ＰＰ ：ポリプロピレン
表５が示すように、着色の程度は容器材質の影響を受け、プラスティック容器の中では、ポリエチレン容器、又はポリプロピレン容器を使用した場合、着色が一層効果的に抑制され、ガラス容器を使用した場合は、着色がさらに一層効果的に抑制された。
本発明の外用組成物は、比較的高濃度のミノキシジルを含みながら、ミノキシジルの低温下での結晶析出が抑制されており、かつ組成物の経時的な着色も抑制されている。さらに、使用感が良好であり、商品価値の高いものである。 Although the composition for external use of the present invention contains a relatively high concentration of minoxidil, crystal precipitation of minoxidil at a low temperature is suppressed, and coloring of the composition over time is also suppressed. Furthermore, the feeling of use is good and the product value is high.
Claims (7)
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