CAJ | 학술논문

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。
목적：건립아위산납록화납주사액세균내독소검사법。방법채용2010년판《중국약전（이부）》부록중세균내독소검사법，대불동비호적양품진행간우시험화세균내독소검사。결과아위산납록화납주사액희석2배시，불간우세균내독소시험，기세균내독소한치가정위0.5 EI/mL。결론채용세균내독소검사법대체열원검사법공제아위산납록화납주사액질량가행。
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.