摘要
目的建立硫酸长春新碱的细菌内毒素检验方法。方法按照《中国药典》2010年版二部附录ⅪE细菌内毒素检查法,分别用2个厂家鲎试剂对3批硫酸长春新碱进行了干扰试验和细菌内毒素检查。结果在供试品稀释法检测中,浓度为0.00104 mg/m L的硫酸长春新碱对湛江安度斯和博康海洋有限公司生产的鲎试剂与细菌内毒素反应无干扰,使用0.03 EU/m L的鲎试剂可对硫酸长春新碱进行细菌内毒素检查。在p H调节法中,硫酸长春新碱用1 mol/m L氢氧化钠调节p H值至7.0后,对鲎试剂与内毒素反应最大不干扰浓度为0.00417 mg/m L,使用0.125EU/m L或灵敏度更高的鲎试剂可对硫酸长春新碱进行细菌内毒素检查。结论细菌内毒素检查法适用于硫酸长春新碱的检查。
Objective To establish the bacterial endotoxins determination method for the vincristine sulfate. Method According to Chinese Pharmacopeia 2010 edition Vol Ⅱ Appendix Ⅺ E, the interference test and bacterial endotoxin test of 3 batches of vincristine sulfate were carried out, using tachypleus amebocyte from 2 different companies. Result With dilution method, maximum non-disturb concentration of vincristine sulfate for bacterial endotoxins test was 0. 00104 mg/mL for Zhanjiang A＆C Biological Ltd and Bokang Marine Biological Co Ltd. With pH modulation method, after adding 1 mol/mL sodium hydroxide to adjust pH of the sample to 7.0, maximum non-disturb concentration of vincristine sulfate for bacterial endotoxins test was 0. 00417mg/mL. Conclusion The method is suitable for the detection of vincristine sulfate.
出处
《实验动物科学》
2014年第6期47-50,共4页
Laboratory Animal Science
关键词
硫酸长春新碱
细菌内毒素
干扰试验
vincristine sulfate
bacterial endotoxins
interfering test
