微量动态显色法检测奥拉西坦注射液中细菌内毒素含量  

Detection of Bacterial Endotoxin Content in Oxiracetam Injection by Using Micro-kinetic Chromogenic Method

作　　者：杨海燕[1] 周继春[1] 张军霞[1] 宋汉敏[1] 张婷婷[1] 郭兴辉[1] Yang Haiyan;Zhou Jichun;Zhang Junxia;Song Hanmin;Zhang Tingting;Guo Xinghui(Henan Provincial Insititute for Food and Drug Control,Zhengzhou,450003,China)

机构地区：[1]河南省食品药品检验所,郑州450003

出　　处：《中国药事》2020年第5期596-601,共6页Chinese Pharmaceutical Affairs

摘　　要：目的:应用微量动态显色法对奥拉西坦注射液进行细菌内毒素定量检测,并与凝胶法结果比较。方法:采用微量动态显色法鲎试剂对奥拉西坦注射液进行干扰试验,采用凝胶法鲎试剂对奥拉西坦注射液进行细菌内毒素检查。结果:本品在终浓度为40 mg·mL-1及以下浓度时对微量动态显色法鲎试剂与细菌内毒素的凝集反应无干扰作用,回收率在50%~200%之间,检测结果与凝胶法一致。结论:本品可采用微量动态显色法定量检测细菌内毒素含量,进行质量控制。Objective: To quantitatively detect the bacterial endotoxins in Oxiracetam injection by using the micro-keinetic chromogenic method and compare the results with those of the gel-clot method. Methods: The micro-keinetic chromogenic tachypleus amebocyte lysate was used in the interference test for Oxiracetam injection while the gel-clot method tachypleus amebocyte lysate was used to detect the bacterial endotoxins. Results: When the final concentration of Oxiracetam injection was at or below 40 mg·mL-1, no interference of the micro-keinetic chromogenic tachypleus amebocyte lysate and the agglutination reaction of bacterial endotoxin were found, with the recovery rates between 50% and 200%. The results were consistent with those of the gel-clot method. Conclusion: Micro-keinetic chromogenic method for quantitatively detecting the bacterial endotoxin can be adopted in the quality control of Oxiracetam injection.

关 键 词：奥拉西坦注射液 微量动态显色法 内毒素定量检测 凝胶法 显色基质 

分 类 号：R927.1[医药卫生—药学]