重组C因子法检测4种生物制剂中细菌内毒素的方法学研究

Investigation on test for bacterial endotoxins using recombinant factor C in 4 biological agents for detection of bacterial endotoxin

目的:考察重组C因子法对生物制剂适用性,建立该方法检测细菌内毒素的质量标准。方法:选取2种代表性的生物重组制剂和2种单克隆抗体制剂,进行重组C因子干扰试验,并用原标准规定的细菌内毒素检查法进行对比实验。按照《中国药典》2020年版四部附录1143细菌内毒素检查法干扰试验的规定,与原检测法的结果进行对比。结果:4种生物制剂回收率均在《中国药典》规定的50%~200%范围内,符合药典规定,并与原实验结果一致。结论:本研究为重组C因子检测生物制剂中的细菌内毒素的方法学和标准的建立提供了实验依据。

Objective:To investigate the applicability of the test for bacterial endotoxins using recombinant factor C in biological agents.To establish the quality standards for the assay of bacterial endotoxins accordingly by investigating of the applicability of bacterial endotoxins test using recombinant factor C.Methods:Two representative recombinant preparations and two monoclonal antibodies were selected for interference test by test for bacterial endotoxins using recombinant factor C,the results were compared with bacteria endotoxin test original standards are regulated.The results of bacterial endotoxin test were compared with those of the original test in accordance with the provisions of Appendix 1143 of the Chinese Pharmacopoeia 2020 Vol Ⅳ.Results:The recoveries of all the biological agents were in the range of 50%-200%,which in line with the requirements of the Chinese Pharmacopoeia.Compared to the original method,there was no significant difference.Conclusion:The method on test for bacterial endotoxins using recombinant factor C provides experimental basis for establishment of methodology and standards for endotoxins in biological agents.