MO, SEI MYOUNG,모세명,LEE, YOU JIN,이유진,SONG, SE HYON,송세현
申请号：
KR1020120120982
公开号：
KR1020130048165A
申请日:
2012.10.30
申请国别(地区):
KR
年份:
2013
代理人:
摘要：
PURPOSE: A pharmaceutical composition containing entecavir with improved stability, and a method for manufacturing the same are provided to reduce the amount of impurity materials during a manufacturing process, and to stabilize an active ingredient which is instable to moisture.CONSTITUTION: A pharmaceutical composition contains entecavir and cyclodextrin and has improved stability for treating hepatitis B virus infection. The molar ratio of entecavir and cyclodextrin is 1:0.1 or more. A method for manufacturing the pharmaceutical composition comprises: a step of dissolving entecavir and cyclodextrin in a solvent and preparing a binding solution a step of adding an pharmaceutically acceptable excipient into a mixing device a step of adding the binding solution into the mixing device and making a granule a step of drying the granule a step of mixing the granule with the excipient and preparing a mixture and a step of forming the mixture in a tablet, a capsule, a powder, or a granule.COPYRIGHT KIPO 2013[Reference numerals] (AA) Total flexible material(ppm)본 발명은 안정성이 향상된 엔테카비어의 약학적 조성물 및 그 제조방법에 관 한 것으로, 엔테카비어와 사이클로덱스트린을 함유하는 안정성이 향상된 엔테카비어의 약학적 조성물 및 그 제조방법이 제공된다.
