文章摘要
王信,高蕾.应用LAL动态浊度法测定复方苦参注射液中细菌内毒素含量[J].中国药品标准,2017,18(6):461-464
应用LAL动态浊度法测定复方苦参注射液中细菌内毒素含量
Application of the Turbidimetric-Kinetic Method Using LAL for the Measurement of Endotoxin in Composite Radix Sophora Flavescentis Injection
投稿时间:2017-11-17  修订日期:2018-01-04
DOI:
中文关键词: 复方苦参注射液  细菌内毒素  动态浊度法  干扰试验  美洲鲎试剂
英文关键词: Composite Radix Sophora Flavescentis Injection  Bacterial endotoxin  Turbidimetric-Kinetic method  Interfere factors test  LAL
基金项目:
作者单位E-mail
王信 国家食品药品监督管理总局高级研修学院 748794962@qq.com;wx@cfdaied.org 
高蕾 科德角国际生物医学科技(北京)有限公司 gao12001@163.com 
摘要点击次数: 204
全文下载次数: 107
中文摘要:
      目的:建立应用美洲鲎试剂LAL的动态浊度法定量检测复方苦参注射液中细菌内毒素试验方法。方法:采用《中国药典》2015年版(四部)中的细菌内毒素检查法。结果:复方苦参注射液用细菌内毒素定量法检测无干扰因素影响,内毒素回收率在50%~200%范围内。结论:使用LAL进行动态浊度法定量检测复方苦参注射液的细菌内毒素是可行的,可用细菌内毒素方法代替兔热原检查法,同时又避免了限量法内毒素检测时的干扰。
英文摘要:
      Objective To develop an assay for determination of bacterial endotoxin (BET) using LAL in Composite Radix Sophora Flavescentis Injection. Methods BET was determinated by turbidimetric-kinetic method. Results: The content in Composite Radix Sophora Flavescentis Injection did not interfere with the quantitation of BET. The recovery of BET was between 50% and 200%.Conclusion: The method using LAL is proved to be suitable for determination of the BET in Composite Radix Sophora Flavescentis Injection and could be used as an alternative for the rabbit pyrogen test to the injection.
  查看/发表评论  下载PDF阅读器
关闭