PHARMACEUTICAL COMPOSITE FORMULATION COMPRISING HMG-COA REDUCTASE INHIBITOR AND ASPIRIN

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.