KIM, YONG IL,金用镒,金用鎰,NA, YOUNG JUN,罗荣俊,羅榮俊,CHOI, JUN YOUNG,崔俊荣,崔俊榮,KIM, MIN JUNG,金珉贞,金珉貞,PARK, JAE HYUN,朴宰贤,朴宰賢,WOO, JONG SOO,禹锺守,禹鍾守
申请号：
TW100146810
公开号：
TW201306878A
申请日:
2011.12.16
申请国别(地区):
TW
年份:
2013
代理人:
摘要：
Provided is a pharmaceutical composite formulation for preventing or treating cardiovascular diseases, which comprises (1) a first particle comprising an HMG-CoA reductase inhibitor and a basic additive and (2) a second particle comprising a core containing aspirin and an enteric coating layer coated on said core, wherein the difference in the average diameters of said first and second particles is 100 μm to 800 μm a method for preparing same and a method of validating the quality of same. The pharmaceutical composite formulation according to the present invention can improve the stability of an active ingredient and prevent adverse impacts between the active ingredients to thereby enable an accurate quality validation of the pharmaceutical composite formulation.提供用於預防或治療心血管疾病之一種藥學複合調配物,其包含(1)包含一種HMG-CoA還原酶抑制劑與一種鹼性添加劑之第一顆粒;及(2)包括含有阿斯匹靈的一核心及塗佈在該核心上的一腸溶衣層之第二顆粒,其中該第一與第二顆粒的平均直徑之差異為100微米至800微米;其一種製備方法;及驗證其品質之一種方法。如本發明之藥學複合調配物可提高一有效成分的安定性及避免有效成分之間的不良影響,從而促成該藥學複合調配物之精確的品質驗證。
