动态浊度法检测细菌内毒素含量在重组铜绿假单胞菌外毒素A制备中的应用

发布时间：2018-04-30 22:09

本文选题：动态浊度法 + 细菌内毒素　；参考：《中国新药杂志》2016年22期

【摘要】：目的:应用动态浊度法监测重组铜绿假单胞菌外毒素A(r EPA)制备各阶段料液中的细菌内毒素含量,为其工艺优化和质量控制提供依据。方法:参考应用《中华人民共和国药典》2015年版三部载录的动态浊度法测定细菌内毒素含量,对该方法的专属性、精密度、重现性、准确性和标准曲线的可靠性进行了验证,并将该方法应用于r EPA制备各阶段料液中细菌内毒素含量的测定及细菌内毒素去除效果的评价。结果:该方法具有较好的专属性、精密度、重现性、准确性。结论:经方法验证显示该方法的专属性、精密度、重现性、准确性等技术参数达到了相关验证要求,结果稳定可靠。现有r EPA制备工艺能稳定、有效地去除细菌内毒素,纯化后r EPA中细菌内毒素含量较低。本研究为r EPA制备过程中细菌内毒素去除效果的评价提供了准确的参考数据。
[Abstract]:Objective: to monitor the content of bacterial endotoxin in the preparation of recombinant Pseudomonas aeruginosa exotoxin ar EPA by dynamic turbidimetric method, and to provide a basis for the optimization of its process and quality control. Methods: the bacterial endotoxin content was determined by the dynamic turbidimetric method published in the 2015 edition of the Chinese Pharmacopoeia. The specificity, precision, reproducibility, accuracy and reliability of the standard curve of the method were verified. The method was applied to the determination of bacterial endotoxin content and the evaluation of the removal effect of bacterial endotoxin in every phase of the preparation of r EPA. Results: this method has good specificity, precision, reproducibility and accuracy. Conclusion: the specificity, precision, reproducibility, accuracy and other technical parameters of the method are proved to meet the requirements of relevant verification, and the results are stable and reliable. The existing preparation process of r EPA was stable and effective in removing bacterial endotoxin. The content of bacterial endotoxin in r EPA was low after purification. This study provides accurate reference data for evaluating the removal of bacterial endotoxin during the preparation of r EPA.
【作者单位】：兰州生物制品研究所有限责任公司;
【基金】：国家“重大新药创制”科技重大专项疫苗综合性大平台(2013ZX09402302-212)
【分类号】：R927.1

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