KIM, YONG IL,김용일,KWON, YEONG JIN,권용진,SEO, DONG WOO,서동우,PARK HYUNG MIN,박형민,PARK, JAE HYUN,박재현,WOO, JONG SOO,우종수
申请号：
KR1020110146897
公开号：
KR1020130078123A
申请日:
2011.12.30
申请国别(地区):
KR
年份:
2013
代理人:
摘要：
PURPOSE: A method for manufacturing a stable pharmaceutical composition containing eperisone or a pharmaceutically acceptable salt thereof is provided to suppress generation of related compounds from eperisone, and to maintain the content of an active ingredient through dry-granulation without a solvent.CONSTITUTION: A method for manufacturing a pharmaceutical composition comprises the steps of: mixing eperisone or a pharmaceutically acceptable salt thereof, and a pharmaceutically acceptable excipient in a blender without a solvent and dry-granulating the mixture by compression molding and crush-granulating. Eperisone or the pharmaceutically acceptable salt is eperisone hydrochloride. The pharmaceutical composition contains 10-70 wt% of eperisone or the pharmaceutically acceptable salt. The pharmaceutically acceptable excipient is a combination of a dispersing agent, a disintegrant, and a binder. The dispersing agent is selected from the group consisting of lactose, microcrystalline cellulose, mannitol, and a mixture thereof.COPYRIGHT KIPO 2013[Reference numerals] (AA) Severe condition-1 (BB,GG) Related compound 1 (CC,HH) Example 1 (DD,II) Comparative example 1 (EE,JJ) Comparative example 2 (FF) Severe condition-2본 발명은 에페리손 또는 이의 약학적으로 허용 가능한 염을 포함하는 안정한 약학 조성물의 제조 방법 및 이에 의해 제조된 약학 조성물에 관한 것으로서, 본 발명의 제조방법에 따르면 용매의 존재 없이 건식 과립화하여 에페리손 함유 약학 조성물을 제조함으로써 에페리손에서 기인하는 유연물질의 생성을 억제하고 활성성분의 함량을 유지할 수 있어 안정성이 우수한 약학 조성물을 제조할 수 있다.
