TWI424838B - Composition of soft contact lens and method for inhibiting adsorption - Google Patents
Composition of soft contact lens and method for inhibiting adsorption Download PDFInfo
- Publication number
- TWI424838B TWI424838B TW095148807A TW95148807A TWI424838B TW I424838 B TWI424838 B TW I424838B TW 095148807 A TW095148807 A TW 095148807A TW 95148807 A TW95148807 A TW 95148807A TW I424838 B TWI424838 B TW I424838B
- Authority
- TW
- Taiwan
- Prior art keywords
- soft contact
- contact lens
- composition
- acid
- group
- Prior art date
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- 239000000203 mixture Substances 0.000 title claims description 81
- 238000001179 sorption measurement Methods 0.000 title claims description 37
- 238000000034 method Methods 0.000 title claims description 14
- 230000002401 inhibitory effect Effects 0.000 title claims description 13
- 239000003814 drug Substances 0.000 claims description 48
- 150000003839 salts Chemical class 0.000 claims description 46
- 229940079593 drug Drugs 0.000 claims description 27
- HEMHJVSKTPXQMS-UHFFFAOYSA-M Sodium hydroxide Chemical compound [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 claims description 18
- 150000001412 amines Chemical class 0.000 claims description 17
- 229940024606 amino acid Drugs 0.000 claims description 16
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- -1 monoterpenoid compound Chemical class 0.000 claims description 15
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- SQDAZGGFXASXDW-UHFFFAOYSA-N 5-bromo-2-(trifluoromethoxy)pyridine Chemical compound FC(F)(F)OC1=CC=C(Br)C=N1 SQDAZGGFXASXDW-UHFFFAOYSA-N 0.000 claims description 12
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- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 claims description 12
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- KIUKXJAPPMFGSW-DNGZLQJQSA-N (2S,3S,4S,5R,6R)-6-[(2S,3R,4R,5S,6R)-3-Acetamido-2-[(2S,3S,4R,5R,6R)-6-[(2R,3R,4R,5S,6R)-3-acetamido-2,5-dihydroxy-6-(hydroxymethyl)oxan-4-yl]oxy-2-carboxy-4,5-dihydroxyoxan-3-yl]oxy-5-hydroxy-6-(hydroxymethyl)oxan-4-yl]oxy-3,4,5-trihydroxyoxane-2-carboxylic acid Chemical compound CC(=O)N[C@H]1[C@H](O)O[C@H](CO)[C@@H](O)[C@@H]1O[C@H]1[C@H](O)[C@@H](O)[C@H](O[C@H]2[C@@H]([C@@H](O[C@H]3[C@@H]([C@@H](O)[C@H](O)[C@H](O3)C(O)=O)O)[C@H](O)[C@@H](CO)O2)NC(C)=O)[C@@H](C(O)=O)O1 KIUKXJAPPMFGSW-DNGZLQJQSA-N 0.000 claims description 6
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- FMCGSUUBYTWNDP-UHFFFAOYSA-N N-Methylephedrine Natural products CN(C)C(C)C(O)C1=CC=CC=C1 FMCGSUUBYTWNDP-UHFFFAOYSA-N 0.000 claims description 4
- OKPNYGAWTYOBFZ-UHFFFAOYSA-N Pirenoxine Chemical compound C12=NC3=CC=CC=C3OC2=CC(=O)C2=C1C(=O)C=C(C(=O)O)N2 OKPNYGAWTYOBFZ-UHFFFAOYSA-N 0.000 claims description 4
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- CNIIGCLFLJGOGP-UHFFFAOYSA-N 2-(1-naphthalenylmethyl)-4,5-dihydro-1H-imidazole Chemical compound C=1C=CC2=CC=CC=C2C=1CC1=NCCN1 CNIIGCLFLJGOGP-UHFFFAOYSA-N 0.000 claims 2
- ZJVFLBOZORBYFE-UHFFFAOYSA-N Ibudilast Chemical compound C1=CC=CC2=C(C(=O)C(C)C)C(C(C)C)=NN21 ZJVFLBOZORBYFE-UHFFFAOYSA-N 0.000 claims 2
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Description
本發明係有關一種含有選自具2級胺基及/或3級胺基之胺、及該鹽之鹼性藥物的軟性隱形鏡片用組成物、以及抑制上述鹼性藥物對軟性隱形鏡片之吸附方法。
於戴入軟性隱形鏡片時,鏡片表面為乾燥時容易附著來自外界之花粉、污染物質,進而容易引起發癢、發炎、充血等之過敏症狀。因此,自古以來企求含有抗發炎成分、抗阻胺成分、或抗充血成分之軟性隱形鏡片使用者用組成物。
抗發炎成分、抗阻胺成分、或抗充血成分,為具有2級胺基及/或3級胺基之鹼性化合物,係為已知,惟由於此等鹼性藥物與軟性隱形鏡片之親和性高,故使用作為軟性隱形鏡片使用者用組成物時,吸附於鏡片表面上且經過一段時間後會有囤積於鏡片內部之可能性,故對鏡片之物性或戴入時之使用感、及副作用等有不良的影響。因此,為適應於軟性隱形鏡片予以使用時,必須抑制鹼性藥物吸附於鏡片的情形。
自古以來,抑制藥物吸附於軟性隱形鏡片之方法,提案有以高分子化合物、非離子界面活性劑抑制脂溶性維生素吸附的方法(參照專利文獻1:日本特開2001-158734號公報)、以胺基酸等抑制甘草酸二鉀之吸附方法(參照專利文獻2:特開2001-2563號公報)。然而,仍未開發有關抑制上述鹼性藥物吸附於軟性隱形鏡片之眼科用組成物。而且,使組成物之pH值調整為5~6,以抑制馬來酸氯化苯吡胺吸附於容器的方法(參照專利文獻3:特開2002-249445號公報),配合環糊精且抑制吸附於容器的方法(參照專利文獻4:特開2004-359679號公報)係為已知,惟抑制對軟性隱形鏡片之吸附方法仍為不知。此外,有關本發明之習知技術文獻例如下所述。
〔專利文獻1〕日本特開2001-158734號公報〔專利文獻2〕日本特開2001-2563號公報〔專利文獻3〕日本特開2002-249445號公報〔專利文獻4〕日本特開2004-359679號公報〔專利文獻5〕日本特開2002-322048號公報〔專利文獻6〕日本特開2001-122774號公報〔專利文獻7〕日本特開2004-2364號公報〔專利文獻8〕日本特開2003-252800號公報〔專利文獻9〕日本特開2001-158750號公報〔專利文獻10〕日本特開2003-2837號公報
本發明係有鑑於上述情形,以提供一種可抑制選自具有2級胺基及/或3級胺基之胺、及該鹽所成群的鹼性藥物吸附於軟性隱形鏡片之軟性隱形鏡片用組成物為目的。而且,以提供一種可抑制上述鹼性藥物對軟性隱形鏡片之吸附方法為目的。
本發明人等為達成上述目的時,再三深入研究的結果,發現藉由在含有選自具有2級胺基及/或3級胺基之胺、以及其鹽的鹼性藥物之軟性隱形鏡片用組成物中,配合L-天門冬胺酸鉀等之胺基酸或其鹽、硫酸鈉軟骨素等之酸性黏多糖或其鹽、或環糊精,且使組成物之pH值為3.5~4.8,可以抑制上述鹼性藥物吸附於軟性隱形鏡片之方法,遂而完成本發明。
因此,提供下述發明。
[1]一種軟性隱形鏡片用組成物,其特徵為含有(A)選自具有2級胺基及/或3級胺基的胺、及其鹽之鹼性藥物、(B)1種或2種以上選自胺基酸及其鹽、酸性黏多糖及其鹽、以及環糊精,且pH值為3.5~4.8。
[2]如[1]記載之軟性隱形鏡片用組成物,其中(A)成分為1種或2種以上選自腎上腺素、麻黃素、甲基麻黃素、萘唑啉、脫羥腎上腺素、新斯的明、二苯胺明、氯菲尼拉明、四氫唑啉、普拉洛芬、待克菲那、尿囊素、可多替芬、阿扎斯特、左卡巴斯汀、胺來占諾、異丁斯特、比嘧司特、樂美弗洒辛、歐弗洒欣、諾弗洒辛、見大黴素、希索黴素、小諾黴素、鹽酸丁氧普魯卡因、地斯的明、第莫洛、鹽酸卡特諾、培朵普利、地匹福林、毛果芸香鹼、吡諾克辛、環戊通、托品醯胺及此等之鹽。
[3]如[1]或[2]記載之軟性隱形鏡片用組成物,其中胺基酸及其鹽係為1種或2種以上選自L-麩醯胺、ε-胺基己酸、L-天門冬胺酸及此等之鹽。
[4]如[1]~[3]中任一項記載之軟性隱形鏡片用組成物,其中酸性黏多糖及其鹽係為1種或2種以上選自硫酸軟骨素、多硫酸軟骨素、透明質酸及此等之鹽類。
[5]如[1]~[4]中任一項記載之軟性隱形鏡片用組成物,其中環糊精係為1種或2種以上選自α-環糊精、β-環糊精、及γ-環糊精。
[6]如[1]~[5]中任一項之軟性隱形鏡片用組成物,其中另含有單萜類化合物及/或倍半萜類化合物。
[7]如[1]~[6]中任一項之軟性隱形鏡片用組成物,其中另含有1種或2種以上選自硼酸緩衝劑、醋酸緩衝劑、磷酸緩衝劑、碳酸緩衝劑、檸檬酸緩衝劑及緩血酸胺(Trometamol)之緩衝劑。
[8]如[1]~[7]中任一項之軟性隱形鏡片用組成物,其係為點眼劑、軟性隱形鏡片戴入液、軟性隱形鏡片取出液、或軟性隱形鏡片保護液。
[9]一種抑制該鹼性藥物吸附於軟性隱形鏡片之方法,其特徵為在含有選自具2級胺基及/或3級胺基之胺、以及其鹽之鹼性藥物的軟性隱形鏡片用組成物中,配合1種或2種以上選自胺基酸及其鹽、酸性黏多糖及其鹽、以及環糊精。
藉由本發明,於含有具2級胺基及/或3級胺基之胺、及選自該鹽之鹼性藥物的軟性隱形鏡片用組成物中,可達成抑制上述鹼性藥物吸附於軟性隱形鏡片的情形。
本發明之軟性隱形鏡片用組成物,係在該組成物與軟性隱形鏡片接觸的狀態下,包含軟性隱形鏡片使用者所使用的眼科用組成物(戴入液、點眼液、取出液等)、或軟性隱形鏡片保養時所使用的軟性隱形鏡片保護劑(洗淨劑、消毒液、洗濯劑、保存劑、濕潤劑、上述多目的組成物等)。
本發明之(A)成分係為選自具2級胺基及/或3級胺基之胺、及其鹽的鹼性藥物,例如抗發炎成分、抗阻胺成分、或抗充血成分等。具體而言,具2級胺基及/或3級胺基之胺、其鹽,以腎上腺素、麻黃素、甲基麻黃素、萘唑啉、脫羥腎上腺素、新斯的明、二苯胺明、氯菲尼拉明、四氫唑啉、普拉洛芬、待克菲那、尿囊素、可多替芬、阿扎斯特、左卡巴斯汀、胺來占諾、異丁斯特、比嘧司特、樂美弗洒辛、歐弗洒欣、諾弗洒辛、見大黴素、希索黴素、小諾黴素、鹽酸丁氧普魯卡因、地斯的明、第莫洛、鹽酸卡特諾、培朵普利、地匹福林、毛果芸香鹼、吡諾克辛、環戊通、托品醯胺及此等之鹽較佳。更具體而言,例如鹽酸腎上腺素、鹽酸麻黃素、鹽酸甲基麻黃素、鹽酸萘唑啉、鹽酸脫羥腎上腺素、甲基硫酸新斯的明、鹽酸2-二苯甲氧基-N,N-二甲基乙胺、馬來酸氯化苯吡胺、鹽酸四氫唑啉、富馬酸酮替芬、鹽酸左卡巴斯汀、鹽酸毛果芸香鹼等。上述鹼性藥物可以單獨1種使用,或適當組合2種以上使用。於此等之中,馬來酸氯化苯吡胺、鹽酸2-二苯甲氧基-N,N-二甲基乙胺、鹽酸四氫唑啉、鹽酸萘唑啉、甲基硫酸新斯的明,由於藉由本發明之構成可得顯著的抑制吸附效果,故較佳。
(A)成分之配合量係於軟性隱形鏡片用組成物中以0.001~1.0w/v%(質量/容量%(g/100mL)、以下皆相同)較佳,更佳者為0.001~0.2w/v%,尤佳者為0.002~0.1w/v%,最佳者為0.005~0.1w/v%。
本發明之(B)成分,係為1種或2種以上選自胺基酸及其鹽、酸性黏多糖及其鹽、以及環糊精。藉由在含有(A)鹼性藥物之軟性隱形鏡片用組成物中配合(B)成分,可抑制(A)鹼性藥物吸附於軟性隱性鏡片的情形。於(B)成分中,就在低pH值下之刺激性少而言以酸性黏多糖及其鹽較佳。
胺基酸及其鹽,以L-麩醯胺、ε-胺基己酸、L-天門冬胺酸及此等之鹽(Na、K等之鹼金屬鹽、銨鹽)較佳,具體例如L-麩醯胺、ε-胺基己酸、L-天門冬胺酸、L-麩醯胺鈉、L-天門冬胺酸鉀、L-天門冬胺酸鎂、L-天門冬胺酸鉀鎂、此等之鹽等,可以單獨1種使用或適當組合2種以上使用。其中,就作為低pH質組成物時對眼睛之刺激性少而言,以L-天門冬胺酸、L-天門冬胺酸鹽較佳。
酸性黏多糖及其鹽,例如硫酸軟骨素、多硫酸軟骨素、透明質酸及此等之鹽(Na、K等之鹼金屬鹽、銨鹽)、肝素、角質硫酸等,可單獨1種使用或適當組合2種以上使用。於此等之中,以硫酸軟骨素、多硫酸軟骨素、透明質酸及此等之鹽較佳。
環糊精例如有α-環糊精、β-環糊精、γ-環糊精、δ-環糊精等,可單獨1種使用或適當組合2種以上使用。於此等之中,以α-環糊精、β-環糊精、及γ-環糊精較佳。
配合胺基酸及其鹽時,胺基酸及其鹽之配合量在軟性隱形鏡片用組成物中以0.01~3w/v%較佳,更佳者為0.025~1w/v%。配合量過少時,抑制鹼性藥物對軟性隱形眼鏡之吸附效果不充分,超過3w/v%時,會有使用感降低的情形。
配合酸性黏多糖及其鹽時,酸性黏多糖及其鹽之配合量在軟性隱形用組成物中以0.01~1w/v%較佳,更佳者為0.025~0.5w/v%。配合量過少時,抑制鹼性藥物對軟性隱形眼鏡之吸附效果不充分,超過1w/v%時,使用後會有黏膩感。
配合環糊精時,環糊精之配合量在軟性隱形鏡片用組成物中以0.01~3w/v%較佳,更佳者為0.05~1w/v%。配合量過少時,抑制鹼性藥物對軟性隱形眼鏡之吸附效果不充分,超過3w/v%時,會有溶解性惡化情形。
於本發明之軟性隱形鏡片用組成物中,以配合單萜類化合物及/或倍半萜類化合物較佳。而且,亦可使用含有此等之精油等。具體而言,例如樟腦、庫魯民頓(譯音)No.71212、香葉醇、薄荷水、薄荷醇、龍腦、尤加利樹油、茴香油、佛手油、沉香醇、N-乙基-對-萜烷-羧基萜醯胺(例如WS-3、高砂香料工業(股)製)等。此等之配合量在軟性隱形鏡片用組成物中以0.001~0.1w/v%之範圍較佳。另外,使配合量為0.0005~0.03w/v%之範圍時,由於具有緩和刺激感之效果,故較佳。
於本發明之軟性隱形鏡片用組成物中,以另外配合緩衝劑較佳,緩衝劑例如1種或2種以上選自硼酸、硼砂等之硼系緩衝劑、醋酸、醋酸鈉、醋酸鉀等之醋酸系緩衝劑、磷酸氫鈉、磷酸二氫鈉、磷酸二氫鉀等之磷酸系緩衝劑、碳酸鈉、碳酸氫鈉等之碳酸系緩衝劑、檸檬酸、檸檬酸鈉等之檸檬酸系緩衝劑及緩血酸胺(Trometamol)。其中,以緩血酸胺、硼酸、硼砂等之硼系緩衝劑較佳,就防腐效果而言以硼酸、緩血酸胺、或硼酸-緩血酸胺(硼酸與緩血酸胺併用)之混合物較佳。
配合緩衝劑時,緩衝劑之配合量在軟性隱形鏡片用組成物中以0.001~2w/v%較佳,更佳者為0.001~1w/v%,最佳者為0.05~0.5w/v%。配合量過少時,無法保持pH值之安定性,超過2w/v%時,緩衝力過強、在低pH值之領域中會有刺激感。
另外,具有緩衝力之以下述式所示的Q,以18mL以下較佳。在該範圍內,可得刺激感低的組成物。更佳者為14mL以下。Q之下限值以5mL以上較佳。未達5mL時,軟性隱形鏡片用組成物之pH值安定性不充分。
Q=QHCl+QNaOH(於上述式中,QHCl:使100g組成物之pH值降低為3.5時所必要的0.1mol/LHCl量(mL)、QNaOH:使100g組成物之pH值上昇為7.5時所必要的0.1mol/LNaOH量(mL))pH值測定溫度(20℃)
本發明之軟性隱形鏡片用組成物之pH值(20℃)為3.5~4.8,較佳者為3.5~4.5,更佳者為3.6~4.0,尤佳者為3.6~3.9,最佳者為3.7~3.8。pH值過低時、恐會有刺激感變強的情形,超過4.8時,抑制鹼性藥物對軟性隱形眼鏡之吸附效果不充分。而且,pH值之測定係在20℃下使用pH值浸透壓計(HOSM-1)、東亞迪肯肯(股))予以進行。pH值調整劑例如氫氧化鈉、氫氧化鉀、鹽酸等。此等可單獨1種使用或適當組合2種以上使用。此外,就可形成具有良好防腐力之組成物而言,尤以低pH值為3.9以下較佳,pH值為3.5~3.9時,藉由以上述式所示之Q為18mL以下,即使沒有含刺激性防腐劑,仍可製得優異的保存效力、且對眼睛之刺激感低的軟性隱形鏡片用組成物。
於本發明之軟性隱形鏡片用組成物中,可在不會損害本發明之效果的範圍內、視其所需配合點眼劑所使用的各種成分。較佳的配合成分例如除(A)成分外之藥物、安定化劑、增稠化劑、等張化劑、溶解補助劑、抗氧化劑、防腐劑、清涼化劑等。此等可單獨1種使用或適當組合2種以上使用。
除(A)成分外之藥物,例如甘醇酸二鉀、氯化小劈鹼、硫酸小劈鹼、薁磺酸鈉、硫酸鋅、乳酸鋅、氯化溶菌酶等之抗發炎劑、黃素線嘌呤雙核苷酸鈉(活性型維生素B2
)、氰鈷胺素(維生素B12
)、維生素E乙酸酯、泛酸醇、泛酸鈣、泛酸鈉、醋酸松香油、棕櫚酸松香油(維生素A棕櫚酸酯)等之維生素類、L-胺基乙基磺酸(牛磺酸)等之胺基酸、葡萄糖、D-甘露糖醇、木糖醇等之糖類、磺胺甲氧基噁唑、磺胺甲氧基噁唑鈉、磺胺異噁唑、磺胺異嘧啶鈉等之磺胺劑、色甘酸(Cromoglycate)、色甘酸鈉、曲尼司特(Tranilast)等抗過敏劑、氯化鉀、氯化鈉等之淚滴補助成分。
就抑制因戴入隱形鏡片而導致眼睛疲勞、發炎情形而言,以配合維生素或其衍生物、抗發炎劑、淚滴補助成分較佳。
除(A)成分外之藥物配合量,可選擇各藥物之有效適用量,就對眼睛之刺激性、組成物之安定性而言,以在軟性隱形鏡片用組成物中為0.001~5w/v%之範圍較佳。
安定化劑例如乙二胺四醋酸二鈉、乙二胺四醋酸等。乙二胺四醋酸類藉由螯合作用而具有維持組成物之安定性的效果。安定化劑之配合量在軟性隱形鏡片用組成物中以0.003~2w/v%之範圍較佳。
黏稠化劑例如甲基纖維素、羥基丙基甲基纖維素、羥基乙基纖維素等之纖維素系高分子化合物、聚乙烯基吡咯烷酮、聚乙烯醇等之聚乙烯基系高分子化合物、流動石蠟、羧基乙烯基聚合物、聚乙二醇等。黏稠化劑之配合量,在軟性隱形鏡片用組成物中以0.005~3w/v%之範圍較佳。
等張化劑例如氯化鉀、氯化鈉、丙三醇等。等張化劑之配合量,在軟性隱形鏡片用組成物中以0.005~3w/v%之範圍較佳。
溶解補助劑例如丙二醇、聚乙二醇、山梨糖醇等之多元醇、聚山梨酸酯80、聚氧化乙烯聚氧化丙烯醇類、POE(60)硬化蓖麻油等之POE硬化蓖麻油的界面活性劑。溶解補助劑之配合量,在軟性隱形鏡片用組成物中以0.001~3w/v%之範圍較佳。
抗氧化劑例如二丁基羥基甲苯(BHT)、丁基羥基苯甲醚(BHA)、氫醌、沒食子酸丙酯、亞硫酸氫鈉等。抗氧化劑之配合量,在軟性隱形鏡片用組成物中以0.001~1w/v%之範圍較佳。
防腐劑例如氯化芐烷銨、氯化芐基銨、葡糖酸雙氯苯雙呱己烷、山梨酸、山梨酸鉀、氯丁醇、對羥基苯甲酸酯等之對羥基苯甲酸酯類。防腐劑之配合量,在軟性隱形鏡片用組成物中以0.001~0.5w/v%之範圍較佳。
本發明之軟性隱形鏡片用組成物,可使殘留部分為水,且以習知的製造方法予以製造。例如使上述各成分溶解於滅菌精製水、離子交換水等之水、或與乙醇等之醇的混合溶劑等後,使pH值調整為3.5~4.8,視其所需使浸透壓等藉由pH值調整劑、等張化劑適當調整予以製得。所得的組成物,填充於周知的點眼溶器(含有防止紫外線或色素者,就配合成分之安定性而言較佳),且進行薄膜包裝等之包裝,可提供作為保存安定性良好的軟性隱形鏡片用組成物。
本發明之軟性隱形鏡片用組成物,可使用於軟性隱形鏡片戴入時之軟性隱形鏡片使用者用點眼劑、軟性隱形鏡片用戴入時所使用的軟性隱形鏡片戴入液、使軟性隱形眼鏡鏡片取出時所使用的軟性隱形鏡片取出液、軟性隱形鏡片保護劑、軟性隱形鏡片用MPS(洗淨、洗濯、消毒及保存)。其中,以軟性隱形鏡片使用者用點眼液、軟性隱形鏡片戴入液、軟性隱形鏡片取出液、軟性隱形鏡片保護劑較佳。
有關本發明之軟性隱形鏡片用組成物可適用的軟性隱形鏡片用之種類,沒有特別的限制,除重複使用的軟性隱形鏡片外,亦可使用於1日拋棄式軟性隱形鏡片、1周拋棄式軟性隱形鏡片、2周拋棄式軟性隱形鏡片等皆可。
本發明之軟性隱形鏡片用組成物,由於具有可抑制具2級胺基或3級胺基之鹼性藥物對軟性隱形鏡片之吸附效果,故適合使用作為抑制上述鹼性藥物對軟性隱形鏡片之吸附用組成物。而且,可提供一種含有選自具2級胺基或3級胺基之胺、及其鹽的鹼性藥物的軟性隱形鏡片用組成物中,配合1種或2種以上選自胺基酸及其鹽、酸性黏多糖及其鹽、以及環糊精之上述鹼性藥物對軟性隱形鏡片的抑制吸附方法。
於下述中,以實施例及比較例具體地說明本發明,惟本發明不受下述實施例所限制。
使表1~18所示之組成(配合單位w/v%)成分溶解於滅菌精製水後,使各溶液進行無菌過濾,調製軟性隱形鏡片用組成物(試驗液)。有關所得的各組成物,測定pH值(20℃),且進行下述試驗1。結果併記於表1~18。
(對軟性隱形鏡片而言鹼性藥物吸附試驗:n=3)藉由FDA(美國食品醫藥局)使軟性隱形鏡片分為4種類,使用西谷恩斯(譯音)(伯西羅姆(譯音)日本(股)製)、薄片UV14(西頓(股)製)、海夫羅(譯音)Ace(HOYA(股)製)、及亞奇比(譯音)(嬌生及嬌生醫學(股)製)等4種作為典型的鏡片。在5mL之軟性隱形鏡片用組成物中、37℃下浸透1片鏡片7日後,使殘液之鹼性藥物量以液體色層分析法進行定量。同樣地處理沒有浸透有鏡片之軟性隱形鏡片用組成物作為對照用,對照用之鹼性藥物量而言之比例,以下述式為基準,計算對4種鏡片而言鹼性藥物之鏡片吸附率(%)[(對照用鹼性藥物量-殘液之鹼性藥物量)]/對照用鹼性藥物量×100]。對1種軟性隱形鏡片用組成物而言,4種鏡片每種各進行3次測定。結果,求取每種鏡片種類之平均吸附率,以對4種鏡片而言之平均吸附率作為最大吸附率,且以下述評估基準予以表示。而且,含有2種以上之鹼性藥物時,以在全部鹼性藥物之平均吸附率中選擇最大平均吸附率的值表示。
(對軟性隱形鏡片而言之抑制吸附評估標準)◎:對鏡片而言鹼性藥物之平均吸附率(每種鏡片)中,最大平均吸附率未達3%○:對鏡片而言鹼性藥物之平均吸附率(每種鏡片)中,最大平均吸附率為3%以上、未達5%△:對鏡片而言鹼性藥物之平均吸附率(每種鏡片)中,最大平均吸附率為5%以上、未達7%×:對鏡片而言鹼性藥物之平均吸附率(每種鏡片)中,最大平均吸附率為7%以上
使表19~23所示之組成(配合單位w/v%)成分溶解於滅菌精製水後,使各溶液進行無菌過濾,調製軟性隱形鏡片用組成物。有關所得的各組成物,測定pH值(20℃),且進行下述試驗2、3。結果併記於表19~23。
使10名軟性隱形鏡片使用者在戴入軟性隱形鏡片的狀態下,進行試驗液之點眼試驗,以下述基準進行評估使用感(有無刺激感)。
<評估基準>5:沒有刺激性4:幾乎沒有刺激性3:稍有刺激性2:有刺激性1:非常有刺激性
結果,平均點4以上為◎,3以上、未達4者為○,2以上、未達3為△,未達2者為×。
各量取100g之軟性隱形鏡片用組成物,以0.1 mol/LHCl進行滴定,使pH值降至3.5,測定必要的0.1 mol/LHCl之量(QHCl)。
另外,量取100g之軟性隱形鏡片用組成物,以0.1 mol/LNaOH進行滴定,使pH值昇至7.5,測定必要的0.1 mol/LNaOH之量(QNaOH)。
由所得的值求取Q=QHCl+QNaOH而且,pH值之測定係在20℃下進行。
藉由實施例及比較例之結果,確認配合有胺基酸及其鹽、酸性黏多糖及其鹽、環糊精之組成物,具有可抑制鹼性藥物吸附於軟性隱形鏡片之效果。
表6~18中之下述成分,係使用下述者。
聚乙烯醇:可西羅魯(譯音)EG05(日本合成化學工業(股)製)聚乙烯基吡咯烷酮:克里頓(譯音)90F(BASF(股)製)羥基乙基纖維素:HEC CF-H(住友精化(股)製)羥基丙基甲基纖維素:梅頓羅絲(譯音)65SH-400(信越化學工業(股)製)甲基纖維素:梅頓羅絲SM-25(信越化學工業(股)製)
Claims (9)
- 一種軟性隱形鏡片用組成物,其特徵為含有(A)1種或2種以上之選自腎上腺素、麻黃素、甲基麻黃素、萘唑啉、脫羥腎上腺素、新斯的明(Neostigmine)、二苯胺明、氯菲尼拉明、四氫唑啉(Tetrahydrozolin)、普拉洛芬(Pranoprofen)、待克菲那(Diclofenac)、尿囊素、阿扎斯特(Acitazanolast)、胺來占諾(Amlexanox)、異丁斯特(Ibudilast)、比嘧司特(Pemirolast)、見大黴素(Gentamicin)、希索黴素(Sisomicin)、小諾黴素(Micronomycin)、鹽酸卡特諾(Carteolol)、培朵普利(Betaxolol)、地匹福林(Dipivefrin)、吡諾克辛(Pirenoxine)、環戊通(Cyclopentolate)、托品醯胺(Tropicamide)及此等之鹽的鹼性藥物、與(B)下述(B-1)及(B-2)(B-1)0.05~1w/v%的選自L-麩醯胺、ε-胺基己酸、L-天門冬胺酸及此等之鹽的胺基酸或其鹽、(B-2)0.2~1.0w/v%的選自硫酸軟骨素、多硫酸軟骨素、透明質酸及此等之鹽類的1種或2種以上之酸性黏多糖或其鹽,其為pH3.5~3.9者。
- 如申請專利範圍第1項之軟性隱形鏡片用組成物,其中(B)成分為(B-1)選自L-麩醯胺、ε-胺基己酸、L-天門冬胺酸及此等之鹽的1種或2種以上之胺基酸或其鹽。
- 如申請專利範圍第1項之軟性隱形鏡片用組成物,其中(B)成分為(B-2)選自硫酸軟骨素、多硫酸軟骨素、透明質酸及此等之鹽類的1種或2種以上之酸性黏多糖或其鹽。
- 如申請專利範圍第1項之軟性隱形鏡片用組成物,其中(A)成分的配合量為軟性隱形鏡片用組成物中0.001~1.0w/v%。
- 如申請專利範圍第1項之軟性隱形鏡片用組成物,其中另含有單萜類化合物及/或倍半萜類化合物。
- 如申請專利範圍第1項之軟性隱形鏡片用組成物,其中另含有1種或2種以上選自硼酸緩衝劑、醋酸緩衝劑、磷酸緩衝劑、碳酸緩衝劑、檸檬酸緩衝劑及緩血酸胺(Trometamol)之緩衝劑。
- 如申請專利範圍第1項之軟性隱形鏡片用組成物,其係為點眼劑、軟性隱形鏡片戴入液、軟性隱形鏡片取出液、或軟性隱形鏡片保護液。
- 如申請專利範圍第1項之軟性隱形鏡片用組成物,其為如下述式所得之Q為18mL以下者;Q=QHCl+QNaOH(上述式中,QHCl:欲將組成物100g降至pH3.5所需的0.1mol/LHCl量(mL),QNaOH:欲將組成物100g上升至pH7.5所需的0.1mol/LNaOH量(mL),但pH之測定溫度為20℃)。
- 一種抑制該(A)鹼性藥物吸附於軟性隱形鏡片之 方法,其特徵為在含有1種或2種以上之選自腎上腺素、麻黃素、甲基麻黃素、萘唑啉、脫羥腎上腺素、新斯的明(Neostigmine)、二苯胺明、氯菲尼拉明、四氫唑啉(Tetrahydrozolin)、普拉洛芬(Pranoprofen)、待克菲那(Diclofenac)、尿囊素、阿扎斯特(Acitazanolast)、胺來占諾(Amlexanox)、異丁斯特(Ibudilast)、比嘧司特(Pemirolast)、見大黴素(Gentamicin)、希索黴素(Sisomicin)、小諾黴素(micromicin)、鹽酸卡特諾(Carteolol)、培朵普利(Betaxolol)、地匹福林(Dipivefrin)、吡諾克辛(Pirenoxine)、環戊通(Cyclopentolate)、托品醯胺(Tropicamide)及此等之鹽的鹼性藥物的軟性隱形鏡片用組成物中,配合(B)下述(B-1)及(B-2)(B-1)0.05~1w/v%的選自L-麩醯胺、ε-胺基己酸、L-天門冬胺酸及此等之鹽的胺基酸或其鹽、(B-2)0.2~1.0w/v%的選自硫酸軟骨素、多硫酸軟骨素、透明質酸及此等之鹽類的1種或2種以上之酸性黏多糖或其鹽,上述組成物的pH值為3.5~3.9。
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JP2022526917A (ja) | 2019-03-26 | 2022-05-27 | アルデイラ セラピューティクス, インコーポレイテッド | 眼科用製剤およびその使用 |
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KR102221923B1 (ko) | 2019-09-24 | 2021-03-03 | 단국대학교 천안캠퍼스 산학협력단 | 폴리페놀 단량체를 포함하는 항산화 기능성 콘택트렌즈 및 이의 제조방법 |
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CN112129849B (zh) * | 2020-08-20 | 2022-09-09 | 山东绅联生物科技有限公司 | (1-羟基环戊基)苯基乙酸中苯乙酸和2-亚环戊基-2-苯乙酸的检测方法 |
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- 2006-12-25 WO PCT/JP2006/325751 patent/WO2007077783A1/ja active Application Filing
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US8435965B2 (en) | 2013-05-07 |
CN101351199B (zh) | 2013-01-02 |
TW200740426A (en) | 2007-11-01 |
EP1967186A1 (en) | 2008-09-10 |
EP1967186B1 (en) | 2015-03-11 |
KR20080080124A (ko) | 2008-09-02 |
JP5472402B2 (ja) | 2014-04-16 |
JP5892149B2 (ja) | 2016-03-23 |
KR101377378B1 (ko) | 2014-03-21 |
JPWO2007077783A1 (ja) | 2009-06-11 |
EP1967186A4 (en) | 2009-12-09 |
CN101351199A (zh) | 2009-01-21 |
JP2012250987A (ja) | 2012-12-20 |
US20090176737A1 (en) | 2009-07-09 |
JP5196130B2 (ja) | 2013-05-15 |
JP2014074044A (ja) | 2014-04-24 |
WO2007077783A1 (ja) | 2007-07-12 |
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