Abstract
Most heparin originates in China. Although the FDA has implemented stringent analytical and biological stipulations, there are still differences in the biologic actions of these drugs. The purpose of this study was to compare six batches of UFH from a single Chinese supplier to demonstrate any potential differences among these agents. All heparins were profiled for molecular weight using a HPLC. Anticoagulant activity was measured using whole blood activated clotting time (ACT) and plasma based assays (PT, aPTT, Heptest, TT, anti‐Xa and IIa activities). All heparin preparations had a comparable molecular weight (15.8 to 17.3 kDa). In the PT and TT assays no differences were noted in the six agents, however in the Heptest assay, one heparin showed markedly weaker activity than the other products. In the aPTT assay marked differences among agents were observed. Amidolytic anti‐IIa activities and anti‐Xa activity were comparable; IC50 values ranged from 1.4 to 1.9 μg/ml and 1.6 to 2.2 μg/ml for the anti‐IIa and anti‐Xa, respectively. These results showed that while all of the heparins had comparable molecular profiles; the anticoagulant activity of these preparations varied in some assays. While the differences were minimal in the anti‐Xa and anti‐IIa assays, marked differences were noted in the aPTT and ACT. Thus, there is a need for additional testing to compare heparin preparation to assure minimal batch variations.
Published Version
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