TW202335664A - 眼科組成物 - Google Patents
眼科組成物 Download PDFInfo
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- TW202335664A TW202335664A TW112118358A TW112118358A TW202335664A TW 202335664 A TW202335664 A TW 202335664A TW 112118358 A TW112118358 A TW 112118358A TW 112118358 A TW112118358 A TW 112118358A TW 202335664 A TW202335664 A TW 202335664A
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- Prior art keywords
- ophthalmic composition
- appropriate amount
- container
- amount appropriate
- sodium
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- 235000011181 potassium carbonates Nutrition 0.000 description 1
- 239000001508 potassium citrate Substances 0.000 description 1
- 229960002635 potassium citrate Drugs 0.000 description 1
- QEEAPRPFLLJWCF-UHFFFAOYSA-K potassium citrate (anhydrous) Chemical compound [K+].[K+].[K+].[O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O QEEAPRPFLLJWCF-UHFFFAOYSA-K 0.000 description 1
- 235000011082 potassium citrates Nutrition 0.000 description 1
- TYJJADVDDVDEDZ-UHFFFAOYSA-M potassium hydrogencarbonate Chemical compound [K+].OC([O-])=O TYJJADVDDVDEDZ-UHFFFAOYSA-M 0.000 description 1
- OTYBMLCTZGSZBG-UHFFFAOYSA-L potassium sulfate Chemical compound [K+].[K+].[O-]S([O-])(=O)=O OTYBMLCTZGSZBG-UHFFFAOYSA-L 0.000 description 1
- 229910052939 potassium sulfate Inorganic materials 0.000 description 1
- 235000011151 potassium sulphates Nutrition 0.000 description 1
- JVUYWILPYBCNNG-UHFFFAOYSA-N potassium;oxido(oxo)borane Chemical compound [K+].[O-]B=O JVUYWILPYBCNNG-UHFFFAOYSA-N 0.000 description 1
- 230000002265 prevention Effects 0.000 description 1
- 229960004919 procaine Drugs 0.000 description 1
- MFDFERRIHVXMIY-UHFFFAOYSA-N procaine Chemical compound CCN(CC)CCOC(=O)C1=CC=C(N)C=C1 MFDFERRIHVXMIY-UHFFFAOYSA-N 0.000 description 1
- 235000010232 propyl p-hydroxybenzoate Nutrition 0.000 description 1
- 239000004405 propyl p-hydroxybenzoate Substances 0.000 description 1
- 229960003415 propylparaben Drugs 0.000 description 1
- ZUFQODAHGAHPFQ-UHFFFAOYSA-N pyridoxine hydrochloride Chemical compound Cl.CC1=NC=C(CO)C(CO)=C1O ZUFQODAHGAHPFQ-UHFFFAOYSA-N 0.000 description 1
- MIXMJCQRHVAJIO-TZHJZOAOSA-N qk4dys664x Chemical compound O.C1([C@@H](F)C2)=CC(=O)C=C[C@]1(C)[C@@H]1[C@@H]2[C@@H]2C[C@H]3OC(C)(C)O[C@@]3(C(=O)CO)[C@@]2(C)C[C@@H]1O.C1([C@@H](F)C2)=CC(=O)C=C[C@]1(C)[C@@H]1[C@@H]2[C@@H]2C[C@H]3OC(C)(C)O[C@@]3(C(=O)CO)[C@@]2(C)C[C@@H]1O MIXMJCQRHVAJIO-TZHJZOAOSA-N 0.000 description 1
- MCJGNVYPOGVAJF-UHFFFAOYSA-N quinolin-8-ol Chemical compound C1=CN=C2C(O)=CC=CC2=C1 MCJGNVYPOGVAJF-UHFFFAOYSA-N 0.000 description 1
- 229950004535 rebamipide Drugs 0.000 description 1
- 230000001105 regulatory effect Effects 0.000 description 1
- 239000012744 reinforcing agent Substances 0.000 description 1
- 229960003471 retinol Drugs 0.000 description 1
- 235000020944 retinol Nutrition 0.000 description 1
- 239000011607 retinol Substances 0.000 description 1
- 229940108325 retinyl palmitate Drugs 0.000 description 1
- 235000019172 retinyl palmitate Nutrition 0.000 description 1
- 239000011769 retinyl palmitate Substances 0.000 description 1
- 235000019719 rose oil Nutrition 0.000 description 1
- 239000010666 rose oil Substances 0.000 description 1
- 239000000741 silica gel Substances 0.000 description 1
- 229910002027 silica gel Inorganic materials 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
- 235000017281 sodium acetate Nutrition 0.000 description 1
- 229960004249 sodium acetate Drugs 0.000 description 1
- 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
- 239000004299 sodium benzoate Substances 0.000 description 1
- 229910000029 sodium carbonate Inorganic materials 0.000 description 1
- 235000017550 sodium carbonate Nutrition 0.000 description 1
- 235000019812 sodium carboxymethyl cellulose Nutrition 0.000 description 1
- 229920001027 sodium carboxymethylcellulose Polymers 0.000 description 1
- 239000001509 sodium citrate Substances 0.000 description 1
- NLJMYIDDQXHKNR-UHFFFAOYSA-K sodium citrate Chemical compound O.O.[Na+].[Na+].[Na+].[O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O NLJMYIDDQXHKNR-UHFFFAOYSA-K 0.000 description 1
- 235000011083 sodium citrates Nutrition 0.000 description 1
- 235000019259 sodium dehydroacetate Nutrition 0.000 description 1
- 229940079839 sodium dehydroacetate Drugs 0.000 description 1
- AJPJDKMHJJGVTQ-UHFFFAOYSA-M sodium dihydrogen phosphate Chemical compound [Na+].OP(O)([O-])=O AJPJDKMHJJGVTQ-UHFFFAOYSA-M 0.000 description 1
- HRZFUMHJMZEROT-UHFFFAOYSA-L sodium disulfite Chemical compound [Na+].[Na+].[O-]S(=O)S([O-])(=O)=O HRZFUMHJMZEROT-UHFFFAOYSA-L 0.000 description 1
- 235000010267 sodium hydrogen sulphite Nutrition 0.000 description 1
- 229940001584 sodium metabisulfite Drugs 0.000 description 1
- 235000010262 sodium metabisulphite Nutrition 0.000 description 1
- 229940068459 sodium pantothenate Drugs 0.000 description 1
- 239000001488 sodium phosphate Substances 0.000 description 1
- 229910052938 sodium sulfate Inorganic materials 0.000 description 1
- 235000011152 sodium sulphate 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
- JLDCNMJPBBKAHH-UHFFFAOYSA-N sodium;(4-aminophenyl)sulfonyl-pyrimidin-2-ylazanide Chemical compound [Na+].C1=CC(N)=CC=C1S(=O)(=O)[N-]C1=NC=CC=N1 JLDCNMJPBBKAHH-UHFFFAOYSA-N 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
- 235000010199 sorbic acid Nutrition 0.000 description 1
- 239000004334 sorbic acid Substances 0.000 description 1
- 229940075582 sorbic acid Drugs 0.000 description 1
- 235000011071 sorbitan monopalmitate Nutrition 0.000 description 1
- 239000001570 sorbitan monopalmitate Substances 0.000 description 1
- 229940031953 sorbitan monopalmitate Drugs 0.000 description 1
- 235000011078 sorbitan tristearate Nutrition 0.000 description 1
- 239000001589 sorbitan tristearate Substances 0.000 description 1
- 229960004129 sorbitan tristearate Drugs 0.000 description 1
- 239000000600 sorbitol Substances 0.000 description 1
- 235000010356 sorbitol Nutrition 0.000 description 1
- 235000019721 spearmint oil Nutrition 0.000 description 1
- 238000003892 spreading Methods 0.000 description 1
- 150000003431 steroids Chemical class 0.000 description 1
- 239000005720 sucrose Substances 0.000 description 1
- 235000000346 sugar Nutrition 0.000 description 1
- 150000008163 sugars Chemical class 0.000 description 1
- 229960001182 sulfadiazine sodium Drugs 0.000 description 1
- 229960000654 sulfafurazole Drugs 0.000 description 1
- YZMCKZRAOLZXAZ-UHFFFAOYSA-N sulfisomidine Chemical compound CC1=NC(C)=CC(NS(=O)(=O)C=2C=CC(N)=CC=2)=N1 YZMCKZRAOLZXAZ-UHFFFAOYSA-N 0.000 description 1
- 229960001975 sulfisomidine Drugs 0.000 description 1
- 229940104261 taurate Drugs 0.000 description 1
- 229960000337 tetryzoline Drugs 0.000 description 1
- OGIDPMRJRNCKJF-UHFFFAOYSA-N titanium oxide Inorganic materials [Ti]=O OGIDPMRJRNCKJF-UHFFFAOYSA-N 0.000 description 1
- 229960000401 tranexamic acid Drugs 0.000 description 1
- GYDJEQRTZSCIOI-LJGSYFOKSA-N tranexamic acid Chemical compound NC[C@H]1CC[C@H](C(O)=O)CC1 GYDJEQRTZSCIOI-LJGSYFOKSA-N 0.000 description 1
- 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
- WYXIGTJNYDDFFH-UHFFFAOYSA-Q triazanium;borate Chemical compound [NH4+].[NH4+].[NH4+].[O-]B([O-])[O-] WYXIGTJNYDDFFH-UHFFFAOYSA-Q 0.000 description 1
- 235000013337 tricalcium citrate Nutrition 0.000 description 1
- 229910000404 tripotassium phosphate Inorganic materials 0.000 description 1
- 235000019798 tripotassium phosphate Nutrition 0.000 description 1
- BSVBQGMMJUBVOD-UHFFFAOYSA-N trisodium borate Chemical compound [Na+].[Na+].[Na+].[O-]B([O-])[O-] BSVBQGMMJUBVOD-UHFFFAOYSA-N 0.000 description 1
- RYFMWSXOAZQYPI-UHFFFAOYSA-K trisodium phosphate Chemical compound [Na+].[Na+].[Na+].[O-]P([O-])([O-])=O RYFMWSXOAZQYPI-UHFFFAOYSA-K 0.000 description 1
- 229910000406 trisodium phosphate Inorganic materials 0.000 description 1
- 235000019801 trisodium phosphate Nutrition 0.000 description 1
- 229960000281 trometamol Drugs 0.000 description 1
- 229960004791 tropicamide Drugs 0.000 description 1
- 239000004474 valine Substances 0.000 description 1
- 125000000391 vinyl group Chemical group [H]C([*])=C([H])[H] 0.000 description 1
- 229940088594 vitamin Drugs 0.000 description 1
- 235000013343 vitamin Nutrition 0.000 description 1
- 239000011782 vitamin Substances 0.000 description 1
- 229930003231 vitamin Natural products 0.000 description 1
- 239000008215 water for injection Substances 0.000 description 1
- 239000003871 white petrolatum Substances 0.000 description 1
- 239000000811 xylitol Substances 0.000 description 1
- HEBKCHPVOIAQTA-SCDXWVJYSA-N xylitol Chemical compound OC[C@H](O)[C@@H](O)[C@H](O)CO HEBKCHPVOIAQTA-SCDXWVJYSA-N 0.000 description 1
- 235000010447 xylitol Nutrition 0.000 description 1
- 229960002675 xylitol Drugs 0.000 description 1
- 229910052725 zinc Inorganic materials 0.000 description 1
- 239000011701 zinc Substances 0.000 description 1
- 239000011592 zinc chloride Substances 0.000 description 1
- 235000005074 zinc chloride Nutrition 0.000 description 1
- 229960001939 zinc chloride Drugs 0.000 description 1
- 239000011787 zinc oxide Substances 0.000 description 1
- 235000014692 zinc oxide Nutrition 0.000 description 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/08—Solutions
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
- A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
- A61K31/19—Carboxylic acids, e.g. valproic acid
- A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
- A61K31/197—Carboxylic acids, e.g. valproic acid having an amino group the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid, pantothenic acid
- A61K31/198—Alpha-aminoacids, e.g. alanine, edetic acids [EDTA]
Abstract
本發明係關於一種眼科組成物,係含有(A)選自由精胺酸及其鹽所組成之群中1種以上,且收容於容器而成者,該容器係與該眼科組成物相接觸之部分中之一部分或全部由塑膠形成者。
Description
本發明係關於一種眼科組成物。
作為摻合有作為鹼性胺基酸之精胺酸之眼科用醫藥製劑,例如於專利文獻1中揭示有對伴有嚴重之上皮損傷之乾眼症之預防或治療有用的眼科用醫藥製劑。
作為收容眼科用醫藥製劑之容器,已知有聚對苯二甲酸乙二酯製、聚萘二甲酸乙二酯製、聚丙烯製、聚芳酯製、聚對苯二甲酸丁二酯製、聚碳酸酯製及玻璃製之容器(例如專利文獻2)。
專利文獻1:國際公開第2010/107069號
專利文獻2:日本特開2014-214085號公報
[發明所欲解決之課題]
本發明之目的在於提供一種眼科組成物,其係含有選自由精胺酸及其鹽所組成之群中1種以上者,且向塑膠之潤濕得到抑制。
[解決課題之技術手段]
本發明人等意外地發現含有精胺酸及其鹽之眼科組成物與不含精胺酸及其鹽之眼科組成物相比,對塑膠之動態接觸角較大,潤濕得到抑制。本發明係基於該見解者,且提供以下之各發明。
[1]一種眼科組成物,係含有(A)選自由精胺酸及其鹽所組成之群中1種以上,且收容於容器而成者,該容器係與該眼科組成物相接觸之部分中之一部分或全部由塑膠形成者。
[2]如[1]中所記載之眼科組成物,其進而含有(B)緩衝劑。
[3]如[1]或[2]中所記載之眼科組成物,其進而含有選自由(C)等張劑、及(D)黏稠劑所組成之群中之1種以上。
[4]一種方法,係對眼科組成物賦予抑制潤濕塑膠之作用的方法,其包括向該眼科組成物摻合(A)選自由精胺酸及其鹽所組成之群中1種以上之步驟。
[發明之效果]
本發明之眼科組成物由於含有精胺酸或其鹽,故而與不含精胺酸及其鹽之眼科組成物相比,對塑膠之動態接觸角較大,發揮出抑制潤濕之效果。藉此,於將眼科組成物收容於與該眼科組成物相接觸之部分中之一部分或全部由塑膠所形成之容器(塑膠容器)時,亦抑制液體殘留,發揮出液體去除性提高之效果。又,藉此,可抑制眼科組成物之品質之降低、及使用性能之降低。
以下,對用以實施本發明之形態詳細地進行說明。但是,本發明並不限定於以下之實施形態。
於本說明書中,只要未特別記載,則含量之單位「%」係指「w/v%」,與「g/100 mL」含義相同。於本說明書中,只要未特別記載,則縮寫「POE」係指聚氧乙烯,縮寫「POP」係指聚氧丙烯。
[1.眼科組成物]
本實施形態之眼科組成物含有(A)選自由精胺酸及其鹽所組成之群中1種以上(亦僅記載為「(A)成分」)。
<(A)成分>
精胺酸可為游離體,亦可為醫藥上、藥理學上(製藥上)或生理學上所容許之鹽。
作為精胺酸之鹽,具體而言,例如可列舉鹽酸鹽等無機酸鹽等。精胺酸及其鹽可為D體、L體、DL體中之任一者,但較佳為L體。
作為精胺酸及其鹽,較佳為精胺酸及其無機酸鹽,更佳為精胺酸及精胺酸鹽酸鹽,進而較佳為精胺酸。
精胺酸或其鹽亦可使用市售者。精胺酸或其鹽可單獨使用一種,或亦可組合兩種以上而使用。
本實施形態之眼科組成物中之(A)成分之含量並無特別限定,係根據(A)成分之種類、其他摻合成分之種類及含量、眼科組成物之用途及製劑形態等而適當加以設定。作為(A)成分之含量,就更顯著地發揮出本發明之效果之觀點而言,例如,將眼科組成物之總量設為基準,(A)成分之總含量較佳為0.001~10 w/v%,更佳為0.01~10 w/v%,進而較佳為0.05~5 w/v%,進而更佳為0.1~3 w/v%,尤佳為0.1~2 w/v%。
<(B)成分>
本實施形態之眼科組成物可進而含有(B)緩衝劑(亦僅記載為「(B)成分」)。藉由眼科組成物進而含有(B)成分,更顯著地發揮出本發明之效果。
作為緩衝劑,只要為醫藥上、藥理學上(製藥上)或生理學上所容許者,則並無特別限制。作為此種緩衝劑,例如可列舉酸性緩衝劑、鹼性緩衝劑。
作為酸性緩衝劑,例如可列舉:硼酸緩衝劑、磷酸緩衝劑、碳酸緩衝劑、檸檬酸緩衝劑、及乙酸緩衝劑。
作為硼酸緩衝劑,可列舉硼酸或其鹽(硼酸鹼金屬鹽、硼酸鹼土金屬鹽等)。作為磷酸緩衝劑,可列舉磷酸或其鹽(磷酸鹼金屬鹽、磷酸鹼土金屬鹽等)。作為碳酸緩衝劑,可列舉碳酸或其鹽(碳酸鹼金屬鹽、碳酸鹼土金屬鹽等)。作為檸檬酸緩衝劑,可列舉檸檬酸或其鹽(檸檬酸鹼金屬鹽、檸檬酸鹼土金屬鹽等)。作為乙酸緩衝劑,可列舉乙酸或其鹽(乙酸鹼金屬鹽、乙酸鹼土金屬鹽等)。又,作為硼酸緩衝劑、磷酸緩衝劑、碳酸緩衝劑、檸檬酸緩衝劑或乙酸緩衝劑,亦可使用硼酸鹽、磷酸鹽、碳酸鹽、檸檬酸鹽或乙酸鹽之水合物。作為更具體之例,作為硼酸緩衝劑,可例示硼酸或其鹽(硼酸鈉、四硼酸鉀、偏硼酸鉀、硼酸銨、硼砂等);作為磷酸緩衝劑,可例示磷酸或其鹽(磷酸氫二鈉、磷酸二氫鈉、磷酸二氫鉀、磷酸三鈉、磷酸三鉀、磷酸氫鈣、磷酸二氫鈣等);作為碳酸緩衝劑,可例示碳酸或其鹽(碳酸氫鈉、碳酸鈉、碳酸銨、碳酸鉀、碳酸鈣、碳酸氫鉀、碳酸鎂等);作為檸檬酸緩衝劑,可例示檸檬酸或其鹽(檸檬酸鈉、檸檬酸鉀、檸檬酸鈣、檸檬酸二氫鈉、檸檬酸二鈉等);作為乙酸緩衝劑,可例示乙酸或其鹽(乙酸銨、乙酸鉀、乙酸鈣、乙酸鈉等)等。
酸性緩衝劑之中,較佳為硼酸緩衝劑、磷酸緩衝劑、檸檬酸緩衝劑,更佳為硼酸、磷酸氫二鈉、檸檬酸。
作為鹼性緩衝劑,例如可列舉三羥甲基胺基甲烷緩衝劑、2-胺基-2-甲基-1,3-丙二醇。作為三羥甲基胺基甲烷緩衝劑,例如可列舉胺基丁三醇(trometamol)或其鹽(胺基丁三醇鹽酸鹽等)。
鹼性緩衝劑之中,較佳為三羥甲基胺基甲烷緩衝劑、2-胺基-2-甲基-1,3-丙二醇,更佳為胺基丁三醇、2-胺基-2-甲基-1,3-丙二醇。
緩衝劑亦可使用市售者。緩衝劑可單獨使用一種,或亦可組合兩種以上而使用。
本實施形態之眼科組成物中之(B)成分之含量並無特別限定,係根據(B)成分之種類、其他摻合成分之種類及含量、眼科組成物之用途及製劑形態等而適當加以設定。作為(B)成分之含量,就更顯著地發揮出本發明之效果之觀點而言,例如,將眼科組成物之總量設為基準,(B)成分之總含量較佳為0.001~10 w/v%,更佳為0.005~5 w/v%,進而較佳為0.01~4 w/v%,進而更佳為0.01~3 w/v%,尤佳為0.01~2 w/v%,更尤佳為0.01~1.5 w/v%,進而尤佳為0.1~1 w/v%。
本實施形態之眼科組成物中(B)成分相對於(A)成分之含有比率並無特別限定,係根據(A)成分及(B)成分之種類、其他摻合成分之種類及含量、眼科組成物之用途及製劑形態等而適當加以設定。作為(B)成分相對於(A)成分之含有比率,就更顯著地發揮出本發明之效果之觀點而言,例如,相對於本實施形態之眼科組成物中所含之(A)成分之總含量1質量份,(B)成分之總含量較佳為0.005~300質量份,更佳為0.01~250質量份,進而較佳為0.01~100質量份,尤佳為0.05~50質量份,更尤佳為0.1~30質量份,進而尤佳為0.1~20質量份,進而更尤佳為0.5~10質量份,最佳為0.5~5質量份。
<(C)成分>
本實施形態之眼科組成物可進而含有(C)等張劑(亦僅記載為「(C)成分」)。藉由眼科組成物進而含有(C)成分,更顯著地發揮出本發明之效果。(C)成分只要為醫藥上、藥理學上(製藥上)或生理學上所容許者,則並無特別限制。
作為(C)成分之等張劑例如可列舉:離子性等張劑、非離子性等張劑、及兩性等張劑。
作為離子性等張劑,例如可列舉:氯化鈣、氯化鎂、氯化鈉、氯化鉀、氯化銨、硫酸鈣、硫酸鎂、硫酸鈉、硫酸鉀等無機鹽類、乙二胺四乙酸鈉、單乙醇胺、二乙醇胺、及三乙醇胺。
離子性等張劑之中,就更顯著地發揮出本發明之效果之觀點而言,較佳為氯化鈉、乙二胺四乙酸鈉、單乙醇胺。
作為非離子性等張劑,例如可列舉:甘油、丙二醇、聚乙二醇(400、4000、6000等)、葡萄糖、山梨醇、甘露醇、木糖醇、及海藻糖等醇類。
非離子性等張劑之中,就更顯著地發揮出本發明之效果之觀點而言,較佳為甘油、丙二醇。
作為兩性等張劑,例如可列舉:甘胺酸、牛磺酸(胺基乙基磺酸)、及三甲基甘胺酸。
兩性等張劑之中,就更顯著地發揮出本發明之效果之觀點而言,較佳為甘胺酸、牛磺酸。
等張劑亦可使用市售者。等張劑可單獨使用一種,或亦可組合兩種以上而使用。
關於本實施形態之眼科組成物中之(C)等張劑之總含量,就更顯著地發揮出本發明之效果之觀點而言,將眼科組成物之總量設為基準,較佳為0.0001~10 w/v%,更佳為0.0005~7 w/v%,進而較佳為0.001~6 w/v%,進而更佳為0.005~5 w/v%,尤佳為0.005~4 w/v%,更尤佳為0.005~3 w/v%,進而尤佳為0.01~2 w/v%,進而更尤佳為0.01~1 w/v%,最佳為0.1~0.5 w/v%。
本實施形態之眼科組成物中(C)等張劑相對於(A)成分之含有比率並無特別限定,係根據(A)成分及(C)成分之種類、其他摻合成分之種類及含量、眼科組成物之用途及製劑形態等而適當加以設定。作為(C)等張劑相對於(A)成分之含有比率,就更顯著地發揮出本發明之效果之觀點而言,例如,相對於本實施形態之眼科組成物中所含之(A)成分之總含量1質量份,(C)等張劑之總含量較佳為0.0005~500質量份,更佳為0.001~400質量份,進而較佳為0.001~200質量份,進而更佳為0.005~100質量份,尤佳為0.01~50質量份,更尤佳為0.01~30質量份,進而尤佳為0.1~20質量份,進而更尤佳為0.1~10質量份,最佳為0.1~5質量份。
<(D)成分>
本實施形態之眼科組成物可進而含有(D)黏稠劑(亦僅記載為「(D)成分」)。藉由眼科組成物進而含有(D)成分,更顯著地發揮出本發明之效果。(D)成分只要為醫藥上、藥理學上(製藥上)或生理學上所容許者,則並無特別限制。
作為(D)成分之黏稠劑例如可列舉多糖類、及乙烯化合物。
多糖類包含葡聚糖、黏多糖類、三仙膠、結冷膠(gellan gum)、纖維素系高分子化合物及該等之鹽。多糖類可自公知之多糖類中適當選擇而使用。
作為葡聚糖之具體例,例如可列舉葡聚糖40及葡聚糖70。
作為黏多糖類之具體例,例如可列舉:玻尿酸、硫酸軟骨素、聚葡萄胺糖、肝素、乙醯肝素(heparan)、海藻酸、該等之衍生物(例如乙醯化體)及該等之鹽等。
作為黏多糖類,就更顯著地發揮出本發明之效果之觀點而言,較佳為玻尿酸、硫酸軟骨素及該等之鹽。作為玻尿酸之鹽、硫酸軟骨素之鹽,只要為醫藥上、藥理學上(製藥上)或生理學上所容許者,則並無特別限制。作為玻尿酸之鹽、硫酸軟骨素之鹽,例如較佳為鹼金屬鹽,更佳為鈉鹽、鉀鹽等,進而較佳為鈉鹽。作為黏多糖類之鹽,較佳為玻尿酸鈉、硫酸軟骨素鈉。
黏多糖類亦可使用市售者。黏多糖類可單獨使用一種,或亦可組合兩種以上而使用。
作為纖維素系高分子化合物,可使用藉由利用其他官能基取代纖維素之羥基而獲得之纖維素系高分子化合物。作為取代纖維素之羥基之官能基,例如可列舉:甲氧基、乙氧基、羥基甲氧基、羥基乙氧基、羥基丙氧基、羧基甲氧基及羧基乙氧基。纖維素系高分子化合物亦可使用市售者。
作為纖維素系高分子化合物之具體例,例如可列舉:甲基纖維素、乙基纖維素、羥乙基纖維素、羥甲基纖維素、羥丙基纖維素、羥基丙基甲基纖維素(羥丙甲纖維素(hypromellose))、羧甲基纖維素、羧乙基纖維素及該等之鹽。此處,作為鹽,只要為醫藥上、藥理學上(製藥上)或生理學上所容許者即可,其中較佳為鹼金屬鹽,更佳為鈉鹽、鉀鹽等。
作為纖維素系高分子化合物,就更顯著地發揮出本發明之效果之觀點而言,較佳為甲基纖維素、羥乙基纖維素、羥基丙基甲基纖維素(2208、2906、2910等)、羥丙基纖維素、羧甲基纖維素或該等之鹽,更佳為羥基丙基甲基纖維素、羥乙基纖維素、或羧甲基纖維素鈉,進而較佳為羥基丙基甲基纖維素、羥乙基纖維素,進而更佳為羥基丙基甲基纖維素,尤佳為羥基丙基甲基纖維素2208、羥基丙基甲基纖維素2906、羥基丙基甲基纖維素2910。
纖維素系高分子化合物亦可使用市售者。纖維素系高分子化合物可單獨使用一種,或亦可組合兩種以上而使用。
作為多糖類,就更顯著地發揮出本發明之效果之觀點而言,較佳為黏多糖類,更佳為玻尿酸、硫酸軟骨素及該等之鹽,進而較佳為玻尿酸鈉、硫酸軟骨素鈉。
乙烯化合物包含乙烯系高分子化合物及該等之鹽。乙烯化合物可自公知之乙烯化合物中適當選擇而使用。
作為乙烯化合物之具體例,例如可列舉:聚乙烯醇(完全或部分皂化物)等乙烯醇系高分子、聚乙烯吡咯啶酮等乙烯基吡咯啶酮系高分子及羧基乙烯基聚合物、以及該等之鹽。
作為乙烯化合物,就更顯著地發揮出本發明之效果之觀點而言,較佳為聚乙烯醇(部分皂化物)、聚乙烯吡咯啶酮(K17、K25、K30、K90等)、羧基乙烯基聚合物及該等之鹽,更佳為聚乙烯吡咯啶酮及其鹽,進而較佳為聚乙烯吡咯啶酮K30。
乙烯化合物亦可使用市售者。乙烯化合物可單獨使用一種,或亦可組合兩種以上而使用。
關於本實施形態之眼科組成物中之(D)黏稠劑之總含量,就更顯著地發揮出本發明之效果之觀點而言,將眼科組成物之總量設為基準,較佳為0.0005~6 w/v%,更佳為0.001~5 w/v%,進而較佳為0.005~4 w/v%,尤佳為0.01~3 w/v%,更尤佳為0.01~2 w/v%,進而尤佳為0.01~1 w/v%,進而更尤佳為0.1~0.5 w/v%。
本實施形態之眼科組成物中(D)黏稠劑相對於(A)成分之含有比率並無特別限定,係根據(A)成分及(D)黏稠劑之種類、其他摻合成分之種類及含量、眼科組成物之用途及製劑形態等而適當加以設定。作為(D)黏稠劑相對於(A)成分之含有比率,就更顯著地發揮出本發明之效果之觀點而言,例如,相對於本實施形態之眼科組成物中所含之(A)成分之總含量1質量份,(D)黏稠劑之總含量較佳為0.0001~500質量份,更佳為0.0001~300質量份,進而較佳為0.0005~200質量份,尤佳為0.0005~100質量份。
本實施形態之眼科組成物可進而含有非離子界面活性劑。藉由眼科組成物進而含有非離子界面活性劑,更顯著地發揮出本發明之效果。
作為非離子界面活性劑之具體例,例如可列舉:POE(20)山梨醇酐單月桂酸酯(聚山梨醇酯20)、POE(20)山梨醇酐單棕櫚酸酯(聚山梨醇酯40)、POE(20)山梨醇酐單硬脂酸酯(聚山梨醇酯60)、POE(20)山梨醇酐三硬脂酸酯(聚山梨醇酯65)、POE(20)山梨醇酐單油酸酯(聚山梨醇酯80)等POE山梨醇酐脂肪酸酯類;POE(5)氫化蓖麻油(聚氧乙烯氫化蓖麻油5)、POE(10)氫化蓖麻油(聚氧乙烯氫化蓖麻油10)、POE(20)氫化蓖麻油(聚氧乙烯氫化蓖麻油20)、POE(30)氫化蓖麻油(聚氧乙烯氫化蓖麻油30)、POE(40)氫化蓖麻油(聚氧乙烯氫化蓖麻油40)、POE(60)氫化蓖麻油(聚氧乙烯氫化蓖麻油60)、POE(80)氫化蓖麻油(聚氧乙烯氫化蓖麻油80)、POE(100)氫化蓖麻油(聚氧乙烯氫化蓖麻油100)等POE氫化蓖麻油;POE(3)蓖麻油(聚氧乙烯蓖麻油3)、POE(10)蓖麻油(聚氧乙烯蓖麻油10)、POE(35)蓖麻油(聚氧乙烯蓖麻油35)、POE(70)蓖麻油(聚氧乙烯蓖麻油70)等POE蓖麻油;POE(9)月桂醚等POE烷基醚;POE(20)POP(4)鯨蠟醚等POE-POP烷基醚;POE(20)POP(20)二醇(PluronicL44)、POE(42)POP(67)二醇(Poloxamer403、PluronicP123)、POE(54)POP(39)二醇(Poloxamer235、PluronicP85)、POE(120)POP(40)二醇(PluronicF87)、POE(160)POP(30)二醇(Poloxamer188、PluronicF68)、POE(196)POP(67)二醇(Poloxamer407、PluronicF127)、POE(200)POP(70)二醇等POE-POP二醇;硬脂酸聚烴氧10酯(polyoxyl stearate 10)、硬脂酸聚烴氧40酯等聚乙二醇單硬脂酸酯等。再者,於上述中所例示之化合物中,括弧內之數字表示加成莫耳數。
作為非離子界面活性劑,較佳為POE山梨醇酐脂肪酸酯類、聚氧乙烯氫化蓖麻油、聚氧乙烯蓖麻油、聚乙二醇單硬脂酸酯、POE-POP二醇,更佳為POE山梨醇酐脂肪酸酯類、聚氧乙烯氫化蓖麻油、聚氧乙烯蓖麻油、聚乙二醇單硬脂酸酯,進而較佳為POE山梨醇酐脂肪酸酯類、聚氧乙烯氫化蓖麻油,尤佳為聚山梨醇酯80、聚氧乙烯氫化蓖麻油60。
於使用POE-POP二醇作為非離子界面活性劑之情形時,較佳為POE(42)POP(67)二醇、POE(120)POP(40)二醇、POE(160)POP(30)二醇、POE(196)POP(67)二醇、POE(200)POP(70)二醇,更佳為POE(42)POP(67)二醇、POE(196)POP(67)二醇,進而較佳為POE(196)POP(67)二醇。
非離子界面活性劑亦可使用市售者。非離子界面活性劑可單獨使用一種,或亦可組合兩種以上而使用。
本實施形態之眼科組成物中之非離子界面活性劑之含量並無特別限定,係根據非離子界面活性劑之種類、其他摻合成分之種類及含量、眼科組成物之用途及製劑形態等而適當加以設定。作為非離子界面活性劑之含量,就更顯著地發揮出本發明之效果之觀點而言,例如,將眼科組成物之總量設為基準,非離子界面活性劑之總含量較佳為0.0001~10 w/v%,更佳為0.001~5 w/v%,進而較佳為0.005~1 w/v%,進而更佳為0.01~0.5 w/v%,更尤佳為0.01~0.1 w/v%,尤其更佳為0.01~0.05 w/v%。
本實施形態之眼科組成物中非離子界面活性劑相對於(A)成分之含有比率並無特別限定,係根據(A)成分及非離子界面活性劑之種類、其他摻合成分之種類及含量、眼科組成物之用途及製劑形態等而適當加以設定。作為非離子界面活性劑相對於(A)成分之含有比率,就更顯著地發揮出本發明之效果之觀點而言,例如,相對於本實施形態之眼科組成物中所含之(A)成分之總含量1質量份,非離子界面活性劑之總含量較佳為0.0001~10質量份,更佳為0.0005~5質量份,進而較佳為0.001~3質量份,進而更佳為0.01~1質量份,尤佳為0.01~0.5重量份。
本實施形態之眼科組成物可進而含有螯合劑。藉由眼科組成物進而含有螯合劑,更顯著地發揮出本發明之效果。
作為螯合劑,例如可列舉:乙二胺二乙酸(EDDA)、乙二胺三乙酸、N-(2-羥基乙基)乙二胺三乙酸(HEDTA)、二伸乙基三胺五乙酸(DTPA)、及艾提壯酸(etidronic acid)。
螯合劑亦可使用市售者。螯合劑可單獨使用一種,或亦可組合兩種以上而使用。
本實施形態之眼科組成物中之螯合劑之含量並無特別限定,係根據螯合劑之種類、其他摻合成分之種類及含量、眼科組成物之用途及製劑形態等而適當加以設定。作為螯合劑之含量,就更顯著地發揮出本發明之效果之觀點而言,例如,將眼科組成物之總量設為基準,螯合劑之總含量較佳為0.001~1 w/v%,更佳為0.005~0.5 w/v%,進而較佳為0.01~0.2 w/v%。
本實施形態之眼科組成物中螯合劑相對於(A)成分之含有比率並無特別限定,係根據(A)成分及螯合劑之種類、其他摻合成分之種類及含量、眼科組成物之用途及製劑形態等而適當加以設定。作為螯合劑相對於(A)成分之含有比率,就更顯著地發揮出本發明之效果之觀點而言,例如,相對於本實施形態之眼科組成物中所含之(A)成分之總含量1質量份,螯合劑之總含量較佳為0.001~10質量份,更佳為0.005~5質量份,進而較佳為0.005~3質量份,進而更佳為0.01~1質量份,尤佳為0.01~0.5重量份。
本實施形態之眼科組成物可進而含有殺菌劑或防腐劑。藉由眼科組成物進而含有殺菌劑或防腐劑,更顯著地發揮出本發明之效果。
殺菌劑或防腐劑係具有殺菌作用或抑菌作用之化合物、及其鹽。殺菌劑或防腐劑可自公知之防腐劑或抗菌劑中適當選擇而使用。
作為殺菌劑或防腐劑之具體例,例如可列舉:陽離子系殺菌劑(防腐劑)(苄烷銨、本索寧(benzethonium)、洛赫西定(chlorhexidine)、阿來西定(alexidine)、聚己雙胍(polihexanide))、烷基聚胺基乙基甘胺酸(alkylpolyaminoethylglycine)、苯甲酸、氯丁醇、山梨酸、去氫乙酸、對羥基苯甲酸酯(例如對羥基苯甲酸甲酯、對羥基苯甲酸乙酯、對羥基苯甲酸丙酯及對羥基苯甲酸丁酯等對羥基苯甲酸酯)、羥基喹啉、苯乙醇、苄醇、聚四級銨鹽類、Gurokiru(Rhodia公司製造,商品名)、鋅、磺胺異唑(sulfisoxazole)、磺胺二甲嘧啶(sulfisomidine)及磺胺甲異唑(sulfamethoxazole)、以及該等之鹽。
作為殺菌劑或防腐劑之鹽之具體例,例如可列舉:鹽酸烷基二胺基乙基甘胺酸、苯甲酸鈉、氯化苄烷銨、氯化本索寧、葡萄糖酸洛赫西定、山梨酸鉀、去氫乙酸鈉、硫酸羥基喹啉、鹽酸聚己雙胍、泊利氯銨(polidronium chloride)、氯化鋅、磺胺索嘧啶鈉及磺胺甲異唑鈉。
作為殺菌劑或防腐劑,較佳為陽離子系殺菌劑(防腐劑)、聚四級銨鹽類、氯丁醇,更佳為氯化苄烷銨、葡萄糖酸洛赫西定、山梨酸鉀、阿來西定、鹽酸聚己雙胍、泊利氯銨、氯丁醇,進而較佳為鹽酸聚己雙胍、阿來西定、泊利氯銨、氯丁醇,進而更佳為鹽酸聚己雙胍、氯丁醇。
就更顯著地發揮出本發明之效果之觀點而言,殺菌劑或防腐劑若組合兩種以上使用則更佳。其中,較佳為陽離子系殺菌劑(防腐劑)與聚四級銨鹽類、陽離子系殺菌劑(防腐劑)與氯丁醇之組合,更佳為泊利氯銨與陽離子系殺菌劑(防腐劑)、陽離子系殺菌劑(防腐劑)與氯丁醇之組合,進而較佳為泊利氯銨與鹽酸聚己雙胍、泊利氯銨與阿來西定、或氯化苄烷銨與氯丁醇之組合。
殺菌劑或防腐劑亦可使用市售者。殺菌劑或防腐劑可單獨使用一種,或亦可組合兩種以上而使用。
本實施形態之眼科組成物中之殺菌劑或防腐劑之含量並無特別限定,係根據殺菌劑或防腐劑之種類、其他摻合成分之種類及含量、眼科組成物之用途及製劑形態等而適當加以設定。作為殺菌劑或防腐劑之含量,就更顯著地發揮出本發明之效果之觀點而言,例如,將眼科組成物之總量設為基準,殺菌劑或防腐劑之總含量較佳為0.00001~2 w/v%,更佳為0.00001~1 w/v%,進而較佳為0.00005~0.5 w/v%,進而更佳為0.00005~0.4 w/v%。
於殺菌劑或防腐劑為阿來西定、鹽酸聚己雙胍或泊利氯銨之情形時,將眼科組成物之總量設為基準,殺菌劑或防腐劑之總含量較佳為0.000001~0.01 w/v%,其中較佳為0.000001~0.005 w/v%,其中較佳為0.000005~0.002 w/v%,其中較佳為0.000005~0.001 w/v%,其中較佳為0.00001~0.0005 w/v%,其中較佳為0.00005~0.0002 w/v%,其中較佳為0.00007~0.0002 w/v%。
就更進一步提高本發明之效果之觀點而言,本實施形態之眼科組成物較佳為進而含有胺基酸類(其中,作為(A)成分、(C)成分及(D)成分之胺基酸類除外)。
作為胺基酸類,例如可列舉:天冬胺酸、麩胺酸、丙胺酸、天冬醯胺、麩醯胺、脯胺酸、離胺酸、組胺酸、絲胺酸、甲硫胺酸、蘇胺酸、半胱胺酸、胺基乙酸、纈胺酸、色胺酸、苯基丙胺酸、白胺酸、異白胺酸以及該等之鹽等。作為胺基酸類,就更顯著地發揮出本發明之效果之觀點而言,較佳為天冬胺酸、麩胺酸及該等之鹽。
胺基酸類可為D體、L體、DL體中之任一者,但較佳為L體。
胺基酸類亦可使用市售者。胺基酸類可單獨使用一種,或亦可組合兩種以上而使用。
本實施形態之眼科組成物中胺基酸類之含量並無特別限定,係根據胺基酸類之種類、其他摻合成分之種類及含量、眼科組成物之用途及製劑形態等而適當加以設定。作為胺基酸類之含量,就更顯著地發揮出本發明之效果之觀點而言,例如,將眼科組成物之總量設為基準,胺基酸類之總含量較佳為0.001~5 w/v%,更佳為0.01 w/v%~2 w/v%,進而較佳為0.1~1 w/v%。
本實施形態之眼科組成物中胺基酸類相對於(A)成分之含有比率並無特別限定,係根據(A)成分及胺基酸類之種類、其他摻合成分之種類及含量、眼科組成物之用途及製劑形態等而適當加以設定。作為胺基酸類相對於(A)成分之含有比率,就更顯著地發揮出本發明之效果之觀點而言,例如,相對於本實施形態之眼科組成物中所含之(A)成分之總含量1質量份,胺基酸類之總含量較佳為0.001~5質量份,更佳為0.01~2質量份,進而較佳為0.1~1質量份。
就更進一步提高本發明之效果之觀點而言,本實施形態之眼科組成物較佳為進而含有類萜。作為類萜,只要為醫藥上、藥理學上(製藥上)或生理學上所容許者,則並無特別限制。作為此種類萜,例如可列舉:薄荷腦、薄荷酮、樟腦、冰片、香葉草醇、桉樹腦、香茅醇、香旱芹酮、大茴香腦、丁香酚、檸檬烯、沈香醇、乙酸沈香酯、該等之衍生物等。該等化合物可為D體、L體或DL體中之任一者。又,於本發明中,作為類萜,亦可使用含有上述化合物之精油。作為此種精油,例如可列舉:桉葉油、香柑油、辣薄荷油(peppermint oil)、清涼薄荷油、綠薄荷油、薄荷油、茴香油、桂皮油、玫瑰油等。該等類萜可單獨使用一種,或亦可任意地組合兩種以上而使用。
該等類萜之中,較佳為薄荷腦、樟腦、冰片等,作為含有該等之較佳之精油,可例示:清涼薄荷油、辣薄荷油、薄荷油、樟腦油等。更佳為薄荷腦。
類萜亦可使用市售者。類萜可單獨使用一種,或亦可組合兩種以上而使用。
於含有類萜之情形時,作為本實施形態之眼科組成物中之類萜之含量,就更顯著地發揮出本發明之效果之觀點而言,例如,將眼科組成物之總量設為基準,類萜之總含量較佳為0.00005~1 w/v%,更佳為0.0001~0.5 w/v%,進而較佳為0.001~0.1 w/v%。
本實施形態之眼科組成物中類萜相對於(A)成分之含有比率並無特別限定,係根據(A)成分及類萜之種類、其他摻合成分之種類及含量、眼科組成物之用途及製劑形態等而適當加以設定。作為類萜相對於(A)成分之含有比率,就更顯著地發揮出本發明之效果之觀點而言,例如,相對於本實施形態之眼科組成物中所含之(A)成分之總含量1質量份,類萜之總含量較佳為0.00005~1質量份,更佳為0.0001~0.5質量份,進而較佳為0.001~0.1質量份。
本實施形態之眼科組成物之pH只要在醫藥上、藥理學上(製藥上)或生理學上所容許之範圍內,則並無特別限定。作為本實施形態之眼科組成物之pH,例如可為4.0~9.5,較佳為4.0~9.0,更佳為4.5~9.0,進而較佳為4.5~8.5,進而更佳為5.0~8.5,尤佳為5.5~8.5。
本實施形態之眼科組成物視需要可調節為活體所容許之範圍內之滲透壓比。適當之滲透壓比根據應用部位、劑型等而有所不同,但就更顯著地發揮出本發明之效果之觀點而言,例如較佳為設為0.05~6,更佳為設為0.4~5,進而較佳為設為0.6~3,進而更佳為設為0.8~2。滲透壓之調整可使用無機鹽類、多元醇等,並藉由該技術領域中已知之方法進行。滲透壓比係基於日本藥典第十六次修訂版,設為試樣之滲透壓相對於286 mOsm(0.9 w/v%氯化鈉水溶液之滲透壓)之比,滲透壓係以日本藥典所記載之滲透壓測定法(凝固點降低法)為參考而進行測定。再者,滲透壓比測定用標準液(0.9 w/v%氯化鈉水溶液)可使氯化鈉(日本藥典標準試劑)於500~650℃乾燥40~50分鐘後,於乾燥器(矽膠)中放置冷卻,精確地稱量0.900 g,溶解於純化水中而精確地製備為100 mL,或使用市售之滲透壓比測定用標準液(0.9 w/v%氯化鈉水溶液)。
本實施形態之眼科組成物之黏度只要在醫藥上、藥理學上(製藥上)或生理學上所容許之範圍內,則並無特別限定。作為本實施形態之眼科組成物之黏度,例如可列舉:利用旋轉黏度計(RE550型黏度計,東產業公司製造,轉子;1°34'×R24)測定之20℃下之黏度較佳為0.01~10000 mPa・s,更佳為0.05~8000 mPa・s,進而較佳為0.1~1000 mPa・s,進而更佳為1~100 mPa・s,尤佳為1~10 mPa・s,更尤佳為1~5 mPa・s。
於本實施形態之眼科組成物中,只要在不損及本發明之效果之範圍,則除可含有上述成分以外,亦可將選自各種藥理活性成分及生理活性成分之成分組合而含有適當量。該成分並無特別限制,例如可例示一般用醫藥品製造銷售承認基準2012年版(一般社團法人 Regulatory Science學會 監修)中所記載之眼科用藥中之有效成分。作為於眼科用藥中使用之成分,具體而言,例如可列舉如下所述之成分。
抗組織胺劑:例如異丙海汀(iproheptine)、鹽酸二苯胺(diphenhydramine Hydrochloride)、順丁烯二酸氯苯那敏(chlorpheniramine maleate)、反丁烯二酸可多替芬(ketotifen fumarate)、鹽酸奧洛他定(olopatadine hydrochloride)、鹽酸左卡巴司汀(levocabastine hydrochloride)等。
抗過敏劑:例如色甘酸鈉、曲尼司特(tranilast)、吡嘧司特鉀(potassium pemirolast)等。
類固醇劑:例如丙酸氟替卡松(fluticasone propionate)、糠酸氟替卡松、糠酸莫米松(mometasone furoate)、丙酸倍氯米松(beclomethasone dipropionate)、氟尼縮松(flunisolide)等。
消炎劑:例如甘草次酸、甘草酸二鉀、普拉洛芬(pranoprofen)、水楊酸甲酯、乙二醇水楊酸酯、尿囊素、傳明酸、ε-胺基己酸、黃連素、薁磺酸鈉(sodium azulene sulfonate)、氯化溶菌酶、硫酸鋅、乳酸鋅、甘草等。
充血去除劑:鹽酸四氫唑啉、硝酸四氫唑啉、鹽酸萘甲唑啉、硝酸萘甲唑啉、腎上腺素、鹽酸腎上腺素、鹽酸麻黃鹼、鹽酸去氧腎上腺素、dl-鹽酸甲基麻黃鹼等。
眼肌調節藥劑:例如具有與乙醯膽鹼類似之活性中心之膽鹼酯酶抑制劑、具體而言有甲基硫酸新斯的明、托品醯胺(tropicamide)、土木香素(helenien)、硫酸阿托品等。
維生素類:例如黃素腺嘌呤二核苷酸鈉(flavin adenine dinucleotide sodium)、氰鈷胺素、鹽酸吡哆醇、泛醇、泛酸鈣、泛酸鈉、視黃醇棕櫚酸酯、視黃醇乙酸酯、維生素E乙酸酯等。
收斂劑:例如鋅白、乳酸鋅、硫酸鋅等。
局部麻醉劑:例如利多卡因、普魯卡因等。
其他:瑞巴派特(rebamipide)等。
於本實施形態之眼科組成物中,只要在不損及本發明之效果之範圍,則可根據其用途及製劑形態,依據常法,適當選擇各種添加物,併用一種或一種以上而含有適當量。作為此種添加物,例如可例示醫藥品添加物事典2007(日本醫藥品添加劑協會編輯)中所記載之各種添加物。作為代表性成分,可列舉以下之添加物。
載體:例如水、含水乙醇等水性溶劑。
基劑:例如辛基十二烷醇、氧化鈦、溴化鉀、Plastibase、液態石蠟、輕質液態石蠟、精製羊毛脂、白色凡士林等。
pH調節劑:鹽酸、乙酸、氫氧化鈉、氫氧化鉀、氫氧化鈣、氫氧化鎂、三乙醇胺、二異丙醇胺等。
糖類:例如單糖類、二糖類、具體而言有麥芽糖、蔗糖、環糊精等。
穩定劑:二丁基羥基甲苯、丁基羥基苯甲醚、甲醛次硫酸氫鈉(保險粉(rongalite))、亞硫酸氫鈉、焦亞硫酸鈉、單硬脂酸鋁、單硬脂酸甘油酯、環糊精等。
陰離子界面活性劑:聚氧乙烯烷基醚磷酸鹽、聚氧乙烯烷基醚硫酸鹽、烷基苯磺酸鹽、烷基硫酸鹽、N-醯基牛磺酸鹽等。
兩性界面活性劑:月桂基二甲基胺基乙酸甜菜鹼等。
本實施形態之眼科組成物例如可藉由以成為所需之含量之方式添加及混合(A)成分、及視需要之其他含有成分而製備。具體而言,例如可藉由利用純化水使上述成分溶解或懸浮,調整為特定之pH及滲透壓,並利用過濾滅菌等進行滅菌處理而製備。
本實施形態之眼科組成物可根據目的而採取各種劑型,例如可列舉:液劑、凝膠劑、半固形劑(軟膏等)、凝膠軟膏劑等。該等之中,較佳為液劑。又,液劑之中,較佳為水性液劑。於將本實施形態之眼科組成物製成水性液劑之情形時,相對於眼科組成物之總量,例如水之含量為50 w/v%以上,較佳為70 w/v%以上,更佳為80 w/v%以上,進而較佳為90 w/v%以上,進而更佳為95 w/v%以上。作為本實施形態之眼科組成物中所使用之水,只要使用醫藥上、藥理學上(製藥上)或生理學上所容許之水即可,作為此種水,例如可列舉:蒸餾水、普通水、純化水、滅菌純化水、注射用水、注射用蒸餾水。
本實施形態之眼科組成物係於眼科領域中所使用者,只要為以與眼相接觸之方式使用者,則對其製劑形態並無限制。例如可列舉:滴眼劑(其中,滴眼劑包含隱形眼鏡佩戴中可滴入之滴眼劑)、眼軟膏劑、洗眼劑(其中,洗眼劑包含隱形眼鏡佩戴中可洗眼之洗眼劑)、隱形眼鏡佩戴液、隱形眼鏡保養用液劑(隱形眼鏡消毒液、隱形眼鏡用保存液、隱形眼鏡用洗淨液、隱形眼鏡用洗淨保存液、隱形眼鏡用消毒/洗淨/保存液(多功能溶液(multi-purpose solution)等)等。該等之中,較佳為滴眼劑、洗眼劑及隱形眼鏡佩戴液、隱形眼鏡保養用液劑。尤其是本實施形態之眼科組成物由於使用時之滴加量之偏差較少,故而尤其適宜用於一次之使用量較少之滴眼劑、隱形眼鏡佩戴液。再者,於本說明書中,於僅表述為隱形眼鏡之情形時,包含包括硬性隱形眼鏡、透氧性硬性隱形眼鏡、軟性隱形眼鏡、聚矽氧水凝膠隱形眼鏡在內之所有隱形眼鏡。
本實施形態之眼科組成物係依據與其製劑形態相應之使用方法而使用。例如,於眼科組成物為滴眼劑(包含隱形眼鏡用滴眼劑)之情形時,只要向裸眼或佩戴有隱形眼鏡之眼中滴入適量該滴眼劑即可。又,於眼科組成物為洗眼劑(包含隱形眼鏡用洗眼劑)之情形時,亦只要對裸眼或佩戴有隱形眼鏡之眼使用適量該洗眼劑進行洗眼即可。又,於眼科組成物為隱形眼鏡佩戴液之情形時,係藉由在隱形眼鏡之佩戴時使隱形眼鏡與適量該佩戴液相接觸而使用。進而,於眼科組成物為隱形眼鏡保養用液劑之情形時,藉由以下等方式使用:將隱形眼鏡浸漬於適量之該保養用液劑中,或使隱形眼鏡接觸該保養用液劑並進行擦洗。於浸漬隱形眼鏡之情形時,浸漬時間通常只要為1分鐘以上即可,較佳為10分鐘以上,更佳為1小時以上,進而較佳為4小時以上。
<塑膠容器>
本實施形態之眼科組成物係收容於容器中而提供,該容器係與該眼科組成物相接觸之部分中之一部分或全部由塑膠所形成者(亦僅記載為「塑膠容器」)。
作為構成塑膠之聚合物,例如可列舉:聚對苯二甲酸乙二酯(PET)、聚對苯二甲酸丁二酯(PBT)、聚萘二甲酸乙二酯、聚芳酯、聚碳酸酯、聚乙烯(PE;高密度聚乙烯(HDPE)、低密度聚乙烯(LDPE))、聚丙烯(PP)、聚苯乙烯(PS)、丙烯腈-丁二烯-苯乙烯(ABS)、聚甲基戊烯(PMP)、聚醯亞胺、及構成該等之單體之共聚物、以及混合有該等兩種以上者。作為構成塑膠之聚合物,較佳為聚對苯二甲酸乙二酯(PET)、聚對苯二甲酸丁二酯(PBT)、聚乙烯(PE)、聚丙烯(PP),更佳為聚對苯二甲酸乙二酯(PET)、聚乙烯(PE)。又,塑膠可含有彈性體。
塑膠可含有穩定劑等添加劑。又,塑膠亦可為含有玻璃纖維等補強劑以進行強化而成者。
塑膠並未特別限制,可使用市售者。作為市售品,例如可列舉:聚對苯二甲酸乙二酯RT543C(Japan Unipet股份有限公司)、聚碳酸酯S-3000R(Mitsubishi Engineering-Plastics股份有限公司)、丙烯腈-丁二烯-苯乙烯150(Techno Polymer股份有限公司)、聚苯乙烯403R(PS Japan股份有限公司)、高密度聚乙烯HR120R(Japan Polyethylene股份有限公司)、低密度聚乙烯175K(Tosoh股份有限公司)、聚丙烯NLB340G(Japan Polypropylene股份有限公司)、彈性體AR830C(Aron Kasei股份有限公司)、Novaduran(註冊商標)5010R5(Mitsubishi Engineering-Plastics股份有限公司製造)、VALOX(註冊商標)315(SABIC Japan LLC)及VALOX(註冊商標)195(SABIC Japan LLC)。
作為收容眼科組成物之塑膠容器,例如有滴眼容器、洗眼液容器、隱形眼鏡佩戴液收容容器、隱形眼鏡保養用液收容容器(包含隱形眼鏡洗淨液收容容器、隱形眼鏡保存液收容容器、隱形眼鏡消毒液收容容器、隱形眼鏡多功能溶液收容容器等)等。收容眼科組成物之容器中之與眼科組成物相接觸之部分例如可列舉:中栓、開孔中栓、容器內表面(於容器由多層所構成之構造之情形時,為最內側之層)。
本實施形態之塑膠容器中,與眼科組成物相接觸之部分中之一部分或全部係由塑膠所形成。例如,於塑膠容器為具有開孔中栓(噴嘴)之容器之情形時,可僅開孔中栓部分由塑膠所形成,開孔中栓以外之收容部分等可由塑膠所形成,又,亦可整個容器由塑膠所形成。
本實施形態之塑膠容器只要與眼科組成物相接觸之部分中之一部分由塑膠所形成即可,但就更進一步顯著地發揮出本發明之效果之觀點而言,較佳為與眼科組成物相接觸之部分之全部由塑膠所形成。又,塑膠容器可由單獨一種塑膠所形成,亦可由兩種以上之塑膠所形成。例如,於塑膠容器為具有開孔中栓(噴嘴)之容器之情形時,可開孔中栓部分由例如含有聚乙烯(PE)之塑膠所形成,開孔中栓以外之收容部分等可由例如含有聚對苯二甲酸乙二酯(PET)之塑膠所形成。
作為收容本實施形態之眼科組成物之容器及容器注入口周邊部之較佳之組合,為聚對苯二甲酸乙二酯製容器與聚乙烯製容器注入口周邊部之組合,更佳為聚對苯二甲酸乙二酯製滴眼容器與聚乙烯製噴嘴之組合,尤佳為聚對苯二甲酸乙二酯製滴眼容器與低密度聚乙烯製噴嘴之組合。又,作為收容本實施形態之眼科組成物之容器及容器注入口周邊部之組合,亦較佳為聚對苯二甲酸乙二酯製容器與聚丙烯製噴嘴之組合、聚丙烯製容器與聚丙烯製噴嘴之組合。又,作為收容本實施形態之眼科組成物之容器及容器注入口周邊部之組合,亦較佳為聚乙烯製容器與聚乙烯製噴嘴之組合、或其一體成型之容器,其中低密度聚乙烯製容器與低密度聚乙烯製噴嘴之組合、或其一體成型之容器為佳。
塑膠容器之形狀及容量並無特別限定,只要根據用途適當加以設定即可。例如,於塑膠容器為收容滴眼劑或隱形眼鏡佩戴液之容器之情形時,例如容量可為0.1 mL以上且50 mL以下,較佳為2 mL以上且40 mL以下,更佳為4 mL以上且25 mL以下。又,若塑膠容器為收容洗眼劑或隱形眼鏡保養用液之容器,則例如容量可為40 mL以上且600 mL以下。又,若塑膠容器為收容洗眼劑或隱形眼鏡保養用液之容器,則作為另一態樣,例如容量可為5 mL以上且20 mL以下。
作為塑膠容器之種類,只要為眼科領域中通常使用之容器即可,具體而言,例如可為滴眼容器、洗眼液容器、隱形眼鏡佩戴液收容容器、隱形眼鏡保養用液收容容器(包含隱形眼鏡洗淨液收容容器、隱形眼鏡保存液收容容器、隱形眼鏡消毒液收容容器、隱形眼鏡多功能溶液收容容器等)。容器之種類較佳為滴眼容器、隱形眼鏡佩戴液收容容器、隱形眼鏡保養用液收容容器。
塑膠容器可為收容多次之使用量之多劑量型,亦可為收容單次之使用量之單位劑量型。
本實施形態之眼科組成物亦能夠以裝入塑膠容器中之眼科組成物之形式提供。又,本發明亦可視作於塑膠容器中收容有本發明之眼科組成物之眼科用製品(滴眼劑、洗眼劑、隱形眼鏡相關製品等)。
[2.對塑膠之潤濕之抑制]
本實施形態之眼科組成物抑制對塑膠之潤濕。因此,作為本發明之一實施形態,提供一種方法,係對眼科組成物賦予抑制對塑膠之潤濕的作用之方法,其包括向該眼科組成物摻合(A)選自由精胺酸及其鹽所組成之群中1種以上之步驟。
再者,關於本實施形態中之(A)成分之種類及含量等、其他成分之種類及含量等、眼科組成物之製劑形態及用途等,如[1.眼科組成物]中所說明。
[實施例]
以下,基於試驗例具體地說明本發明,但本發明並不限定於該等。
[試驗方法:動態接觸角(前進角)之測定方法]
使用接觸角量測器DM-501(協和界面科學股份有限公司製造),依照該接觸角量測器之擴張/收縮法之測定順序,測定各試驗液之動態接觸角(前進角)。動態接觸角(前進角)為固體與液體之界面進行運動時之接觸角。
具體而言,將表1所示之容器材質置於接觸角量測器之台上,將試驗液設置於分配器。於室溫下將試驗液之液滴1 μL滴加至容器材質上而呈半球狀著落。其次,迅速地使分配器之液體噴出部之前端於半球上部接觸液體。於該狀態下,以噴出速度6 μL/sec連續地噴出試驗液,自側面每0.1秒對液滴之形狀拍攝15次。為了使測定條件一致,於算出動態接觸角之變化率時成對之試驗液係使用同一容器材質,並於同一溫度條件下(室溫下)持續進行測定。
[表1]
容器材質 | 標準 |
聚對苯二甲酸乙二酯(PET) | 滴眼瓶(容量13 mL) |
低密度聚乙烯(LDPE) | 滴眼瓶(容量5 mL) |
高密度聚乙烯(HDPE) | 軟性隱形眼鏡用消毒劑用容器(容量500 mL) |
聚丙烯(PP) | 離心管(容量15 mL) |
丙烯腈-丁二烯-苯乙烯(ABS) | 方型容器(容量15 mL)(36×36×14 mm) |
聚對苯二甲酸丁二酯(PBT) | 板(50×50×2 mm) |
聚甲基戊烯(PMP) | 離心管(容量15 mL) |
其次,使用該接觸角量測器之分析軟體FAMAS,對各圖像求出左右之接觸角。此處,接觸角係指:自塑膠板之表面、試驗液及空氣之接觸點P拉至試驗液之切線與拉至塑膠板之表面之切線所成的角之中,包含試驗液之側之角。關於各液滴,接觸點P存在左右之2點。液滴隨著試驗液之噴出而擴散,隨之接觸角發生變化,繼而表現出大致固定之行為。因此,對各圖像算出左右之接觸角之平均值,依拍攝成圖像之順序將該平均值排列,於選擇連續之5個時,將該5個平均值之標準偏差最初達到2.0°以下時之最初的平均值(5個平均值之中最先拍攝到之圖像中之左右之接觸角的平均值)設為該測定中之動態接觸角之測定值。再者,關於所有試驗液,於標準偏差最初達到2.0°以下之後,未觀察到大於2.0°之標準偏差。於在液滴進行擴散之過程中接觸角未發生變化之情形時,亦依據上述基準獲得動態接觸角之測定值。
對各試驗液重複進行3次上述操作,將所獲得之3個測定值之平均值設為該試驗液之動態接觸角。3個測定值之標準偏差於所有試驗液中為2.0°以下。
[試驗例1:動態接觸角(前進角)之評價(1)]
藉由常法製備表2、3-1及3-2所示之各實施例之試驗液、及與各實施例對應之配方液。表2、3-1及3-2中之各成分之單位為w/v%。再者,所謂對應之配方液係自各實施例之試驗液之配方去除L-精胺酸,利用適量鹽酸及氫氧化鈉調整pH所得之配方(其餘部分為純化水)。例如,與實施例1-1之試驗液對應之配方液係含有硼酸0.05 w/v%之pH8.0之配方液。與實施例1-12之試驗液對應之配方液係含有硼酸0.1 w/v%及氯化鈉0.8 w/v%之pH5.0之配方液。再者,關於實施例1-6及實施例1-15,分別使用與實施例1-5及實施例1-14對應之配方液作為對應之配方液。
依據上述試驗方法所示之順序,對表1所示之容器材質,求出各實施例之試驗液及對應之配方液之動態接觸角(3個測定值之平均值)。繼而,藉由下述[式1],算出實施例之試驗液之動態接觸角相對於對應之配方液的變化率。所算出之結果係示於表2、3-1及3-2。
[式1]動態接觸角之變化率(%)={(實施例之試驗液之動態接觸角/對應之配方液之動態接觸角)-1}×100
又,關於實施例1-2、1-7、1-9、1-17、1-22及1-25之試驗液,於與對應之配方液一併進行熱處理後,供於動態接觸角之測定。熱處理係指將試驗液於製備後向10 mL容量玻璃製頂空小玻璃瓶中以5 mL逐漸填充,並於60℃下靜置13天,相當於在室溫下保管約3年之情形。其他試驗液係於製備後立即進行試驗。
[表2]
實施例 1-1 | 實施例 1-2 | 實施例 1-3 | 實施例 1-4 | 實施例 1-5 | 實施例 1-6 | 實施例 1-7 | 實施例 1-8 | 實施例 1-9 | 實施例 1-10 | 實施例 1-11 | 實施例 1-12 | 實施例 1-13 | |
L-精胺酸 | 0.5 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 3 | 1 | 0.5 | 1 |
硼酸 | 0.05 | - | - | - | 1 | 1 | 1 | - | - | 2 | 1 | 0.1 | - |
磷酸氫鈉 | - | - | - | 1 | - | - | - | - | - | - | - | - | - |
胺基丁三醇 | - | - | - | - | - | - | - | 1 | 1 | - | - | - | - |
乙二胺四乙酸鈉 | - | 0.1 | - | - | - | - | - | - | - | - | - | - | - |
單乙醇胺 | - | - | - | - | - | - | - | - | - | - | - | - | 1 |
氯化鈉 | - | - | - | - | - | - | - | - | - | - | - | 0.8 | - |
玻尿酸鈉 | - | - | - | - | - | 0.1 | - | - | - | - | - | - | - |
鹽酸 | 適量 | 適量 | 適量 | 適量 | 適量 | 適量 | 適量 | 適量 | 適量 | 適量 | 適量 | 適量 | 適量 |
氫氧化鈉 | 適量 | 適量 | 適量 | 適量 | 適量 | 適量 | 適量 | 適量 | 適量 | 適量 | 適量 | 適量 | 適量 |
純化水 | 其餘部分 | 其餘部分 | 其餘部分 | 其餘部分 | 其餘部分 | 其餘部分 | 其餘部分 | 其餘部分 | 其餘部分 | 其餘部分 | 其餘部分 | 其餘部分 | 其餘部分 |
pH | 8.0 | 7.0 | 7.0 | 7.0 | 7.0 | 7.0 | 7.0 | 7.0 | 7.0 | 5.0 | 7.0 | 5.0 | 7.0 |
滲透壓比 | 0.15 | 0.41 | 0.42 | 0.67 | 0.82 | 0.91 | 0.82 | 0.93 | 0.93 | 1.06 | 0.82 | 1.19 | 1.56 |
容器材質 | PET | PET | PET | PET | PET | PET | PET | PET | PET | PET | PP | PP | PP |
動態接觸角之變化率(%) | 4.1% | 5.6% | 6.7% | 8.2% | 14.1% | 17.0% | 8.0% | 9.7% | 5.2% | 10.3% | 4.8% | 7.3% | 6.6% |
[表3-1]
實施例 1-14 | 實施例 1-15 | 實施例 1-16 | 實施例 1-17 | 實施例 1-18 | 實施例 1-19 | 實施例 1-20 | 實施例 1-21 | 實施例 1-22 | 實施例 1-23 | 實施例 1-24 | 實施例 1-25 | 實施例 1-26 | |
L-精胺酸 | 1.5 | 1.5 | 1 | 1 | 1 | 0.5 | 1 | 1 | 1 | 2 | 0.05 | 1 | 0.01 |
硼酸 | 0.3 | 0.3 | - | - | - | 0.05 | - | - | - | - | 1 | - | - |
磷酸氫鈉 | - | - | - | - | - | - | - | 1 | - | - | - | 1 | - |
乙二胺四乙酸鈉 | - | - | - | - | - | - | 0.1 | - | - | - | - | - | - |
胺基丁三醇 | - | - | 1 | - | - | - | - | - | 1 | 0.06 | - | - | - |
檸檬酸 | - | - | - | - | - | - | - | - | - | - | - | - | 0.5 |
單乙醇胺 | - | - | - | 1 | - | - | - | - | - | - | - | - | - |
玻尿酸鈉 | - | 0.01 | - | - | - | - | - | - | - | - | - | - | - |
鹽酸 | 適量 | 適量 | 適量 | 適量 | 適量 | 適量 | 適量 | 適量 | 適量 | 適量 | 適量 | 適量 | 適量 |
氫氧化鈉 | 適量 | 適量 | 適量 | 適量 | 適量 | 適量 | 適量 | 適量 | 適量 | 適量 | 適量 | 適量 | 適量 |
純化水 | 其餘部分 | 其餘部分 | 其餘部分 | 其餘部分 | 其餘部分 | 其餘部分 | 其餘部分 | 其餘部分 | 其餘部分 | 其餘部分 | 其餘部分 | 其餘部分 | 其餘部分 |
pH | 7.0 | 7.0 | 7.0 | 7.0 | 7.0 | 8.0 | 7.0 | 7.0 | 7.0 | 8.5 | 7.0 | 7.0 | 6.0 |
滲透壓比 | 0.4 | 0.4 | 0.93 | 1.56 | 0.42 | 0.15 | 0.41 | 0.67 | 0.93 | 0.6 | 0.6 | 0.67 | 1.98 |
容器材質 | HDPE | HDPE | HDPE | HDPE | LDPE | LDPE | LDPE | LDPE | LDPE | PBT | PBT | ABS | PMP |
動態接觸角之變化率(%) | 2.3% | 5.7% | 7.7% | 7.7% | 5.6% | 2.1% | 6.8% | 9.0% | 10.8% | 6.5% | 7.7% | 10.7% | 9.6% |
[表3-2]
實施例 1-27 | 實施例 1-28 | |
L-精胺酸 | 1 | 0.8 |
2-胺基-2-甲基-1,3-丙二醇 | 0.7 | 0.4 |
鹽酸 | 適量 | 適量 |
氫氧化鈉 | 適量 | 適量 |
純化水 | 其餘部分 | 其餘部分 |
pH | 7.5 | 6.1 |
滲透壓比 | 0.66 | 0.47 |
容器材質 | HDPE | PET |
動態接觸角之變化率(%) | 7.8% | 5.4% |
如表2、3-1及3-2所示,於條件不同之任一試驗中均確認到,含有L-精胺酸之實施例之試驗液其動態接觸角較不含L-精胺酸之配方液之動態接觸角增大。即,明確含有(A)選自由精胺酸及其鹽所組成之群中1種以上之眼科組成物之動態接觸角增大,對塑膠容器之潤濕抑制作用提高。又,確認到除含有L-精胺酸以外,進而含有(C)成分之玻尿酸鈉之實施例1-6及1-15之試驗液其動態接觸角較不含玻尿酸鈉之與實施例1-5及1-14對應之配方液之動態接觸角增大。進而確認到,進行了熱處理之眼科組成物之動態接觸角亦增大,於長時間保管之情形時,亦可抑制對塑膠容器之潤濕。
[試驗例2:動態接觸角(前進角)之評價(2)]
藉由常用方法製備表4所示之各實施例之試驗液、及與各實施例對應之配方液。表4中之各成分之單位為w/v%。再者,所謂對應之配方液係指自各實施例之試驗液之配方去除L-精胺酸以外之成分,利用適量鹽酸及氫氧化鈉調整pH所得之配方(其餘部分為純化水)。例如,與實施例2-1之試驗液對應之配方液係含有L-精胺酸0.1 w/v%之pH7.5之配方液。與實施例2-3之試驗液對應之配方液係含有L-精胺酸0.08 w/v%之pH9.0之配方液。
依據上述試驗方法所示之順序,對表1所示之容器材質,求出各實施例之試驗液及對應之配方液之動態接觸角(3個測定值之平均值)。繼而,藉由上述[式1],算出實施例之試驗液之動態接觸角相對於對應之配方液的變化率。所算出之結果係示於表4。
[表4]
實施例 2-1 | 實施例 2-2 | 實施例 2-3 | 實施例 2-4 | 實施例 2-5 | 實施例 2-6 | 實施例 2-7 | 實施例 2-8 | 實旄例 2-9 | 實施例 2-10 | 實施例 2-11 | |
L-精胺酸 | 0.1 | 0.5 | 0.08 | 0.5 | 2 | 0.8 | 1 | 1 | 0.5 | 0.1 | 1 |
硼酸 | - | - | - | - | - | - | - | - | - | - | 1 |
羥基丙基甲基纖維素2910 | - | - | - | - | - | - | - | 5 | - | - | - |
羥基丙基甲基纖維素2906 | - | - | - | - | 0.01 | - | - | - | - | - | - |
硫酸軟骨素鈉 | 0.5 | - | - | - | - | - | - | - | - | - | - |
玻尿酸鈉 | - | - | - | 0.1 | - | - | 0.01 | - | - | - | - |
聚乙烯吡咯啶酮K30 | - | - | 3 | - | - | - | - | - | - | - | - |
羧基乙烯基聚合物 | - | - | - | - | - | - | - | - | - | 0.01 | - |
丙二醇 | - | - | - | - | - | 1.2 | - | - | - | - | - |
牛磺酸 | - | 1 | - | - | - | - | - | - | - | - | - |
甘胺酸 | - | - | - | - | - | - | - | - | 0.005 | - | - |
氯化鈉 | - | - | 1 | - | - | - | - | - | - | - | - |
甘油 | - | - | - | - | - | - | - | - | - | 2 | - |
鹽酸 | 適量 | 適量 | 適量 | 適量 | 適量 | 適量 | 適量 | 適量 | 適量 | 適量 | 適量 |
氫氧化鈉 | 適量 | 適量 | 適量 | 適量 | 適量 | 適量 | 適量 | 適量 | 適量 | 適量 | 適量 |
純化水 | 其餘部分 | 其餘部分 | 其餘部分 | 其餘部分 | 其餘部分 | 其餘部分 | 其餘部分 | 其餘部分 | 其餘部分 | 其餘部分 | 其餘部分 |
pH | 7.5 | 6.0 | 9.0 | 7.5 | 7.0 | 7.5 | 6.0 | 7.0 | 7.0 | 5.0 | 7.0 |
滲透壓比 | 0.06 | 0.45 | 1.2 | 0.19 | 0.7 | 0.82 | 0.349 | 0.4 | 0.24 | 0.83 | 0.82 |
容器材質 | PET | PET | PET | LDPE | LDPE | HDPE | PP | PP | PBT | PMP | PET |
動態接觸角之變化率(%) | 11.0% | 8.2% | 15.2% | 12.9% | 9.7% | 3.6% | 4.8% | 6.2% | 3.7% | 13.7% | 11.1% |
羥基丙基甲基纖維素2910:Metolose TC-5E(信越化學工業公司製造) 羥基丙基甲基纖維素2906:Metolose 65SH-4000(信越化學工業公司製造) 羧基乙烯基聚合物:Carbopol 980(CBC公司製造) 甘油:濃甘油(日局) |
如表4所示,確認到藉由含有(A)成分,並且進而含有選自由(B)緩衝劑、或(C)等張劑及(D)黏稠劑所組成之群中1種以上,動態接觸角進一步增大,對塑膠容器之潤濕抑制作用進一步提高。
[試驗例3:滴加量之偏差之評價]
藉由常用方法製備表6所示之各實施例及各比較例之試驗液。表6中之各成分之單位為w/v%。其次,於表5所示之容器中收容各試驗液。
[表5]
容器本體之材質 | 開孔中栓之材質 | 試驗液之收容量 | |
容器1 | PET(容量13 mL) | LDPE | 10 mL |
容器2 | HDPE(容量500 mL) | PP | 300 mL |
關於容器1,使開孔中栓大致垂直朝下地滴加,於滴加每1滴時測定滴加重量,並重複20次該操作。關於容器2,使開孔中栓大致朝向水平地滴加,於每滴加10滴時測定滴加重量,並重複10次該操作。於每測定1次滴加重量時,利用無絨織物(lint free)(小津產業公司製造)擦拭開孔中栓之外表面,以使開孔中栓之外表面不會殘留液體。其次,根據平均滴加量(AVG:mg)及標準偏差(SD:mg),藉由下述[式2],算出滴加量之偏差(變異係數CV:%)。
[式2]滴加量之偏差(CV:%)=(標準偏差(SD:mg)/平均滴加量(AVG:mg))×100
進而,使用下述[式3],算出實施例之滴加量之偏差相對於對應之比較例之改善率(%)。所算出之結果係示於表6。
[式3]實施例之滴加量之偏差相對於對應之比較例之改善率(%)=(實施例之滴加量之偏差/對應之比較例之滴加量之偏差)×100
再者,所謂對應之比較例,實施例3-1為比較例3-1,實施例3-2及3-3為比較例3-2,實施例3-4及3-5為比較例3-3。
[表6]
比較例 3-1 | 實施例 3-1 | 比較例 3-2 | 實施例 3-2 | 實施例 3-3 | 比較例 3-3 | 實施例 3-4 | 實施例 3-5 | |
L-精胺酸 | - | 1 | - | 1 | 1 | - | 0.1 | 0.1 |
硼酸 | - | - | 1 | 1 | 1 | - | - | - |
玻尿酸鈉 | - | - | - | - | 0.1 | - | - | - |
羧基乙烯基聚合物 | - | - | - | - | - | - | - | 0.05 |
鹽酸 | 適量 | 適量 | 適量 | 適量 | 適量 | 適量 | 適量 | 適量 |
氫氧化鈉 | 適量 | 適量 | 適量 | 適量 | 適量 | 適量 | 適量 | 適量 |
純化水 | 其餘部分 | 其餘部分 | 其餘部分 | 其餘部分 | 其餘部分 | 其餘部分 | 其餘部分 | 其餘部分 |
pH | 7.0 | 7.0 | 7.0 | 7.0 | 7.0 | 5.0 | 5.0 | 5.0 |
黏度(20℃,mPa・s) | - | 1.1 | - | 1.1 | 7.5 | - | 1.0 | 3.2 |
容器 | 容器1 | 容器1 | 容器1 | 容器1 | 容器1 | 容器2 | 容器2 | 容器2 |
滴加量之偏差相對於對應之比較例之改善率(%) | - | 25% | - | 15% | 28% | - | 4.3% | 17% |
羧基乙烯基聚合物:Carbopol 980(CBC公司製造) |
如表6所示,確認到與不含L-精胺酸之比較例之試驗液相比,於含有L-精胺酸之實施例之試驗液中,滴加量之偏差得到改善(實施例3-1、3-2及3-4)。又,確認到若添加L-精胺酸並且進而添加(C)成分之玻尿酸鈉或羧基乙烯基聚合物,則滴加量之偏差顯著地改善(實施例3-3及3-5)。
(眼科組成物製備與容器收容例)
藉由表7中所記載之配方製備製劑例1~10之眼科組成物。將各眼科組成物填充至表7所示之容器例1-1~1-4之含塑膠之容器本體中,於容器之開口部安裝表7所示之容器例1-1~1-4之含塑膠之開孔中栓或附有蓋之液體注出部。又,將各眼科組成物填充至表7所示之容器例2-1~2-2之含塑膠之容器本體及液體注出部中。容器例2-1~2-2為容器本體與液體注出部一體成型而成之容器。表中之數值之單位除表中有記載者以外,均為「w/v%」。
[表7]
製劑例1 | 製劑例2 | 製劑例3 | 製劑例4 | 製劑例5 | 製劑例6 | 製劑例7 | 製劑例8 | 製劑例9 | 製劑例10 | ||
鹽酸聚己雙胍 | 1 ppm | 1.5 ppm | - | - | - | 1.5 ppm | 1 ppm | - | - | - | |
阿來西定 | - | 3 ppm | 1.6 ppm | - | - | - | - | - | - | - | |
泊利氯銨 | 10 ppm | 3 ppm | 10 ppm | - | - | - | - | - | - | - | |
氯化苄烷銨 | - | - | - | 0.01 | 0.005 | - | - | 0.01 | 0.015 | 0.004 | |
氯丁醇 | - | - | - | - | - | 0.3 | - | - | - | - | |
鹽酸四氫唑啉 | - | - | - | 0.05 | - | - | - | 0.05 | - | - | |
鹽酸萘甲唑啉 | - | - | - | - | 0.003 | - | - | - | - | - | |
甲基硫酸新斯的明 | - | - | - | - | 0.005 | - | - | 0.005 | - | - | |
ε-胺基己酸 | - | - | - | 1 | - | 2 | - | 1 | - | - | |
尿囊素 | - | - | - | - | 0.3 | - | - | - | - | - | |
甘草酸二鉀 | - | - | - | 0.25 | - | 0.25 | - | 0.1 | 0.25 | 0.25 | |
硫酸鋅 | - | - | - | - | - | - | - | 0.05 | - | - | |
氯化黃連素 | - | - | - | - | 0.025 | - | - | - | - | - | |
薁磺酸鈉 | - | - | - | - | - | 0.02 | - | - | - | - | |
順丁烯二酸氯苯那敏 | - | - | - | 0.03 | 0.03 | 0.03 | - | - | - | - | |
鹽酸二苯胺 | - | - | - | - | - | - | - | 0.05 | - | - | |
鹽酸吡哆醇 | - | - | - | 0.1 | - | 0.1 | - | 0.1 | - | - | |
泛醇 | - | - | - | - | - | - | - | 0.05 | - | - | |
氰鈷胺素 | - | - | - | - | 0.02 | - | - | - | - | - | |
d-α-維生素E乙酸酯 | - | - | - | - | - | 0.05 | - | - | - | - | |
L-天冬胺酸鉀 | - | - | - | 0.5 | 1 | - | - | 1 | - | - | |
L-天冬胺酸鎂鉀 | - | - | - | - | - | - | 1 | - | - | - | |
硫酸軟骨素酯鈉 | - | - | - | 0.5 | 0.1 | - | 0.5 | 0.5 | 0.5 | 0.5 | |
玻尿酸鈉 | 0.015 | 0.01 | 0.015 | - | - | - | 0.02 | - | 0.1 | 0.1 | |
色甘酸鈉 | - | - | - | 1 | - | - | - | - | - | - | |
普拉洛芬 | - | - | - | 0.05 | - | - | - | - | - | - | |
瑞巴派特 | - | - | - | - | - | - | - | - | 2 | - | |
曲尼司特 | - | - | - | 0.5 | - | - | - | - | - | - | |
硼酸 | 0.6 | 0.4 | 0.8 | 1 | 0.3 | 1 | - | 0.4 | - | - | |
硼砂 | 0.1 | 0.05 | 0.2 | 0.2 | 0.1 | 0.2 | - | 0.1 | - | - | |
檸檬酸 | - | 0.3 | - | - | - | - | - | 0.1 | - | - | |
磷酸氫鈉 | - | - | - | - | 0.1 | - | 0.5 | - | - | - | |
磷酸二氫鈉 | - | - | - | - | 0.05 | - | 0.02 | - | - | - | |
氯化鈉 | 0.1 | 0.3 | 0.4 | - | 0.2 | - | 0.5 | - | - | - | |
氯化鉀 | 0.05 | 0.05 | 0.05 | - | - | - | 0.1 | - | - | - | |
乙二胺四乙酸鈉 | 0.01 | - | 0.1 | - | 0.1 | 0.05 | 0.05 | 0.05 | - | - | |
艾提壯酸 | - | 0.05 | - | - | - | - | - | - | - | - | |
薄荷腦 | - | 0.002 | - | 0.008 | 0.02 | - | 0.005 | 0.002 | - | - | |
樟腦 | - | - | - | 0.002 | 0.002 | - | 0.01 | 0.003 | - | - | |
冰片 | - | - | - | - | 0.005 | - | - | - | - | - | |
香葉草醇 | - | - | - | - | 0.005 | - | - | - | - | - | |
桉葉油 | - | - | - | 0.01 | 0.005 | - | - | - | - | - | |
香柑 | - | - | - | 0.001 | - | - | 0.005 | - | - | - | |
薄荷油 | - | - | - | 0.005 | - | - | - | - | - | - | |
L-精胺酸 | 1.3 | 0.7 | 0.5 | 0.5 | 0.7 | 0.1 | 1.5 | 0.3 | 0.5 | 0.7 | |
羥丙甲纖維素 | - | 0.05 | - | 0.1 | - | - | 0.3 | - | - | - | |
羥乙基纖維素 | - | - | - | - | - | 0.1 | - | - | - | - | |
羧基乙烯基聚合物 | - | - | - | - | 0.1 | - | - | - | - | - | |
聚乙烯醇 | - | - | - | - | - | - | 0.2 | - | - | - | |
甲基纖維素 | - | - | - | - | - | - | - | 0.1 | - | - | |
聚氧乙烯氫化蓖麻油 | 0.05 | 0.05 | 0.05 | 0.2 | 0.5 | - | 0.2 | 0.1 | - | - | |
Poloxamer407 | - | 0.05 | - | 0.1 | 0.1 | - | 0.1 | - | - | - | |
泊洛沙胺(Poloxamine) | - | 0.1 | - | - | - | - | - | - | - | - | |
聚離胺酸 | - | 0.01 | - | - | - | - | - | - | - | - | |
濃甘油 | - | - | - | - | - | - | 0.3 | - | - | - | |
芝麻油 | - | - | - | - | 0.07 | - | 0.05 | 0.01 | - | - | |
鹽酸 | 適量 | 適量 | 適量 | 適量 | 適量 | 適量 | 適量 | 適量 | 適量 | 適量 | |
氫氧化鈉 | 適量 | 適量 | 適量 | 適量 | 適量 | 適量 | 適量 | 適量 | 適量 | 適量 | |
純化水 | 其餘量 | 其餘量 | 其餘量 | 其餘量 | 其餘量 | 其餘量 | 其餘量 | 其餘量 | 其餘量 | 其餘量 | |
pH | 6.5 | 7.5 | 7 | 6.5 | 7.5 | 5.5 | 7 | 7 | 8 | 7.5 | |
容器例1-1 | 容器本體 | PET | PET | PET | PET | PET | PET | PET | PET | PET | PET |
開孔中栓或附有蓋之液體注出部 | PP | PP | PP | LDPE | LDPE | LDPE | LDPE | LDPE | LDPE | LDPE | |
容器例1-2 | 容器本體 | HDPE | HDPE | HDPE | PET | PET | PET | PET | PET | PET | PET |
開孔中栓或附有蓋之液體注出部 | PP | PP | PP | PBT | PBT | PBT | PBT | PBT | PBT | PBT | |
容器例1-3 | 容器本體 | - | - | - | PET | PET | PET | PET | PET | PET | PET |
開孔中栓或附有蓋之液體注出部 | - | - | - | PET | PET | PET | PET | PET | PET | PET | |
容器例1-4 | 容器本體 | HDPE | HDPE | HDPE | PP | - | - | - | PP | PP | - |
開孔中栓或附有蓋之液體注出部 | HDPE | HDPE | HDPE | LDPE | - | - | - | LDPE | LDPE | - | |
容器例2-1 | 容器本體及液體注出部 | LDPE | LDPE | LDPE | LDPE | LDPE | LDPE | LDPE | LDPE | LDPE | LDPE |
容器例2-2 | 容器本體及液體注出部 | PET | PET | PET | - | - | - | - | - | - | - |
無
無
Claims (4)
- 一種眼科組成物,係含有(A)選自由精胺酸及其鹽所組成之群中1種以上,該眼科組成物係隱形眼鏡保養用液劑,且收容於容器而成者,該容器係與該眼科組成物相接觸之部分中之一部分或全部由塑膠形成者。
- 如申請專利範圍第1項之眼科組成物,其進而含有(B)緩衝劑。
- 如申請專利範圍第1或2項之眼科組成物,其進而含有選自由(C)等張劑、及(D)黏稠劑所組成之群中之1種以上。
- 一種方法,係對眼科組成物賦予抑制潤濕塑膠之作用的方法,其包括於該眼科組成物摻合(A)選自由精胺酸及其鹽所組成之群中1種以上之步驟。
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