JP7465066B2 - Emulsion stabilizer - Google Patents
Emulsion stabilizer Download PDFInfo
- Publication number
- JP7465066B2 JP7465066B2 JP2019112049A JP2019112049A JP7465066B2 JP 7465066 B2 JP7465066 B2 JP 7465066B2 JP 2019112049 A JP2019112049 A JP 2019112049A JP 2019112049 A JP2019112049 A JP 2019112049A JP 7465066 B2 JP7465066 B2 JP 7465066B2
- Authority
- JP
- Japan
- Prior art keywords
- emulsion
- weight
- emulsion composition
- oil
- alcohol
- 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.)
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- 239000000839 emulsion Substances 0.000 title claims description 185
- 239000003381 stabilizer Substances 0.000 title claims description 51
- 239000000203 mixture Substances 0.000 claims description 91
- -1 polyoxyethylene Polymers 0.000 claims description 46
- 239000003921 oil Substances 0.000 claims description 41
- 235000019198 oils Nutrition 0.000 claims description 40
- NNJVILVZKWQKPM-UHFFFAOYSA-N Lidocaine Chemical compound CCN(CC)CC(=O)NC1=C(C)C=CC=C1C NNJVILVZKWQKPM-UHFFFAOYSA-N 0.000 claims description 31
- 229960004194 lidocaine Drugs 0.000 claims description 29
- 150000003839 salts Chemical class 0.000 claims description 21
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims description 18
- 239000007788 liquid Substances 0.000 claims description 17
- 229920003171 Poly (ethylene oxide) Polymers 0.000 claims description 14
- 238000000034 method Methods 0.000 claims description 14
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 claims description 13
- BXWNKGSJHAJOGX-UHFFFAOYSA-N hexadecan-1-ol Chemical compound CCCCCCCCCCCCCCCCO BXWNKGSJHAJOGX-UHFFFAOYSA-N 0.000 claims description 12
- 239000002562 thickening agent Substances 0.000 claims description 12
- 150000001298 alcohols Chemical class 0.000 claims description 11
- 150000005846 sugar alcohols Polymers 0.000 claims description 11
- 239000004094 surface-active agent Substances 0.000 claims description 11
- VBICKXHEKHSIBG-UHFFFAOYSA-N 1-monostearoylglycerol Chemical compound CCCCCCCCCCCCCCCCCC(=O)OCC(O)CO VBICKXHEKHSIBG-UHFFFAOYSA-N 0.000 claims description 10
- PUPZLCDOIYMWBV-UHFFFAOYSA-N (+/-)-1,3-Butanediol Chemical compound CC(O)CCO PUPZLCDOIYMWBV-UHFFFAOYSA-N 0.000 claims description 9
- 229960000541 cetyl alcohol Drugs 0.000 claims description 8
- 235000011187 glycerol Nutrition 0.000 claims description 8
- 230000006641 stabilisation Effects 0.000 claims description 8
- 238000011105 stabilization Methods 0.000 claims description 8
- 239000004359 castor oil Substances 0.000 claims description 7
- 235000019438 castor oil Nutrition 0.000 claims description 7
- ZEMPKEQAKRGZGQ-XOQCFJPHSA-N glycerol triricinoleate Natural products CCCCCC[C@@H](O)CC=CCCCCCCCC(=O)OC[C@@H](COC(=O)CCCCCCCC=CC[C@@H](O)CCCCCC)OC(=O)CCCCCCCC=CC[C@H](O)CCCCCC ZEMPKEQAKRGZGQ-XOQCFJPHSA-N 0.000 claims description 7
- 239000004166 Lanolin Substances 0.000 claims description 6
- 235000019388 lanolin Nutrition 0.000 claims description 6
- 229940039717 lanolin Drugs 0.000 claims description 6
- 238000002156 mixing Methods 0.000 claims description 6
- QIQXTHQIDYTFRH-UHFFFAOYSA-N octadecanoic acid Chemical compound CCCCCCCCCCCCCCCCCC(O)=O QIQXTHQIDYTFRH-UHFFFAOYSA-N 0.000 claims description 6
- 229940075507 glyceryl monostearate Drugs 0.000 claims description 5
- 239000001788 mono and diglycerides of fatty acids Substances 0.000 claims description 5
- 229940058015 1,3-butylene glycol Drugs 0.000 claims description 4
- HIQIXEFWDLTDED-UHFFFAOYSA-N 4-hydroxy-1-piperidin-4-ylpyrrolidin-2-one Chemical compound O=C1CC(O)CN1C1CCNCC1 HIQIXEFWDLTDED-UHFFFAOYSA-N 0.000 claims description 4
- 229920002675 Polyoxyl Polymers 0.000 claims description 4
- 229920002125 Sokalan® Polymers 0.000 claims description 4
- 239000000739 antihistaminic agent Substances 0.000 claims description 4
- 235000019437 butane-1,3-diol Nutrition 0.000 claims description 4
- 239000004205 dimethyl polysiloxane Substances 0.000 claims description 4
- 235000013870 dimethyl polysiloxane Nutrition 0.000 claims description 4
- 229940057995 liquid paraffin Drugs 0.000 claims description 4
- CKQVRZJOMJRTOY-UHFFFAOYSA-N octadecanoic acid;propane-1,2,3-triol Chemical compound OCC(O)CO.CCCCCCCCCCCCCCCCCC(O)=O CKQVRZJOMJRTOY-UHFFFAOYSA-N 0.000 claims description 4
- 229920000435 poly(dimethylsiloxane) Polymers 0.000 claims description 4
- 239000000230 xanthan gum Substances 0.000 claims description 4
- 235000010493 xanthan gum Nutrition 0.000 claims description 4
- 229920001285 xanthan gum Polymers 0.000 claims description 4
- 229940082509 xanthan gum Drugs 0.000 claims description 4
- GUGOEEXESWIERI-UHFFFAOYSA-N Terfenadine Chemical compound C1=CC(C(C)(C)C)=CC=C1C(O)CCCN1CCC(C(O)(C=2C=CC=CC=2)C=2C=CC=CC=2)CC1 GUGOEEXESWIERI-UHFFFAOYSA-N 0.000 claims description 3
- JDLSRXWHEBFHNC-UHFFFAOYSA-N Ufenamate Chemical compound CCCCOC(=O)C1=CC=CC=C1NC1=CC=CC(C(F)(F)F)=C1 JDLSRXWHEBFHNC-UHFFFAOYSA-N 0.000 claims description 3
- 230000001387 anti-histamine Effects 0.000 claims description 3
- 229950010121 ufenamate Drugs 0.000 claims description 3
- DGYSDXLCLKPUBR-SLPNHVECSA-N prednisolone valerate acetate Chemical compound C1CC2=CC(=O)C=C[C@]2(C)[C@@H]2[C@@H]1[C@@H]1CC[C@@](C(=O)COC(C)=O)(OC(=O)CCCC)[C@@]1(C)C[C@@H]2O DGYSDXLCLKPUBR-SLPNHVECSA-N 0.000 claims 2
- 229950008480 prednisolone valerate acetate Drugs 0.000 claims 2
- 235000015112 vegetable and seed oil Nutrition 0.000 claims 2
- 239000008158 vegetable oil Substances 0.000 claims 2
- 239000000306 component Substances 0.000 description 17
- 235000014113 dietary fatty acids Nutrition 0.000 description 13
- 239000000194 fatty acid Substances 0.000 description 13
- 229930195729 fatty acid Natural products 0.000 description 13
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 13
- 239000008346 aqueous phase Substances 0.000 description 12
- 238000000926 separation method Methods 0.000 description 11
- 239000007787 solid Substances 0.000 description 11
- 230000000087 stabilizing effect Effects 0.000 description 10
- 239000004615 ingredient Substances 0.000 description 9
- 230000000699 topical effect Effects 0.000 description 9
- 239000003814 drug Substances 0.000 description 8
- 239000003589 local anesthetic agent Substances 0.000 description 8
- 229940079593 drug Drugs 0.000 description 7
- 238000009472 formulation Methods 0.000 description 7
- 238000003860 storage Methods 0.000 description 7
- 239000002537 cosmetic Substances 0.000 description 6
- 239000002736 nonionic surfactant Substances 0.000 description 6
- 239000012071 phase Substances 0.000 description 6
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 description 5
- DNIAPMSPPWPWGF-UHFFFAOYSA-N monopropylene glycol Natural products CC(O)CO DNIAPMSPPWPWGF-UHFFFAOYSA-N 0.000 description 5
- LYCAIKOWRPUZTN-UHFFFAOYSA-N Ethylene glycol Chemical compound OCCO LYCAIKOWRPUZTN-UHFFFAOYSA-N 0.000 description 4
- 229920001214 Polysorbate 60 Polymers 0.000 description 4
- 229940121363 anti-inflammatory agent Drugs 0.000 description 4
- 239000002260 anti-inflammatory agent Substances 0.000 description 4
- 230000001754 anti-pyretic effect Effects 0.000 description 4
- 239000002221 antipyretic Substances 0.000 description 4
- 239000006071 cream Substances 0.000 description 4
- 230000000694 effects Effects 0.000 description 4
- 238000004519 manufacturing process Methods 0.000 description 4
- 229920002503 polyoxyethylene-polyoxypropylene Polymers 0.000 description 4
- 239000001993 wax Substances 0.000 description 4
- 239000004215 Carbon black (E152) Substances 0.000 description 3
- RTZKZFJDLAIYFH-UHFFFAOYSA-N Diethyl ether Chemical compound CCOCC RTZKZFJDLAIYFH-UHFFFAOYSA-N 0.000 description 3
- 125000004432 carbon atom Chemical group C* 0.000 description 3
- MTHSVFCYNBDYFN-UHFFFAOYSA-N diethylene glycol Chemical compound OCCOCCO MTHSVFCYNBDYFN-UHFFFAOYSA-N 0.000 description 3
- PRAKJMSDJKAYCZ-UHFFFAOYSA-N dodecahydrosqualene Natural products CC(C)CCCC(C)CCCC(C)CCCCC(C)CCCC(C)CCCC(C)C PRAKJMSDJKAYCZ-UHFFFAOYSA-N 0.000 description 3
- 239000010696 ester oil Substances 0.000 description 3
- 150000004665 fatty acids Chemical class 0.000 description 3
- 230000002349 favourable effect Effects 0.000 description 3
- 229930195733 hydrocarbon Natural products 0.000 description 3
- 150000002430 hydrocarbons Chemical class 0.000 description 3
- 239000006210 lotion Substances 0.000 description 3
- 238000002360 preparation method Methods 0.000 description 3
- 229920002545 silicone oil Polymers 0.000 description 3
- 238000003756 stirring Methods 0.000 description 3
- JNYAEWCLZODPBN-JGWLITMVSA-N (2r,3r,4s)-2-[(1r)-1,2-dihydroxyethyl]oxolane-3,4-diol Chemical compound OC[C@@H](O)[C@H]1OC[C@H](O)[C@H]1O JNYAEWCLZODPBN-JGWLITMVSA-N 0.000 description 2
- 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 2
- ULQISTXYYBZJSJ-UHFFFAOYSA-N 12-hydroxyoctadecanoic acid Chemical compound CCCCCCC(O)CCCCCCCCCCC(O)=O ULQISTXYYBZJSJ-UHFFFAOYSA-N 0.000 description 2
- WNWHHMBRJJOGFJ-UHFFFAOYSA-N 16-methylheptadecan-1-ol Chemical compound CC(C)CCCCCCCCCCCCCCCO WNWHHMBRJJOGFJ-UHFFFAOYSA-N 0.000 description 2
- XDOFQFKRPWOURC-UHFFFAOYSA-N 16-methylheptadecanoic acid Chemical compound CC(C)CCCCCCCCCCCCCCC(O)=O XDOFQFKRPWOURC-UHFFFAOYSA-N 0.000 description 2
- LVYLCBNXHHHPSB-UHFFFAOYSA-N 2-hydroxyethyl salicylate Chemical compound OCCOC(=O)C1=CC=CC=C1O LVYLCBNXHHHPSB-UHFFFAOYSA-N 0.000 description 2
- 239000004698 Polyethylene Substances 0.000 description 2
- 239000002253 acid Substances 0.000 description 2
- 150000005215 alkyl ethers Chemical class 0.000 description 2
- POJWUDADGALRAB-UHFFFAOYSA-N allantoin Chemical compound NC(=O)NC1NC(=O)NC1=O POJWUDADGALRAB-UHFFFAOYSA-N 0.000 description 2
- 230000003110 anti-inflammatory effect Effects 0.000 description 2
- KVYGGMBOZFWZBQ-UHFFFAOYSA-N benzyl nicotinate Chemical compound C=1C=CN=CC=1C(=O)OCC1=CC=CC=C1 KVYGGMBOZFWZBQ-UHFFFAOYSA-N 0.000 description 2
- YKPUWZUDDOIDPM-SOFGYWHQSA-N capsaicin Chemical compound COC1=CC(CNC(=O)CCCC\C=C\C(C)C)=CC=C1O YKPUWZUDDOIDPM-SOFGYWHQSA-N 0.000 description 2
- GPLRAVKSCUXZTP-UHFFFAOYSA-N diglycerol Chemical compound OCC(O)COCC(O)CO GPLRAVKSCUXZTP-UHFFFAOYSA-N 0.000 description 2
- 239000002612 dispersion medium Substances 0.000 description 2
- NOPFSRXAKWQILS-UHFFFAOYSA-N docosan-1-ol Chemical compound CCCCCCCCCCCCCCCCCCCCCCO NOPFSRXAKWQILS-UHFFFAOYSA-N 0.000 description 2
- UKMSUNONTOPOIO-UHFFFAOYSA-N docosanoic acid Chemical compound CCCCCCCCCCCCCCCCCCCCCC(O)=O UKMSUNONTOPOIO-UHFFFAOYSA-N 0.000 description 2
- POULHZVOKOAJMA-UHFFFAOYSA-N dodecanoic acid Chemical compound CCCCCCCCCCCC(O)=O POULHZVOKOAJMA-UHFFFAOYSA-N 0.000 description 2
- 238000005516 engineering process Methods 0.000 description 2
- 239000000499 gel Substances 0.000 description 2
- 125000003976 glyceryl group Chemical group [H]C([*])([H])C(O[H])([H])C(O[H])([H])[H] 0.000 description 2
- 238000010438 heat treatment Methods 0.000 description 2
- IPCSVZSSVZVIGE-UHFFFAOYSA-N hexadecanoic acid Chemical compound CCCCCCCCCCCCCCCC(O)=O IPCSVZSSVZVIGE-UHFFFAOYSA-N 0.000 description 2
- JYGXADMDTFJGBT-VWUMJDOOSA-N hydrocortisone Chemical compound O=C1CC[C@]2(C)[C@H]3[C@@H](O)C[C@](C)([C@@](CC4)(O)C(=O)CO)[C@@H]4[C@@H]3CCC2=C1 JYGXADMDTFJGBT-VWUMJDOOSA-N 0.000 description 2
- CGIGDMFJXJATDK-UHFFFAOYSA-N indomethacin Chemical compound CC1=C(CC(O)=O)C2=CC(OC)=CC=C2N1C(=O)C1=CC=C(Cl)C=C1 CGIGDMFJXJATDK-UHFFFAOYSA-N 0.000 description 2
- JVTAAEKCZFNVCJ-UHFFFAOYSA-N lactic acid Chemical compound CC(O)C(O)=O JVTAAEKCZFNVCJ-UHFFFAOYSA-N 0.000 description 2
- 229960004393 lidocaine hydrochloride Drugs 0.000 description 2
- YECIFGHRMFEPJK-UHFFFAOYSA-N lidocaine hydrochloride monohydrate Chemical compound O.[Cl-].CC[NH+](CC)CC(=O)NC1=C(C)C=CC=C1C YECIFGHRMFEPJK-UHFFFAOYSA-N 0.000 description 2
- OSWPMRLSEDHDFF-UHFFFAOYSA-N methyl salicylate Chemical compound COC(=O)C1=CC=CC=C1O OSWPMRLSEDHDFF-UHFFFAOYSA-N 0.000 description 2
- GLDOVTGHNKAZLK-UHFFFAOYSA-N octadecan-1-ol Chemical compound CCCCCCCCCCCCCCCCCCO GLDOVTGHNKAZLK-UHFFFAOYSA-N 0.000 description 2
- 239000002674 ointment Substances 0.000 description 2
- SSZBUIDZHHWXNJ-UHFFFAOYSA-N palmityl stearate Chemical compound CCCCCCCCCCCCCCCCCC(=O)OCCCCCCCCCCCCCCCC SSZBUIDZHHWXNJ-UHFFFAOYSA-N 0.000 description 2
- 235000019271 petrolatum Nutrition 0.000 description 2
- 238000005191 phase separation Methods 0.000 description 2
- 229920001983 poloxamer Polymers 0.000 description 2
- 229920000573 polyethylene Polymers 0.000 description 2
- 229920001223 polyethylene glycol Polymers 0.000 description 2
- 235000010482 polyoxyethylene sorbitan monooleate Nutrition 0.000 description 2
- 239000000244 polyoxyethylene sorbitan monooleate Substances 0.000 description 2
- 229920000053 polysorbate 80 Polymers 0.000 description 2
- YGSDEFSMJLZEOE-UHFFFAOYSA-N salicylic acid Chemical compound OC(=O)C1=CC=CC=C1O YGSDEFSMJLZEOE-UHFFFAOYSA-N 0.000 description 2
- HLZKNKRTKFSKGZ-UHFFFAOYSA-N tetradecan-1-ol Chemical compound CCCCCCCCCCCCCCO HLZKNKRTKFSKGZ-UHFFFAOYSA-N 0.000 description 2
- NOOLISFMXDJSKH-UTLUCORTSA-N (+)-Neomenthol Chemical compound CC(C)[C@@H]1CC[C@@H](C)C[C@@H]1O NOOLISFMXDJSKH-UTLUCORTSA-N 0.000 description 1
- KIUKXJAPPMFGSW-DNGZLQJQSA-N (2S,3S,4S,5R,6R)-6-[(2S,3R,4R,5S,6R)-3-Acetamido-2-[(2S,3S,4R,5R,6R)-6-[(2R,3R,4R,5S,6R)-3-acetamido-2,5-dihydroxy-6-(hydroxymethyl)oxan-4-yl]oxy-2-carboxy-4,5-dihydroxyoxan-3-yl]oxy-5-hydroxy-6-(hydroxymethyl)oxan-4-yl]oxy-3,4,5-trihydroxyoxane-2-carboxylic acid Chemical compound CC(=O)N[C@H]1[C@H](O)O[C@H](CO)[C@@H](O)[C@@H]1O[C@H]1[C@H](O)[C@@H](O)[C@H](O[C@H]2[C@@H]([C@@H](O[C@H]3[C@@H]([C@@H](O)[C@H](O)[C@H](O3)C(O)=O)O)[C@H](O)[C@@H](CO)O2)NC(C)=O)[C@@H](C(O)=O)O1 KIUKXJAPPMFGSW-DNGZLQJQSA-N 0.000 description 1
- CUNWUEBNSZSNRX-RKGWDQTMSA-N (2r,3r,4r,5s)-hexane-1,2,3,4,5,6-hexol;(z)-octadec-9-enoic acid Chemical compound OC[C@H](O)[C@@H](O)[C@H](O)[C@H](O)CO.OC[C@H](O)[C@@H](O)[C@H](O)[C@H](O)CO.CCCCCCCC\C=C/CCCCCCCC(O)=O.CCCCCCCC\C=C/CCCCCCCC(O)=O.CCCCCCCC\C=C/CCCCCCCC(O)=O CUNWUEBNSZSNRX-RKGWDQTMSA-N 0.000 description 1
- QYIXCDOBOSTCEI-QCYZZNICSA-N (5alpha)-cholestan-3beta-ol Chemical compound C([C@@H]1CC2)[C@@H](O)CC[C@]1(C)[C@@H]1[C@@H]2[C@@H]2CC[C@H]([C@H](C)CCCC(C)C)[C@@]2(C)CC1 QYIXCDOBOSTCEI-QCYZZNICSA-N 0.000 description 1
- YYGNTYWPHWGJRM-UHFFFAOYSA-N (6E,10E,14E,18E)-2,6,10,15,19,23-hexamethyltetracosa-2,6,10,14,18,22-hexaene Chemical compound CC(C)=CCCC(C)=CCCC(C)=CCCC=C(C)CCC=C(C)CCC=C(C)C YYGNTYWPHWGJRM-UHFFFAOYSA-N 0.000 description 1
- OHILSKSRDDTCIR-WKSAPEMMSA-N (8s,9r,10s,11s,13s,14s,16r,17r)-9-fluoro-11,17-dihydroxy-17-(2-hydroxyacetyl)-10,13,16-trimethyl-6,7,8,11,12,14,15,16-octahydrocyclopenta[a]phenanthren-3-one;hydrochloride Chemical compound Cl.C1CC2=CC(=O)C=C[C@]2(C)[C@]2(F)[C@@H]1[C@@H]1C[C@@H](C)[C@@](C(=O)CO)(O)[C@@]1(C)C[C@@H]2O OHILSKSRDDTCIR-WKSAPEMMSA-N 0.000 description 1
- ALSTYHKOOCGGFT-KTKRTIGZSA-N (9Z)-octadecen-1-ol Chemical compound CCCCCCCC\C=C/CCCCCCCCO ALSTYHKOOCGGFT-KTKRTIGZSA-N 0.000 description 1
- WRIDQFICGBMAFQ-UHFFFAOYSA-N (E)-8-Octadecenoic acid Natural products CCCCCCCCCC=CCCCCCCC(O)=O WRIDQFICGBMAFQ-UHFFFAOYSA-N 0.000 description 1
- FFJCNSLCJOQHKM-CLFAGFIQSA-N (z)-1-[(z)-octadec-9-enoxy]octadec-9-ene Chemical compound CCCCCCCC\C=C/CCCCCCCCOCCCCCCCC\C=C/CCCCCCCC FFJCNSLCJOQHKM-CLFAGFIQSA-N 0.000 description 1
- ZORQXIQZAOLNGE-UHFFFAOYSA-N 1,1-difluorocyclohexane Chemical compound FC1(F)CCCCC1 ZORQXIQZAOLNGE-UHFFFAOYSA-N 0.000 description 1
- DURPTKYDGMDSBL-UHFFFAOYSA-N 1-butoxybutane Chemical compound CCCCOCCCC DURPTKYDGMDSBL-UHFFFAOYSA-N 0.000 description 1
- LEBVLXFERQHONN-UHFFFAOYSA-N 1-butyl-N-(2,6-dimethylphenyl)piperidine-2-carboxamide Chemical compound CCCCN1CCCCC1C(=O)NC1=C(C)C=CC=C1C LEBVLXFERQHONN-UHFFFAOYSA-N 0.000 description 1
- ZXNAIPHYBVMMPY-KTKRTIGZSA-N 1-erucoylglycerol Chemical compound CCCCCCCC\C=C/CCCCCCCCCCCC(=O)OCC(O)CO ZXNAIPHYBVMMPY-KTKRTIGZSA-N 0.000 description 1
- IXPNQXFRVYWDDI-UHFFFAOYSA-N 1-methyl-2,4-dioxo-1,3-diazinane-5-carboximidamide Chemical compound CN1CC(C(N)=N)C(=O)NC1=O IXPNQXFRVYWDDI-UHFFFAOYSA-N 0.000 description 1
- RZRNAYUHWVFMIP-KTKRTIGZSA-N 1-oleoylglycerol Chemical compound CCCCCCCC\C=C/CCCCCCCC(=O)OCC(O)CO RZRNAYUHWVFMIP-KTKRTIGZSA-N 0.000 description 1
- FRPZMMHWLSIFAZ-UHFFFAOYSA-N 10-undecenoic acid Chemical compound OC(=O)CCCCCCCCC=C FRPZMMHWLSIFAZ-UHFFFAOYSA-N 0.000 description 1
- 229940114072 12-hydroxystearic acid Drugs 0.000 description 1
- JNAYPSWVMNJOPQ-UHFFFAOYSA-N 2,3-bis(16-methylheptadecanoyloxy)propyl 16-methylheptadecanoate Chemical compound CC(C)CCCCCCCCCCCCCCC(=O)OCC(OC(=O)CCCCCCCCCCCCCCC(C)C)COC(=O)CCCCCCCCCCCCCCC(C)C JNAYPSWVMNJOPQ-UHFFFAOYSA-N 0.000 description 1
- CIVCELMLGDGMKZ-UHFFFAOYSA-N 2,4-dichloro-6-methylpyridine-3-carboxylic acid Chemical compound CC1=CC(Cl)=C(C(O)=O)C(Cl)=N1 CIVCELMLGDGMKZ-UHFFFAOYSA-N 0.000 description 1
- ILCOCZBHMDEIAI-UHFFFAOYSA-N 2-(2-octadecoxyethoxy)ethanol Chemical compound CCCCCCCCCCCCCCCCCCOCCOCCO ILCOCZBHMDEIAI-UHFFFAOYSA-N 0.000 description 1
- FLPJVCMIKUWSDR-UHFFFAOYSA-N 2-(4-formylphenoxy)acetamide Chemical compound NC(=O)COC1=CC=C(C=O)C=C1 FLPJVCMIKUWSDR-UHFFFAOYSA-N 0.000 description 1
- FKOKUHFZNIUSLW-UHFFFAOYSA-N 2-Hydroxypropyl stearate Chemical compound CCCCCCCCCCCCCCCCCC(=O)OCC(C)O FKOKUHFZNIUSLW-UHFFFAOYSA-N 0.000 description 1
- XTIUAXFQEAMQRU-UHFFFAOYSA-N 2-[4-(butylamino)benzoyl]oxyethyl-diethylazanium;chloride Chemical compound [Cl-].CCCCNC1=CC=C(C(=O)OCC[NH+](CC)CC)C=C1 XTIUAXFQEAMQRU-UHFFFAOYSA-N 0.000 description 1
- MSWZFWKMSRAUBD-IVMDWMLBSA-N 2-amino-2-deoxy-D-glucopyranose Chemical compound N[C@H]1C(O)O[C@H](CO)[C@@H](O)[C@@H]1O MSWZFWKMSRAUBD-IVMDWMLBSA-N 0.000 description 1
- SPCKHVPPRJWQRZ-UHFFFAOYSA-N 2-benzhydryloxy-n,n-dimethylethanamine;2-hydroxypropane-1,2,3-tricarboxylic acid Chemical compound OC(=O)CC(O)(C(O)=O)CC(O)=O.C=1C=CC=CC=1C(OCCN(C)C)C1=CC=CC=C1 SPCKHVPPRJWQRZ-UHFFFAOYSA-N 0.000 description 1
- ICIDSZQHPUZUHC-UHFFFAOYSA-N 2-octadecoxyethanol Chemical compound CCCCCCCCCCCCCCCCCCOCCO ICIDSZQHPUZUHC-UHFFFAOYSA-N 0.000 description 1
- GECRRQVLQHRVNH-MRCUWXFGSA-N 2-octyldodecyl (z)-octadec-9-enoate Chemical compound CCCCCCCCCCC(CCCCCCCC)COC(=O)CCCCCCC\C=C/CCCCCCCC GECRRQVLQHRVNH-MRCUWXFGSA-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
- LQJBNNIYVWPHFW-UHFFFAOYSA-N 20:1omega9c fatty acid Natural products CCCCCCCCCCC=CCCCCCCCC(O)=O LQJBNNIYVWPHFW-UHFFFAOYSA-N 0.000 description 1
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- 229960003511 macrogol Drugs 0.000 description 1
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- 239000012533 medium component Substances 0.000 description 1
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- INWLQCZOYSRPNW-UHFFFAOYSA-N mepivacaine Chemical compound CN1CCCCC1C(=O)NC1=C(C)C=CC=C1C INWLQCZOYSRPNW-UHFFFAOYSA-N 0.000 description 1
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- 239000004200 microcrystalline wax Substances 0.000 description 1
- 235000019808 microcrystalline wax Nutrition 0.000 description 1
- 229940114937 microcrystalline wax Drugs 0.000 description 1
- 229940043348 myristyl alcohol Drugs 0.000 description 1
- 229940078812 myristyl myristate Drugs 0.000 description 1
- WQEPLUUGTLDZJY-UHFFFAOYSA-N n-Pentadecanoic acid Natural products CCCCCCCCCCCCCCC(O)=O WQEPLUUGTLDZJY-UHFFFAOYSA-N 0.000 description 1
- JXTPJDDICSTXJX-UHFFFAOYSA-N n-Triacontane Natural products CCCCCCCCCCCCCCCCCCCCCCCCCCCCCC JXTPJDDICSTXJX-UHFFFAOYSA-N 0.000 description 1
- TZBAVQKIEKDGFH-UHFFFAOYSA-N n-[2-(diethylamino)ethyl]-1-benzothiophene-2-carboxamide;hydrochloride Chemical compound [Cl-].C1=CC=C2SC(C(=O)NCC[NH+](CC)CC)=CC2=C1 TZBAVQKIEKDGFH-UHFFFAOYSA-N 0.000 description 1
- GOQYKNQRPGWPLP-UHFFFAOYSA-N n-heptadecyl alcohol Natural products CCCCCCCCCCCCCCCCCO GOQYKNQRPGWPLP-UHFFFAOYSA-N 0.000 description 1
- FBUKVWPVBMHYJY-UHFFFAOYSA-M nonanoate Chemical compound CCCCCCCCC([O-])=O FBUKVWPVBMHYJY-UHFFFAOYSA-M 0.000 description 1
- 239000007764 o/w emulsion Substances 0.000 description 1
- OQCDKBAXFALNLD-UHFFFAOYSA-N octadecanoic acid Natural products CCCCCCCC(C)CCCCCCCCC(O)=O OQCDKBAXFALNLD-UHFFFAOYSA-N 0.000 description 1
- NKBWPOSQERPBFI-UHFFFAOYSA-N octadecyl octadecanoate Chemical compound CCCCCCCCCCCCCCCCCCOC(=O)CCCCCCCCCCCCCCCCC NKBWPOSQERPBFI-UHFFFAOYSA-N 0.000 description 1
- HMMGMWAXVFQUOA-UHFFFAOYSA-N octamethylcyclotetrasiloxane Chemical compound C[Si]1(C)O[Si](C)(C)O[Si](C)(C)O[Si](C)(C)O1 HMMGMWAXVFQUOA-UHFFFAOYSA-N 0.000 description 1
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- ZQPPMHVWECSIRJ-KTKRTIGZSA-N oleic acid Chemical compound CCCCCCCC\C=C/CCCCCCCC(O)=O ZQPPMHVWECSIRJ-KTKRTIGZSA-N 0.000 description 1
- 229940055577 oleyl alcohol Drugs 0.000 description 1
- XMLQWXUVTXCDDL-UHFFFAOYSA-N oleyl alcohol Natural products CCCCCCC=CCCCCCCCCCCO XMLQWXUVTXCDDL-UHFFFAOYSA-N 0.000 description 1
- 150000007524 organic acids Chemical class 0.000 description 1
- 150000007530 organic bases Chemical class 0.000 description 1
- 229950006098 orthocaine Drugs 0.000 description 1
- 229960000986 oxetacaine Drugs 0.000 description 1
- 229940098695 palmitic acid Drugs 0.000 description 1
- FJKROLUGYXJWQN-UHFFFAOYSA-N papa-hydroxy-benzoic acid Natural products OC(=O)C1=CC=C(O)C=C1 FJKROLUGYXJWQN-UHFFFAOYSA-N 0.000 description 1
- 239000012188 paraffin wax Substances 0.000 description 1
- 229940116257 pepper extract Drugs 0.000 description 1
- 229940066842 petrolatum Drugs 0.000 description 1
- 239000008194 pharmaceutical composition Substances 0.000 description 1
- 230000035790 physiological processes and functions Effects 0.000 description 1
- 229920000259 polyoxyethylene lauryl ether Polymers 0.000 description 1
- 235000010486 polyoxyethylene sorbitan monolaurate Nutrition 0.000 description 1
- 239000000256 polyoxyethylene sorbitan monolaurate Substances 0.000 description 1
- 235000010989 polyoxyethylene sorbitan monostearate Nutrition 0.000 description 1
- 239000001818 polyoxyethylene sorbitan monostearate Substances 0.000 description 1
- 229920001296 polysiloxane Polymers 0.000 description 1
- 239000001267 polyvinylpyrrolidone Substances 0.000 description 1
- 229920000036 polyvinylpyrrolidone Polymers 0.000 description 1
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 description 1
- 229960002800 prednisolone acetate Drugs 0.000 description 1
- BOFKYYWJAOZDPB-FZNHGJLXSA-N prednival Chemical compound C1CC2=CC(=O)C=C[C@]2(C)[C@@H]2[C@@H]1[C@@H]1CC[C@@](C(=O)CO)(OC(=O)CCCC)[C@@]1(C)C[C@@H]2O BOFKYYWJAOZDPB-FZNHGJLXSA-N 0.000 description 1
- 239000003755 preservative agent Substances 0.000 description 1
- 229960004919 procaine Drugs 0.000 description 1
- MFDFERRIHVXMIY-UHFFFAOYSA-N procaine Chemical compound CCN(CC)CCOC(=O)C1=CC=C(N)C=C1 MFDFERRIHVXMIY-UHFFFAOYSA-N 0.000 description 1
- 230000001737 promoting effect Effects 0.000 description 1
- 229960003981 proparacaine Drugs 0.000 description 1
- 229940093625 propylene glycol monostearate Drugs 0.000 description 1
- 239000004170 rice bran wax Substances 0.000 description 1
- 235000019384 rice bran wax Nutrition 0.000 description 1
- 229960004889 salicylic acid Drugs 0.000 description 1
- 239000012176 shellac wax Substances 0.000 description 1
- 235000010413 sodium alginate Nutrition 0.000 description 1
- 239000000661 sodium alginate Substances 0.000 description 1
- 229940005550 sodium alginate Drugs 0.000 description 1
- 235000019812 sodium carboxymethyl cellulose Nutrition 0.000 description 1
- 229920001027 sodium carboxymethylcellulose Polymers 0.000 description 1
- 239000004328 sodium tetraborate Substances 0.000 description 1
- 235000010339 sodium tetraborate Nutrition 0.000 description 1
- JGMJQSFLQWGYMQ-UHFFFAOYSA-M sodium;2,6-dichloro-n-phenylaniline;acetate Chemical compound [Na+].CC([O-])=O.ClC1=CC=CC(Cl)=C1NC1=CC=CC=C1 JGMJQSFLQWGYMQ-UHFFFAOYSA-M 0.000 description 1
- 239000002904 solvent Substances 0.000 description 1
- 229940035044 sorbitan monolaurate Drugs 0.000 description 1
- 235000011069 sorbitan monooleate Nutrition 0.000 description 1
- 239000001593 sorbitan monooleate Substances 0.000 description 1
- 229940035049 sorbitan monooleate Drugs 0.000 description 1
- 235000011071 sorbitan monopalmitate Nutrition 0.000 description 1
- 239000001570 sorbitan monopalmitate Substances 0.000 description 1
- 229940031953 sorbitan monopalmitate Drugs 0.000 description 1
- 235000011076 sorbitan monostearate Nutrition 0.000 description 1
- 239000001587 sorbitan monostearate Substances 0.000 description 1
- 229940035048 sorbitan monostearate Drugs 0.000 description 1
- 229960005078 sorbitan sesquioleate Drugs 0.000 description 1
- 235000019337 sorbitan trioleate Nutrition 0.000 description 1
- 229960000391 sorbitan trioleate Drugs 0.000 description 1
- 229940032094 squalane Drugs 0.000 description 1
- 229940031439 squalene Drugs 0.000 description 1
- TUHBEKDERLKLEC-UHFFFAOYSA-N squalene Natural products CC(=CCCC(=CCCC(=CCCC=C(/C)CCC=C(/C)CC=C(C)C)C)C)C TUHBEKDERLKLEC-UHFFFAOYSA-N 0.000 description 1
- 229940098760 steareth-2 Drugs 0.000 description 1
- 229940100458 steareth-21 Drugs 0.000 description 1
- 239000008117 stearic acid Substances 0.000 description 1
- 229960004274 stearic acid Drugs 0.000 description 1
- 150000003431 steroids Chemical class 0.000 description 1
- SEEPANYCNGTZFQ-UHFFFAOYSA-N sulfadiazine Chemical compound C1=CC(N)=CC=C1S(=O)(=O)NC1=NC=CC=N1 SEEPANYCNGTZFQ-UHFFFAOYSA-N 0.000 description 1
- 229960004306 sulfadiazine Drugs 0.000 description 1
- 229960002372 tetracaine Drugs 0.000 description 1
- GKCBAIGFKIBETG-UHFFFAOYSA-N tetracaine Chemical compound CCCCNC1=CC=C(C(=O)OCCN(C)C)C=C1 GKCBAIGFKIBETG-UHFFFAOYSA-N 0.000 description 1
- TUNFSRHWOTWDNC-HKGQFRNVSA-N tetradecanoic acid Chemical compound CCCCCCCCCCCCC[14C](O)=O TUNFSRHWOTWDNC-HKGQFRNVSA-N 0.000 description 1
- DZKXJUASMGQEMA-UHFFFAOYSA-N tetradecyl tetradecanoate Chemical compound CCCCCCCCCCCCCCOC(=O)CCCCCCCCCCCCC DZKXJUASMGQEMA-UHFFFAOYSA-N 0.000 description 1
- GYDJEQRTZSCIOI-LJGSYFOKSA-N tranexamic acid Chemical compound NC[C@H]1CC[C@H](C(O)=O)CC1 GYDJEQRTZSCIOI-LJGSYFOKSA-N 0.000 description 1
- 229960000401 tranexamic acid Drugs 0.000 description 1
- 229960002703 undecylenic acid Drugs 0.000 description 1
- 239000011782 vitamin Substances 0.000 description 1
- 235000013343 vitamin Nutrition 0.000 description 1
- 229940088594 vitamin Drugs 0.000 description 1
- 229930003231 vitamin Natural products 0.000 description 1
- 235000019155 vitamin A Nutrition 0.000 description 1
- 239000011719 vitamin A Substances 0.000 description 1
- 229940072358 xylocaine 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
Landscapes
- Medicinal Preparation (AREA)
- Cosmetics (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Description
本発明は、乳化組成物の性状を安定化させるためのリドカインの用途に関する。 The present invention relates to the use of lidocaine to stabilize the properties of an emulsion composition.
乳化組成物は、水性成分と油性成分を配合でき、様々な製剤処方に対応できると共に、皮膚に適用した際の使用感も優れている。このため、乳化組成物は、外用医薬品や化粧料の分野において汎用されている。しかしながら、乳化組成物は、長期間保存すると、分離が生じ易く、乳化安定性の点で欠点がある。 Emulsion compositions can be blended with aqueous and oily components, can be used in a variety of formulations, and have an excellent feel when applied to the skin. For this reason, emulsion compositions are widely used in the fields of topical medicines and cosmetics. However, emulsion compositions are prone to separation when stored for long periods of time, and have drawbacks in terms of emulsion stability.
乳化安定性を向上させる方法としては、乳化組成物の粘度を高くする方法が用いられている。しかしながら、高粘度の乳化組成物を製造するには、特定量以上の高級アルコールを配合するか、多量の増粘剤を配合する必要がある。そして、単なる粘度の向上による乳化安定化には限界があり依然として満足できる乳化安定性を備えているとはいえない。更に、多量の増粘剤の配合は、乳化組成物にべたつきを生じさせ、使用感の低下を招くことになる。 As a method for improving emulsion stability, a method of increasing the viscosity of the emulsion composition is used. However, to produce an emulsion composition with a high viscosity, it is necessary to blend a specific amount or more of higher alcohol or to blend a large amount of thickener. Furthermore, there is a limit to the emulsion stabilization that can be achieved by simply increasing viscosity, and it cannot be said that the emulsion stability is still satisfactory. Furthermore, blending a large amount of thickener causes the emulsion composition to become sticky, resulting in a decrease in the feeling of use.
そこで、特定量以上の高級アルコールの配合や多量の増粘剤の配合を要さずに高粘度の乳化組成物を製造する方法として、特許文献１に、非イオン性界面活性剤、炭素数１６以上の直鎖状高級アルコール、及び油分を含む油相と、水を含む水相とを７０℃以上の温度で乳化してＯ／Ｗ乳化物を調製し、当該Ｏ／Ｗ乳化物を攪拌しながら冷却し、水相中で油相がαゲルを形成する温度領域のピーク温度以上７０℃未満で撹拌を停止することによって、優れた乳化安定性を有する高粘度Ｏ／Ｗクリームを得る方法が記載されている。しかしながら、この方法は乳化工程以降の操作が煩雑であり、製造簡便性の点で欠点がある。 In this regard, Patent Document 1 describes a method for producing a high-viscosity emulsion composition without the need to incorporate a specific amount or more of higher alcohol or a large amount of thickener, in which an oil phase containing a nonionic surfactant, a linear higher alcohol having 16 or more carbon atoms, and an oil component and an aqueous phase containing water are emulsified at a temperature of 70°C or higher to prepare an O/W emulsion, the O/W emulsion is cooled with stirring, and stirring is stopped at a temperature above the peak temperature in the temperature range where the oil phase forms an α-gel in the aqueous phase and below 70°C, thereby obtaining a high-viscosity O/W cream with excellent emulsion stability. However, this method has drawbacks in terms of ease of production, as the operations after the emulsification process are complicated.
このような従来技術を背景として、簡易な手法で優れた乳化安定性を備えさせる製剤化技術の開発が望まれていた。 Given this background of conventional technology, there was a need to develop a formulation technology that provides excellent emulsion stability using a simple method.
一方、リドカインは、局所麻酔剤又は解熱消炎剤として、医薬品又は医薬部外品の皮膚外用剤に配合して用いられている。例えば、特許文献２には、トラネキサム酸またはその塩、および局所麻酔剤を含有する抗炎症用医薬組成物が記載されており、局所麻酔剤としてリドカインが用いられることが記載されている。特許文献３には、メントールと媒体成分と経皮吸収性薬効成分とを含む清涼感付与外用組成物であって、が記載されており、経皮吸収性薬効成分としてリドカイン等の解熱消炎剤が用いられることが記載されている。特許文献４には、所定量の抗ヒスタミン薬の塩酸塩及び局所麻酔薬の塩酸塩の少なくともいずれか、所定量のエタノール、所定量のホウ砂及び／又はホウ酸、並びに有機酸及び／又は有機塩基を含有する外用組成物が記載されており、局所麻酔薬の塩酸塩としてリドカイン塩酸塩が用いられることが記載されている。 On the other hand, lidocaine is used as a local anesthetic or antipyretic anti-inflammatory agent by being mixed into pharmaceutical or quasi-drug skin topical preparations. For example, Patent Document 2 describes an anti-inflammatory pharmaceutical composition containing tranexamic acid or its salt and a local anesthetic, and describes the use of lidocaine as the local anesthetic. Patent Document 3 describes a cooling sensation-imparting topical composition containing menthol, a medium component, and a transdermally absorbable medicinal ingredient, and describes the use of an antipyretic anti-inflammatory agent such as lidocaine as the transdermally absorbable medicinal ingredient. Patent Document 4 describes a topical composition containing a predetermined amount of at least one of an antihistamine hydrochloride and a local anesthetic hydrochloride, a predetermined amount of ethanol, a predetermined amount of borax and/or boric acid, and an organic acid and/or an organic base, and describes the use of lidocaine hydrochloride as the local anesthetic hydrochloride.
本発明の目的は、優れた乳化安定性を有する乳化組成物を提供することである。 The object of the present invention is to provide an emulsion composition having excellent emulsion stability.
本発明者は、鋭意検討を行ったところ、驚くべきことに、これまで乳化安定化効果が知られていなかったリドカイン及び／又はその塩を乳化組成物に配合することによって、乳化組成物の乳化安定性が向上することを見出した。本発明は、この知見に基づいて更に検討を重ねることにより完成したものである。 The inventors of the present invention conducted extensive research and surprisingly found that the emulsion stability of an emulsion composition can be improved by incorporating lidocaine and/or a salt thereof, which was not previously known to have an emulsion stabilizing effect, into the emulsion composition. The present invention was completed through further research based on this finding.
即ち、本発明は、下記に掲げる態様の発明を提供する。
項１． リドカイン及び／又はその塩を含有する、乳化組成物の乳化安定化剤。
項２． 前記乳化組成物が、高級アルコール、エステル油、液状炭化水素油、及びシリコーン油からなる群より選択される油分を含有する、項１に記載の乳化組成物の乳化安定化剤。
項３． 前記乳化組成物が、グリセリン脂肪酸エステル、ポリオキシエチレン硬化ヒマシ油、ポリエチレングリコール脂肪酸エステルからなる群より選択されるノニオン性界面活性剤を含有する、項１又は２に記載の乳化組成物の乳化安定化剤。
項４． 前記リドカイン及び／又はその塩が、総量で、前記乳化組成物中０．１～５．０重量％となるように用いられる、項１～３のいずれかに記載の乳化組成物の乳化安定化剤。
項５． 乳化組成物中にリドカイン及び／又はその塩を配合する、乳化安定化方法。
That is, the present invention provides the following aspects.
Item 1. An emulsion stabilizer for an emulsion composition, comprising lidocaine and/or a salt thereof.
Item 2. The emulsion stabilizer for an emulsion composition according to Item 1, wherein the emulsion composition contains an oil component selected from the group consisting of higher alcohols, ester oils, liquid hydrocarbon oils, and silicone oils.
Item 3. The emulsion stabilizer for an emulsion composition according to Item 1 or 2, wherein the emulsion composition contains a nonionic surfactant selected from the group consisting of glycerin fatty acid esters, polyoxyethylene hydrogenated castor oil, and polyethylene glycol fatty acid esters.
Item 4. The emulsion stabilizer for an emulsion composition according to any one of Items 1 to 3, wherein the lidocaine and/or a salt thereof is used in an amount of 0.1 to 5.0% by weight in total in the emulsion composition.
Item 5. A method for stabilizing an emulsion, comprising blending lidocaine and/or a salt thereof into an emulsion composition.
本発明によると、乳化組成物に優れた乳化安定性を備えさせることができる。 According to the present invention, it is possible to provide an emulsion composition with excellent emulsion stability.
１．乳化安定化剤
本発明の乳化組成物の乳化安定化剤は、リドカイン及び／又はその塩を含有することを特徴とする。以下、本発明の乳化安定化剤について詳述する。
1. Emulsion stabilizer The emulsion stabilizer of the emulsion composition of the present invention is characterized by containing lidocaine and/or a salt thereof. The emulsion stabilizer of the present invention will be described in detail below.
リドカイン及び／又はその塩
本発明の乳化安定化剤は、乳化安定化作用を有する成分として、リドカイン及び／又はその塩を含有する。リドカインは、２－（ジエチルアミノ）－Ｎ－（２，６－ジメチルフェニル）アセタミドとも称され、局所麻酔効果又は解熱消炎効果を有することが知られている公知の薬剤である。
The emulsion stabilizer of the present invention contains lidocaine and /or a salt thereof as a component having an emulsion stabilizing effect. Lidocaine, also known as 2-(diethylamino)-N-(2,6-dimethylphenyl)acetamide, is a known drug known to have a local anesthetic effect or an antipyretic and anti-inflammatory effect.
リドカインの塩としては、薬学的に許容されるものである限り特に制限されないが、具体的には、塩酸塩等の無機酸塩が挙げられる。 There are no particular limitations on the salt of lidocaine as long as it is pharma- ceutical acceptable, but specific examples include inorganic acid salts such as hydrochloride.
本発明の乳化安定化剤において、有効成分は、リドカイン及びその塩の中から１種を選択して単独で使用してもよく、また２種以上を組み合わせて使用してもよい。リドカイン及びその塩の中でも、好ましい乳化安定化効果を得る観点から、好ましくはリドカイン及び塩酸リドカイン（キシロカイン）が挙げられ、さらに好ましくはリドカインが挙げられる。 In the emulsion stabilizer of the present invention, the active ingredient may be one selected from lidocaine and its salts and used alone, or two or more may be used in combination. Among lidocaine and its salts, from the viewpoint of obtaining a preferable emulsion stabilizing effect, lidocaine and lidocaine hydrochloride (xylocaine) are preferred, and lidocaine is even more preferred.
本発明の乳化安定化剤の乳化組成物中への配合量としては特に限定されないが、例えば、乳化組成物中、リドカイン及びその塩の総量で、例えば０．１～５．０重量％が挙げられる。より好ましい乳化安定化効果を得る観点から、本発明の乳化安定化剤の乳化組成物中への配合量としては、リドカイン及びその塩の総量で、好ましくは０．２～５．０重量％、より好ましくは０．５～５．０重量％、０．５～４．０重量％、又は０．５～３．０重量％が挙げられる。 The amount of the emulsion stabilizer of the present invention to be blended in the emulsion composition is not particularly limited, but may be, for example, 0.1 to 5.0% by weight of the total amount of lidocaine and its salts in the emulsion composition. From the viewpoint of obtaining a more preferable emulsion stabilization effect, the amount of the emulsion stabilizer of the present invention to be blended in the emulsion composition is preferably 0.2 to 5.0% by weight, more preferably 0.5 to 5.0% by weight, 0.5 to 4.0% by weight, or 0.5 to 3.0% by weight of the total amount of lidocaine and its salts.
また、本発明の乳化安定化剤は乳化安定性に優れているため、リドカイン及び／又はその塩が本来の局所麻酔剤又は解熱消炎剤としての有効量より少ない場合であっても、効果的に乳化安定化効果を得ることができる。このような観点から、本発明の乳化安定化剤の乳化組成物中への配合量は、リドカイン及びその塩の総量で、例えば０．１～０．４重量％、０．１～０．３重量％、０．１～０．２重量％、又は０．２～０．３重量％であってもよい。 In addition, since the emulsion stabilizer of the present invention has excellent emulsion stability, even if the amount of lidocaine and/or its salt is less than the effective amount as a local anesthetic or antipyretic/anti-inflammatory agent, an effective emulsion stabilizing effect can be obtained. From this viewpoint, the amount of the emulsion stabilizer of the present invention blended in the emulsion composition may be, for example, 0.1 to 0.4% by weight, 0.1 to 0.3% by weight, 0.1 to 0.2% by weight, or 0.2 to 0.3% by weight of the total amount of lidocaine and its salt.
乳化組成物
本発明の乳化安定化剤が配合される乳化組成物としては、油分、水、及び界面活性剤を含有している限り特に限定されない。
Emulsion Composition The emulsion composition in which the emulsion stabilizer of the present invention is blended is not particularly limited as long as it contains oil, water, and a surfactant.
（油分）
油分は、乳化組成物の油相の基剤成分として用いられる。油分としては薬学的又は香粧学的に許容されることを限度として特に制限されないが、例えば、液状油、固形油、高級アルコール等が挙げられる。これらの油分は、１種単独で使用してもよく、また２種以上を組み合わせて使用してもよい。
(Oil content)
The oil is used as a base component of the oil phase of the emulsion composition. The oil is not particularly limited as long as it is pharma- ceutically or cosmetically acceptable, and examples thereof include liquid oil, solid oil, higher alcohol, etc. These oils may be used alone or in combination of two or more.
本発明の乳化安定化剤が配合される乳化組成物における油分の含有量については、乳化組成物の乳化タイプ、形態、用途等に応じて適宜設定すればよいが、例えば、５～６０重量％、好ましくは７～３０重量％、より好ましくは１０～１５重量％が挙げられる。 The oil content in the emulsion composition containing the emulsion stabilizer of the present invention may be appropriately set depending on the emulsion type, form, and application of the emulsion composition, but may be, for example, 5 to 60% by weight, preferably 7 to 30% by weight, and more preferably 10 to 15% by weight.
・液状油
液状油とは、２５℃において液状の形態を保つ油である。本発明の乳化安定化剤が配合される乳化組成物で使用される液状油としては、化粧料や外用医薬品等に通常用いられるものであればよく、例えば、；オレイン酸、インステアリン酸等の脂肪酸；エチルヘキサン酸セチル、パルミチン酸エチルヘキシル、ミリスチン酸オクチルドデシル、ジエチルヘキサン酸ネオペンチルグリコール、トリ２－エチルへキサン酸グリセリル、オレイン酸オクチルドデシル、ミリスチン酸イソプロピル、トリイソステアリン酸グリセリル、ジバラメトキシケイヒ酸－モノエチルへキサン酸グリセリル等のエステル油；ジメチルポリシロキサン、メチルハイドロジエンポリシロキサン、メチルフェニルポリシロキサン、オクタメチルシクロテトラシロキサン等のシリコーン油；流動パラフィン、スクワレン、スクワラン等の液状炭化水素油等が挙げられる。
Liquid Oil Liquid oil is an oil that maintains a liquid form at 25° C. The liquid oil used in the emulsion composition containing the emulsion stabilizer of the present invention may be any oil that is commonly used in cosmetics, topical medicines, and the like, and examples thereof include fatty acids such as oleic acid and isostearic acid; ester oils such as cetyl ethylhexanoate, ethylhexyl palmitate, octyldodecyl myristate, neopentyl glycol diethylhexanoate, glyceryl tri-2-ethylhexanoate, octyldodecyl oleate, isopropyl myristate, glyceryl triisostearate, and glyceryl di-methylmethoxycinnamate-monoethylhexanoate; silicone oils such as dimethylpolysiloxane, methylhydrogenpolysiloxane, methylphenylpolysiloxane, and octamethylcyclotetrasiloxane; and liquid hydrocarbon oils such as liquid paraffin, squalene, and squalane.
これらの液状油の中でも、本発明の乳化安定化剤による乳化安定化効果をより好ましく得る観点から、好ましくは、エステル油、シリコーン油、液状炭化水素油が挙げられ
、より好ましくはミリスチン酸イソプロピル、ジメチルポリシロキサン、流動パラフィンが挙げられる。
Of these liquid oils, from the viewpoint of obtaining a more favorable emulsion stabilizing effect by the emulsion stabilizer of the present invention, preferred are ester oils, silicone oils, and liquid hydrocarbon oils, and more preferred are isopropyl myristate, dimethylpolysiloxane, and liquid paraffin.
これらの液状油は、１種単独で使用してもよく、また２種以上を組み合わせて使用してもよい。 These liquid oils may be used alone or in combination of two or more.
本発明の乳化安定化剤が配合される乳化組成物に液状油を含有させる場合、その含有量については、特に制限されず、乳化組成物の乳化タイプ、形態、用途等に応じて適宜設定すればよいが、例えば、０．０１～３０重量％、好ましくは０．１～２０重量％、より好ましくは１～１５重量％、さらに好ましくは５～１０重量％が挙げられる。 When liquid oil is contained in the emulsion composition containing the emulsion stabilizer of the present invention, the content is not particularly limited and may be appropriately set depending on the emulsion type, form, and application of the emulsion composition, but may be, for example, 0.01 to 30% by weight, preferably 0.1 to 20% by weight, more preferably 1 to 15% by weight, and even more preferably 5 to 10% by weight.
・固形油
固形油とは、２５℃において固形の形態を保つ油である。本発明の乳化安定化剤が配合される乳化組成物で使用される固形油としては、通常化粧料や外用医薬品等に用いられるものであればよく、例えば、キャンデリラロウ、コメヌカロウ、ミツロウ、綿ロウ、カルナウバロウ、ラノリン、セラックロウ、オゾケライト、セレシン、ポリエチレンワックス、マイクロクリスタリンワックス、ワセリン、ラウリン酸、ミリスチン酸、パルミチン酸、ステアリン酸、ベヘニン酸、１２－ヒドロキシステアリン酸、ウンデシレン酸、ミリスチン酸ミリスチル、ミリスチン酸セチル、ステアリン酸ステアリル、ステアリン酸セチル、パルミチン酸セチル、ステアリン酸コレステリル、オレイン酸コレステリル、パルミチン酸デキストリン、ステアリン酸イヌリン、水素添加ホホバ油、セレシンワックス、固形パラフィンワックス、ポリエチレンワックス、シリコーンワックス等の固形油が挙げられる。
Solid Oil A solid oil is an oil that maintains a solid form at 25° C. The solid oil used in the emulsion composition containing the emulsion stabilizer of the present invention may be any solid oil that is usually used in cosmetics, topical medicines, etc., and examples thereof include candelilla wax, rice bran wax, beeswax, cotton wax, carnauba wax, lanolin, shellac wax, ozokerite, ceresin, polyethylene wax, microcrystalline wax, petrolatum, lauric acid, myristic acid, palmitic acid, stearic acid, behenic acid, 12-hydroxystearic acid, undecylenic acid, myristyl myristate, cetyl myristate, stearyl stearate, cetyl stearate, cetyl palmitate, cholesteryl stearate, cholesteryl oleate, dextrin palmitate, inulin stearate, hydrogenated jojoba oil, ceresin wax, solid paraffin wax, polyethylene wax, and silicone wax.
これらの固形油は、１種単独で使用してもよく、また２種以上を組み合わせて使用してもよい。 These solid oils may be used alone or in combination of two or more.
本発明の乳化安定化剤が配合される乳化組成物に固形油を含有させる場合、その含有量については、特に制限されず、乳化組成物の乳化タイプ、形態、用途等に応じて適宜設定すればよいが、例えば、０．１～５０重量％、好ましくは１～３０重量％、更に好ましくは５～１５重量％が挙げられる。 When solid oil is contained in the emulsion composition containing the emulsion stabilizer of the present invention, the content is not particularly limited and may be appropriately set depending on the emulsion type, form, and application of the emulsion composition, but may be, for example, 0.1 to 50% by weight, preferably 1 to 30% by weight, and more preferably 5 to 15% by weight.
・高級アルコール
高級アルコールとは、１分子中の炭素原子数が６個以上の１価アルコールである。本発明の乳化安定化剤が配合される乳化組成物で使用される高級アルコールにおける１分子中の炭素原子数について、６以上であればよいが、好ましくは６～３４、更に好ましくは１４～２２が挙げられる。
Higher alcohols are monohydric alcohols having 6 or more carbon atoms in one molecule. The number of carbon atoms in one molecule of the higher alcohol used in the emulsion composition containing the emulsion stabilizer of the present invention may be 6 or more, preferably 6 to 34, and more preferably 14 to 22.
本発明の乳化安定化剤が配合される乳化組成物で使用される高級アルコールとしては、通常化粧料や外用医薬品等に用いられるものであればよく、例えば、ミリスチルアルコール、セチルアルコール（セタノール）、オレイルアルコール、ステアリルアルコール、イソステアリルアルコール、ベヘニルアルコール、ラノリンアルコール等が挙げられる。 The higher alcohol used in the emulsion composition containing the emulsion stabilizer of the present invention may be any alcohol normally used in cosmetics and topical medicines, such as myristyl alcohol, cetyl alcohol (cetanol), oleyl alcohol, stearyl alcohol, isostearyl alcohol, behenyl alcohol, and lanolin alcohol.
これらの高級アルコールの中でも、本発明の乳化安定化剤による乳化安定化効果をより好ましく得る観点から、好ましくは、セチルアルコール（セタノール）、ラノリンアルコールが挙げられる。 Among these higher alcohols, cetyl alcohol (cetanol) and lanolin alcohol are preferred from the viewpoint of obtaining a more favorable emulsion stabilizing effect by the emulsion stabilizer of the present invention.
これらの高級アルコールは、１種単独で使用してもよく、また２種以上を組み合わせて使用してもよい。 These higher alcohols may be used alone or in combination of two or more.
本発明の乳化安定化剤が配合される乳化組成物に高級アルコールを含有させる場合、その含有量については、特に制限されず、乳化組成物の乳化タイプ、形態、用途等に応じて適宜設定すればよいが、例えば、０．１～５０重量％、好ましくは１～３０重量％、より好ましくは２～１５重量％、更に好ましくは３～１０重量％が挙げられる。 When a higher alcohol is contained in the emulsion composition containing the emulsion stabilizer of the present invention, the content is not particularly limited and may be appropriately set depending on the emulsion type, form, and use of the emulsion composition, but may be, for example, 0.1 to 50% by weight, preferably 1 to 30% by weight, more preferably 2 to 15% by weight, and even more preferably 3 to 10% by weight.
また、本発明の乳化安定化剤が配合される乳化組成物において、液状油と高級アルコールを組み合わせて使用する場合、これらの比率については、特に制限されないが、例えば、液状油１００重量部当たり、高級アルコールが１～２００重量部、好ましくは１０～１５０重量部、より好ましくは２０～１００重量部、更に好ましくは３０～６０重量部が挙げられる。 When liquid oil and higher alcohol are used in combination in an emulsion composition containing the emulsion stabilizer of the present invention, the ratio between them is not particularly limited, but for example, 1 to 200 parts by weight, preferably 10 to 150 parts by weight, more preferably 20 to 100 parts by weight, and even more preferably 30 to 60 parts by weight of higher alcohol per 100 parts by weight of liquid oil.
（水）
水は、乳化組成物の水相の基剤成分として含まれる。本発明の乳化安定化剤が配合される乳化組成物における水の含有量について、乳化組成物の乳化タイプ、形態、用途等に応じて適宜設定すればよいが、例えば、３０～９５重量％、好ましくは３０～９０重量％、より好ましくは３０～８０重量％、更に好ましくは３０～７５重量％が挙げられる。
(water)
Water is contained as a base component of the aqueous phase of the emulsion composition. The content of water in the emulsion composition containing the emulsion stabilizer of the present invention may be appropriately set depending on the emulsion type, form, application, etc. of the emulsion composition, and may be, for example, 30 to 95% by weight, preferably 30 to 90% by weight, more preferably 30 to 80% by weight, and even more preferably 30 to 75% by weight.
また、本発明の乳化安定化剤は保存後の分離を抑制する優れた乳化安定性を備えているため、本来的に水相分離がより一層生じやすい、水を多く含む場合であっても、優れた乳化安定性を備えさせることが可能になる。このような本発明の効果を鑑みれば、本発明の乳化安定化剤が配合される乳化組成物の好適な態様として、水の含有量が比較的多い乳化組成物が挙げられる。より具体的には、本発明の乳化安定化剤が配合される乳化組成物における水の含有量の好適な例として、５０～９０重量％、好ましくは６０～８０重量％、更に好ましくは６５～７５重量％が挙げられる。 In addition, since the emulsion stabilizer of the present invention has excellent emulsion stability that suppresses separation after storage, it is possible to provide excellent emulsion stability even in cases where a large amount of water is contained, in which aqueous phase separation is inherently more likely to occur. In view of such effects of the present invention, a suitable embodiment of an emulsion composition containing the emulsion stabilizer of the present invention is an emulsion composition having a relatively high water content. More specifically, a suitable example of the water content in an emulsion composition containing the emulsion stabilizer of the present invention is 50 to 90% by weight, preferably 60 to 80% by weight, and more preferably 65 to 75% by weight.
（界面活性剤）
界面活性剤としては、薬学的又は香粧学的に許容されることを限度として特に制限されないが、例えば、ノニオン性界面活性剤、アニオン性界面活性剤、カチオン性界面活性剤、両性界面活性剤等が挙げられる。これらの界面活性剤の中でも、本発明の乳化安定化剤による乳化安定化効果をより好ましく得る観点から、好ましくはノニオン性界面活性剤が挙げられる。
(Surfactant)
The surfactant is not particularly limited as long as it is pharma- ceutically or cosmetically acceptable, and examples thereof include nonionic surfactants, anionic surfactants, cationic surfactants, amphoteric surfactants, etc. Among these surfactants, nonionic surfactants are preferred from the viewpoint of obtaining a more favorable emulsion stabilizing effect by the emulsion stabilizer of the present invention.
ノニオン性界面活性剤としては、具体的には、ポリオキシエチレン硬化ヒマシ油；ソルビタン脂肪酸エステル類（例えば、ソルビタンモノオレエート、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、ソルビタンセスキオレエート、ソルビタントリオレエート、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等）；グリセリン脂肪酸エステル類（例えば、モノ綿実油脂肪酸グリセリル、モノエルカ酸グリセリル、セスキオレイン酸グリセリル、モノステアリン酸グリセリル（ステアリン酸グリセリン）、α，α’－オレイン酸ピログルタミン酸グリセリル、モノステアリン酸グリセリンリンゴ酸等）；プロピレングリコール脂肪酸エステル類（例えば、モノステアリン酸プロピレングリコール等）；グリセリンアルキルエーテル；ステアレス－２；ポリオキシエチレンソルビタン脂肪酸エステル類（例えば、ポリオキシエチレンソルビタンモノオレエート、ポリオキシエチレンソルビタンモノステアレート、ポリオキシエチレンソルビタンテトラオレエート等）；ポリオキシエチレンソルビット脂肪酸エステル類（例えば、ポリオキシエチレンソルビットモノラウレート、ポリオキシエチレンソルビットモノオレエート、ポリオキシエチレンソルビットペンタオレエート、ポリオキシエチレンソルビットモノステアレート等）；ポリオキシエチレングリセリン脂肪酸エステル類（例えば、ポリオキシエチレングリセリンモノステアレート、ポリオキシエチレングリセリンモノイソステアレート、ポリオキシエチレングリセリントリイソステアレート等）；ポリオキシエチレン脂肪酸エステル類（例えば、ポリオキシエチレンモノオレエート、ポリオキシエチレンモノステアレート（ステアリン酸ポリオキシル）、ポリオキシエチレンジステアレート、ポリオキシエチレンモノジオレエート、ジステアリン酸エチレングリコール等）；ポリオキシエチレンアルキルエーテル類（例えば、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オレイルエーテル、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ベヘニルエーテル、ポリオキシエチレン２－オクチルドデシルエーテル、ポリオキシエチレンコレスタノールエーテル等）；プルロニック型類（例えば、プルロニック等）；ポリオキシエチレン・ポリオキシプロピレンアルキルエーテル類（例えば、ポリオキシエチレン・ポリオキシプロピレン－セチルエーテル、ポリオキシエチレン・ポリオキシプロピレン－２－デシルテトラデシルエーテル、ポリオキシエチレン・ポリオキシプロピレンモノブチルエーテル、ポリオキシエチレン・ポリオキシプロピレン水添ラノリン、ポリオキシエチレン・ポリオキシプロピレングリセリンエーテル等）；ステアレス－２１等が挙げられる。 Specific examples of nonionic surfactants include polyoxyethylene hydrogenated castor oil; sorbitan fatty acid esters (e.g., sorbitan monooleate, sorbitan monoisostearate, sorbitan monolaurate, sorbitan monopalmitate, sorbitan monostearate, sorbitan sesquioleate, sorbitan trioleate, diglycerol sorbitan penta-2-ethylhexyl acid, diglycerol sorbitan tetra-2-ethylhexyl acid, etc.); glycerin fatty acid esters (e.g., monoglyceryl cottonseed oil fatty acid, glyceryl monoerucate, glyceryl sesquioleate, glyceryl monostearate (glycerin stearate), α,α'-pioleate, glyceryl ... glyceryl monostearate, glyceryl malate, etc.); propylene glycol fatty acid esters (e.g., propylene glycol monostearate, etc.); glycerin alkyl ether; steareth-2; polyoxyethylene sorbitan fatty acid esters (e.g., polyoxyethylene sorbitan monooleate, polyoxyethylene sorbitan monostearate, polyoxyethylene sorbitan tetraoleate, etc.); polyoxyethylene sorbitan fatty acid esters (e.g., polyoxyethylene sorbitan monolaurate, polyoxyethylene sorbitan monooleate, polyoxyethylene sorbitan pentaoleate, polyoxyethylene sorbit monostearate, etc.); polyoxyethylene glycerin fatty acid esters (e.g., polyoxyethylene glycerin monostearate, polyoxyethylene glycerin monoisostearate, polyoxyethylene glycerin triisostearate, etc.); polyoxyethylene fatty acid esters (e.g., polyoxyethylene monooleate, polyoxyethylene monostearate (polyoxyl stearate), polyoxyethylene distearate, polyoxyethylene monodioleate, ethylene glycol distearate, etc.); polyoxyethylene alkyl ethers (e.g., polyoxyethylene lauryl ether, polyoxyethylene oleyl ether, polyoxyethylene polyoxyethylene stearyl ether, polyoxyethylene behenyl ether, polyoxyethylene 2-octyldodecyl ether, polyoxyethylene cholestanol ether, etc.); Pluronic types (e.g., Pluronic, etc.); polyoxyethylene-polyoxypropylene alkyl ethers (e.g., polyoxyethylene-polyoxypropylene-cetyl ether, polyoxyethylene-polyoxypropylene-2-decyltetradecyl ether, polyoxyethylene-polyoxypropylene monobutyl ether, polyoxyethylene-polyoxypropylene hydrogenated lanolin, polyoxyethylene-polyoxypropylene glycerin ether, etc.); steareth-21, etc.
これらのノニオン性界面活性剤の中でも、本発明の乳化安定化剤による乳化安定化効果をより一層向上させるという観点から、好ましくはポリオキシエチレン硬化ヒマシ油、グリセリンポリグリセリン脂肪酸類、ポリオキシエチレン脂肪酸エステル類が挙げられ、より好ましくは、ポリオキシエチレン硬化ヒマシ油、モノステアリン酸グリセリル（ステアリン酸グリセリン）、ポリオキシエチレンモノステアレート（ステアリン酸ポリオキシル）が挙げられる。 Among these nonionic surfactants, from the viewpoint of further improving the emulsion stabilizing effect of the emulsion stabilizer of the present invention, polyoxyethylene hydrogenated castor oil, glycerin polyglycerin fatty acids, and polyoxyethylene fatty acid esters are preferred, and polyoxyethylene hydrogenated castor oil, glyceryl monostearate (glycerin stearate), and polyoxyethylene monostearate (polyoxyl stearate) are more preferred.
これらの界面活性剤は、１種単独で使用してもよく、また２種以上を組み合わせて使用してもよい。 These surfactants may be used alone or in combination of two or more.
本発明の乳化安定化剤が配合される乳化組成物において、界面活性剤の含有量については、使用する界面活性剤の種類等に応じて適宜設定すればよいが、例えば０．５～７重量％、好ましくは１～５重量％、より好ましくは２～５重量％、更に好ましくは３～５重量％が挙げられる。 In the emulsion composition containing the emulsion stabilizer of the present invention, the content of the surfactant may be appropriately set depending on the type of surfactant used, and may be, for example, 0.5 to 7% by weight, preferably 1 to 5% by weight, more preferably 2 to 5% by weight, and even more preferably 3 to 5% by weight.
（その他の成分）
本発明の乳化安定化剤が配合される乳化組成物は、前述する成分の他に、必要に応じて、通常使用される他の添加剤が含まれていてもよい。このような添加剤としては、例えば、多価アルコール、増粘剤、ｐＨ調節剤、緩衝剤、可溶化剤、キレート剤、防腐剤、保存剤、酸化防止剤、安定化剤、香料、着色料等が挙げられる。
(Other ingredients)
The emulsion composition containing the emulsion stabilizer of the present invention may contain, in addition to the above-mentioned components, other commonly used additives as necessary, such as polyhydric alcohols, thickeners, pH regulators, buffers, solubilizers, chelating agents, preservatives, antioxidants, stabilizers, fragrances, colorants, etc.
多価アルコールとしては、薬学的又は香粧学的に許容されることを限度として特に制限されないが、例えば、プロピレングリコール、１，３－ブチレングリコール（ＢＧ）、エチレングリコール、イソプレングリコール、ジエチレングリコール、ジプロピレングリコール等の２価アルコール；グリセリン等の３価アルコール、マクロゴール４０００、マクロゴール６０００等のポリエチレングリコール等が挙げられる。これらの多価アルコールは、１種単独で使用してもよく、また２種以上を組み合わせて使用してもよい。これらの多価アルコールの中でも、乳化安定性をより一層向上させるという観点から、好ましくは２価アルコール、３価アルコールが挙げられ、より好ましくは１，３－ブチレングリコール（ＢＧ）、グリセリンが挙げられる。本発明の乳化安定化剤が配合される乳化組成物において、多価アルコールを含有させる場合、その含有量については、使用する多価アルコールの種類等に応じて適宜設定すればよいが、例えば１～２０重量％、好ましくは５～１５重量％、より好ましくは７～１３重量％が挙げられる。 The polyhydric alcohol is not particularly limited as long as it is pharma- ceutically or cosmetically acceptable, and examples thereof include dihydric alcohols such as propylene glycol, 1,3-butylene glycol (BG), ethylene glycol, isoprene glycol, diethylene glycol, and dipropylene glycol; trihydric alcohols such as glycerin; and polyethylene glycols such as Macrogol 4000 and Macrogol 6000. These polyhydric alcohols may be used alone or in combination of two or more. Among these polyhydric alcohols, from the viewpoint of further improving emulsion stability, dihydric alcohols and trihydric alcohols are preferred, and 1,3-butylene glycol (BG) and glycerin are more preferred. When a polyhydric alcohol is contained in the emulsion composition containing the emulsion stabilizer of the present invention, the content of the polyhydric alcohol may be appropriately set according to the type of polyhydric alcohol used, and may be, for example, 1 to 20% by weight, preferably 5 to 15% by weight, and more preferably 7 to 13% by weight.
増粘剤は、本発明の乳化安定化剤による乳化安定化効果をより一層向上させるという観点から配合することが好ましい。増粘剤としては、薬学的又は香粧学的に許容されることを限度として特に制限されないが、例えば、カルボキシビニルポリマー、ヒプロメロース、ポリビニルピロリドン、アルギン酸ナトリウム、エチルセルロース、カルボキシメチルセルロースナトリウム、キサンタンガム、カラギーナン等が挙げられ、好ましくは、カルボキシビニルポリマー、キサンタンガムが挙げられる。本発明の乳化安定化剤が配合される乳化組成物において、増粘剤を含有させる場合、その含有量については、使用する増粘剤の種類等に応じて適宜設定すればよいが、例えば０．１～２重量％、好ましくは０．１～０．６重量％、より好ましくは０．２～０．６重量％が挙げられる。 It is preferable to incorporate a thickener from the viewpoint of further improving the emulsion stabilizing effect of the emulsion stabilizer of the present invention. The thickener is not particularly limited as long as it is pharma- ceutical or cosmetically acceptable, but examples thereof include carboxyvinyl polymer, hypromellose, polyvinylpyrrolidone, sodium alginate, ethyl cellulose, sodium carboxymethylcellulose, xanthan gum, carrageenan, etc., and preferably carboxyvinyl polymer and xanthan gum. When a thickener is contained in an emulsion composition containing the emulsion stabilizer of the present invention, the content thereof may be appropriately set according to the type of thickener used, and may be, for example, 0.1 to 2% by weight, preferably 0.1 to 0.6% by weight, and more preferably 0.2 to 0.6% by weight.
更に、本発明の乳化安定化剤が配合される乳化組成物は、前述する成分の他に、薬学的又は香粧学的な生理機能を発揮できる薬効成分が、必要に応じて含まれていてもよい。このような薬効成分としては、例えば、ステロイド剤（デキサメタゾン、塩酸デキサメタゾン、酢酸デキサメタゾン、塩酸ヒドロコルチゾン、吉草酸プレドニゾロン、酢酸プレドニゾロン等）、抗ヒスタミン剤（ジフェンヒドラミン、塩酸ジフェンヒドラミン、マレイン酸クロルフェニラミン等）、局所麻酔剤（リドカイン、ジブカイン、プロカイン、テトラカイン、ブピバカイン、メピバカイン、クロロプロカイン、プロパラカイン、メプリルカイン又はこれらの塩）、安息香酸アルキルエステル（例えばアミノ安息香酸エチル、塩酸パラブチルアミノ安息香酸ジエチルアミノエチル）、オルソカイン、オキセサゼイン、オキシポリエントキシデカン、ロートエキス、ペルカミンパーゼ、テシットデシチン等）、抗炎症剤（ウフェナマート、アラントイン、サリチル酸、サリチル酸グリコール、サリチル酸メチル、インドメタシン、フェルビナク、ジクロフェナクナトリウム、ロキソプロフェンナトリウム等）、殺菌剤（塩化ベンザルコニウム、塩化デカリニウム、塩化ベンゼトニウム、塩化セチルピリジニウム、イソプロピルメチルフェノール、塩酸クロルヘキシジン、グルコン酸クロルヘキシジン、アンモニア水、スルファジアジン、乳酸、フェノール等）、鎮痒剤（クロタミトン、チアントール等）、皮膚保護剤（コロジオン、ヒマシ油等）、血行促進成分（ノニル酸ワニリルアミド、ニコチン酸ベンジルエステル、カプサイシン、トウガラシエキス等）、ビタミン類（ビタミンＡ，Ｂ，Ｃ，Ｄ，Ｅ等）、ムコ多糖類（コンドロイチン硫酸ナトリウム、グルコサミン、ヒアルロン酸等）等が挙げられる。これらの薬効成分は、１種単独で使用してもよく、また２種以上を組み合わせて使用してもよい。また、本発明の乳化安定化剤が配合される乳化組成物において、これらの薬効成分を含有させる場合、その含有量については、使用する薬効成分の種類、期待する効果等に応じて適宜設定すればよい。 Furthermore, the emulsion composition containing the emulsion stabilizer of the present invention may contain, in addition to the above-mentioned components, medicinal ingredients capable of exerting pharmaceutical or cosmetic physiological functions, as necessary. Examples of such medicinal ingredients include steroids (dexamethasone, dexamethasone hydrochloride, dexamethasone acetate, hydrocortisone hydrochloride, prednisolone valerate, prednisolone acetate, etc.), antihistamines (diphenhydramine, diphenhydramine hydrochloride, chlorpheniramine maleate, etc.), local anesthetics (lidocaine, dibucaine, procaine, tetracaine, bupivacaine, mepivacaine, chloroprocaine, proparacaine, meprylcaine, or salts thereof), alkyl benzoates (e.g., ethyl aminobenzoate, diethylaminoethyl p-butylaminobenzoate hydrochloride), orthocaine, oxethazaine, oxypolyethyleneoxydecane, Scopolia extract, percaminepase, tesitdesitin, etc.), and anti-inflammatory agents (ufenamate, allantoin). , salicylic acid, glycol salicylate, methyl salicylate, indomethacin, felbinac, diclofenac sodium, loxoprofen sodium, etc.), bactericides (benzalkonium chloride, dequalinium chloride, benzethonium chloride, cetylpyridinium chloride, isopropylmethylphenol, chlorhexidine hydrochloride, chlorhexidine gluconate, aqueous ammonia, sulfadiazine, lactic acid, phenol, etc.), antipruritic agents (crotamiton, thianthol, etc.), skin protectants (collodion, castor oil, etc.), blood circulation promoting components (vanillylamide nonylate, benzyl nicotinate, capsaicin, chili pepper extract, etc.), vitamins (vitamins A, B, C, D, E, etc.), mucopolysaccharides (sodium chondroitin sulfate, glucosamine, hyaluronic acid, etc.), etc. These medicinal components may be used alone or in combination of two or more. Furthermore, when these medicinal ingredients are contained in the emulsion composition containing the emulsion stabilizer of the present invention, the content of the ingredients may be appropriately set depending on the type of medicinal ingredient used, the desired effect, etc.
（製剤形態・用途）
本発明の乳化安定化剤が配合される乳化組成物の乳化タイプは、油中水型又は水中油型のいずれであってもよい。本発明の乳化安定化剤によって、高温保存後の分離をも抑制する優れた乳化安定性が得られるため、本発明の乳化安定化剤が配合される乳化組成物が、本来的に水相分離がより一層生じやすい、水中油型のような水を多く含むものであっても、優れた乳化安定性を備えさせることが可能になる。このような本発明の効果を鑑みれば、本発明の乳化安定化剤が配合される乳化組成物の好ましい乳化タイプは、水の含有量が比較的多い水中油型である。
(Formulation and Use)
The emulsion type of the emulsion composition containing the emulsion stabilizer of the present invention may be either water-in-oil type or oil-in-water type. The emulsion stabilizer of the present invention can provide excellent emulsion stability that suppresses separation even after high-temperature storage, so that even if the emulsion composition containing the emulsion stabilizer of the present invention contains a large amount of water, such as the oil-in-water type, which is inherently more prone to aqueous phase separation, it can have excellent emulsion stability. In view of the effects of the present invention, the preferred emulsion type of the emulsion composition containing the emulsion stabilizer of the present invention is the oil-in-water type, which contains a relatively large amount of water.
本発明の乳化安定化剤が配合される乳化組成物は、化粧料、外用医薬部外品、外用医薬品等の外用剤として使用することができる。本発明の乳化安定化剤が配合される乳化組成物の製品形態については、特に制限されないが、例えば、クリーム剤、軟膏剤、乳液剤、ゲル剤、油剤、ローション剤、リニメント剤、エアゾール剤等が挙げられる。これらの中でも、好ましくは、クリーム剤、軟膏剤、乳液剤、ローション剤が挙げられ、より好ましくは、クリーム剤、乳液剤、ローション剤が挙げられる。 The emulsion composition containing the emulsion stabilizer of the present invention can be used as an external preparation such as a cosmetic, topical quasi-drug, or topical medicine. The product form of the emulsion composition containing the emulsion stabilizer of the present invention is not particularly limited, but examples thereof include creams, ointments, emulsions, gels, oils, lotions, liniments, and aerosols. Of these, creams, ointments, emulsions, and lotions are preferred, and creams, emulsions, and lotions are more preferred.
（製造方法）
本発明の乳化安定化剤が配合される乳化組成物は、乳化タイプに応じて、公知の乳化製剤の製剤化手法に従って製造することができる。例えば、本発明の乳化安定化剤が配合される乳化組成物の製造方法としては、含有させる成分を水溶性成分と油性成分に分けて、水溶性成分を含む水相と、油性成分を含む油相とを調製し、これらを公知の手法に従って乳化させる方法が挙げられる。
(Production method)
The emulsion composition containing the emulsion stabilizer of the present invention can be manufactured according to the formulation method of known emulsion preparations depending on the emulsion type.For example, the method of manufacturing the emulsion composition containing the emulsion stabilizer of the present invention includes a method of dividing the components to be contained into water-soluble components and oily components, preparing an aqueous phase containing the water-soluble components and an oily phase containing the oily components, and emulsifying them according to a known method.
２．乳化安定化方法
上述するように、リドカイン及び／又はその塩は、乳化組成物において優れた乳化安定性を発現させる。従って、本発明は、更に、乳化組成物中にリドカイン及び／又はその塩を配合する乳化安定化方法を提供する。
As described above, lidocaine and/or a salt thereof exert excellent emulsion stability in an emulsion composition. Therefore, the present invention further provides a method for emulsion stabilization, which comprises blending lidocaine and/or a salt thereof in an emulsion composition.
本発明の乳化安定化方法において、乳化安定化とは、保存後において乳化組成物の分離を抑制することをいう。分離とは、乳化組成物から、水相及び／又は油相が分離することをいう。乳化安定化のより好ましい態様としては、保存後において乳化組成物からの水相の分離を抑制することが挙げられ、より好ましい態様としては、保存後において乳化組成物の乳化状態が均一であること、つまりエマルジョン中の液滴が分散媒中に均一に分散した状態が保たれることが挙げられる。 In the emulsion stabilization method of the present invention, emulsion stabilization refers to suppressing separation of the emulsion composition after storage. Separation refers to separation of the aqueous phase and/or oil phase from the emulsion composition. A more preferred aspect of emulsion stabilization is suppressing separation of the aqueous phase from the emulsion composition after storage, and a more preferred aspect is maintaining the emulsion state of the emulsion composition uniform after storage, that is, maintaining a state in which the droplets in the emulsion are uniformly dispersed in the dispersion medium.
本発明の乳化安定化方法において、使用するリドカイン及び／又はその塩の種類や含有量、乳化組成物に配合される成分の種類や含有量、及び製剤形態等については、前記「１．乳化安定化剤」の場合と同様である。 In the emulsion stabilization method of the present invention, the type and content of lidocaine and/or its salt used, the type and content of ingredients blended in the emulsion composition, and the formulation form are the same as those described above in "1. Emulsion stabilizer."
以下に実施例を示して本発明をより具体的に説明するが、本発明はこれらに限定されるものではない。 The present invention will be explained in more detail below with reference to examples, but the present invention is not limited to these.
試験例
表１に示す組成の乳化組成物を調製した。具体的には、表１に示す（I）の各成分を６５～７５℃で加熱混合し固形分を溶解させて得た油相に、表１に示す（II）の各成分を６５～７５℃で加熱混合し固形分を溶解させて得た水相を加えて、ホモミキサーを用いて乳化し、３５℃まで冷却撹拌することにより、クリーム状の水中油型乳化組成物を製造した。
Test Example An emulsion composition was prepared having the composition shown in Table 1. Specifically, an oil phase was obtained by heating and mixing each component (I) shown in Table 1 at 65 to 75°C to dissolve the solids, and an aqueous phase was obtained by heating and mixing each component (II) shown in Table 1 at 65 to 75°C to dissolve the solids. The mixture was emulsified using a homomixer, and cooled to 35°C with stirring to produce a creamy oil-in-water emulsion composition.
得られた各乳化組成物１０ｇを、ガラス瓶（スクリュー管瓶Ｎｏ．４、容量１３．５ｍＬ、マルエム社製、透明）に充填し、密封して、６０℃で３週間保存した。保存後の各乳化組成物を目視にて観察し、以下の基準に基づいて乳化安定性を評価した。結果を表１に示す。
×：水相の分離が明確に認められる。
△：水相の分離がやや認められる。
○：クリーミング傾向があるが、分離は認められない。
◎：乳化状態が均一で、分離は認められない。
なお、クリーミング傾向とは、乳化状態の不均一状態をいい、具体的には、生成したエマルジョン中の液滴が、分散媒との比重差によって浮上又は沈降する過程にある状態をいう。
10 g of each of the obtained emulsion compositions was filled into a glass bottle (screw tube bottle No. 4, capacity 13.5 mL, manufactured by Maruemu Co., Ltd., transparent), sealed, and stored at 60° C. for 3 weeks. After storage, each emulsion composition was visually observed, and the emulsion stability was evaluated based on the following criteria. The results are shown in Table 1.
×: Separation of the aqueous phase was clearly observed.
Δ: Some separation of the aqueous phase was observed.
◯: Creaming tendency is observed, but no separation is observed.
◎: The emulsion is uniform and no separation is observed.
The creaming tendency refers to a non-uniform emulsified state, specifically, a state in which droplets in the generated emulsion are in the process of floating up or sinking down due to the difference in specific gravity with the dispersion medium.
表１から明らかなように、リドカインを含まない乳化組成物（比較例１）は保存後において水相が分離したため、乳化状態に顕著な不安定性が認められた。これに対し、乳化組成物に対してリドカインを配合した場合（実施例１～４）には、優れた乳化安定性が得られたことが分かった。この乳化安定性の向上効果は、特に実施例２～４において顕著であった。 As is clear from Table 1, the emulsion composition not containing lidocaine (Comparative Example 1) showed significant instability in the emulsion state, as the aqueous phase separated after storage. In contrast, it was found that excellent emulsion stability was obtained when lidocaine was added to the emulsion composition (Examples 1 to 4). This improvement in emulsion stability was particularly noticeable in Examples 2 to 4.
処方例
表２に示す処方の乳化組成物を、上記試験例と同様にして調製した。いずれの処方の乳化組成物も、優れた乳化安定性が得られていた。
Formulation Examples Emulsion compositions having the formulations shown in Table 2 were prepared in the same manner as in the above-mentioned Test Examples. All of the emulsion compositions had excellent emulsion stability.
Claims (2)
前記乳化組成物は、液状油、高級アルコール、界面活性剤、多価アルコール、及び増粘剤を含有し、
前記液状油は、ミリスチン酸イソプロピル、ジメチルポリシロキサン、及び流動パラフィンを含み、前記液状油の含有量は５～１０重量％であり、
前記高級アルコールは、セチルアルコール（セタノール）、及びラノリンアルコールを含み、前記高級アルコールの含有量は３～１０重量％であり、
前記界面活性剤は、ポリオキシエチレン硬化ヒマシ油、モノステアリン酸グリセリル（ステアリン酸グリセリン）、及びポリオキシエチレンモノステアレート（ステアリン酸ポリオキシル）を含み、前記界面活性剤の含有量は１～５重量％であり、
前記多価アルコールは、グリセリン、及び１，３－ブチレングリコールを含み、前記多価アルコールの含有量は７～１３重量％であり、
前記増粘剤は、キサンタンガム、及びカルボキシビニルポリマーを含み、前記増粘剤の含有量は０．２～０．６重量％であり、
前記リドカイン及び／又はその塩が、総量で、前記乳化組成物中０．１～５．０重量％となるように用いられる、乳化組成物の乳化安定化剤。 An emulsion stabilizer for an emulsion composition (excluding those containing ufenamate, those containing an antihistamine and/or vegetable oil, and those containing prednisolone valerate acetate), which contains lidocaine and/or a salt thereof,
The emulsion composition contains a liquid oil, a higher alcohol, a surfactant, a polyhydric alcohol, and a thickener,
The liquid oil contains isopropyl myristate, dimethylpolysiloxane, and liquid paraffin, and the content of the liquid oil is 5 to 10% by weight;
The higher alcohols include cetyl alcohol (cetanol) and lanolin alcohol, and the content of the higher alcohols is 3 to 10% by weight;
The surfactant comprises polyoxyethylene hydrogenated castor oil, glyceryl monostearate (glycerin stearate), and polyoxyethylene monostearate (polyoxyl stearate), and the content of the surfactant is 1 to 5% by weight;
The polyhydric alcohol includes glycerin and 1,3-butylene glycol, and the content of the polyhydric alcohol is 7 to 13% by weight;
The thickener comprises xanthan gum and a carboxyvinyl polymer, and the content of the thickener is 0.2 to 0.6% by weight;
An emulsion stabilizer for an emulsion composition, wherein the lidocaine and/or a salt thereof is used in an amount of 0.1 to 5.0% by weight in total in the emulsion composition .
A method for emulsion stabilization, comprising blending lidocaine and/or a salt thereof in a total amount of 0.1 to 5.0% by weight into an emulsion composition (excluding those containing ufenamate, those containing an antihistamine and/or a vegetable oil, and those containing prednisolone valerate acetate) containing 5 to 10% by weight of a liquid oil containing isopropyl myristate, dimethylpolysiloxane, and liquid paraffin, 3 to 10% by weight of a higher alcohol containing cetyl alcohol (cetanol) and lanolin alcohol, 1 to 5% by weight of a surfactant containing polyoxyethylene hydrogenated castor oil, glyceryl monostearate (glycerin stearate), and polyoxyethylene monostearate (polyoxyl stearate), 7 to 13% by weight of a polyhydric alcohol containing glycerin and 1,3-butylene glycol, and 0.2 to 0.6% by weight of a thickener containing xanthan gum and a carboxyvinyl polymer.
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| JP2019156772A (en) | 2018-03-14 | 2019-09-19 | ロート製薬株式会社 | External composition |
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| WO1998020852A1 (en) | 1996-11-12 | 1998-05-22 | Pharmacia & Upjohn Company | Pharmaceutical compositions containing kukui nut oil |
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