阿魏酸钠氯化钠注射液细菌内毒素检查法研究

摘要

Objective To establish a method for the bacterial endotoxin test of Sodium Ferulate and Sodium Chloride Injection. Methods The bacterial endotoxin test in the Appendix Ⅺ E of the Chinese Pharmacopoeia(version 2010,VoI Ⅱ)was adopted to con-duct the interference test and the bacterial endotoxin test for different batches of samples. Results The twice dilution of Sodium Feru-late and Sodium Chloride Injection had no interference to the bacterial endotoxin test,the bacterial endotoxin limit value can be set as 0. 5 EI/mL. Conclusion Sodium Ferulate and Sodium Chloride Injection adopting the bacterial endotoxin test instead of the pyrogen test method for controlling the quality is feasible.%目的：建立阿魏酸钠氯化钠注射液细菌内毒素检查法。方法采用2010年版《中国药典（二部）》附录中细菌内毒素检查法，对不同批号的样品进行干扰试验和细菌内毒素检查。结果阿魏酸钠氯化钠注射液稀释2倍时，不干扰细菌内毒素试验，其细菌内毒素限值可定为0.5 EI/mL。结论采用细菌内毒素检查法代替热原检查法控制阿魏酸钠氯化钠注射液质量可行。