ENOXAPARINSODIUM,EP표준

개요Enoxaparin sodium is the sodium salt of a low-molecular-mass heparin that is obtained by alkaline depolymerisation of the benzyl ester derivative of heparin from porcine intestinal mucosa. Enoxaparin sodium is an antithrombotic agent (ATC code B01AB05) characterized by a higher ratio of antithrombotic activity to anticoagulant activity compared to unfractionated heparin.Specifically, Enoxaparin sodium as the sodium salt of depolymerized Heparin is subject to characteristic structural modifications from the effects of the depolymerization reaction. Characteristic structures such as partial transformation of glucosamines into mannosamines, formation of 1,6-anydro derivatives and 2,3 epoxide residues with subsequent conversion to galacturonic acid and the change in the proportion of the sulfated and non-sulfated residues are some of the changes that constitute Enoxaparin a structurally difficult to characterize molecule. As such no single technique or parameter is adequate to fully characterize the Enoxaparin molecule as part of a biosimilarity exercise against the reference.

용도Enoxaparin is marketed under the brand name Lovenox and as a generic drug under the name enoxaparin sodium for injection.Enoxaparin sodium is intended for use in the treatment of deep vein thrombosis; prophylaxis of ischemic complications of unstable angina and non-Q-wave myocardial infarction, and treatment of acute deep vein thrombosis.