注射用右丙亚胺的细菌内毒素检查

Test of Bacterial Endotoxin in Dexrazoxane,ICRF-187 for Injection

目的:建立注射用右丙亚胺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集反应的原理对注射用右丙亚胺中的细菌内毒素进行检查。结果:注射用右丙亚胺以乳酸钠溶液作为缓冲剂,其不干扰浓度为1 mg·mL^(-1),限值确定为每1mg 注射用右丙亚胺中含细菌内毒素量应小于0.35 EU。结论:注射用右丙亚胺中的细菌内毒素检查可以用鲎试验法,此法灵敏可靠,方便经济。

Objective：To establish the determination method of bacterial endotoxin in dexrazoxane, ICRF- 187 for injection. Method：Dexrazoxane, ICRF -187 for injection was examined by tachypleus ameboyte lysate solvent test. Results：The sample was diluted to 1 mg· mL^-1 without confusion and the limit of bacterial endotoxin should be lower than 0. 35 EU · mg^- 1. Conclusion. Bacterial endotoxin test is accurate and suitable for the detection of bacterial endotoxin in dexrazoxane ,ICRF- 187 for injection.