Feasibility of Detecting Bacterial Endotoxins in Low Molecular Weight Heparins Calcium Injection by TAL / 中国药房

ABSTRACT

OBJECTIVE:To explore the feasibility of detecting bacterial endoxins in low molecular weight heparins calcium injection LMWHC by tachypleus amebocyte lysate(TAL).METHODS:Bacterial endotoxins in samples were detected qualita?tively and quantitatively by kinetic turbidimetric assay and gel-clot method.RESULTS:Diluted to the concentration of25IU/ml,LMWHC had an obvious interference action to the TAL test,while not at the concentration of12.5IU/ml.The contents of bacterial endotoxins in all samples were less than0.01EU/IU.CONCLUSION:It is feasible to detect bacterial endotoxins in LMWHC by TAL test.