JP5514270B2 - アシタザノラスト含有組成物 - Google Patents
アシタザノラスト含有組成物 Download PDFInfo
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- JP5514270B2 JP5514270B2 JP2012150049A JP2012150049A JP5514270B2 JP 5514270 B2 JP5514270 B2 JP 5514270B2 JP 2012150049 A JP2012150049 A JP 2012150049A JP 2012150049 A JP2012150049 A JP 2012150049A JP 5514270 B2 JP5514270 B2 JP 5514270B2
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- 239000000203 mixture Substances 0.000 title description 83
- 150000003839 salts Chemical class 0.000 claims description 28
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- 229950001122 acitazanolast Drugs 0.000 claims description 25
- 239000000739 antihistaminic agent Substances 0.000 claims description 25
- 238000002156 mixing Methods 0.000 claims description 25
- OSASVXMJTNOKOY-UHFFFAOYSA-N chlorobutanol Chemical compound CC(C)(O)C(Cl)(Cl)Cl OSASVXMJTNOKOY-UHFFFAOYSA-N 0.000 claims description 24
- -1 oxtriphyrin Chemical compound 0.000 claims description 22
- 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 21
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- 239000003889 eye drop Substances 0.000 claims description 21
- NOOLISFMXDJSKH-UHFFFAOYSA-N DL-menthol Natural products CC(C)C1CCC(C)CC1O NOOLISFMXDJSKH-UHFFFAOYSA-N 0.000 claims description 19
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- 238000002360 preparation method Methods 0.000 claims description 12
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- RYYVLZVUVIJVGH-UHFFFAOYSA-N caffeine Chemical compound CN1C(=O)N(C)C(=O)C2=C1N=CN2C RYYVLZVUVIJVGH-UHFFFAOYSA-N 0.000 claims description 6
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- GLZPCOQZEFWAFX-UHFFFAOYSA-N Geraniol Chemical compound CC(C)=CCCC(C)=CCO GLZPCOQZEFWAFX-UHFFFAOYSA-N 0.000 claims description 4
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- DSSYKIVIOFKYAU-XCBNKYQSSA-N (R)-camphor Chemical compound C1C[C@@]2(C)C(=O)C[C@@H]1C2(C)C DSSYKIVIOFKYAU-XCBNKYQSSA-N 0.000 claims description 2
- SPSPIUSUWPLVKD-UHFFFAOYSA-N 2,3-dibutyl-6-methylphenol Chemical compound CCCCC1=CC=C(C)C(O)=C1CCCC SPSPIUSUWPLVKD-UHFFFAOYSA-N 0.000 claims description 2
- KYHQZNGJUGFTGR-LURJTMIESA-N 7-[(2s)-2-hydroxypropyl]-1,3-dimethylpurine-2,6-dione Chemical compound CN1C(=O)N(C)C(=O)C2=C1N=CN2C[C@@H](O)C KYHQZNGJUGFTGR-LURJTMIESA-N 0.000 claims description 2
- 241000723346 Cinnamomum camphora Species 0.000 claims description 2
- 239000005792 Geraniol Substances 0.000 claims description 2
- GLZPCOQZEFWAFX-YFHOEESVSA-N Geraniol Natural products CC(C)=CCC\C(C)=C/CO GLZPCOQZEFWAFX-YFHOEESVSA-N 0.000 claims description 2
- BYPFEZZEUUWMEJ-UHFFFAOYSA-N Pentoxifylline Chemical compound O=C1N(CCCCC(=O)C)C(=O)N(C)C2=C1N(C)C=N2 BYPFEZZEUUWMEJ-UHFFFAOYSA-N 0.000 claims description 2
- SQBWCQROZHGTAU-UHFFFAOYSA-N [1-[bis(2-methylpropyl)amino]-3-(1,3-dimethyl-2,6-dioxopurin-7-yl)propan-2-yl] benzoate Chemical compound C1=NC=2N(C)C(=O)N(C)C(=O)C=2N1CC(CN(CC(C)C)CC(C)C)OC(=O)C1=CC=CC=C1 SQBWCQROZHGTAU-UHFFFAOYSA-N 0.000 claims description 2
- CKDOCTFBFTVPSN-UHFFFAOYSA-N borneol Natural products C1CC2(C)C(C)CC1C2(C)C CKDOCTFBFTVPSN-UHFFFAOYSA-N 0.000 claims description 2
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- 235000010354 butylated hydroxytoluene Nutrition 0.000 claims description 2
- 229930008380 camphor Natural products 0.000 claims description 2
- 229960000846 camphor Drugs 0.000 claims description 2
- GHKISGDRQRSCII-UHFFFAOYSA-N chelidonine Natural products C1=C2C3N(C)CC4=C(OCO5)C5=CC=C4C3C(O)CC2=CC2=C1OCO2 GHKISGDRQRSCII-UHFFFAOYSA-N 0.000 claims description 2
- 239000001926 citrus aurantium l. subsp. bergamia wright et arn. oil Substances 0.000 claims description 2
- UGMCXQCYOVCMTB-UHFFFAOYSA-K dihydroxy(stearato)aluminium Chemical compound CCCCCCCCCCCCCCCCCC(=O)O[Al](O)O UGMCXQCYOVCMTB-UHFFFAOYSA-K 0.000 claims description 2
- 229960002819 diprophylline Drugs 0.000 claims description 2
- DTGKSKDOIYIVQL-UHFFFAOYSA-N dl-isoborneol Natural products C1CC2(C)C(O)CC1C2(C)C DTGKSKDOIYIVQL-UHFFFAOYSA-N 0.000 claims description 2
- KSCFJBIXMNOVSH-UHFFFAOYSA-N dyphylline Chemical compound O=C1N(C)C(=O)N(C)C2=C1N(CC(O)CO)C=N2 KSCFJBIXMNOVSH-UHFFFAOYSA-N 0.000 claims description 2
- 239000010642 eucalyptus oil Substances 0.000 claims description 2
- 229940044949 eucalyptus oil Drugs 0.000 claims description 2
- 239000010643 fennel seed oil Substances 0.000 claims description 2
- 229940113087 geraniol Drugs 0.000 claims description 2
- 229940067107 phenylethyl alcohol Drugs 0.000 claims description 2
- 229960004767 proxyphylline Drugs 0.000 claims description 2
- XWGJFPHUCFXLBL-UHFFFAOYSA-M rongalite Chemical compound [Na+].OCS([O-])=O XWGJFPHUCFXLBL-UHFFFAOYSA-M 0.000 claims description 2
- 235000019719 rose oil Nutrition 0.000 claims description 2
- 239000010666 rose oil Substances 0.000 claims description 2
- HRZFUMHJMZEROT-UHFFFAOYSA-L sodium disulfite Chemical compound [Na+].[Na+].[O-]S(=O)S([O-])(=O)=O HRZFUMHJMZEROT-UHFFFAOYSA-L 0.000 claims description 2
- 235000010262 sodium metabisulphite Nutrition 0.000 claims description 2
- 229960004559 theobromine Drugs 0.000 claims description 2
- LENZDBCJOHFCAS-UHFFFAOYSA-N tris Chemical compound OCC(N)(CO)CO LENZDBCJOHFCAS-UHFFFAOYSA-N 0.000 claims description 2
- 229960000281 trometamol Drugs 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
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- 230000007794 irritation Effects 0.000 description 21
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- DNIAPMSPPWPWGF-UHFFFAOYSA-N Propylene glycol Chemical compound CC(O)CO DNIAPMSPPWPWGF-UHFFFAOYSA-N 0.000 description 12
- 239000007788 liquid Substances 0.000 description 12
- 229940012356 eye drops Drugs 0.000 description 11
- 229960000520 diphenhydramine Drugs 0.000 description 10
- ZZVUWRFHKOJYTH-UHFFFAOYSA-N diphenhydramine Chemical compound C=1C=CC=CC=1C(OCCN(C)C)C1=CC=CC=C1 ZZVUWRFHKOJYTH-UHFFFAOYSA-N 0.000 description 10
- 230000000694 effects Effects 0.000 description 10
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- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 description 8
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- LRFVTYWOQMYALW-UHFFFAOYSA-N 9H-xanthine Chemical class O=C1NC(=O)NC2=C1NC=N2 LRFVTYWOQMYALW-UHFFFAOYSA-N 0.000 description 6
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- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid Chemical compound OC(=O)CC(O)(C(O)=O)CC(O)=O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 description 6
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- DGAQECJNVWCQMB-PUAWFVPOSA-M Ilexoside XXIX Chemical compound C[C@@H]1CC[C@@]2(CC[C@@]3(C(=CC[C@H]4[C@]3(CC[C@@H]5[C@@]4(CC[C@@H](C5(C)C)OS(=O)(=O)[O-])C)C)[C@@H]2[C@]1(C)O)C)C(=O)O[C@H]6[C@@H]([C@H]([C@@H]([C@H](O6)CO)O)O)O.[Na+] DGAQECJNVWCQMB-PUAWFVPOSA-M 0.000 description 5
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- QIQXTHQIDYTFRH-UHFFFAOYSA-N octadecanoic acid Chemical compound CCCCCCCCCCCCCCCCCC(O)=O QIQXTHQIDYTFRH-UHFFFAOYSA-N 0.000 description 1
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- PRGUDWLMFLCODA-UHFFFAOYSA-N oxybuprocaine hydrochloride Chemical compound [Cl-].CCCCOC1=CC(C(=O)OCC[NH+](CC)CC)=CC=C1N PRGUDWLMFLCODA-UHFFFAOYSA-N 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
- 229960004172 pyridoxine hydrochloride Drugs 0.000 description 1
- 235000019171 pyridoxine hydrochloride Nutrition 0.000 description 1
- 239000011764 pyridoxine hydrochloride Substances 0.000 description 1
- IUVKMZGDUIUOCP-BTNSXGMBSA-N quinbolone Chemical compound O([C@H]1CC[C@H]2[C@H]3[C@@H]([C@]4(C=CC(=O)C=C4CC3)C)CC[C@@]21C)C1=CCCC1 IUVKMZGDUIUOCP-BTNSXGMBSA-N 0.000 description 1
- MUPFEKGTMRGPLJ-ZQSKZDJDSA-N raffinose Chemical compound O[C@H]1[C@H](O)[C@@H](CO)O[C@@]1(CO)O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO[C@@H]2[C@@H]([C@@H](O)[C@@H](O)[C@@H](CO)O2)O)O1 MUPFEKGTMRGPLJ-ZQSKZDJDSA-N 0.000 description 1
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- QGNJRVVDBSJHIZ-QHLGVNSISA-N retinyl acetate Chemical compound CC(=O)OC\C=C(/C)\C=C\C=C(/C)\C=C\C1=C(C)CCCC1(C)C QGNJRVVDBSJHIZ-QHLGVNSISA-N 0.000 description 1
- 235000019173 retinyl acetate Nutrition 0.000 description 1
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- 235000019172 retinyl palmitate Nutrition 0.000 description 1
- 239000011769 retinyl palmitate Substances 0.000 description 1
- 229920002477 rna polymer Polymers 0.000 description 1
- 239000004576 sand Substances 0.000 description 1
- 239000008159 sesame oil Substances 0.000 description 1
- 235000011803 sesame oil Nutrition 0.000 description 1
- 229910001961 silver nitrate Inorganic materials 0.000 description 1
- 239000002884 skin cream Substances 0.000 description 1
- GQTHJBOWLPZUOI-FJXQXJEOSA-M sodium D-pantothenate Chemical compound [Na+].OCC(C)(C)[C@@H](O)C(=O)NCCC([O-])=O GQTHJBOWLPZUOI-FJXQXJEOSA-M 0.000 description 1
- 239000001632 sodium acetate Substances 0.000 description 1
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- WXMKPNITSTVMEF-UHFFFAOYSA-M sodium benzoate Chemical compound [Na+].[O-]C(=O)C1=CC=CC=C1 WXMKPNITSTVMEF-UHFFFAOYSA-M 0.000 description 1
- 235000010234 sodium benzoate Nutrition 0.000 description 1
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- 159000000000 sodium salts Chemical class 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
- 235000019345 sodium thiosulphate Nutrition 0.000 description 1
- 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
- WTWSHHITWMVLBX-DKWTVANSSA-M sodium;(2s)-2-aminobutanedioate;hydron Chemical compound [Na+].[O-]C(=O)[C@@H](N)CC(O)=O WTWSHHITWMVLBX-DKWTVANSSA-M 0.000 description 1
- XTXYCJOBMKKQOW-UHFFFAOYSA-N sodium;(4-aminophenyl)sulfonyl-(2,6-dimethylpyrimidin-4-yl)azanide Chemical compound [Na+].CC1=NC(C)=CC([N-]S(=O)(=O)C=2C=CC(N)=CC=2)=N1 XTXYCJOBMKKQOW-UHFFFAOYSA-N 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
- RMLUKZWYIKEASN-UHFFFAOYSA-M sodium;2-amino-9-(2-hydroxyethoxymethyl)purin-6-olate Chemical compound [Na+].O=C1[N-]C(N)=NC2=C1N=CN2COCCO RMLUKZWYIKEASN-UHFFFAOYSA-M 0.000 description 1
- GEYJUFBPCGDENK-UHFFFAOYSA-M sodium;3,8-dimethyl-5-propan-2-ylazulene-1-sulfonate Chemical compound [Na+].CC(C)C1=CC=C(C)C2=C(S([O-])(=O)=O)C=C(C)C2=C1 GEYJUFBPCGDENK-UHFFFAOYSA-M 0.000 description 1
- 239000007787 solid Substances 0.000 description 1
- 235000010199 sorbic acid Nutrition 0.000 description 1
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- 235000011069 sorbitan monooleate Nutrition 0.000 description 1
- 239000001593 sorbitan monooleate Substances 0.000 description 1
- 229940035049 sorbitan monooleate Drugs 0.000 description 1
- 239000003549 soybean oil Substances 0.000 description 1
- 235000012424 soybean oil Nutrition 0.000 description 1
- 229960001294 spiramycin Drugs 0.000 description 1
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- 229930191512 spiramycin Natural products 0.000 description 1
- 239000007921 spray Substances 0.000 description 1
- UQZIYBXSHAGNOE-XNSRJBNMSA-N stachyose Chemical compound O[C@H]1[C@H](O)[C@@H](CO)O[C@@]1(CO)O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO[C@@H]2[C@@H]([C@@H](O)[C@@H](O)[C@@H](CO[C@@H]3[C@@H]([C@@H](O)[C@@H](O)[C@@H](CO)O3)O)O2)O)O1 UQZIYBXSHAGNOE-XNSRJBNMSA-N 0.000 description 1
- 235000019698 starch Nutrition 0.000 description 1
- 239000008107 starch Substances 0.000 description 1
- 229960002385 streptomycin sulfate Drugs 0.000 description 1
- 239000000126 substance Substances 0.000 description 1
- 239000001384 succinic acid Substances 0.000 description 1
- 229960005137 succinic acid Drugs 0.000 description 1
- 239000005720 sucrose Substances 0.000 description 1
- 229960005404 sulfamethoxazole Drugs 0.000 description 1
- FEPTXVIRMZIGFY-UHFFFAOYSA-N sulfisoxazole diolamine Chemical compound OCCNCCO.CC1=NOC(NS(=O)(=O)C=2C=CC(N)=CC=2)=C1C FEPTXVIRMZIGFY-UHFFFAOYSA-N 0.000 description 1
- JLKIGFTWXXRPMT-UHFFFAOYSA-N sulphamethoxazole Chemical compound O1C(C)=CC(NS(=O)(=O)C=2C=CC(N)=CC=2)=N1 JLKIGFTWXXRPMT-UHFFFAOYSA-N 0.000 description 1
- 229950001956 suplatast Drugs 0.000 description 1
- 239000004094 surface-active agent Substances 0.000 description 1
- 239000011975 tartaric acid Substances 0.000 description 1
- 235000002906 tartaric acid Nutrition 0.000 description 1
- 229960003080 taurine Drugs 0.000 description 1
- 229950011558 tazanolast Drugs 0.000 description 1
- 125000000999 tert-butyl group Chemical group [H]C([H])([H])C(*)(C([H])([H])[H])C([H])([H])[H] 0.000 description 1
- 229960002494 tetracaine hydrochloride Drugs 0.000 description 1
- 229960004989 tetracycline hydrochloride Drugs 0.000 description 1
- 229940021790 tetrahydrozoline hydrochloride Drugs 0.000 description 1
- BJORNXNYWNIWEY-UHFFFAOYSA-N tetrahydrozoline hydrochloride Chemical compound Cl.N1CCN=C1C1C2=CC=CC=C2CCC1 BJORNXNYWNIWEY-UHFFFAOYSA-N 0.000 description 1
- 229960005221 timolol maleate Drugs 0.000 description 1
- OGIDPMRJRNCKJF-UHFFFAOYSA-N titanium oxide Inorganic materials [Ti]=O OGIDPMRJRNCKJF-UHFFFAOYSA-N 0.000 description 1
- 229960000707 tobramycin Drugs 0.000 description 1
- NLVFBUXFDBBNBW-PBSUHMDJSA-N tobramycin Chemical compound N[C@@H]1C[C@H](O)[C@@H](CN)O[C@@H]1O[C@H]1[C@H](O)[C@@H](O[C@@H]2[C@@H]([C@@H](N)[C@H](O)[C@@H](CO)O2)O)[C@H](N)C[C@@H]1N NLVFBUXFDBBNBW-PBSUHMDJSA-N 0.000 description 1
- 229940042585 tocopherol acetate Drugs 0.000 description 1
- 229950009883 tocopheryl nicotinate Drugs 0.000 description 1
- 210000002105 tongue Anatomy 0.000 description 1
- 235000010487 tragacanth Nutrition 0.000 description 1
- 239000000196 tragacanth Substances 0.000 description 1
- 229940116362 tragacanth Drugs 0.000 description 1
- NZHGWWWHIYHZNX-CSKARUKUSA-N tranilast Chemical compound C1=C(OC)C(OC)=CC=C1\C=C\C(=O)NC1=CC=CC=C1C(O)=O NZHGWWWHIYHZNX-CSKARUKUSA-N 0.000 description 1
- 229960005342 tranilast Drugs 0.000 description 1
- VZCYOOQTPOCHFL-UHFFFAOYSA-N trans-butenedioic acid Natural products OC(=O)C=CC(O)=O VZCYOOQTPOCHFL-UHFFFAOYSA-N 0.000 description 1
- 229960002117 triamcinolone acetonide Drugs 0.000 description 1
- YNDXUCZADRHECN-JNQJZLCISA-N triamcinolone acetonide Chemical compound C1CC2=CC(=O)C=C[C@]2(C)[C@]2(F)[C@@H]1[C@@H]1C[C@H]3OC(C)(C)O[C@@]3(C(=O)CO)[C@@]1(C)C[C@@H]2O YNDXUCZADRHECN-JNQJZLCISA-N 0.000 description 1
- MWKJTNBSKNUMFN-UHFFFAOYSA-N trifluoromethyltrimethylsilane Chemical compound C[Si](C)(C)C(F)(F)F MWKJTNBSKNUMFN-UHFFFAOYSA-N 0.000 description 1
- VSQQQLOSPVPRAZ-RRKCRQDMSA-N trifluridine Chemical compound C1[C@H](O)[C@@H](CO)O[C@H]1N1C(=O)NC(=O)C(C(F)(F)F)=C1 VSQQQLOSPVPRAZ-RRKCRQDMSA-N 0.000 description 1
- 229960003962 trifluridine Drugs 0.000 description 1
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- CBEQULMOCCWAQT-WOJGMQOQSA-N triprolidine Chemical compound C1=CC(C)=CC=C1C(\C=1N=CC=CC=1)=C/CN1CCCC1 CBEQULMOCCWAQT-WOJGMQOQSA-N 0.000 description 1
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- 229920002554 vinyl polymer Polymers 0.000 description 1
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- 239000011576 zinc lactate Substances 0.000 description 1
- 235000000193 zinc lactate Nutrition 0.000 description 1
- 229940050168 zinc lactate Drugs 0.000 description 1
- NWONKYPBYAMBJT-UHFFFAOYSA-L zinc sulfate Chemical compound [Zn+2].[O-]S([O-])(=O)=O NWONKYPBYAMBJT-UHFFFAOYSA-L 0.000 description 1
- 229960001763 zinc sulfate Drugs 0.000 description 1
- 229910000368 zinc sulfate Inorganic materials 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)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Description
及び/又はその塩と、(ii)抗ヒスタミン剤を含有する組成物において、(iii)メントール
を配合することにより、粘膜や皮膚に対する刺激や不快感を抑制でき、良好な使用感が得られることを見出した。更に、メントールの配合割合を0.0002〜0.004重量%にすること
により一層良好な使用感を実現できること、及びメントールと共にクロロブタノールを配合することによっても使用感を一層向上させ得ることを見出した。本発明は、これらの知見に基づいて、更に検討を重ねることにより完成したものである。
項1.(i)アシタザノラスト及び/又はその塩、(ii)抗ヒスタミン剤、及び(iii)メントールを含有することを特徴とする、組成物。
項2. (iii)成分を0.0002〜0.004重量%の割合で含有する、項1に記載の組成物。
項3. 更に、(iv)クロロブタノールを含有する、項1又は2に記載の組成物。
項4. (ii)抗ヒスタミン剤が、ジフェンヒドラミン、クロルフェニラミン、及びこれらの塩よりなる群から選択される少なくとも1種である、項1乃至3のいずれかに記載の組成物。
項5. 局所粘膜適用製剤である、項1乃至4のいずれかに記載の組成物。
項6. 眼科用組成物である、項1乃至5のいずれかに記載の組成物。
1-1.(i)アシタザノラスト及び/又はその塩、(ii)抗ヒスタミン剤、及び(iii)メントールを含有し、且つ該(iii)成分を0.0002〜0.004重量%の割合で含有することを特徴とする、組成物。
1-2.更に、(iv)クロロブタノールを含有する、1-1に記載の組成物。
1-3.(ii)抗ヒスタミン剤が、ジフェンヒドラミン、クロルフェニラミン、及びこれらの塩よりなる群から選択される少なくとも1種である、1-1又は1-2に記載の組成物。
1-4.局所粘膜適用製剤である、1-1乃至1-3のいずれかに記載の組成物。
1-5. 眼科用組成物である、1-1乃至1-4のいずれかに記載の組成物。
2-1.(i)アシタザノラスト及び/又はその塩、(ii)抗ヒスタミン剤、(iii)メントール、及び(iv)クロロブタノールを含有することを特徴とする、組成物。
2-2.(ii)抗ヒスタミン剤が、ジフェンヒドラミン、クロルフェニラミン、及びこれらの塩よりなる群から選択される少なくとも1種である、2-1に記載の組成物。
2-3.局所粘膜適用製剤である、2-1又は2-2に記載の組成物。
2-4. 眼科用組成物である、2-1乃至2-3のいずれかに記載の組成物。
3-1.(i)アシタザノラスト及び/又はその塩、(ii)抗ヒスタミン剤、及び(iii)メントールを含有することを特徴とする眼科用組成物(但し、キサンチン誘導体を含む組成物を除く)。
3-2.更に、(iv)クロロブタノールを含有する、3-1に記載の組成物。
3-3.(ii)抗ヒスタミン剤が、ジフェンヒドラミン、クロルフェニラミン、及びこれらの塩よりなる群から選択される少なくとも1種である、3-1又は3-2に記載の組成物。
3-4.局所粘膜適用製剤である、3-1乃至3-3のいずれかに記載の組成物。
名)、分子式C9H7N5O3で示される公知の化合物である。該化合物は、公知の方法により合成される。
の形態であってもよい。
される。通常、組成物中の(i)成分の配合割合として、該成分の総量で0.0001〜2重量%、好ましくは0.0005〜1重量%、更に好ましくは0.001〜0.5重量%、特に好ましくは0.005〜0.11重量%が例示される。
成分乃至(iv)成分が配合されていることによって、これらの成分の組み合わせに対しても、その使用感を良好にできるので、当該(i)及び(ii)成分を配合した組成物を実用化する
上で特に有用である。
〜0.05重量%が例示される。
は、特に制限されないが、例えば上記(i)成分100重量部に対して、上記(ii)成分が0.1〜10000重量部、好ましくは0.45〜2000重量部、更に好ましくは0.9〜1000重量部となる比率
が例示される。
れるメントールは、d体、l体、dl体のいずれであってもよいが、好ましくはl体である。メントールを上記(i)及び(ii)成分と組み合わせて含有することにより、キサンチン誘導
体等の他の刺激低減成分を含まなくとも、良好な使用感を得ることができる。ここで、キ
サンチン誘導体とは、下記式(1)で表される化合物であり、具体例としては、カフェイン、テオフィリン、オクストリフィリン、ダイフィリン、ジイソブチルアミノベンゾイルオキシプロピルテオフィリン、テオブロミン、ジプロフィリン、プロキシフィリン、及びペントキシフィリンが挙げられる。
、0.00015〜0.5重量%、好ましくは0.0002〜0.05重量%、更に好ましくは0.0003〜0.036
重量%が例示される。
また、上記(iv)成分は、上記配合割合を充足し、更に上記(i)成分に対する配合比が以下
の範囲を満たしておくことが望ましい:上記(i)成分100重量部に対して、上記(iv)成分が通常2〜26000重量部、好ましくは45〜4000重量部、更に好ましくは50〜400重量部。
ン、塩酸オキシテトラサイクリン、オフロキサシン、ノルフロキサシン、レボフロキサシン、塩酸ロメフロキサシン、スルベニシンナトリウム、塩酸セフメノキシム、ベンジルペニシリンカリウム、硫酸ベルベリン、塩化ベルベリン、ホウ酸、コリスチンメタスルホン酸ナトリウム、エリスロマイシン、ラクトビオン酸エリスロマイシン、キタサマイシン、スピラマイシン、硫酸フラジオマイシン、硫酸ポリミキシン、ジベカシン、アミカシン、硫酸アミカシン、アシクロビル、イオドデオキシサイチジン、イドクスウリジン、シクロサイチジン、シトシンアラビノシド、トリフルオロチミジン、ブロモデオキシウリジン、ポリビニルアルコールヨウ素、ヨウ素、アムホテリシンB、イソコナゾール、エコナゾール、クロトリマゾール、ナイスタチン、ピマリシン、フルオロシトシン、ミコナゾールなど。
ルバコール、塩酸レボブノロール、ジピバル酸エピネフリン、臭化ジスチグミン、ニプラジロール、マレイン酸チモロール、ラタノプロストなど。
ンなど)、モノオレイン酸POEソルビタン、POE硬化ヒマシ油(具体的には、POE(60)硬化ヒマシ油など)、ステアリン酸ポリオキシルなどの非イオン性界面活性剤;アルキルジアミノエチルグリシンなどのグリシン型両性界面活性剤;アルキル4級アンモニウム塩(具体的には、塩化ベンザルコニウム、塩化ベンゼトニウムなどの陽イオン界面活性剤など。なお、括弧内の数字は付加モル数を示す。
して、キサンチン誘導体を含まない組成物が挙げられる。
試験例1
表1に示す組成の点眼剤(実施例1−2及び比較例1−3)を調製し、これらの点眼剤を用いてビジュアルアナログスケール(VAS)により不快度の評価を行った。具体的には、
4人のパネラーに上記点眼剤を点眼し、点眼時に感じられる「刺激感」、「ねばつき感」、「異物感」及び「不快な味」の4項目について、それぞれ10cmの線が引いてある自覚症状調査シートに、感じられない場合を0cm、感じられる場合を5cm、強く感じられる場合を10cmとして、パネラーが感じた症状の程度のところにチェックしてもらい、自覚症状の重症度としてこの長さ(cm)を測定し、これを不快度スコアとした。各評価項目毎に4名のパネラーのスコア平均値を算出することにより、不快度の評価を行った。また、別にアシタザノラスト・1水和物を含まないこと以外は比較例1と同様の処方の点
眼剤をブランクとして試験を行い、平均値を各スコアより引いた。更に、各項目の不快度スコアの総和をトータル不快度指数とし、点眼時の全体的な不快度を算出し比較した。
る場合に、優れた刺激低減効果が認められ、向上した使用感が得られることが明らかとなった。更に、メントールと共に、クロロブタノールを配合することによっても、その使用感が良好になることが確認された。
表2に示す組成の点眼剤(実施例3−4及び比較例4−6)を調製し、これらの点眼剤を用いてビジュアルアナログスケール(VAS)により、点眼時に感じられる「刺激感」の評
価試験を行った。本試験は、パネラー2名により、上記試験例1と同様の方法で実施した。2名のパネラーのスコア平均値を算出することにより、刺激感の評価をした。なお、ブランクとしては、アシタザノラストを含まないこと以外は比較例4と同様の点眼剤を用いた。
常法に従って、以下の表3及び4に記載の処方の点眼剤、洗眼剤、コンタクトレンズ装着液(表中、CL装着液と表記する)及びコンタクトレンズ用消毒剤(表中、CL消毒剤と表記する)を調製した。
アシタザノラスト一水和物 100mg
マレイン酸クロルフェニラミン 30mg
l−メントール 0.3mg
プロピレングリコール 500mg
パラオキシ安息香酸メチル 300mg
ポリオキシエチレン硬化ヒマシ油 2g
モノステアリン酸グリセリン 3g
流動パラフィン 10g
白色ワセリン 適量
全量 100g
上記処方の眼軟膏剤(無菌製剤)を、公知の方法により調製した。
アシタザノラスト一水和物 100mg
塩酸ジフェンヒドラミン 50mg
l−メントール 10mg
クロロブタノール 200mg
プロピレングリコール 500mg
パラオキシ安息香酸メチル 300mg
ポリオキシエチレン硬化ヒマシ油 2g
モノステアリン酸グリセリン 3.5g
流動パラフィン 10g
白色ワセリン 適量
全量 100g
上記処方の眼軟膏剤(無菌製剤)を、公知の方法により調製した。
Claims (6)
- (i)アシタザノラスト及び/又はその塩、(ii)抗ヒスタミン剤、及び(iii)メントールを含有することを特徴とし、(i)成分100重量部に対する、(ii)成分の配合比率が0.9〜1000重量部である、点眼剤(ただし、カフェイン、テオフィリン、オクストリフィリン、ダイフィリン、ジイソブチルアミノベンゾイルオキシプロピルテオフィリン、テオブロミン、ジプロフィリン、プロキシフィリン、及びペントキシフィリンを含まない)。
- (i)成分を0.0001〜2重量%、(ii)成分を0.0001〜0.5重量%、(iii)成分を0.00015〜0.5重量%の割合で含有する、請求項1に記載の点眼剤。
- 更に、(iv)クロロブタノールを含有する、請求項1又は2に記載の点眼剤。
- 更に、ボルネオール、ゲラニオール、ベルガモット油、ユーカリ油、カンフル、フェニルエチルアルコール、クールミント油、ハッカ油、ハッカ水、ウィキョウ油、及びローズ油からなる群より選択される少なくとも1種の香料成分を含有する、請求項1乃至3のいずれかに記載の点眼剤。
- 更に、ジブチルヒドロキシトルエン、トロメタモール、ナトリウムホルムアルデヒドスルホキシレート(ロンガリット)、トコフェロール、ピロ亜硫酸ナトリウム、モノエタノールアミン、モノステアリン酸アルミニウム及びモノステアリン酸グリセリンからなる群より選択される少なくとも1種の安定化剤を含有する、請求項1乃至4のいずれかに記載の点眼剤。
- 抗アレルギー用である、請求項1乃至5のいずれかに記載の点眼剤。
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