重组C因子法用于维生素B_(6)注射液细菌内毒素检测的研究  

Study on the Detection of Bacterial Endotoxin in Vitamin B_(6) Injection by Recombinant Factor C Method

作　　者：洪颖 翁鹭娜 盖雅婷 林丽花 HONG Ying;WENG Luna;GAI Yating;LIN Lihua(Xiamen Institute for Food and Drug Quality Control,Fujian Xiamen 361000,China)

机构地区：[1]厦门市食品药品质量检验研究院,福建厦门361000

出　　处：《中国医药导刊》2023年第10期1008-1013,共6页Chinese Journal of Medicinal Guide

基　　金：厦门市市场监督管理局科技项目(项目编号:XMSJ202116;项目名称:重组C因子法用于药品检验中内毒素检查的研究)。

摘　　要：目的:探讨重组C因子法用于维生素B_(6)注射液中细菌内毒素检测的可行性。方法:分别使用凝胶法和重组C因子法对维生素B_(6)注射液中细菌内毒素的检测进行方法学研究。结果:凝胶法干扰试验结果显示,不同厂家生产的维生素B_(6)注射液,以及使用不同厂家的鲎试剂,干扰试验结果差异较大。重组C因子法用于维生素B_(6)注射液细菌内毒素检测的结果显示,样品稀释50~400倍时,回收率均符合规定。结论:使用凝胶法对维生素B_(6)注射液中的细菌内毒素进行检测可能存在较大干扰;经过方法学研究,重组C因子法可以用于维生素B_(6)注射液中细菌内毒素的检测。Objective:To investigate the feasibility of adopting recombinant factor C method for the detection of bacterial endotoxin in vitamin B_(6) injection.Methods:The methodological study for the detection of bacterial endotoxin in vitamin B_(6) injection was carried out by gel-colt method and recombinant factor C method.Results:The interference test of gel-colt method showed that the results of vitamin B_(6) injections produced by different manufacturers and limulus agent from different manufacturers were quite different.The test results of recombinant factor C method for the detection of bacterial endotoxin in vitamin B_(6) injection showed that the recovery rate was compliance with the standards when the sample was diluted 50-400 times.Conclusion:The gel-colt method for the detection of bacterial endotoxin in vitamin B_(6) injection may have interference.The result of methodological research showed that recombinant factor C method can be used for the detection of bacterial endotoxin in vitamin B_(6).

关 键 词：维生素B_(6)注射液 细菌内毒素 重组C因子法 干扰试验 

分 类 号：R927.1[医药卫生—药学]