KIM, YONG IL,김용일,KIM, KYEONG SOO,김경수,PARK, SEUNG JAE,박승재,PARK, JAE HYUN,박재현,WOO, JONG SOO,우종수
申请号：
KR1020110146867
公开号：
KR1020130078101A
申请日:
2011.12.30
申请国别(地区):
KR
年份:
2013
代理人:
摘要：
PURPOSE: A fixed-dose combination formulation containing losartan, amlodipine, and hydrochlorothiazide with excellent release rate and stability for preventing or treating cardiovascular diseases is provided to minimize side effects and to prevent or treat cardiovascular diseases with product stability.CONSTITUTION: A fixed-dose combination formulation for preventing or treating cardiovascualr diseases contains losartan or a pharmaceutically acceptable salt thereof amlodipine or a pharmaceutically acceptable salt thereof and hydrochlorothiazide. Each active ingredient is separately filled in a capsule. A method for manufacturing the fixed-dose combination formulation comprises the steps of: mixing or granulating losartan or the pharmaceutically acceptable salt, and a pharmaceutically acceptable excipient, and tableting to obtain a losartan tablet part mixing or granulating amlodipine or the pharmaceutically acceptable salt, and a pharmaceutically acceptable excipient, and tableting to obtain an amlodipine tablet part mixing or granulating hydrochlorothiazide and a pharmaceutically acceptable excipient, and tableting to obtain a hydrochlorothiazide tablet part and filling same soft capsules with each tablet part.COPYRIGHT KIPO 2013[Reference numerals] (AA) Losartan tablet (BB) Amlodipine tablet (CC) Hydrochlorothiazide tablet본 발명은 용출률 및 안정성이 우수한, 로자탄, 암로디핀 및 히드로클로로티아자이드를 포함하는 심혈관계 질환의 예방 또는 치료용 고정 용량 조합 제형에 관한 것으로서, 본 발명에 따른 고정 용량 조합 제형은 기존 단일 제제 및 복합제에 비해 부작용을 최소화시킬 수 있으며, 용출률이 우수하여 각 단일제품과 생물학적으로 동등하거나 더 뛰어날 뿐 아니라 경시변화에 따른 제품 안정성이 우수하여, 심혈관계 질환의 예방 또는 치료에 유용하게 사용될 수 있다.
