ORAL COMPLEX COMPOSITION COMPRISING OMEGA-3 FATTY ACID ESTER AND HMG-COA REDUCTASE INHIBITOR

摘要

PURPOSE: An oral complex composition containing omega-3 fatty acid ester and HMG-CoA reductase inhibitor and a method for manufacturing the same are provided to enhance blood HDL level and lower TG level and to ensure storage stability. CONSTITUTION: An oral complex composition contains: a soft capsule core containing omega-3 fatty acid ester; a first coating layer which is coated on the core and contains functional coating substrates; a second coating layer which is formed on the surface of the first coating layer and contains rosuvastatin or pharmaceutically acceptable salts and polyvinyl alcohol, polyvinyl alcohol-polyethylene glycol graft polymers or a mixture thereof. The functional coating substrate is cellulose acetate, polyvinyl acetate, ethyl cellulose, (meth)acrylate copolymers or a mixture thereof. [Reference numerals] (AA) Elution change of rosuvastatin; (BB) Elution rate(%); (CC) Crestor; (DD) Comparative embodiment 2; (EE) Comparative embodiment 4; (FF) Comparative embodiment 5; (GG) Comparative embodiment 6; (HH) Embodiment 8; (II) Embodiment 9; (JJ) Embodiment 10; (KK) Embodiment 11; (LL) Embodiment 12; (MM) Initial phase(10 minutes); (NN) Six month later (10 minutes)