采用鲎试剂检查低分子量肝素钙注射液中细菌内毒素的可行性研究

Feasibility of Detecting Bacterial Endotoxins in Low Molecular Weight Heparins Calcium Injection by TAL

目的:探讨采用鲎试剂法对低分子量肝素钙注射液进行细菌内毒素检查的可行性。方法:采用动态浊度法和凝胶法,通过干扰试验,对样品中的细菌内毒素进行定性和定量检测。结果:将样品中低分子量肝素钙含量稀释至25I U/ml时对鲎试验检查有明显的干扰作用,而稀释至12·5I U/ml时则无干扰作用,样品中细菌内毒素的含量均小于0·01EU/I U。结论:本文建立的低分子量肝素钙注射液细菌内毒素检查法可行。

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 qualitatively and quantitatively by kinetic turbidimetric assay and gel- clot method. RESULTS： Diluted to the concentration of 25IU/ ml, LMWHC had an obvious interference action to the TAL test, while not at the concentration of 12.5IU/ml. The contents of bacterial endotoxins in all samples were less than 0.01EU/ IU,CONCLUSION： It is feasible to detect bacterial endotoxins in LMWHC by TAL test.