SHIN DONG YEOP,신동엽,KIM HU SEONG,김후성,LEE GEUN HYEOG,이근혁,KIM KYUNG JOON,김경준,CHO YUN SEOK,조윤석,O MI JIN,오미진,KIM MI JUNG,김미정
申请号：
KR1020180024470
公开号：
KR1020190103710A
申请日:
2018.02.28
申请国别(地区):
KR
年份:
2019
代理人:
摘要：
The present invention provides a solution type eye drop preparation which has a pH value of 4.0 to 5.0 and comprises, in an aqueous medium: (2R,3R,4S)-6-amino-4-[N-(4-chlorophenyl)-N-(1H-imidazole-2-ilmethyl)amino]-3-hydroxy-2-methyl-2-dimethoxymethyl-3,4-dihydro-2H-1-benzopyran or pharmaceutically acceptable salts thereof； propylene glycol as a stabilizer； and a pH adjusting agent. According to the present invention, the eye drop preparation not only comprises (2R,3R,4S)-6-amino-4-[N-(4-chlorophenyl)-N-(1H-imidazole-2-ilmethyl)amino]-3-hydroxy-2-methyl-2-dimethoxymethyl-3,4-dihydro-2H-1-benzopyran or pharmaceutically acceptable salts thereof at high concentrations, but also has excellent stability. Further, a pharmaceutical composition for preventing or treating macular degeneration can be stored for a long period of time.본 발명은 수성 매질 중에 (2R,3R,4S)-6-아미노-4-[N-(4-클로로페닐)-N-(1H-이미다졸-2-일메틸)아미노]-3-하이드록시-2-메틸-2-다이메톡시메틸-3,4-다이하이드로-2H-1-벤조피란 또는 이의 약학적으로 허용가능한 염； 안정화제로서 프로필렌글리콜； 및 pH 조절제를 포함하고, 4.0 ∼ 5.0의 pH를 갖는, 용액 형태의 점안제를 제공한다. 본 발명의 점안제는 (2R,3R,4S)-6-아미노-4-[N-(4-클로로페닐)-N-(1H-이미다졸-2-일메틸)아미노]-3-하이드록시-2-메틸-2-다이메톡시메틸-3,4-다이하이드로-2H-1-벤조피란 또는 이의 약학적으로 허용가능한 염을 고농도로 함유할 수 있을 뿐만 아니라 우수한 안정성을 갖는다. 또한, 본 발명에 따른 황반변성의 예방 또는 치료를 위한 의약품은 장기간 동안 보관이 가능하다.
