Limulus reagents are widely used to detect bacterial endotoxins in pharmaceutical products,but the production of limulus reagents is restricted due to the scarcity of limulus resources.As a substitute for limulus reagents,recombinant limulus C factor(rFC)can be obtained by gene engineering and can specifically detect endotoxins without dependence on animal resources.The study reviews the detection mechanism,development history and pharmacopoeia approval of rFC.Studies have shown that rFC method has the advantages of strong specificity and independent of animal resources,and has been gradually recognized by pharmacopoeia as a reliable solution to solve the shortage of limulus reagents.It has important application prospects.
关键词
鲎C因子/基因工程/鲎试剂/药典
Key words
Limulus C factor/Genetic engineering/Tachypleus Amebocyte Lysate/Pharmacopeia
维普
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