氯法拉滨注射液的细菌内毒素检查
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[摘要] 目的:建立氯法拉滨注射液中细菌内毒素的检查方法。方法:利用鲎试剂与细菌内毒素产生凝聚反应的原理对氯法拉滨注射液中的细菌内毒素进行检查。结果:氯法拉滨注射液在浓度为0.05～0.50 mg/ml对测定均无干扰作用,限度确定为每毫克氯法拉滨中含内毒素的量应小于2.5 EU。结论:氯法拉滨注射液中的细菌内毒素检查可用鲎试验法,此法灵敏可靠,方便经济。
[关键词] 干扰试验;细菌内毒素;氯法拉滨注射液
[中图分类号]R927.2[文献标识码]A [文章编号]1673-7210(2010)01(c)-052-02
Test on bacterial endotoxin in Clofarabine Injection
HAN Jiyong, BAO Xiaoli, CHEN Xiangfeng
(Jiangsu Aosaikang Pharmaceutical Co., Ltd., Nanjing 211112, China)
[Abstract] Objective: To establish the determination method of bacterial endotoxin in clofarabin Injection. Methods: Clofarabin injection was examined by principle of TAL and bacterial endotoxin response through cohesion. Results: The sample was diluted to 0.05-0.50 mg/ml without confusion and the limit of bacterial endotoxin should be lower than 2.5 EU/mg. Conclusion: Bacterial endotoxin test is accurate and suitable for the detection of bacterial endotoxin in clofarabin injection ......
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