氢化泼尼松注射液细菌内毒素检查法的研究

Research on the Hydroprednisone Injection Bacterial Endotoxins Test

目的:建立氢化泼尼松注射液的细菌内毒素检查法。方法:按《中国药典》2010年版二部附录细菌内毒素检查法,用不同厂家的鲎试剂对4个批号的氢化泼尼松注射液分别进行干扰试验和细菌内毒素检查。结果:氢化泼尼松注射液稀释到16倍(质量浓度为0.3125g/L)时,对细菌内毒素检查法无干扰,细菌内毒素限值为4EU·mg-1,按照拟定标准,4批样品细菌内毒素检查均符合规定。结论:所建立的鲎试剂法可用于氢化泼尼松注射液的细菌内毒素检查。

Objective：To establish a method of bacterial endotoxin test of Hydroprednisone Injection. Method：Based on the bacterial endoconducted on the samples from 4 batches of Hydroprednisone Injection by using tachypleus amebocyte lysate （TAL） from different manufacturers. Relults. Hydroprednisone Injection solution with dilution to 16 times （mass concentration 0.3125g/L） had no interference on the bacterial endotoxin test. The limit value of the bacterial endotoxin was 4EU· mg^-1.According to the established standard, the bacterial endotoxin test in the 4 batches of samples conformed to the stipulation. Conclusion： The established TAL method may be applicable for the bacterial endotoxin test of Hydroprednisone Injection.