JP2006036675A - External preparation - Google Patents
External preparation Download PDFInfo
- Publication number
- JP2006036675A JP2006036675A JP2004217759A JP2004217759A JP2006036675A JP 2006036675 A JP2006036675 A JP 2006036675A JP 2004217759 A JP2004217759 A JP 2004217759A JP 2004217759 A JP2004217759 A JP 2004217759A JP 2006036675 A JP2006036675 A JP 2006036675A
- Authority
- JP
- Japan
- Prior art keywords
- external preparation
- alkyl ester
- acid alkyl
- isopropylmethylphenol
- added
- 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
- 238000002360 preparation method Methods 0.000 title claims abstract description 42
- NTCYWJCEOILKNG-ROLPUNSJSA-N [(1r,2s)-1-hydroxy-1-phenylpropan-2-yl]-dimethylazanium;chloride Chemical compound Cl.CN(C)[C@@H](C)[C@H](O)C1=CC=CC=C1 NTCYWJCEOILKNG-ROLPUNSJSA-N 0.000 claims abstract description 38
- 229940073563 dl- methylephedrine hydrochloride Drugs 0.000 claims abstract description 38
- IJALWSVNUBBQRA-UHFFFAOYSA-N 4-Isopropyl-3-methylphenol Chemical compound CC(C)C1=CC=C(O)C=C1C IJALWSVNUBBQRA-UHFFFAOYSA-N 0.000 claims abstract description 36
- NFIDBGJMFKNGGQ-UHFFFAOYSA-N isopropylmethylphenol Natural products CC(C)CC1=CC=CC=C1O NFIDBGJMFKNGGQ-UHFFFAOYSA-N 0.000 claims abstract description 36
- XUGNVMKQXJXZCD-UHFFFAOYSA-N isopropyl palmitate Chemical compound CCCCCCCCCCCCCCCC(=O)OC(C)C XUGNVMKQXJXZCD-UHFFFAOYSA-N 0.000 claims abstract description 9
- HIQIXEFWDLTDED-UHFFFAOYSA-N 4-hydroxy-1-piperidin-4-ylpyrrolidin-2-one Chemical compound O=C1CC(O)CN1C1CCNCC1 HIQIXEFWDLTDED-UHFFFAOYSA-N 0.000 claims abstract description 6
- 239000000203 mixture Substances 0.000 claims description 32
- 235000014113 dietary fatty acids Nutrition 0.000 claims description 21
- 239000000194 fatty acid Substances 0.000 claims description 21
- 229930195729 fatty acid Natural products 0.000 claims description 21
- XLOMVQKBTHCTTD-UHFFFAOYSA-N Zinc monoxide Chemical compound [Zn]=O XLOMVQKBTHCTTD-UHFFFAOYSA-N 0.000 claims description 20
- 239000002674 ointment Substances 0.000 claims description 20
- POJWUDADGALRAB-UHFFFAOYSA-N allantoin Chemical compound NC(=O)NC1NC(=O)NC1=O POJWUDADGALRAB-UHFFFAOYSA-N 0.000 claims description 14
- 239000006071 cream Substances 0.000 claims description 12
- 238000004040 coloring Methods 0.000 claims description 11
- 229960001296 zinc oxide Drugs 0.000 claims description 10
- 239000011787 zinc oxide Substances 0.000 claims description 10
- ALEXXDVDDISNDU-JZYPGELDSA-N cortisol 21-acetate Chemical compound C1CC2=CC(=O)CC[C@]2(C)[C@@H]2[C@@H]1[C@@H]1CC[C@@](C(=O)COC(=O)C)(O)[C@@]1(C)C[C@@H]2O ALEXXDVDDISNDU-JZYPGELDSA-N 0.000 claims description 9
- 229960001067 hydrocortisone acetate Drugs 0.000 claims description 9
- POJWUDADGALRAB-PVQJCKRUSA-N Allantoin Natural products NC(=O)N[C@@H]1NC(=O)NC1=O POJWUDADGALRAB-PVQJCKRUSA-N 0.000 claims description 7
- 229960000458 allantoin Drugs 0.000 claims description 7
- NOOLISFMXDJSKH-UHFFFAOYSA-N DL-menthol Natural products CC(C)C1CCC(C)CC1O NOOLISFMXDJSKH-UHFFFAOYSA-N 0.000 claims description 6
- 239000010642 eucalyptus oil Substances 0.000 claims description 5
- 229940044949 eucalyptus oil Drugs 0.000 claims description 5
- 235000021355 Stearic acid Nutrition 0.000 claims description 3
- XDOFQFKRPWOURC-UHFFFAOYSA-N iso-octadecanoic acid Natural products CC(C)CCCCCCCCCCCCCCC(O)=O XDOFQFKRPWOURC-UHFFFAOYSA-N 0.000 claims description 3
- 229940041616 menthol Drugs 0.000 claims description 3
- 238000000034 method Methods 0.000 claims description 3
- IPCSVZSSVZVIGE-UHFFFAOYSA-N n-hexadecanoic acid Natural products CCCCCCCCCCCCCCCC(O)=O IPCSVZSSVZVIGE-UHFFFAOYSA-N 0.000 claims description 3
- OQCDKBAXFALNLD-UHFFFAOYSA-N octadecanoic acid Natural products CCCCCCCC(C)CCCCCCCCC(O)=O OQCDKBAXFALNLD-UHFFFAOYSA-N 0.000 claims description 3
- 239000008117 stearic acid Substances 0.000 claims description 3
- 238000003860 storage Methods 0.000 claims description 3
- WRIDQFICGBMAFQ-UHFFFAOYSA-N (E)-8-Octadecenoic acid Natural products CCCCCCCCCC=CCCCCCCC(O)=O WRIDQFICGBMAFQ-UHFFFAOYSA-N 0.000 claims description 2
- LQJBNNIYVWPHFW-UHFFFAOYSA-N 20:1omega9c fatty acid Natural products CCCCCCCCCCC=CCCCCCCCC(O)=O LQJBNNIYVWPHFW-UHFFFAOYSA-N 0.000 claims description 2
- QSBYPNXLFMSGKH-UHFFFAOYSA-N 9-Heptadecensaeure Natural products CCCCCCCC=CCCCCCCCC(O)=O QSBYPNXLFMSGKH-UHFFFAOYSA-N 0.000 claims description 2
- 235000006679 Mentha X verticillata Nutrition 0.000 claims description 2
- 235000002899 Mentha suaveolens Nutrition 0.000 claims description 2
- 235000001636 Mentha x rotundifolia Nutrition 0.000 claims description 2
- 239000005642 Oleic acid Substances 0.000 claims description 2
- ZQPPMHVWECSIRJ-UHFFFAOYSA-N Oleic acid Natural products CCCCCCCCC=CCCCCCCCC(O)=O ZQPPMHVWECSIRJ-UHFFFAOYSA-N 0.000 claims description 2
- 235000021314 Palmitic acid Nutrition 0.000 claims description 2
- 239000003795 chemical substances by application Substances 0.000 claims description 2
- QXJSBBXBKPUZAA-UHFFFAOYSA-N isooleic acid Natural products CCCCCCCC=CCCCCCCCCC(O)=O QXJSBBXBKPUZAA-UHFFFAOYSA-N 0.000 claims description 2
- WQEPLUUGTLDZJY-UHFFFAOYSA-N n-Pentadecanoic acid Natural products CCCCCCCCCCCCCCC(O)=O WQEPLUUGTLDZJY-UHFFFAOYSA-N 0.000 claims description 2
- 239000003921 oil Substances 0.000 claims 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 claims 1
- 235000021360 Myristic acid Nutrition 0.000 claims 1
- TUNFSRHWOTWDNC-UHFFFAOYSA-N Myristic acid Natural products CCCCCCCCCCCCCC(O)=O TUNFSRHWOTWDNC-UHFFFAOYSA-N 0.000 claims 1
- 238000013329 compounding Methods 0.000 claims 1
- 235000020778 linoleic acid Nutrition 0.000 claims 1
- OYHQOLUKZRVURQ-IXWMQOLASA-N linoleic acid Natural products CCCCC\C=C/C\C=C\CCCCCCCC(O)=O OYHQOLUKZRVURQ-IXWMQOLASA-N 0.000 claims 1
- CXMXRPHRNRROMY-UHFFFAOYSA-N n-Decanedioic acid Natural products OC(=O)CCCCCCCCC(O)=O CXMXRPHRNRROMY-UHFFFAOYSA-N 0.000 claims 1
- 238000002156 mixing Methods 0.000 abstract description 20
- 239000005526 vasoconstrictor agent Substances 0.000 abstract description 3
- 125000005907 alkyl ester group Chemical group 0.000 abstract description 2
- CRBJBYGJVIBWIY-UHFFFAOYSA-N 2-isopropylphenol Chemical compound CC(C)C1=CC=CC=C1O CRBJBYGJVIBWIY-UHFFFAOYSA-N 0.000 abstract 1
- 239000002253 acid Substances 0.000 abstract 1
- 125000001931 aliphatic group Chemical group 0.000 abstract 1
- 238000002845 discoloration Methods 0.000 abstract 1
- 239000007788 liquid Substances 0.000 description 69
- GLDOVTGHNKAZLK-UHFFFAOYSA-N octadecan-1-ol Chemical compound CCCCCCCCCCCCCCCCCCO GLDOVTGHNKAZLK-UHFFFAOYSA-N 0.000 description 30
- 238000003756 stirring Methods 0.000 description 28
- 238000010438 heat treatment Methods 0.000 description 25
- XAGFODPZIPBFFR-UHFFFAOYSA-N aluminium Chemical compound [Al] XAGFODPZIPBFFR-UHFFFAOYSA-N 0.000 description 22
- 229910052782 aluminium Inorganic materials 0.000 description 22
- 229940057995 liquid paraffin Drugs 0.000 description 21
- 235000019271 petrolatum Nutrition 0.000 description 20
- 239000003871 white petrolatum Substances 0.000 description 18
- 230000000052 comparative effect Effects 0.000 description 17
- QELSKZZBTMNZEB-UHFFFAOYSA-N propylparaben Chemical compound CCCOC(=O)C1=CC=C(O)C=C1 QELSKZZBTMNZEB-UHFFFAOYSA-N 0.000 description 16
- -1 and for example Substances 0.000 description 13
- 229960000541 cetyl alcohol Drugs 0.000 description 13
- BXWNKGSJHAJOGX-UHFFFAOYSA-N hexadecan-1-ol Chemical compound CCCCCCCCCCCCCCCCO BXWNKGSJHAJOGX-UHFFFAOYSA-N 0.000 description 13
- GOQYKNQRPGWPLP-UHFFFAOYSA-N n-heptadecyl alcohol Natural products CCCCCCCCCCCCCCCCCO GOQYKNQRPGWPLP-UHFFFAOYSA-N 0.000 description 13
- NNJVILVZKWQKPM-UHFFFAOYSA-N Lidocaine Chemical compound CCN(CC)CC(=O)NC1=C(C)C=CC=C1C NNJVILVZKWQKPM-UHFFFAOYSA-N 0.000 description 12
- 229960004194 lidocaine Drugs 0.000 description 12
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 11
- ZAKOWWREFLAJOT-CEFNRUSXSA-N D-alpha-tocopherylacetate Chemical compound CC(=O)OC1=C(C)C(C)=C2O[C@@](CCC[C@H](C)CCC[C@H](C)CCCC(C)C)(C)CCC2=C1C ZAKOWWREFLAJOT-CEFNRUSXSA-N 0.000 description 10
- 239000008213 purified water Substances 0.000 description 10
- 229940042585 tocopherol acetate Drugs 0.000 description 10
- DNIAPMSPPWPWGF-UHFFFAOYSA-N Propylene glycol Chemical compound CC(O)CO DNIAPMSPPWPWGF-UHFFFAOYSA-N 0.000 description 9
- NOOLISFMXDJSKH-KXUCPTDWSA-N (-)-Menthol Chemical compound CC(C)[C@@H]1CC[C@@H](C)C[C@H]1O NOOLISFMXDJSKH-KXUCPTDWSA-N 0.000 description 8
- UKMSUNONTOPOIO-UHFFFAOYSA-N docosanoic acid Chemical compound CCCCCCCCCCCCCCCCCCCCCC(O)=O UKMSUNONTOPOIO-UHFFFAOYSA-N 0.000 description 8
- LXCFILQKKLGQFO-UHFFFAOYSA-N methylparaben Chemical compound COC(=O)C1=CC=C(O)C=C1 LXCFILQKKLGQFO-UHFFFAOYSA-N 0.000 description 8
- 235000010232 propyl p-hydroxybenzoate Nutrition 0.000 description 8
- 239000004405 propyl p-hydroxybenzoate Substances 0.000 description 8
- 229960003415 propylparaben Drugs 0.000 description 8
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerol Natural products OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 description 7
- 229920003171 Poly (ethylene oxide) Polymers 0.000 description 7
- PUPZLCDOIYMWBV-UHFFFAOYSA-N (+/-)-1,3-Butanediol Chemical compound CC(O)CCO PUPZLCDOIYMWBV-UHFFFAOYSA-N 0.000 description 6
- 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 6
- LRJOMUJRLNCICJ-JZYPGELDSA-N Prednisolone acetate Chemical compound C1CC2=CC(=O)C=C[C@]2(C)[C@@H]2[C@@H]1[C@@H]1CC[C@@](C(=O)COC(=O)C)(O)[C@@]1(C)C[C@@H]2O LRJOMUJRLNCICJ-JZYPGELDSA-N 0.000 description 6
- 229960002800 prednisolone acetate Drugs 0.000 description 6
- 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 5
- DBAKFASWICGISY-BTJKTKAUSA-N Chlorpheniramine maleate Chemical compound OC(=O)\C=C/C(O)=O.C=1C=CC=NC=1C(CCN(C)C)C1=CC=C(Cl)C=C1 DBAKFASWICGISY-BTJKTKAUSA-N 0.000 description 5
- DBMJMQXJHONAFJ-UHFFFAOYSA-M Sodium laurylsulphate Chemical compound [Na+].CCCCCCCCCCCCOS([O-])(=O)=O DBMJMQXJHONAFJ-UHFFFAOYSA-M 0.000 description 5
- 229940046978 chlorpheniramine maleate Drugs 0.000 description 5
- 238000001816 cooling Methods 0.000 description 5
- 229960003338 crotamiton Drugs 0.000 description 5
- DNTGGZPQPQTDQF-XBXARRHUSA-N crotamiton Chemical compound C/C=C/C(=O)N(CC)C1=CC=CC=C1C DNTGGZPQPQTDQF-XBXARRHUSA-N 0.000 description 5
- 229960000525 diphenhydramine hydrochloride Drugs 0.000 description 5
- 150000004665 fatty acids Chemical class 0.000 description 5
- 239000012188 paraffin wax Substances 0.000 description 5
- 235000019333 sodium laurylsulphate Nutrition 0.000 description 5
- 235000010493 xanthan gum Nutrition 0.000 description 5
- 239000000230 xanthan gum Substances 0.000 description 5
- 229920001285 xanthan gum Polymers 0.000 description 5
- 229940082509 xanthan gum Drugs 0.000 description 5
- FDCJDKXCCYFOCV-UHFFFAOYSA-N 1-hexadecoxyhexadecane Chemical compound CCCCCCCCCCCCCCCCOCCCCCCCCCCCCCCCC FDCJDKXCCYFOCV-UHFFFAOYSA-N 0.000 description 4
- VBICKXHEKHSIBG-UHFFFAOYSA-N 1-monostearoylglycerol Chemical compound CCCCCCCCCCCCCCCCCC(=O)OCC(O)CO VBICKXHEKHSIBG-UHFFFAOYSA-N 0.000 description 4
- 235000021357 Behenic acid Nutrition 0.000 description 4
- 229940116226 behenic acid Drugs 0.000 description 4
- 229940082500 cetostearyl alcohol Drugs 0.000 description 4
- 229960000520 diphenhydramine Drugs 0.000 description 4
- ZZVUWRFHKOJYTH-UHFFFAOYSA-N diphenhydramine Chemical compound C=1C=CC=CC=1C(OCCN(C)C)C1=CC=CC=C1 ZZVUWRFHKOJYTH-UHFFFAOYSA-N 0.000 description 4
- 235000011187 glycerol Nutrition 0.000 description 4
- 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 4
- 238000002844 melting Methods 0.000 description 4
- 230000008018 melting Effects 0.000 description 4
- 235000010270 methyl p-hydroxybenzoate Nutrition 0.000 description 4
- 239000004292 methyl p-hydroxybenzoate Substances 0.000 description 4
- 229960002216 methylparaben Drugs 0.000 description 4
- QIQXTHQIDYTFRH-UHFFFAOYSA-N octadecanoic acid Chemical compound CCCCCCCCCCCCCCCCCC(O)=O QIQXTHQIDYTFRH-UHFFFAOYSA-N 0.000 description 4
- 239000007787 solid Substances 0.000 description 4
- OULAJFUGPPVRBK-UHFFFAOYSA-N tetratriacontyl alcohol Natural products CCCCCCCCCCCCCCCCCCCCCCCCCCCCCCCCCCO OULAJFUGPPVRBK-UHFFFAOYSA-N 0.000 description 4
- DSSYKIVIOFKYAU-XCBNKYQSSA-N (R)-camphor Chemical compound C1C[C@@]2(C)C(=O)C[C@@H]1C2(C)C DSSYKIVIOFKYAU-XCBNKYQSSA-N 0.000 description 3
- 229940058015 1,3-butylene glycol Drugs 0.000 description 3
- ZWEHNKRNPOVVGH-UHFFFAOYSA-N 2-Butanone Chemical compound CCC(C)=O ZWEHNKRNPOVVGH-UHFFFAOYSA-N 0.000 description 3
- LYCAIKOWRPUZTN-UHFFFAOYSA-N Ethylene glycol Chemical compound OCCO LYCAIKOWRPUZTN-UHFFFAOYSA-N 0.000 description 3
- MPDGHEJMBKOTSU-UHFFFAOYSA-N Glycyrrhetinsaeure Natural products C12C(=O)C=C3C4CC(C)(C(O)=O)CCC4(C)CCC3(C)C1(C)CCC1C2(C)CCC(O)C1(C)C MPDGHEJMBKOTSU-UHFFFAOYSA-N 0.000 description 3
- 239000003899 bactericide agent Substances 0.000 description 3
- 235000019437 butane-1,3-diol Nutrition 0.000 description 3
- 125000004432 carbon atom Chemical group C* 0.000 description 3
- 229940000425 combination drug Drugs 0.000 description 3
- 239000003814 drug Substances 0.000 description 3
- 229960003720 enoxolone Drugs 0.000 description 3
- 238000004519 manufacturing process Methods 0.000 description 3
- 229940080236 sodium cetyl sulfate Drugs 0.000 description 3
- GGHPAKFFUZUEKL-UHFFFAOYSA-M sodium;hexadecyl sulfate Chemical compound [Na+].CCCCCCCCCCCCCCCCOS([O-])(=O)=O GGHPAKFFUZUEKL-UHFFFAOYSA-M 0.000 description 3
- ULQISTXYYBZJSJ-UHFFFAOYSA-N 12-hydroxyoctadecanoic acid Chemical compound CCCCCCC(O)CCCCCCCCCCC(O)=O ULQISTXYYBZJSJ-UHFFFAOYSA-N 0.000 description 2
- NSVFSAJIGAJDMR-UHFFFAOYSA-N 2-[benzyl(phenyl)amino]ethyl 5-(5,5-dimethyl-2-oxido-1,3,2-dioxaphosphinan-2-yl)-2,6-dimethyl-4-(3-nitrophenyl)-1,4-dihydropyridine-3-carboxylate Chemical compound CC=1NC(C)=C(C(=O)OCCN(CC=2C=CC=CC=2)C=2C=CC=CC=2)C(C=2C=C(C=CC=2)[N+]([O-])=O)C=1P1(=O)OCC(C)(C)CO1 NSVFSAJIGAJDMR-UHFFFAOYSA-N 0.000 description 2
- WJLVQTJZDCGNJN-UHFFFAOYSA-N Chlorhexidine hydrochloride Chemical compound Cl.Cl.C=1C=C(Cl)C=CC=1NC(N)=NC(N)=NCCCCCCN=C(N)N=C(N)NC1=CC=C(Cl)C=C1 WJLVQTJZDCGNJN-UHFFFAOYSA-N 0.000 description 2
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 description 2
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 description 2
- 239000004166 Lanolin Substances 0.000 description 2
- DJDFFEBSKJCGHC-UHFFFAOYSA-N Naphazoline Chemical compound Cl.C=1C=CC2=CC=CC=C2C=1CC1=NCCN1 DJDFFEBSKJCGHC-UHFFFAOYSA-N 0.000 description 2
- 239000004264 Petrolatum Substances 0.000 description 2
- 229920002675 Polyoxyl Polymers 0.000 description 2
- XSQUKJJJFZCRTK-UHFFFAOYSA-N Urea Chemical compound NC(N)=O XSQUKJJJFZCRTK-UHFFFAOYSA-N 0.000 description 2
- FPVRUILUEYSIMD-RPRRAYFGSA-N [(8s,9r,10s,11s,13s,14s,16r,17r)-9-fluoro-11-hydroxy-17-(2-hydroxyacetyl)-10,13,16-trimethyl-3-oxo-6,7,8,11,12,14,15,16-octahydrocyclopenta[a]phenanthren-17-yl] acetate Chemical compound C1CC2=CC(=O)C=C[C@]2(C)[C@]2(F)[C@@H]1[C@@H]1C[C@@H](C)[C@@](C(=O)CO)(OC(C)=O)[C@@]1(C)C[C@@H]2O FPVRUILUEYSIMD-RPRRAYFGSA-N 0.000 description 2
- 239000004480 active ingredient Substances 0.000 description 2
- 230000000844 anti-bacterial effect Effects 0.000 description 2
- 229940121375 antifungal agent Drugs 0.000 description 2
- 239000003429 antifungal agent Substances 0.000 description 2
- 229920003064 carboxyethyl cellulose Polymers 0.000 description 2
- 229960004504 chlorhexidine hydrochloride Drugs 0.000 description 2
- 229960001747 cinchocaine Drugs 0.000 description 2
- PUFQVTATUTYEAL-UHFFFAOYSA-N cinchocaine Chemical compound C1=CC=CC2=NC(OCCCC)=CC(C(=O)NCCN(CC)CC)=C21 PUFQVTATUTYEAL-UHFFFAOYSA-N 0.000 description 2
- IVHBBMHQKZBJEU-UHFFFAOYSA-N cinchocaine hydrochloride Chemical compound [Cl-].C1=CC=CC2=NC(OCCCC)=CC(C(=O)NCC[NH+](CC)CC)=C21 IVHBBMHQKZBJEU-UHFFFAOYSA-N 0.000 description 2
- 229960003657 dexamethasone acetate Drugs 0.000 description 2
- 229940045574 dibucaine hydrochloride Drugs 0.000 description 2
- NOPFSRXAKWQILS-UHFFFAOYSA-N docosan-1-ol Chemical compound CCCCCCCCCCCCCCCCCCCCCCO NOPFSRXAKWQILS-UHFFFAOYSA-N 0.000 description 2
- POULHZVOKOAJMA-UHFFFAOYSA-N dodecanoic acid ester group Chemical group C(CCCCCCCCCCC)(=O)O POULHZVOKOAJMA-UHFFFAOYSA-N 0.000 description 2
- 229950003102 efonidipine Drugs 0.000 description 2
- 125000001495 ethyl group Chemical group [H]C([H])([H])C([H])([H])* 0.000 description 2
- 229940075507 glyceryl monostearate Drugs 0.000 description 2
- 208000014617 hemorrhoid Diseases 0.000 description 2
- 230000008676 import Effects 0.000 description 2
- 229960000905 indomethacin Drugs 0.000 description 2
- 229940093629 isopropyl isostearate Drugs 0.000 description 2
- SIOLDWZBFABPJU-UHFFFAOYSA-N isotridecanoic acid Chemical compound CC(C)CCCCCCCCCC(O)=O SIOLDWZBFABPJU-UHFFFAOYSA-N 0.000 description 2
- 235000019388 lanolin Nutrition 0.000 description 2
- 229940039717 lanolin Drugs 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
- 239000001788 mono and diglycerides of fatty acids Substances 0.000 description 2
- 229960004760 naphazoline hydrochloride Drugs 0.000 description 2
- KSCKTBJJRVPGKM-UHFFFAOYSA-N octan-1-olate;titanium(4+) Chemical compound [Ti+4].CCCCCCCC[O-].CCCCCCCC[O-].CCCCCCCC[O-].CCCCCCCC[O-] KSCKTBJJRVPGKM-UHFFFAOYSA-N 0.000 description 2
- ZQPPMHVWECSIRJ-KTKRTIGZSA-N oleic acid Chemical compound CCCCCCCC\C=C/CCCCCCCC(O)=O ZQPPMHVWECSIRJ-KTKRTIGZSA-N 0.000 description 2
- IWDCLRJOBJJRNH-UHFFFAOYSA-N p-cresol Chemical compound CC1=CC=C(O)C=C1 IWDCLRJOBJJRNH-UHFFFAOYSA-N 0.000 description 2
- 229940066842 petrolatum Drugs 0.000 description 2
- 229920003023 plastic Polymers 0.000 description 2
- 239000004033 plastic Substances 0.000 description 2
- 239000001818 polyoxyethylene sorbitan monostearate Substances 0.000 description 2
- 235000010989 polyoxyethylene sorbitan monostearate Nutrition 0.000 description 2
- NEOZOXKVMDBOSG-UHFFFAOYSA-N propan-2-yl 16-methylheptadecanoate Chemical compound CC(C)CCCCCCCCCCCCCCC(=O)OC(C)C NEOZOXKVMDBOSG-UHFFFAOYSA-N 0.000 description 2
- 239000003381 stabilizer Substances 0.000 description 2
- BYJAVTDNIXVSPW-UHFFFAOYSA-N tetryzoline Chemical compound N1CCN=C1C1C2=CC=CC=C2CCC1 BYJAVTDNIXVSPW-UHFFFAOYSA-N 0.000 description 2
- 229940070710 valerate Drugs 0.000 description 2
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- 125000001436 propyl group Chemical group [H]C([*])([H])C([H])([H])C([H])([H])[H] 0.000 description 1
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- ZUFQODAHGAHPFQ-UHFFFAOYSA-N pyridoxine hydrochloride Chemical compound Cl.CC1=NC=C(CO)C(CO)=C1O ZUFQODAHGAHPFQ-UHFFFAOYSA-N 0.000 description 1
- 235000019171 pyridoxine hydrochloride Nutrition 0.000 description 1
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- 239000011764 pyridoxine hydrochloride Substances 0.000 description 1
- 239000002994 raw material Substances 0.000 description 1
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- 229910052708 sodium Inorganic materials 0.000 description 1
- 239000011734 sodium Substances 0.000 description 1
- 235000010378 sodium ascorbate Nutrition 0.000 description 1
- 229960005055 sodium ascorbate Drugs 0.000 description 1
- PPASLZSBLFJQEF-RKJRWTFHSA-M sodium ascorbate Substances [Na+].OC[C@@H](O)[C@H]1OC(=O)C(O)=C1[O-] PPASLZSBLFJQEF-RKJRWTFHSA-M 0.000 description 1
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- AKHNMLFCWUSKQB-UHFFFAOYSA-L sodium thiosulfate Chemical compound [Na+].[Na+].[O-]S([O-])(=O)=S AKHNMLFCWUSKQB-UHFFFAOYSA-L 0.000 description 1
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- DSOWAKKSGYUMTF-GZOLSCHFSA-M sodium;(1e)-1-(6-methyl-2,4-dioxopyran-3-ylidene)ethanolate Chemical compound [Na+].C\C([O-])=C1/C(=O)OC(C)=CC1=O DSOWAKKSGYUMTF-GZOLSCHFSA-M 0.000 description 1
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- TUNFSRHWOTWDNC-HKGQFRNVSA-N tetradecanoic acid Chemical group CCCCCCCCCCCCC[14C](O)=O TUNFSRHWOTWDNC-HKGQFRNVSA-N 0.000 description 1
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- 239000008158 vegetable oil Substances 0.000 description 1
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- GVJHHUAWPYXKBD-IEOSBIPESA-N α-tocopherol Chemical compound OC1=C(C)C(C)=C2O[C@@](CCC[C@H](C)CCC[C@H](C)CCCC(C)C)(C)CCC2=C1C GVJHHUAWPYXKBD-IEOSBIPESA-N 0.000 description 1
Landscapes
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Abstract
Description
本発明は、dl−塩酸メチルエフェドリンを配合した外用剤に関し、更に詳しくは、dl−塩酸メチルエフェドリン及びイソプロピルメチルフェノールを同時に配合した外用剤の経時的な着色を抑制し、実用的に長期にわたり安定に保つことのできる外用剤に関する。
The present invention relates to an external preparation containing dl-methylephedrine hydrochloride, and more specifically, suppresses coloring over time of an external preparation containing dl-methylephedrine hydrochloride and isopropylmethylphenol at the same time, and is practically stable over a long period of time. The present invention relates to an external preparation that can be kept at a high level.
dl−塩酸メチルエフェドリンは、交感神経興奮作用、気管支拡張作用、鎮咳作用を有するため(非特許文献1参照)、感冒薬や咳止め等に汎用されている成分である。例えばリン酸ジヒドロコデイン、d−マレイン酸クロルフェニラミン、グアヤコールスルホン酸カリウム、塩化リゾチーム、キキョウ乾燥エキス、キョウニンエキス及びケイヒとの配合薬等が市販されている(非特許文献2参照)。また、血管収縮剤として外用痔疾用薬製造(輸入)承認基準(非特許文献3参照)にも収載されており、痔疾患時の止血効果に実績がある成分である。例えば酢酸ヒドロコルチゾン、リドカイン、乾燥硫酸アルミニウムカリウム 、塩酸クロルヘキシジン、アラントイン、ビタミンA油及び酢酸トコフェロールとの配合薬が市販されている(非特許文献4参照)。 Since dl-methylephedrine hydrochloride has a sympathomimetic excitatory action, bronchodilator action, and antitussive action (see Non-Patent Document 1), it is a component that is widely used for cold medicine and cough. For example, a combination drug of dihydrocodeine phosphate, d-chlorpheniramine d-maleate, potassium guaiacol sulfonate, lysozyme chloride, dried kyoto extract, kyonin extract, keihi, etc. is commercially available (see Non-Patent Document 2). In addition, it is listed as a vasoconstrictor in the manufacturing (import) approval standard (see Non-Patent Document 3) for external hemorrhoid medicine, and is a component that has a proven record in hemostatic effect during hemorrhoid disease. For example, a combination drug of hydrocortisone acetate, lidocaine, dry potassium aluminum sulfate, chlorhexidine hydrochloride, allantoin, vitamin A oil and tocopherol acetate is commercially available (see Non-Patent Document 4).
一方、イソプロピルメチルフェノールは、殺菌、防腐、防黴剤としてクリーム剤等の外用剤に使用される成分である(非特許文献5参照)。殺菌剤として外用痔疾用薬製造(輸入)承認基準(非特許文献3参照)にも収載されており、酢酸ヒドロコルチゾン、塩酸ナファゾリン、酸化亜鉛、リドカイン及びアラントインとの配合薬が市販されている(非特許文献6参照)。
それぞれの成分を単独で外用剤に処方しても、特に経時変化は認められないが、両成分を同時に外用剤に配合した場合、経時変化が起こり、褐色に着色する。
外用剤に配合した成分の着色を抑制する手段としては、コウジ酸の着色を特定の天然植物油を配合することにより抑制した皮膚外用剤(特許文献1、2参照)、安定化剤としてチオ硫酸ナトリウムを配合してインドメタシンの着色を抑制した皮膚外用剤(特許文献3参照)が知られている。しかしながら、dl−塩酸メチルエフェドリンとイソプロピルメチルフェノールを同時に配合した外用剤の着色を抑制する技術は知られていなかった。
Even if each component is formulated into an external preparation alone, no change with time is observed, but when both components are blended with the external preparation at the same time, the change with time occurs and the color is brown.
As means for suppressing coloring of components blended in external preparations, skin external preparations that suppress coloring of kojic acid by blending with specific natural vegetable oils (see Patent Documents 1 and 2), sodium thiosulfate as a stabilizer An external preparation for skin (see Patent Document 3) in which coloring of indomethacin is suppressed by blending of is known. However, a technique for suppressing coloring of an external preparation containing dl-methylephedrine hydrochloride and isopropylmethylphenol at the same time has not been known.
dl−塩酸メチルエフェドリン及びイソプロピルメチルフェノールを単独で外用剤に処方しても、特に経時変化は認められないが、両成分を同時に外用剤に配合した場合、経時変化が起こり、褐色に着色する。本発明は、dl−塩酸メチルエフェドリン及びイソプロピルメチルフェノールを同時に配合した外用剤の経時的な着色を抑制することを課題とする。
Even if dl-methylephedrine hydrochloride and isopropylmethylphenol are independently formulated into an external preparation, no change over time is observed, but when both components are blended in the external preparation simultaneously, the change over time occurs and the color is brown. This invention makes it a subject to suppress the coloring over time of the external preparation which mix | blended dl-methylephedrine hydrochloride and isopropylmethylphenol simultaneously.
上記課題を解決するため鋭意研究を実施した結果、dl−塩酸メチルエフェドリン及びイソプロピルメチルフェノールを同時に配合した外用剤に、脂肪酸アルキルエステルを添加することにより、経時的な着色を抑制することを見出し、本発明を完成するに至った。
すなわち、本発明は、(a)dl−塩酸メチルエフェドリン、(b)イソプロピルメチルフェノール及び(c)脂肪酸アルキルエステルを配合した外用剤である。
As a result of diligent research to solve the above problems, it was found that, by adding a fatty acid alkyl ester to an external preparation containing dl-methylephedrine hydrochloride and isopropylmethylphenol at the same time, coloring over time is suppressed, The present invention has been completed.
That is, this invention is an external preparation which mix | blended (a) dl-methyl ephedrine hydrochloride, (b) isopropyl methyl phenol, and (c) fatty-acid alkylester.
本発明によれば、dl−塩酸メチルエフェドリン及びイソプロピルメチルフェノールを同時に配合した外用剤に脂肪酸アルキルエステルを添加することにより、長期間着色が抑制された外用剤を提供することが可能となった。
ADVANTAGE OF THE INVENTION According to this invention, it became possible to provide the external preparation in which coloring was suppressed for a long period of time by adding a fatty-acid alkylester to the external preparation which mix | blended dl-methylephedrine hydrochloride and isopropylmethylphenol simultaneously.
本発明のdl−塩酸メチルエフェドリンは、通常の医薬品に使用されるものであればよく、例えば日本薬局方収載品を使用することができる。dl−塩酸メチルエフェドリンの濃度は、0.005〜0.5%(w/w)が好ましく、特に0.05〜0.2%(w/w)が好ましいが、適宜増減させて含有させることが可能である。 The dl-methylephedrine hydrochloride of the present invention is not limited as long as it is used for ordinary pharmaceuticals, and for example, products listed in the Japanese Pharmacopoeia can be used. The concentration of dl-methylephedrine hydrochloride is preferably 0.005 to 0.5% (w / w), and particularly preferably 0.05 to 0.2% (w / w). Is possible.
本発明のイソプロピルメチルフェノールは、通常の医薬品に使用されるものであればよい。イソプロピルメチルフェノールの濃度は、好ましくは0.01〜3.0%(w/w)、特に好ましくは0.02〜2.0%(w/w)とすることがよい。 The isopropylmethylphenol of this invention should just be used for a normal pharmaceutical. The concentration of isopropylmethylphenol is preferably 0.01 to 3.0% (w / w), particularly preferably 0.02 to 2.0% (w / w).
本発明で使用する脂肪酸アルキルエステルとしては、炭素数10〜20の高級脂肪酸のアルキルエステルがあげられる。好ましい脂肪酸は炭素数12〜18の高級脂肪酸で、直鎖又は分岐炭化水素基、ヒドロキシル基等を有するものも使用できる。
脂肪酸アルキルエステルの例として、脂肪酸部位がラウリン酸、ミリスチン酸、パルミチン酸、ステアリン酸、ベヘン酸、オレイン酸、リノール酸、イソステアリン酸、イソパルミチン酸、イソトリデカン酸、イソノナン酸、12−ヒドロキシステアリン酸等があげられ、これらの高級脂肪酸と炭素数1以上のアルコールとのエステルが使用される。特に日本薬局方通則で定める常温において液状であるものが好ましい。具体的には、アジピン酸ジイソプロピル、セバシン酸ジイソプロピル、セバシン酸ジエチル、オリーブオレイン酸エチル、イソステアリン酸イソプロピル、ミリスチン酸イソプロピル、ミリスチン酸ブチル、パルミチン酸イソプロピル、パルミチン酸セチル、リノール酸エチル、リノール酸イソプロピルなどがあげられる。
脂肪酸アルキルエステルの濃度は、0.05〜20.0%(w/w)が好ましく、特に1.0〜20.0%(w/w)が好ましいが、脂肪酸アルキルエステルの種類や目的に応じて適宜増減させて含有させることが可能である。
Examples of fatty acid alkyl esters used in the present invention include alkyl esters of higher fatty acids having 10 to 20 carbon atoms. Preferable fatty acids are higher fatty acids having 12 to 18 carbon atoms, and those having linear or branched hydrocarbon groups, hydroxyl groups, and the like can also be used.
Examples of fatty acid alkyl esters include fatty acid moieties such as lauric acid, myristic acid, palmitic acid, stearic acid, behenic acid, oleic acid, linoleic acid, isostearic acid, isopalmitic acid, isotridecanoic acid, isononanoic acid, 12-hydroxystearic acid, etc. These esters of higher fatty acids and alcohols having 1 or more carbon atoms are used. In particular, those that are liquid at room temperature as defined by the Japanese Pharmacopoeia General Rules are preferred. Specifically, diisopropyl adipate, diisopropyl sebacate, diethyl sebacate, ethyl olive oleate, isopropyl isostearate, isopropyl myristate, butyl myristate, isopropyl palmitate, cetyl palmitate, ethyl linoleate, isopropyl linoleate, etc. Can be given.
The concentration of the fatty acid alkyl ester is preferably 0.05 to 20.0% (w / w), particularly preferably 1.0 to 20.0% (w / w), depending on the type and purpose of the fatty acid alkyl ester. It is possible to increase or decrease the content appropriately.
本発明の外用剤としては、油脂性軟膏剤、水溶性軟膏剤、クリーム剤(乳剤性軟膏剤)リニメント剤、ローション剤が挙げられ、このうち、油脂性軟膏剤、クリーム剤が好ましく使用される。この外用剤中には、前述のdl−塩酸メチルエフェドリン、イソプロピルメチルフェノールおよび脂肪酸アルキルエステル以外に、必要に応じて他の基剤および有効成分、添加剤を加えることができる。 Examples of the external preparation of the present invention include oleaginous ointment, water-soluble ointment, cream (emulsion ointment) liniment, and lotion. Of these, oleaginous ointment and cream are preferably used. . In this external preparation, in addition to the above-mentioned dl-methylephedrine hydrochloride, isopropylmethylphenol and fatty acid alkyl ester, other bases, active ingredients and additives can be added as necessary.
本発明の外用剤に使用される基剤は、ワセリン、プラスチベース、パラフィン、流動パラフィン、軽質流動パラフィン、サラシミツロウ、ベヘニルアルコール、ステアリルアルコール、セタノール、ステアリン酸、ベヘニン酸、シリコーン油などの油脂性基剤、水、マクロゴール、エタノール、メチルエチルケトン、綿実油、オリーブ油、落花生油などの溶剤、ポリオキシエチレン硬化ヒマシ油、ポリオキシエチレンソルビタン脂肪酸エステル、グリセリン脂肪酸エステル、ポリオキシエチレン脂肪酸エステル、ポリオキシエチレンアルキルエーテル、ソルビタン脂肪酸エステル、ポリオキシエチレンポリオキシプロピレングリコール、ラウリル硫酸ナトリウム、セチル硫酸ナトリウムなどの乳化剤、ポリビニルピロリドン、カルボキシメチルセルロース、コロイド性含水ケイ酸アルミニウム、キサンタンガム、ローカストビーンガム、トラガントガム、グアーガム、ゼラチン、アラビアゴム、アルギン酸、アルブミンなどの増粘剤、オキシベンゾン、ジブチルヒドロキシトルエン、エデト酸ナトリウムなどの安定化剤、ヒアルロン酸ナトリウム、コンドロイチン硫酸ナトリウム、グリセリン、1,3−ブチレングリコール、プロピレングリコール、尿素、ショ糖、エリスリトール、ソルビトールなどの保湿剤、パラオキシ安息香酸メチル、パラオキシ安息香酸エチル、パラオキシ安息香酸プロピル、パラオキシ安息香酸ブチル、デヒドロ酢酸ナトリウム、p−クレゾールなどの防腐剤であり、剤形に応じて適宜選択して使用する。 The base used for the external preparation of the present invention is an oily base such as petrolatum, plastibase, paraffin, liquid paraffin, light liquid paraffin, white beeswax, behenyl alcohol, stearyl alcohol, cetanol, stearic acid, behenic acid, silicone oil, etc. , Water, macrogol, ethanol, methyl ethyl ketone, cottonseed oil, olive oil, peanut oil and other solvents, polyoxyethylene hydrogenated castor oil, polyoxyethylene sorbitan fatty acid ester, glycerin fatty acid ester, polyoxyethylene fatty acid ester, polyoxyethylene alkyl ether, Emulsifiers such as sorbitan fatty acid ester, polyoxyethylene polyoxypropylene glycol, sodium lauryl sulfate, sodium cetyl sulfate, polyvinylpyrrolidone, carboxymethyl Cellulose, colloidal hydrous aluminum silicate, xanthan gum, locust bean gum, tragacanth gum, guar gum, gelatin, gum arabic, alginic acid, albumin and other thickeners, stabilizers such as oxybenzone, dibutylhydroxytoluene, sodium edetate, hyaluronic acid Moisturizer such as sodium, sodium chondroitin sulfate, glycerin, 1,3-butylene glycol, propylene glycol, urea, sucrose, erythritol, sorbitol, methyl paraoxybenzoate, ethyl paraoxybenzoate, propyl paraoxybenzoate, butyl paraoxybenzoate These are preservatives such as sodium dehydroacetate and p-cresol, which are appropriately selected according to the dosage form.
本発明の外用剤に使用される有効成分は治療目的によって更に追加することが可能である。例えば、吉草酸酢酸プレドニゾロン、酢酸ヒドロコルチゾン等のステロイド剤、ブフェキサマク、ジクロフェナック、ケトプロフェン、インドメタシン、グリチルレチン酸などの非ステロイド消炎鎮痛剤、塩酸ジフェンヒドラミン、塩酸ジフェニルピラリン、マレイン酸クロルフェニラミンなどの抗ヒスタミン剤、酸化亜鉛などの収斂剤、塩酸クロルヘキシジンなどの殺菌剤、アスコルビン酸ナトリウム、塩酸ピリドキシン、トコフェロール、酢酸トコフェロールなどのビタミン剤、クロタミトンなどの鎮痒剤、トルナフタート、ビホナゾール、硝酸ミコナゾールなどの抗真菌剤、塩酸ナファゾリン、塩酸テトラヒドロゾリンなどの血管収縮剤、アラントインなどの創傷治癒剤、メントール、ボルネオール、カンフル、ハッカ油、ユーカリ油などの清涼化剤などが挙げられる。このうち、酸化亜鉛、アラントイン、酢酸ヒドロコルチゾン、メントール、ハッカ油又はユーカリ油から選ばれた1種以上を配合した場合、本発明の効果がより顕著に現れる。
このようにして得られた本発明の外用剤は、長期間の保存によっても着色が抑制され、性状の変化が少なく安定な製剤を提供することが可能である。
The active ingredient used in the external preparation of the present invention can be further added depending on the therapeutic purpose. For example, steroids such as prednisolone valerate and hydrocortisone acetate, nonsteroidal analgesics such as bufexamac, diclofenac, ketoprofen, indomethacin, glycyrrhetinic acid, antihistamines such as diphenhydramine hydrochloride, diphenylpyramine hydrochloride, chlorpheniramine maleate, zinc oxide Astringents such as chlorhexidine hydrochloride, bactericides such as sodium ascorbate, pyridoxine hydrochloride, tocopherol, tocopherol acetate, antibacterial agents such as crotamiton, antifungal agents such as tolnaphthalate, bifonazole, miconazole nitrate, naphazoline hydrochloride, hydrochloric acid Vasoconstrictors such as tetrahydrozoline, wound healing agents such as allantoin, menthol, borneol, camphor, peppermint oil, eucalyptus oil How fresheners and the like. Among these, when 1 or more types chosen from zinc oxide, allantoin, hydrocortisone acetate, menthol, mint oil, or eucalyptus oil are mix | blended, the effect of this invention appears more notably.
The external preparation of the present invention thus obtained can suppress coloring even after long-term storage, and can provide a stable preparation with little change in properties.
本発明の外用剤は通常、以下の操作によって調製するが、本発明を達成することができる調製方法であれば良く、特に限定はされない。例えば、イソプロピルメチルフェノールをパルミチン酸イソプロピルに加熱溶解し、dl−塩酸メチルエフェドリンを分散させ、ワセリン等の軟膏基剤を加え、必要に応じて他の薬剤を添加した後、練合しながら冷却し、適当なアルミチューブ等に充填することによって油脂性軟膏剤を得る。
The external preparation of the present invention is usually prepared by the following operation, but any preparation method capable of achieving the present invention may be used and is not particularly limited. For example, isopropylmethylphenol is heated and dissolved in isopropyl palmitate, dl-methylephedrine hydrochloride is dispersed, ointment base such as petrolatum is added, and other agents are added as necessary, and then cooled while kneading. An oily ointment is obtained by filling an appropriate aluminum tube or the like.
以下に実施例及び比較例をもって本発明を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。
EXAMPLES The present invention will be specifically described below with reference to examples and comparative examples, but the present invention is not limited to these.
(実施例1)
白色ワセリン43.35g及び固形パラフィン8gを70〜80℃で溶融し、それにジブカイン0.25g、ジフェンヒドラミン0.2g、ステアリルアルコール4g、セタノール2g及びポリオキシエチレンソルビタンモノステアレート5gを加え、1液とする。パルミチン酸イソプロピル5gにイソプロピルメチルフェノール0.2gを加熱溶解し、流動パラフィン28gを加え、dl−塩酸メチルエフェドリン0.5g及び酢酸ヒドロコルチゾン0.5gを添加し、攪拌分散させて2液とする。1液と2液を混和させた後、加熱溶融し、これに酢酸トコフェロール3.0gを添加し、減圧下、攪拌冷却後、アルミチューブに充填して油脂性軟膏剤とした。
Example 1
43.35 g of white petrolatum and 8 g of solid paraffin were melted at 70 to 80 ° C., to which 0.25 g of dibucaine, 0.2 g of diphenhydramine, 4 g of stearyl alcohol, 2 g of cetanol and 5 g of polyoxyethylene sorbitan monostearate were added. To do. 0.2 g of isopropylmethylphenol is dissolved by heating in 5 g of isopropyl palmitate, 28 g of liquid paraffin is added, 0.5 g of dl-methylephedrine hydrochloride and 0.5 g of hydrocortisone acetate are added, and the mixture is stirred and dispersed to form two liquids. After mixing the first and second liquids, the mixture was melted by heating, to which 3.0 g of tocopherol acetate was added, stirred and cooled under reduced pressure, and then filled into an aluminum tube to obtain an oily ointment.
(実施例2)
白色ワセリン67.4gを70〜80℃で溶融し、それにリドカイン3.0gおよびセトステアリルアルコール8gを加え、1液とする。ミリスチン酸イソプロピル3gにイソプロピルメチルフェノール0.1gを加熱溶解し、流動パラフィン16gを加え、dl−塩酸メチルエフェドリン0.1g及びグリチルレチン酸0.2gを添加し、攪拌分散させて2液とする。1液と2液を混和させた後、加熱溶融し、これに酢酸トコフェロール2g及びL−メントール0.2gを添加し、減圧下、攪拌冷却後、アルミチューブに充填して油脂性軟膏剤とした。
(Example 2)
67.4 g of white petrolatum is melted at 70 to 80 ° C., and 3.0 g of lidocaine and 8 g of cetostearyl alcohol are added to make 1 liquid. In 3 g of isopropyl myristate, 0.1 g of isopropylmethylphenol is dissolved by heating, 16 g of liquid paraffin is added, 0.1 g of dl-methylephedrine hydrochloride and 0.2 g of glycyrrhetinic acid are added, and the mixture is stirred and dispersed to form two liquids. 1 liquid and 2 liquids were mixed and then melted by heating, to which 2 g of tocopherol acetate and 0.2 g of L-menthol were added, stirred and cooled under reduced pressure, then filled into an aluminum tube to obtain an oily ointment. .
(実施例3)
白色ワセリン63.4gを70〜80℃で溶融し、それにリドカイン3g、ステアリルアルコール2g及びセタノール2gを加え、1液とする。パルミチン酸イソプロピル3gにイソプロピルメチルフェノール0.1gを加熱溶解し、流動パラフィン20gを加え、dl−塩酸メチルエフェドリン0.5g、酢酸ヒドロコルチゾン0.5g、アラントイン1g及び酸化亜鉛4gを添加し、攪拌分散させて2液とする。1液と2液を混和させた後、加熱溶融し、これにユーカリ油0.5gを添加し、減圧下、攪拌冷却後、アルミチューブに充填して油脂性軟膏剤とした。
(Example 3)
63.4 g of white petrolatum is melted at 70 to 80 ° C., and 3 g of lidocaine, 2 g of stearyl alcohol and 2 g of cetanol are added to make 1 liquid. Dissolve 0.1 g of isopropylmethylphenol in 3 g of isopropyl palmitate with heating, add 20 g of liquid paraffin, add 0.5 g of dl-methylephedrine hydrochloride, 0.5 g of hydrocortisone acetate, 1 g of allantoin and 4 g of zinc oxide, and disperse with stirring. 2 liquids. After mixing the first and second liquids, the mixture was melted by heating, 0.5 g of eucalyptus oil was added thereto, and after stirring and cooling under reduced pressure, the aluminum tube was filled to obtain an oily ointment.
(実施例4)
白色ワセリン51.45g及び固形パラフィン6gを70〜80℃で溶融し、それにリドカイン2g及びセタノール9gを加え、1液とする。セバシン酸ジエチル1g及びイソステアリン酸イソプロピル4gにイソプロピルメチルフェノール0.5gを加熱溶解し、流動パラフィン25gを加え、dl−塩酸メチルエフェドリン0.3g、酢酸プレドニゾロン0.25gを添加し、攪拌分散させて2液とする。1液と2液を混和させた後、加熱溶融し、これにl−メントール0.5gを添加し、減圧下、攪拌冷却後、アルミチューブに充填して油脂性軟膏剤とした。
Example 4
51.45 g of white petrolatum and 6 g of solid paraffin are melted at 70 to 80 ° C., and 2 g of lidocaine and 9 g of cetanol are added to make 1 liquid. Isolate 1 g of diethyl sebacate and 4 g of isopropyl isostearate by heating and dissolving 0.5 g of isopropylmethylphenol, add 25 g of liquid paraffin, add 0.3 g of dl-methylephedrine hydrochloride and 0.25 g of prednisolone acetate, stir and disperse. Use liquid. After mixing 1st liquid and 2nd liquid, it melted by heating, 0.5 g of l-menthol was added thereto, and after stirring and cooling under reduced pressure, it was filled in an aluminum tube to obtain an oily ointment.
(実施例5)
白色ワセリン12g及びプラスチベース23gを約80℃で溶融し、それにカルボキシエチルセルロース21.3gを加え、1液とする。パルミチン酸イソプロピル2gにイソプロピルメチルフェノール0.2gを加熱溶解し、流動パラフィン30gを加え、dl−塩酸メチルエフェドリン0.5g、マレイン酸クロルフェニラミン1g及び酸化亜鉛10gを添加し、攪拌分散させて2液とする。1液と2液を混和させた後、加熱溶融し、減圧下、攪拌冷却後、アルミチューブに充填して油脂性軟膏剤とした。
(Example 5)
12 g of white petrolatum and 23 g of plastic base are melted at about 80 ° C., and 21.3 g of carboxyethyl cellulose is added thereto to make one liquid. 0.2 g of isopropylmethylphenol is dissolved by heating in 2 g of isopropyl palmitate, 30 g of liquid paraffin is added, 0.5 g of dl-methylephedrine hydrochloride, 1 g of chlorpheniramine maleate and 10 g of zinc oxide are added, and dispersed by stirring. Use liquid. After mixing 1 liquid and 2 liquids, they were heated and melted, stirred and cooled under reduced pressure, and then filled into an aluminum tube to obtain an oily ointment.
(実施例6)
白色ワセリン66gを70〜80℃で溶融し、それにリドカイン1g及びステアリルアルコール6gを加え、1液とする。イソオクタン酸セチル4gにイソプロピルメチルフェノール0.1gを加熱溶解し、流動パラフィン17.15g及びクロタミトン5gを加え、dl−塩酸メチルエフェドリン0.1g、吉草酸酢酸プレドニゾロン0.15gを添加し、攪拌分散させて2液とする。1液と2液を混和させた後、加熱溶融し、これに酢酸トコフェロール0.5gを添加し、減圧下、攪拌冷却後、アルミチューブに充填して油脂性軟膏剤とした。
(Example 6)
66 g of white petrolatum is melted at 70 to 80 ° C., and 1 g of lidocaine and 6 g of stearyl alcohol are added to make 1 liquid. Dissolve 0.1 g of isopropylmethylphenol in 4 g of cetyl isooctanoate with heating, add 17.15 g of liquid paraffin and 5 g of crotamiton, add 0.1 g of dl-methylephedrine hydrochloride and 0.15 g of prednisolone acetate valerate, and disperse with stirring. 2 liquids. After mixing the first and second liquids, the mixture was melted by heating, to which 0.5 g of tocopherol acetate was added, stirred and cooled under reduced pressure, and then filled into an aluminum tube to obtain an oily ointment.
(実施例7)
白色ワセリン15g、ステアリルアルコール8g、セタノール14g、メチルパラベン0.1g及びプロピルパラベン0.1gを加熱溶解し、1液とする。パルミチン酸イソプロピル2gにイソプロピルメチルフェノール0.2gを加熱溶解し、流動パラフィン10gを加え、酢酸プレドニゾロン0.5gを分散させ、1液と混和し、2液とする。加温した精製水35.95gに塩酸ジブカイン0.25g、塩酸ジフェンヒドラミン0.2gおよびdl−塩酸メチルエフェドリン0.2gを溶解し、プロピレングリコール12g及びラウリル硫酸ナトリウム1.5gを加え、攪拌分散させて3液とする。2液と3液を混和させた後、80℃に保温し、減圧下、ホモミキサー回転数3000rpmで30分間乳化させ、攪拌冷却後、アルミチューブに充填してクリーム剤とした。
(Example 7)
15 g of white petrolatum, 8 g of stearyl alcohol, 14 g of cetanol, 0.1 g of methylparaben and 0.1 g of propylparaben are heated and dissolved to make one solution. In 2 g of isopropyl palmitate, 0.2 g of isopropylmethylphenol is heated and dissolved, 10 g of liquid paraffin is added, 0.5 g of prednisolone acetate is dispersed, and mixed with 1 solution to make 2 solutions. Dissolve 0.25 g of dibucaine hydrochloride, 0.2 g of diphenhydramine hydrochloride and 0.2 g of dl-methylephedrine hydrochloride in 35.95 g of heated purified water, add 12 g of propylene glycol and 1.5 g of sodium lauryl sulfate, and stir and disperse. Three liquids are used. After mixing the second and third liquids, the mixture was kept at 80 ° C., emulsified for 30 minutes under a reduced pressure at 3000 rpm homomixer, stirred and cooled, and then filled into an aluminum tube to obtain a cream.
(実施例8)
白色ワセリン4g、ステアリルアルコール8g、セタノール6g、ポリオキシエチレン(2)セチルエーテル3g、ポリオキシエチレン(20)セチルエーテル3g及びプロピルパラベン0.1gを加熱溶解し、1液とする。ミリスチン酸イソプロピル10gにイソプロピルメチルフェノール0.1gを加熱溶解し、酢酸デキサメタゾン0.03gを分散させ、これに、流動パラフィン7g及びクロタミトン5gを添加し、攪拌混和し、1液と混和し、2液とする。加温した精製水48.97gに塩酸ジフェンヒドラミン1.0gおよびdl−塩酸メチルエフェドリン0.1gを溶解し、キサンタンガム0.2gを加え、攪拌分散させて3液とする。2液と3液を混和させた後、80℃に保温し、l−メントール3.5gを添加した後、減圧下、ホモミキサー回転数3000rpmで30分間乳化させ、攪拌冷却後、アルミチューブに充填してクリーム剤とした。
(Example 8)
4 g of white petrolatum, 8 g of stearyl alcohol, 6 g of cetanol, 3 g of polyoxyethylene (2) cetyl ether, 3 g of polyoxyethylene (20) cetyl ether and 0.1 g of propylparaben are heated and dissolved to form one liquid. Dissolve 0.1 g of isopropylmethylphenol in 10 g of isopropyl myristate with heating to disperse 0.03 g of dexamethasone acetate, add 7 g of liquid paraffin and 5 g of crotamiton, mix with stirring, mix with 1 solution, mix 2 solutions And Dissolve 1.0 g of diphenhydramine hydrochloride and 0.1 g of dl-methylephedrine hydrochloride in 48.97 g of heated purified water, add 0.2 g of xanthan gum, and stir and disperse to make 3 liquids. Mix 2 and 3 liquids, keep warm at 80 ° C., add 3.5 g of l-menthol, emulsify for 30 minutes under reduced pressure at 3000 rpm homomixer, stir cool, then fill into aluminum tube And used as a cream.
(実施例9)
ミリスチン酸イソプロピル20gに精製ラノリン16gおよびイソプロピルメチルフェノール0.5g、メチルパラベン0.1g及びプロピルパラベン0.1gを加え、加熱溶解し、1液とする。セトステアリルアルコール4.5gおよびラウリル硫酸ナトリウム0.5gを混和し、加熱融解した後、0.2gの精製水を添加し、110℃まで加熱し、冷却し、2液とする。加温した精製水52.3gに塩酸リドカイン2g、マレイン酸クロルフェニラミン0.3g、dl−塩酸メチルエフェドリン0.5gを加え、攪拌溶解させて3液とする。1液と2液および3液を混和させた後、80℃に保温し、dl−カンフル3gを添加した後、減圧下、ホモミキサー回転数3000rpmで30分間乳化させ、攪拌冷却後、アルミチューブに充填してクリーム剤とした。
Example 9
To 20 g of isopropyl myristate, add 16 g of purified lanolin, 0.5 g of isopropylmethylphenol, 0.1 g of methylparaben and 0.1 g of propylparaben, dissolve with heating to make one solution. After mixing 4.5 g of cetostearyl alcohol and 0.5 g of sodium lauryl sulfate and heating and melting, 0.2 g of purified water is added, heated to 110 ° C., cooled, and made into two liquids. 2 g of lidocaine hydrochloride, 0.3 g of chlorpheniramine maleate, and 0.5 g of dl-methylephedrine hydrochloride are added to 52.3 g of heated purified water, and dissolved by stirring to obtain 3 solutions. Mix 1st liquid, 2nd liquid and 3rd liquid, heat at 80 ° C, add 3g of dl-camphor, emulsify for 30 minutes under reduced pressure at 3000 rpm homomixer, stir and cool, then cool to aluminum tube Filled into a cream.
(実施例10)
白色ワセリン4.5g、ステアリルアルコール4g、セタノール2g、ベヘニン酸2g、酢酸トコフェロール0.5g、ジフェンヒドラミン1g、リドカイン0.5g、プロピルパラベン0.1gを加熱溶解し、1液とする。パルミチン酸イソプロピル2gにイソプロピルメチルフェノール0.1gを加熱融解し、流動パラフィン5.5gにモノステアリン酸グリセリン4g、ステアリン酸ポリオキシル40 4gを加え、攪拌溶融し、酸化亜鉛5gを添加し、攪拌分散させ2液とする。加温した精製水49.2gにdl−塩酸メチルエフェドリン0.2gを溶解し、1,3−ブチレングリコール5g、濃グリセリン10g、セチル硫酸ナトリウム 0.1g、キサンタンガム0.3gを加え、攪拌分散させて3液とする。1液と2液および3液を混和させた後、80℃に保温し、減圧下、ホモミキサー回転数2000rpmで40分間乳化させ、攪拌冷却後、アルミチューブに充填してクリーム剤とした。
(Example 10)
White petrolatum 4.5 g, stearyl alcohol 4 g, cetanol 2 g, behenic acid 2 g, tocopherol acetate 0.5 g, diphenhydramine 1 g, lidocaine 0.5 g and propylparaben 0.1 g are dissolved by heating to make one solution. Melting 0.1 g of isopropylmethylphenol in 2 g of isopropyl palmitate, adding 4 g of glyceryl monostearate and 4 g of polyoxyl stearate to 5.5 g of liquid paraffin, stirring and melting, adding 5 g of zinc oxide, stirring and dispersing. Two liquids are used. Dissolve 0.2 g of dl-methylephedrine hydrochloride in 49.2 g of heated purified water, add 5 g of 1,3-butylene glycol, 10 g of concentrated glycerin, 0.1 g of sodium cetyl sulfate, and 0.3 g of xanthan gum, and stir and disperse. 3 liquids. After mixing liquid 1, liquid 2 and liquid 3, the mixture was kept at 80 ° C., emulsified under reduced pressure at a homomixer rotation speed of 2000 rpm for 40 minutes, stirred and cooled, and then filled into an aluminum tube to obtain a cream.
(比較例1)
白色ワセリン43.35g及び固形パラフィン8gを70〜80℃で溶融し、それにジブカイン0.25g、ジフェンヒドラミン0.2g、ステアリルアルコール4g、セタノール2g及びポリオキシエチレンソルビタンモノステアレート5gを加え、1液とする。流動パラフィン33gにイソプロピルメチルフェノール0.2gを加熱融解し、dl−塩酸メチルエフェドリン0.5g及び酢酸ヒドロコルチゾン0.5gを添加し、攪拌分散させて2液とする。1液と2液を混和させた後、加熱溶融し、これに酢酸トコフェロール3.0gを添加し、減圧下、攪拌冷却後、アルミチューブに充填して油脂性軟膏剤とした。
(Comparative Example 1)
43.35 g of white petrolatum and 8 g of solid paraffin were melted at 70 to 80 ° C., to which 0.25 g of dibucaine, 0.2 g of diphenhydramine, 4 g of stearyl alcohol, 2 g of cetanol and 5 g of polyoxyethylene sorbitan monostearate were added. To do. To 33 g of liquid paraffin, 0.2 g of isopropylmethylphenol is heated and melted, 0.5 g of dl-methylephedrine hydrochloride and 0.5 g of hydrocortisone acetate are added, and the mixture is stirred and dispersed to form two liquids. After mixing the first and second liquids, the mixture was melted by heating, to which 3.0 g of tocopherol acetate was added, stirred and cooled under reduced pressure, and then filled into an aluminum tube to obtain an oily ointment.
(比較例2)
白色ワセリン67.4gを70〜80℃で溶融し、それにリドカイン3.0gおよびセトステアリルアルコール8gを加え、1液とする。流動パラフィン19gにイソプロピルメチルフェノール0.1gを加熱融解し、dl−塩酸メチルエフェドリン0.1g及びグリチルレチン酸0.2gを添加し、攪拌分散させて2液とする。1液と2液を混和させた後、加熱溶融し、これに酢酸トコフェロール2g及びl−メントール0.2gを添加し、減圧下、攪拌冷却後、アルミチューブに充填して油脂性軟膏剤とした。
(Comparative Example 2)
67.4 g of white petrolatum is melted at 70 to 80 ° C., and 3.0 g of lidocaine and 8 g of cetostearyl alcohol are added to make 1 liquid. To 19 g of liquid paraffin, 0.1 g of isopropylmethylphenol is heated and melted, 0.1 g of dl-methylephedrine hydrochloride and 0.2 g of glycyrrhetinic acid are added, and the mixture is stirred and dispersed to form two liquids. 1 liquid and 2 liquids were mixed and then melted by heating. 2 g of tocopherol acetate and 0.2 g of 1-menthol were added thereto, and after stirring and cooling under reduced pressure, the mixture was filled in an aluminum tube to obtain an oily ointment. .
(比較例3)
白色ワセリン63.4gを70〜80℃で溶融し、それにリドカイン3g、ステアリルアルコール2g及びセタノール2gを加え、1液とする。流動パラフィン23gにイソプロピルメチルフェノール0.1gを加熱融解し、dl−塩酸メチルエフェドリン0.5g、酢酸ヒドロコルチゾン0.5g、アラントイン1g及び酸化亜鉛4gを添加し、攪拌分散させて2液とする。1液と2液を混和させた後、加熱溶融し、これにユーカリ油0.5gを添加し、減圧下、攪拌冷却後、アルミチューブに充填して油脂性軟膏剤とした。
(Comparative Example 3)
63.4 g of white petrolatum is melted at 70 to 80 ° C., and 3 g of lidocaine, 2 g of stearyl alcohol and 2 g of cetanol are added to make 1 liquid. To 23 g of liquid paraffin, 0.1 g of isopropylmethylphenol is heated and melted, 0.5 g of dl-methylephedrine hydrochloride, 0.5 g of hydrocortisone acetate, 1 g of allantoin and 4 g of zinc oxide are added, and dispersed by stirring to form two liquids. After mixing the first and second liquids, the mixture was melted by heating, 0.5 g of eucalyptus oil was added thereto, and after stirring and cooling under reduced pressure, the aluminum tube was filled to obtain an oily ointment.
(比較例4)
白色ワセリン51.45g及び固形パラフィン6gを70〜80℃で溶融し、それにリドカイン2g及びセタノール9gを加え、1液とする。流動パラフィン30gにイソプロピルメチルフェノール0.5gを加熱融解し、dl−塩酸メチルエフェドリン0.3g、酢酸プレドニゾロン0.25gを添加し、攪拌分散させて2液とする。1液と2液を混和させた後、加熱溶融し、これにL−メントール0.5gを添加し、減圧下、攪拌冷却後、アルミチューブに充填して油脂性軟膏剤とした。
(Comparative Example 4)
51.45 g of white petrolatum and 6 g of solid paraffin are melted at 70 to 80 ° C., and 2 g of lidocaine and 9 g of cetanol are added thereto to make one liquid. To 30 g of liquid paraffin, 0.5 g of isopropylmethylphenol is heated and melted, 0.3 g of dl-methylephedrine hydrochloride and 0.25 g of prednisolone acetate are added, and the mixture is stirred and dispersed to form two liquids. After mixing 1 liquid and 2 liquid, it melted by heating, 0.5 g of L-menthol was added thereto, and after stirring and cooling under reduced pressure, it was filled in an aluminum tube to obtain an oily ointment.
(比較例5)
白色ワセリン12g及びプラスチベース23gを約80℃で溶融し、それにカルボキシエチルセルロース21.3gを加え、1液とする。流動パラフィン32gにイソプロピルメチルフェノール0.2gを加熱融解し、dl−塩酸メチルエフェドリン0.5g、マレイン酸クロルフェニラミン1g及び酸化亜鉛10gを添加し、攪拌分散させて2液とする。1液と2液を混和させた後、加熱溶融し、減圧下、攪拌冷却後、アルミチューブに充填して油脂性軟膏剤とした。
(Comparative Example 5)
12 g of white petrolatum and 23 g of plastic base are melted at about 80 ° C., and 21.3 g of carboxyethyl cellulose is added thereto to make one liquid. To 32 g of liquid paraffin, 0.2 g of isopropylmethylphenol is heated and melted, 0.5 g of dl-methylephedrine hydrochloride, 1 g of chlorpheniramine maleate and 10 g of zinc oxide are added, and the mixture is stirred and dispersed to form two liquids. After mixing 1 liquid and 2 liquids, they were heated and melted, stirred and cooled under reduced pressure, and then filled into an aluminum tube to obtain an oily ointment.
(比較例6)
白色ワセリン66gを70〜80℃で溶融し、それにリドカイン1g及びステアリルアルコール6gを加え、1液とする。流動パラフィン21.15gにイソプロピルメチルフェノール0.1gを加熱融解し、及びクロタミトン5gを加え、dl−塩酸メチルエフェドリン0.1g、吉草酸酢酸プレドニゾロン0.15gを添加し、攪拌分散させて2液とする。1液と2液を混和させた後、加熱溶融し、これに酢酸トコフェロール0.5gを添加し、減圧下、攪拌冷却後、アルミチューブに充填して油脂性軟膏剤とした。
(Comparative Example 6)
66 g of white petrolatum is melted at 70 to 80 ° C., and 1 g of lidocaine and 6 g of stearyl alcohol are added to make 1 liquid. Heat and melt 0.1 g of isopropylmethylphenol in 21.15 g of liquid paraffin, add 5 g of crotamiton, add 0.1 g of dl-methylephedrine hydrochloride and 0.15 g of prednisolone acetate valerate, stir and disperse, To do. After mixing the first and second liquids, the mixture was melted by heating, to which 0.5 g of tocopherol acetate was added, stirred and cooled under reduced pressure, and then filled into an aluminum tube to obtain an oily ointment.
(比較例7)
白色ワセリン15g、ステアリルアルコール8g、セタノール14g、メチルパラベン0.1g及びプロピルパラベン0.1gを加熱溶解し、1液とする。イソプロピルメチルフェノール0.2gを加熱溶解し、流動パラフィン12gを加え、酢酸プレドニゾロン0.5gを分散させ、1液と混和し、2液とする。加温した精製水35.95gに塩酸ジブカイン0.25g、塩酸ジフェンヒドラミン0.2gおよびdl−塩酸メチルエフェドリン0.2gを溶解し、プロピレングリコール12g及びラウリル硫酸ナトリウム1.5gを加え、攪拌分散させて3液とする。2液と3液を混和させた後、80℃に保温し、減圧下、ホモミキサー回転数3000rpmで30分間乳化させ、攪拌冷却後、アルミチューブに充填してクリーム剤とした。
(Comparative Example 7)
15 g of white petrolatum, 8 g of stearyl alcohol, 14 g of cetanol, 0.1 g of methylparaben and 0.1 g of propylparaben are heated and dissolved to make one solution. Dissolve 0.2 g of isopropylmethylphenol with heating, add 12 g of liquid paraffin, disperse 0.5 g of prednisolone acetate, mix with 1 solution, and make 2 solutions. Dissolve 0.25 g of dibucaine hydrochloride, 0.2 g of diphenhydramine hydrochloride and 0.2 g of dl-methylephedrine hydrochloride in 35.95 g of heated purified water, add 12 g of propylene glycol and 1.5 g of sodium lauryl sulfate, and stir and disperse. Three liquids are used. After mixing the second and third liquids, the mixture was kept at 80 ° C., emulsified for 30 minutes under a reduced pressure at 3000 rpm homomixer, stirred and cooled, and then filled into an aluminum tube to obtain a cream.
(比較例8)
白色ワセリン4g、ステアリルアルコール8g、セタノール6g、ポリオキシエチレン(2)セチルエーテル3g、ポリオキシエチレン(20)セチルエーテル3g及びプロピルパラベン0.1gを加熱溶解し、1液とする。イソプロピルメチルフェノール0.1gを加熱溶解し、酢酸デキサメタゾン0.03gを分散させ、これに、流動パラフィン17g及びクロタミトン5gを添加し、攪拌混和し、1液と混和し、2液とする。加温した精製水48.97gに塩酸ジフェンヒドラミン1.0gおよびdl−塩酸メチルエフェドリン0.1gを溶解し、キサンタンガム0.2gを加え、攪拌分散させて3液とする。2液と3液を混和させた後、80℃に保温し、l−メントール3.5gを添加した後、減圧下、ホモミキサー回転数3000rpmで30分間乳化させ、攪拌冷却後、アルミチューブに充填してクリーム剤とした。
(Comparative Example 8)
4 g of white petrolatum, 8 g of stearyl alcohol, 6 g of cetanol, 3 g of polyoxyethylene (2) cetyl ether, 3 g of polyoxyethylene (20) cetyl ether and 0.1 g of propylparaben are heated and dissolved to form one liquid. Dissolve 0.1 g of isopropylmethylphenol by heating to disperse 0.03 g of dexamethasone acetate, add 17 g of liquid paraffin and 5 g of crotamiton, mix with stirring, mix with 1 solution, and make 2 solutions. Dissolve 1.0 g of diphenhydramine hydrochloride and 0.1 g of dl-methylephedrine hydrochloride in 48.97 g of heated purified water, add 0.2 g of xanthan gum, and stir and disperse to make 3 liquids. Mix 2 and 3 liquids, keep warm at 80 ° C., add 3.5 g of l-menthol, emulsify for 30 minutes under reduced pressure at 3000 rpm homomixer, stir cool, then fill into aluminum tube And used as a cream.
(比較例9)
流動パラフィン20gに精製ラノリン16gおよびイソプロピルメチルフェノール0.5g、メチルパラベン0.1g及びプロピルパラベン0.1gを加え、加熱溶解し、1液とする。セトステアリルアルコール4.5gおよびラウリル硫酸ナトリウム0.5gを混和し、加熱融解した後、0.2gの精製水を添加し、110℃まで加熱し、冷却し、2液とする。加温した精製水52.3gに塩酸リドカイン2g、マレイン酸クロルフェニラミン0.3g、dl−塩酸メチルエフェドリン0.5gを加え、攪拌溶解させて3液とする。1液と2液および3液を混和させた後、80℃に保温し、dl−カンフル3gを添加した後、減圧下、ホモミキサー回転数3000rpmで30分間乳化させ、攪拌冷却後、アルミチューブに充填してクリーム剤とした。
(Comparative Example 9)
To 20 g of liquid paraffin, 16 g of purified lanolin, 0.5 g of isopropylmethylphenol, 0.1 g of methylparaben and 0.1 g of propylparaben are added and dissolved by heating to make one liquid. After mixing 4.5 g of cetostearyl alcohol and 0.5 g of sodium lauryl sulfate and heating and melting, 0.2 g of purified water is added, heated to 110 ° C., cooled, and made into two liquids. 2 g of lidocaine hydrochloride, 0.3 g of chlorpheniramine maleate, and 0.5 g of dl-methylephedrine hydrochloride are added to 52.3 g of heated purified water, and dissolved by stirring to obtain 3 solutions. Mix 1st liquid, 2nd liquid and 3rd liquid, heat at 80 ° C, add 3g of dl-camphor, emulsify for 30 minutes under reduced pressure at 3000 rpm homomixer, stir and cool, then cool to aluminum tube Filled into a cream.
(比較例10)
白色ワセリン4.5g、ステアリルアルコール4g、セタノール2g、ベヘニン酸2g、酢酸トコフェロール0.5g、ジフェンヒドラミン1g、リドカイン0.5g、プロピルパラベン0.1gを加熱溶解し、1液とする。イソプロピルメチルフェノール0.1gを加熱融解し、流動パラフィン7.5gにモノステアリン酸グリセリン4g、ステアリン酸ポリオキシル40 4gを加え、攪拌溶融し、酸化亜鉛5gを添加し、攪拌分散させ2液とする。加温した精製水49.2gにdl−塩酸メチルエフェドリン0.2gを溶解し、1,3−ブチレングリコール5g、濃グリセリン10g、セチル硫酸ナトリウム 0.1g、キサンタンガム0.3gを加え、攪拌分散させて3液とする。1液と2液および3液を混和させた後、80℃に保温し、減圧下、ホモミキサー回転数2000rpmで40分間乳化させ、攪拌冷却後、アルミチューブに充填してクリーム剤とした。
(Comparative Example 10)
White petrolatum 4.5 g, stearyl alcohol 4 g, cetanol 2 g, behenic acid 2 g, tocopherol acetate 0.5 g, diphenhydramine 1 g, lidocaine 0.5 g and propylparaben 0.1 g are dissolved by heating to form one solution. 0.1 g of isopropylmethylphenol is heated and melted, 4 g of glyceryl monostearate and 4 g of polyoxyl stearate are added to 7.5 g of liquid paraffin, and stirred and melted. 5 g of zinc oxide is added and dispersed by stirring to form two liquids. Dissolve 0.2 g of dl-methylephedrine hydrochloride in 49.2 g of heated purified water, add 5 g of 1,3-butylene glycol, 10 g of concentrated glycerin, 0.1 g of sodium cetyl sulfate, and 0.3 g of xanthan gum, and disperse with stirring. 3 liquids. After mixing liquid 1, liquid 2 and liquid 3, the mixture was kept at 80 ° C., emulsified under reduced pressure at a homomixer rotation speed of 2000 rpm for 40 minutes, stirred and cooled, and then filled into an aluminum tube to obtain a cream.
〔試験例〕
(実施例および比較例の外観安定性試験)
上記の方法で製造した実施例及び比較例の各外用剤の製造直後、50℃の苛酷条件下で8週間保存後および40℃相対湿度75%条件下で6箇月間保存した。その検体をアルミチューブから1cm程度押し出し、白色の紙に採取し、肉眼で外観の着色(褐変)を観察した。結果を表1及び表2に示した。なお、着色(褐変)の判定基準は、着色(褐変)が全く認められないものを−、若干認められるものを±、認められるものを+、著しい着色(褐変)が認められるものを++とした。なお、製造直後においては、実施例、比較例のいずれにおいても変化は認められなかった。
[Test example]
(Appearance stability test of Examples and Comparative Examples)
Immediately after the preparation of each of the external preparations of Examples and Comparative Examples produced by the above-mentioned method, it was stored for 8 weeks under severe conditions at 50 ° C. and for 6 months under conditions of 40% relative humidity and 75% relative humidity. The specimen was extruded about 1 cm from an aluminum tube, collected on white paper, and the appearance coloration (browning) was observed with the naked eye. The results are shown in Tables 1 and 2. The criteria for coloration (browning) were-no coloration (browning) was observed at all,-some were slightly recognized, + were recognized, + were marked coloration (browning), ++. . In addition, immediately after manufacture, no change was observed in any of the examples and comparative examples.
表1は50℃で8週間保存した場合の実施例と比較例の外観安定性を対比した表である。
表2は40℃で6ヶ月間保存した場合の実施例と比較例の外観安定性を対比した表である。
表1及び表2より明らかなように、実施例の外用剤は、比較例の外用剤に比べて、保存による着色が抑制されていることが確認された。
As apparent from Tables 1 and 2, it was confirmed that the external preparations of the examples were suppressed from coloring due to storage compared to the external preparations of the comparative examples.
Claims (9)
(A) In the compounding agent of dl-methyl ephedrine hydrochloride and (b) isopropylmethylphenol, (c) A method of suppressing coloring after storage by adding a fatty acid alkyl ester.
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JP2010509374A (en) * | 2006-11-15 | 2010-03-25 | アースリティス レリーフ プラス エル ティー ディー | Topical preparation and its usage |
JP2011144123A (en) * | 2010-01-13 | 2011-07-28 | Ikeda Mohando:Kk | Skin care preparation |
JP2015168675A (en) * | 2014-03-10 | 2015-09-28 | 小林製薬株式会社 | emulsified composition |
CN106702988A (en) * | 2016-11-15 | 2017-05-24 | 河海大学 | Riverway garbage collection boat |
JP2018108992A (en) * | 2016-12-29 | 2018-07-12 | 小林製薬株式会社 | Emulsified cream preparation |
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JP2010509374A (en) * | 2006-11-15 | 2010-03-25 | アースリティス レリーフ プラス エル ティー ディー | Topical preparation and its usage |
US10322155B2 (en) | 2006-11-15 | 2019-06-18 | Arthritis Relief Plus Ltd. | Topical formulation and uses thereof |
US11844820B2 (en) | 2006-11-15 | 2023-12-19 | Arthritis Relief Plus Ltd. | Topical formulation and uses thereof |
JP2011144123A (en) * | 2010-01-13 | 2011-07-28 | Ikeda Mohando:Kk | Skin care preparation |
JP2015168675A (en) * | 2014-03-10 | 2015-09-28 | 小林製薬株式会社 | emulsified composition |
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JP2018108992A (en) * | 2016-12-29 | 2018-07-12 | 小林製薬株式会社 | Emulsified cream preparation |
JP7133309B2 (en) | 2016-12-29 | 2022-09-08 | 小林製薬株式会社 | Emulsified cream formulation |
JP7465066B2 (en) | 2019-06-17 | 2024-04-10 | 小林製薬株式会社 | Emulsion stabilizer |
WO2021187592A1 (en) * | 2020-03-18 | 2021-09-23 | シオノギヘルスケア株式会社 | Pharmaceutical composition containing betamethasone valerate |
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JP7346712B2 (en) | 2020-03-18 | 2023-09-19 | シオノギヘルスケア株式会社 | Pharmaceutical composition containing betamethasone valerate |
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