JP5435818B2 - アズレン含有水性液剤 - Google Patents
アズレン含有水性液剤 Download PDFInfo
- Publication number
- JP5435818B2 JP5435818B2 JP2011122110A JP2011122110A JP5435818B2 JP 5435818 B2 JP5435818 B2 JP 5435818B2 JP 2011122110 A JP2011122110 A JP 2011122110A JP 2011122110 A JP2011122110 A JP 2011122110A JP 5435818 B2 JP5435818 B2 JP 5435818B2
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- Prior art keywords
- acid
- component
- group
- polyoxyethylene
- pharmacologically
- Prior art date
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- 239000007864 aqueous solution Substances 0.000 title claims description 19
- CUFNKYGDVFVPHO-UHFFFAOYSA-N azulene Chemical compound C1=CC=CC2=CC=CC2=C1 CUFNKYGDVFVPHO-UHFFFAOYSA-N 0.000 title description 60
- -1 fatty acid ester Chemical class 0.000 claims description 84
- 150000003839 salts Chemical class 0.000 claims description 61
- 239000007788 liquid Substances 0.000 claims description 58
- 238000002360 preparation method Methods 0.000 claims description 56
- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid Chemical compound OC(=O)CC(O)(C(O)=O)CC(O)=O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 claims description 32
- 238000000034 method Methods 0.000 claims description 27
- 229920003171 Poly (ethylene oxide) Polymers 0.000 claims description 26
- YBHILYKTIRIUTE-UHFFFAOYSA-N berberine Chemical compound C1=C2CC[N+]3=CC4=C(OC)C(OC)=CC=C4C=C3C2=CC2=C1OCO2 YBHILYKTIRIUTE-UHFFFAOYSA-N 0.000 claims description 23
- 229940093265 berberine Drugs 0.000 claims description 23
- QISXPYZVZJBNDM-UHFFFAOYSA-N berberine Natural products COc1ccc2C=C3N(Cc2c1OC)C=Cc4cc5OCOc5cc34 QISXPYZVZJBNDM-UHFFFAOYSA-N 0.000 claims description 23
- 239000000126 substance Substances 0.000 claims description 22
- 239000004359 castor oil Substances 0.000 claims description 20
- 235000019438 castor oil Nutrition 0.000 claims description 20
- 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 20
- 239000000203 mixture Substances 0.000 claims description 17
- NBIIXXVUZAFLBC-UHFFFAOYSA-N Phosphoric acid Chemical compound OP(O)(O)=O NBIIXXVUZAFLBC-UHFFFAOYSA-N 0.000 claims description 16
- 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 claims description 14
- KGBXLFKZBHKPEV-UHFFFAOYSA-N boric acid Chemical compound OB(O)O KGBXLFKZBHKPEV-UHFFFAOYSA-N 0.000 claims description 12
- 239000004327 boric acid Substances 0.000 claims description 12
- 239000003814 drug Substances 0.000 claims description 10
- 229920001214 Polysorbate 60 Polymers 0.000 claims description 8
- 229910000147 aluminium phosphate Inorganic materials 0.000 claims description 8
- 238000004519 manufacturing process Methods 0.000 claims description 8
- 235000014113 dietary fatty acids Nutrition 0.000 claims description 7
- 229930195729 fatty acid Natural products 0.000 claims description 7
- 239000000194 fatty acid Substances 0.000 claims description 7
- 229920001400 block copolymer Polymers 0.000 claims description 6
- KKEMWYNNTBRYMR-UHFFFAOYSA-N azulene-1-sulfonic acid Chemical compound C1=CC=CC=C2C(S(=O)(=O)O)=CC=C21 KKEMWYNNTBRYMR-UHFFFAOYSA-N 0.000 claims description 5
- 229940079593 drug Drugs 0.000 claims description 3
- 229920002503 polyoxyethylene-polyoxypropylene Polymers 0.000 claims description 3
- 229920001451 polypropylene glycol Polymers 0.000 claims description 3
- 229940054534 ophthalmic solution Drugs 0.000 claims 4
- 239000002997 ophthalmic solution Substances 0.000 claims 4
- 229950002760 sodium gualenate Drugs 0.000 claims 1
- 235000002639 sodium chloride Nutrition 0.000 description 57
- 239000002736 nonionic surfactant Substances 0.000 description 24
- 239000000872 buffer Substances 0.000 description 18
- 150000001545 azulenes Chemical class 0.000 description 17
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 description 16
- 229920005989 resin Polymers 0.000 description 16
- 239000011347 resin Substances 0.000 description 16
- 238000012360 testing method Methods 0.000 description 16
- 235000010338 boric acid Nutrition 0.000 description 13
- 239000006172 buffering agent Substances 0.000 description 13
- 239000003889 eye drop Substances 0.000 description 13
- QTBSBXVTEAMEQO-UHFFFAOYSA-N Acetic acid Chemical compound CC(O)=O QTBSBXVTEAMEQO-UHFFFAOYSA-N 0.000 description 12
- FYBWCLKVKGHJKS-UHFFFAOYSA-L berberine sesquihydrate sulfate Chemical compound O.O.O.[O-]S([O-])(=O)=O.C1=C2CC[N+]3=CC4=C(OC)C(OC)=CC=C4C=C3C2=CC2=C1OCO2.C1=C2CC[N+]3=CC4=C(OC)C(OC)=CC=C4C=C3C2=CC2=C1OCO2 FYBWCLKVKGHJKS-UHFFFAOYSA-L 0.000 description 11
- 239000003795 chemical substances by application Substances 0.000 description 11
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- 235000015165 citric acid Nutrition 0.000 description 10
- 239000012085 test solution Substances 0.000 description 10
- 150000003836 berberines Chemical class 0.000 description 9
- 230000015572 biosynthetic process Effects 0.000 description 9
- 230000000694 effects Effects 0.000 description 9
- 235000011007 phosphoric acid Nutrition 0.000 description 9
- 239000003242 anti bacterial agent Substances 0.000 description 8
- 229910021538 borax Inorganic materials 0.000 description 8
- 235000010339 sodium tetraborate Nutrition 0.000 description 8
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 8
- CIWBSHSKHKDKBQ-JLAZNSOCSA-N Ascorbic acid Chemical compound OC[C@H](O)[C@H]1OC(=O)C(O)=C1O CIWBSHSKHKDKBQ-JLAZNSOCSA-N 0.000 description 7
- 230000000844 anti-bacterial effect Effects 0.000 description 7
- 229920001225 polyester resin Polymers 0.000 description 7
- 239000004645 polyester resin Substances 0.000 description 7
- 229920000139 polyethylene terephthalate Polymers 0.000 description 7
- 239000005020 polyethylene terephthalate Substances 0.000 description 7
- 239000000243 solution Substances 0.000 description 7
- FWKQNCXZGNBPFD-UHFFFAOYSA-N Guaiazulene Chemical compound CC(C)C1=CC=C(C)C2=CC=C(C)C2=C1 FWKQNCXZGNBPFD-UHFFFAOYSA-N 0.000 description 6
- HEMHJVSKTPXQMS-UHFFFAOYSA-M Sodium hydroxide Chemical compound [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 description 6
- 239000002253 acid Substances 0.000 description 6
- 229920002678 cellulose Polymers 0.000 description 6
- 239000001913 cellulose Substances 0.000 description 6
- 235000010980 cellulose Nutrition 0.000 description 6
- 230000000052 comparative effect Effects 0.000 description 6
- CDBYLPFSWZWCQE-UHFFFAOYSA-L sodium carbonate Substances [Na+].[Na+].[O-]C([O-])=O CDBYLPFSWZWCQE-UHFFFAOYSA-L 0.000 description 6
- 239000004328 sodium tetraborate Substances 0.000 description 6
- 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
- RVGRUAULSDPKGF-UHFFFAOYSA-N Poloxamer Chemical compound C1CO1.CC1CO1 RVGRUAULSDPKGF-UHFFFAOYSA-N 0.000 description 5
- 239000004698 Polyethylene Substances 0.000 description 5
- 235000011054 acetic acid Nutrition 0.000 description 5
- 229940024606 amino acid Drugs 0.000 description 5
- 235000001014 amino acid Nutrition 0.000 description 5
- 125000005619 boric acid group Chemical class 0.000 description 5
- BNIILDVGGAEEIG-UHFFFAOYSA-L disodium hydrogen phosphate Chemical compound [Na+].[Na+].OP([O-])([O-])=O BNIILDVGGAEEIG-UHFFFAOYSA-L 0.000 description 5
- 150000003016 phosphoric acids Chemical class 0.000 description 5
- 229920003023 plastic Polymers 0.000 description 5
- 239000004033 plastic Substances 0.000 description 5
- 229920000573 polyethylene Polymers 0.000 description 5
- 229910052708 sodium Inorganic materials 0.000 description 5
- 239000011734 sodium Substances 0.000 description 5
- 235000000346 sugar Nutrition 0.000 description 5
- 150000005846 sugar alcohols Polymers 0.000 description 5
- XOAAWQZATWQOTB-UHFFFAOYSA-N taurine Chemical compound NCCS(O)(=O)=O XOAAWQZATWQOTB-UHFFFAOYSA-N 0.000 description 5
- 229940088594 vitamin Drugs 0.000 description 5
- 229930003231 vitamin Natural products 0.000 description 5
- 235000013343 vitamin Nutrition 0.000 description 5
- 239000011782 vitamin Substances 0.000 description 5
- UCTWMZQNUQWSLP-VIFPVBQESA-N (R)-adrenaline Chemical compound CNC[C@H](O)C1=CC=C(O)C(O)=C1 UCTWMZQNUQWSLP-VIFPVBQESA-N 0.000 description 4
- GVJHHUAWPYXKBD-UHFFFAOYSA-N (±)-α-Tocopherol Chemical compound OC1=C(C)C(C)=C2OC(CCCC(C)CCCC(C)CCCC(C)C)(C)CCC2=C1C GVJHHUAWPYXKBD-UHFFFAOYSA-N 0.000 description 4
- LYCAIKOWRPUZTN-UHFFFAOYSA-N Ethylene glycol Chemical compound OCCO LYCAIKOWRPUZTN-UHFFFAOYSA-N 0.000 description 4
- VZCYOOQTPOCHFL-OWOJBTEDSA-N Fumaric acid Chemical class OC(=O)\C=C\C(O)=O VZCYOOQTPOCHFL-OWOJBTEDSA-N 0.000 description 4
- DHMQDGOQFOQNFH-UHFFFAOYSA-N Glycine Chemical compound NCC(O)=O DHMQDGOQFOQNFH-UHFFFAOYSA-N 0.000 description 4
- HTTJABKRGRZYRN-UHFFFAOYSA-N Heparin Chemical compound OC1C(NC(=O)C)C(O)OC(COS(O)(=O)=O)C1OC1C(OS(O)(=O)=O)C(O)C(OC2C(C(OS(O)(=O)=O)C(OC3C(C(O)C(O)C(O3)C(O)=O)OS(O)(=O)=O)C(CO)O2)NS(O)(=O)=O)C(C(O)=O)O1 HTTJABKRGRZYRN-UHFFFAOYSA-N 0.000 description 4
- 229920000161 Locust bean gum Polymers 0.000 description 4
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- QAOWNCQODCNURD-UHFFFAOYSA-N Sulfuric acid Chemical compound OS(O)(=O)=O QAOWNCQODCNURD-UHFFFAOYSA-N 0.000 description 4
- KKEYFWRCBNTPAC-UHFFFAOYSA-N Terephthalic acid Chemical compound OC(=O)C1=CC=C(C(O)=O)C=C1 KKEYFWRCBNTPAC-UHFFFAOYSA-N 0.000 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 description 4
- 239000000654 additive Substances 0.000 description 4
- 150000001413 amino acids Chemical class 0.000 description 4
- 230000003110 anti-inflammatory effect Effects 0.000 description 4
- 125000003118 aryl group Chemical group 0.000 description 4
- 229960000686 benzalkonium chloride Drugs 0.000 description 4
- CADWTSSKOVRVJC-UHFFFAOYSA-N benzyl(dimethyl)azanium;chloride Chemical compound [Cl-].C[NH+](C)CC1=CC=CC=C1 CADWTSSKOVRVJC-UHFFFAOYSA-N 0.000 description 4
- IISBACLAFKSPIT-UHFFFAOYSA-N bisphenol A Chemical compound C=1C=C(O)C=CC=1C(C)(C)C1=CC=C(O)C=C1 IISBACLAFKSPIT-UHFFFAOYSA-N 0.000 description 4
- XBDQKXXYIPTUBI-UHFFFAOYSA-N dimethylselenoniopropionate Natural products CCC(O)=O XBDQKXXYIPTUBI-UHFFFAOYSA-N 0.000 description 4
- 238000009472 formulation Methods 0.000 description 4
- 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 4
- 235000010420 locust bean gum Nutrition 0.000 description 4
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- 230000003204 osmotic effect Effects 0.000 description 4
- XNGIFLGASWRNHJ-UHFFFAOYSA-N phthalic acid Chemical compound OC(=O)C1=CC=CC=C1C(O)=O XNGIFLGASWRNHJ-UHFFFAOYSA-N 0.000 description 4
- 235000010482 polyoxyethylene sorbitan monooleate Nutrition 0.000 description 4
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- 229940068968 polysorbate 80 Drugs 0.000 description 4
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- SCVFZCLFOSHCOH-UHFFFAOYSA-M potassium acetate Chemical compound [K+].CC([O-])=O SCVFZCLFOSHCOH-UHFFFAOYSA-M 0.000 description 4
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- FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 description 3
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- 229910002651 NO3 Inorganic materials 0.000 description 3
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Description
(1)(A)アズレン類、(B)ベルベリン類、(C)緩衝剤、および(D)非イオン界面活性剤を含有することを特徴とする水性液剤。
(2)緩衝剤としてホウ酸類、クエン酸類およびリン酸類よりなる群から選択される1種以上 を含むことを特徴とする(1)記載の水性液剤。
(3)非イオン界面活性剤としてポリオキシエチレン−ポリオキシプロピレンブロックコポリマー、ポリオキシエチレンソルビタン脂肪酸エステル、ポリオキシエチレンヒマシ油、ポリオキシエチレン硬化ヒマシ油よりなる群から選択される1種以上 を含むことを特徴とする(1)または(2)記載の水性液剤。
(4)眼科用製剤であることを特徴とする(1)から(3)のいずれかに記載の水性液剤。
(5)(A)アズレン類、(C)緩衝剤および(D)非イオン界面活性剤を含有する水性液剤に(B)ベルベリン類を含有させ、光安定性を向上させる方法。
(6)(A)アズレン類と(B)ベルベリン類を含有する水性液剤に、(C)緩衝剤および(D)非イオン界面活性剤を含有させ、不溶性物質の生成を抑制する方法。
本発明において、薬理学的又は生理学的に許容できる塩としては、例えば、有機酸塩(例えば、乳酸塩、酢酸塩、酪酸、トリフルオロ酢酸塩、フマル酸塩、マレイン酸塩、酒石酸塩、クエン酸塩、コハク酸塩、マロン酸塩、メタンスルホン酸塩、トルエンスルホン酸塩、トシル酸塩、パルミチン酸塩、ステアリン酸塩など)、無機酸塩(例えば、塩酸塩、硫酸塩、硝酸塩、臭化水素酸塩、リン酸塩など)、有機塩基との塩(例えば、メチルアミン、トリエチルアミン、トリエタノールアミン、モルホリン、ピペラジン、ピロリジン、アミノ酸、トリピリジン、ピコリンなどの有機アミンとの塩など)、無機塩基との塩(例えばアンモニウム塩、ナトリウム、カリウムなどのアルカリ金属、カルシウム、マグネシウムなどのアルカリ土類金属、アルミニウムなどの金属との塩など)などが例示できる。
アズレン類は、単独で又は二種以上組み合わせて使用してもよい。本発明の水性液剤が眼科用組成物の場合、アズレンスルホン酸またはこれらの塩が好ましい。
緩衝剤の含有量がこの濃度範囲よりも著しく低くなると本発明における十分な効果が得られにくく、また著しく高濃度に外れると、特に眼科用組成物の場合は眼刺激が生じる傾向にある。
より具体的には,眼粘膜適用用水性液剤中の各成分の含有量は、例えば、以下の通りである。
眼筋調節薬成分:例えば、0.0001〜0.5%、好ましくは、0.0005〜0.1%、さらに好ましくは0.0005〜0.01%。
抗炎症薬成分または収斂薬成分:例えば、0.0001〜10%、好ましくは0.0001〜5%。
抗ヒスタミン薬成分または抗アレルギー薬成分:例えば、0.0001〜10%、好ましくは0.001〜5%。
ビタミン類:例えば、0.0001〜1%、好ましくは、0.0001〜0.5%。
アミノ酸類:例えば、0.0001〜10%、好ましくは0.001〜3%。
抗菌薬成分または殺菌薬成分:例えば、0.00001〜10%、好ましくは、0.0001〜10%。
糖類:例えば、0.0001〜5%、好ましくは0.001〜5%、さらに好ましくは0.01〜2%。
多糖類又はその誘導体:例えば、0.0001〜2%、好ましくは0.01〜2%、さらに好ましくは0.01〜1%。
セルロース又はその誘導体又はそれらの塩:例えば、0.001〜5%、好ましくは0.01〜1%。
前述以外の水溶性高分子:例えば、0.001〜10%、好ましくは0.001〜5%、さらに好ましくは0.01〜3%。
局所麻酔薬成分:例えば、0.001〜1%、好ましくは0.01〜1%。
ステロイド成分:例えば、0.001〜1%、好ましくは0.01〜1%。
緑内障治療成分:例えば、0.001〜5%、好ましくは0.01〜1%。
白内障治療成分:例えば、0.0001〜10%、好ましくは0.001〜5%。
糖アルコール類:例えば、キシリトール、ソルビトール、マンニトールなど。
これらはd体、l体又はdl体のいずれでもよい。
糖類:例えば、0.001〜10%、好ましくは、0.01〜5%
界面活性剤:例えば、0.0001〜10%、好ましくは、0.005〜5%
防腐剤、殺菌剤又は抗菌剤:例えば、0.00001〜5%、好ましくは、0.0001〜2%
pH調節剤:例えば、0.00001〜5%、好ましくは、0.0001〜2%
等張化剤:例えば、0.001〜10%、好ましくは、0.01〜5%
香料または清涼化剤:例えば、0.00001〜5%、好ましくは、0.0001〜2%
キレート剤:例えば、0.00001〜5%、好ましくは、0.0001〜2%。
下記表1に記載の実施例1〜3および比較例1〜8の処方に従い、精製水に、硫酸ベルベリン、緩衝剤(ホウ酸・ホウ砂、クエン酸ナトリウム、リン酸水素二ナトリウム)、ポリソルベート80(商品名:TO-10M(日光ケミカルズ株式会社製))を溶解し、そこにアズレンスルホン酸ナトリウムを加え、水酸化ナトリウム及び/または塩酸でpH7付近に調整し、試験溶液の全量を100mlとした。それぞれの試験溶液を無色透明のガラス瓶に充填し密封して試験試料とした。
各試験試料について、製造直後ならびに遮光下室温で5日間保管し不溶性物質の生成の有無を目視により観察した。そのうち室温で5日間放置して不溶性物質の生成を認めなかった試験試料については、以下の手順により、光に対する安定性の試験を行った。光安定性試験装置(「Light-Tron LT-120 D3CJ型」、ナガノ科学株式会社製)を用い、得られた各試験試料に、D65蛍光ランプを光源として、25℃の下、0.5万luxの光を60時間連続照射し、試験試料を積算照射量30万lux・hrの光に曝光した。アズレンは光によって分解し、試験試料中の試験溶液が退色するため、光照射前(積算照射量0万lux・hr)および光照射後(積算照射量20万lux・hr、30万lux・hr)の各試験溶液について、分光光度計(「U−3300」、株式会社日立製作所製)を用いて測定波長577nmにおける吸光度を測定した。各試験溶液について得られた吸光度測定値について、以下の式から、各試験溶液におけるアズレンスルホン酸ナトリウムの残存率を求めた。なお、試験に先立ち、アズレンスルホン酸ナトリウムについて、上記波長における吸光度測定値をもって安定した定量が行えることを確認した。各試験試料における結果を表1に示す。なお、不溶性物質の生成の有無に関して、不溶性物質の形成を認めなかった場合は○、不溶性物質の形成を認めた場合は×と表中に示した。
下記表2に記載の実施例3および比較例9、10の処方に従い、精製水に、硫酸ベルベリン、ホウ酸、ホウ砂、ポリソルベート80(商品名:TO-10M(日光ケミカルズ株式会社製))を溶解し、そこにアズレンスルホン酸ナトリウムを加え、全量を100mlとし、試験溶液とした。それぞれの試験溶液15mLを栓付き試験管に分注し、1−オクタノール15mLを添加した後、振とう機にて10分間振とうした。次に2000rpmで10分間で遠心分離を行い、平衡状態に達した後、得られた各試験溶液の水相(下層)について分光光度計(「U−3300」、株式会社日立製作所製)を用いて波長420nmおよび577nmにおける吸光度を測定した。各試験溶液について得られた吸光度測定値について、以下の式から、各試験溶液におけるアズレンスルホン酸ナトリウムおよび硫酸ベルベリンの油相への移行率(%)を求めた。なお、試験に先立ち、アズレンスルホン酸ナトリウムについては577nm、硫酸ベルベリンについては420nmにおける吸光度測定値をもって安定した定量が行えることを確認した。各試験試料における結果を表2に示す。
Claims (10)
- (A)アズレンスルホン酸、及びその薬理学的又は生理学的に許容できる塩からなる群より選択される少なくとも一種、
(B)ベルベリン、及びその薬理学的又は生理学的に許容できる塩からなる群より選択される少なくとも一種、
(C)ホウ酸、クエン酸、リン酸、及びそれらの薬理学的又は生理学的に許容できる塩よりなる群から選択される1種以上、並びに
(D)ポリオキシエチレン−ポリオキシプロピレンブロックコポリマー、ポリオキシエチレンソルビタン脂肪酸エステル、ポリオキシエチレンヒマシ油、及びポリオキシエチレン硬化ヒマシ油よりなる群から選択される1種以上
を含有し、ここで、前記(A)成分1重量部に対して、(B)成分が0.1〜50重量部であり、pH6.5〜8.5であることを特徴とする眼科用水性液剤。 - (A)成分と(B)成分の合計量1重量部に対して(D)成分が0.1〜300重量部である請求項1記載の眼科用水性液剤。
- (A)成分の含有量が0.0004〜0.05w/v%、(B)成分の含有量が0.001〜0.1w/v%である請求項1又は2に記載の眼科用水性液剤。
- (D)成分の含有量が0.001〜5w/v%である請求項1〜3いずれかに記載の眼科用水性液剤。
- (C)成分の含有量が0.001〜10.0w/v%である請求項1〜4いずれかに記載の眼科用水性液剤。
- 眼科用水性液剤において(A)アズレンスルホン酸、及びその薬理学的又は生理学的に許容できる塩からなる群より選択される少なくとも一種、(B)ベルベリン、及びその薬理学的又は生理学的に許容できる塩からなる群より選択される少なくとも一種、(C)ホウ酸、クエン酸、リン酸、及びそれらの薬理学的又は生理学的に許容できる塩よりなる群から選択される1種以上、並びに(D)ポリオキシエチレン−ポリオキシプロピレンブロックコポリマー、ポリオキシエチレンソルビタン脂肪酸エステル、ポリオキシエチレンヒマシ油、及びポリオキシエチレン硬化ヒマシ油よりなる群から選択される1種以上を含有させ、且つ該眼科用水性液剤のpHを6.5〜8.5とすることを特徴とする、前記(A)成分の光安定性を向上させる方法。
- (A)成分と(B)成分の合計量1重量部に対して(D)成分が0.1〜300重量部である請求項6記載の方法。
- (A)アズレンスルホン酸、及びその薬理学的又は生理学的に許容できる塩からなる群より選択される少なくとも一種、(B)ベルベリン、及びその薬理学的又は生理学的に許容できる塩からなる群より選択される少なくとも一種、(C)ホウ酸、クエン酸、リン酸、及びそれらの薬理学的又は生理学的に許容できる塩よりなる群から選択される1種以上、並びに(D)ポリオキシエチレン−ポリオキシプロピレンブロックコポリマー、ポリオキシエチレンソルビタン脂肪酸エステル、ポリオキシエチレンヒマシ油、及びポリオキシエチレン硬化ヒマシ油よりなる群から選択される1種以上を含有し、pHが6.5〜8.5である水性液剤を調製し、容器に無菌充填することを特徴とする、前記(A)成分が光安定化された眼科用水性液剤の製造方法。
- (A)アズレンスルホン酸、及びその薬理学的又は生理学的に許容できる塩からなる群より選択される少なくとも一種、(B)ベルベリン、及びその薬理学的又は生理学的に許容できる塩からなる群より選択される少なくとも一種、(C)ホウ酸、クエン酸、リン酸、及びそれらの薬理学的又は生理学的に許容できる塩よりなる群から選択される1種以上、並びに(D)ポリオキシエチレン−ポリオキシプロピレンブロックコポリマー、ポリオキシエチレンソルビタン脂肪酸エステル、ポリオキシエチレンヒマシ油、及びポリオキシエチレン硬化ヒマシ油よりなる群から選択される1種以上を含有し、pHが6.5〜8.5である水性液剤を調製し、容器に無菌充填することを特徴とする、前記(A)成分が光安定化され、且つ不溶性物質の生成が抑制された眼科用水性液剤の製造方法。
- (A)成分と(B)成分の合計量1重量部に対して(D)成分が0.1〜300重量部である請求項9記載の方法。
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