硫酸长春新碱的细菌内毒素检查方法研究

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 /mL 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/mL 的鲎试剂可对硫酸长春新碱进行细菌内毒素检查。在 pH 调节法中，硫酸长春新碱 用 1 mol /mL 氢氧化钠调节 pH 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 /mL，使用 0. 125 EU/mL 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。

Study on Determination Method of the Bacterial Endotoxins for the Vincristine Sulfate

Abstract: 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．