重组C因子检测银杏叶提取物注射液细菌内毒素的方法学研究  

Investigation on the applicability of bacterial endotoxins test using recombinant factor C in extract of Ginkgo biloba leaves injection for detection of bacterial endotoxin

作　　者：王文佳[1] 江世杰 何华虹 李薇[1] WANG Wenjia;JIANG Shijie;HE Huahong;LI Wei(Guangzhou Institute for Drug Control,Guangzhou 510160,China)

机构地区：[1]广州市药品检验所,广州510160

出　　处：《中国药品标准》2023年第6期601-604,共4页Drug Standards of China

基　　金：广州市市场监督管理局科技项目(2021kj38)。

摘　　要：目的:建立银杏叶提取物注射液的重组C因子细菌内毒素检测方法。方法:使用重组C因子法进行细菌内毒素方法学研究,并用鲎试剂动态显色法、家兔法对银杏叶提取物注射液进行对比研究。结果:金纳多注射液稀释至400倍及以下浓度进行试验,回收率均在《中国药典》规定的50%~200%范围内,符合药典规定,并与动态显色法和热原法结果一致。结论:本研究为重组C因子检测中药注射液细菌内毒素的方法学和标准的建立提供了实验依据。Objective:To establish bacterial endotoxins test using recombinant factor C on the extract of Ginkgo biloba leaves injection.Methods:The bacterial endotoxins test using recombinant factor C was used on extract of Ginkgo biloba leaves injection.The results of KCA and rabbits pyrogen test of were compared with bacterial endotoxins test using recombinant factor C.Results:When Ginkgo biloba extract injection was diluted at 400 times or higher,the recovery rate was within the range of 50% to 200% specified in the Chinese pharmacopoeia.The recovery rate meets the requirements of the pharmacopoeia.The test results were consistent with the results of Kinetic chromogenic assay(KCA) and pyrogen method.Conclusion:This study provides experimental basis for the establishment of methodology and standards for the detection of bacterial endotoxins using recombinant factor C in traditional Chinese medicine injections.

关 键 词：重组C因子 质量标准 细菌内毒素 热原 中药注射剂 银杏叶提取物注射液 

分 类 号：R921.2[医药卫生—药学]