固定化ヒスチジンを用いたエンドトキシン特異定量法の生物学的製剤への応用

摘要

The immobilized L-histidine PyroSep (PS) was shown to be useful for determination of endotoxin in biological products with high precision. This method eliminated the erroneous results which occur with the conventional method using the Limulus reagents QCL-1000 and Endospecy. The recovery of spiked endotoxin by the PS method using both Limulus reageuts were 100+-25% in all human serum albumin products. In immunoglobulin products diluted sixteen-fold, endotoxin recovery by the PS method was satisfactory whereas that by the conventional method was not. In the conventional method, endotoxin content in Factor VIII coagulation products cannot be determined by both Limulus reagents because of its inhibitory effect in the presence of Endospecy and accelerating effect in the presence of QCL-1000. In contrast, the PS method gave recovery of endotoxin at nearly 100% with both Limulus reagents. Endotoxin content in anti-coagulation factor ATIII products could not be determined by conventional method due to a severe inhibitory effect, but could be done in most of these products by the PS method. In some natural- and recombinant-type interferon products, endotoxin content was not well determined by the conventional method but could be determined by the PS method.