红花黄色素氯化钠注射液的细菌内毒素检查方法学研究

Study on bacterial endotoxin test in safflor yellow and sodium chloride injection

目的研究红花黄色素氯化钠注射液对细菌内毒素检查试验的干扰情况,建立其细菌内毒素限量检查的方法。方法采用细菌内毒素凝胶法,用两个厂家的鲎试剂对提供的红花黄色素氯化钠注射液连续3批样品进行干扰试验。结果红花黄色素氯化钠注射液最大非干扰浓度为0.4 mg/ml。结论红花黄色素氯化钠注射液用细菌内毒素检查法进行细菌内毒素检测是可行的,其内毒素限值为每ml含内毒素量应小于0.5 EU。

Objective To study the interference of safflor yellow and sodium chloride injection in bacterial endotoxin test, and to establish an method of endotoxin limit test in this drug. Methods The gel-clot method was used to determine the interference of safflor yellow and sodium chloride injection with tachypleus amebocyte lysate （TAL） made by two manufacturers. Results The max- imum concentration of safflor yellow and sodium chloride injection without interfering effect was 0.4 mg/ml. Conclusion Bacterial endotoxin test could be used for safflor yellow and sodium chloride injection. The bacterial endotoxin limit of safflor yellow and sodium chloride injection should be less than 0.5 EU/ml.