CAJ | 학술논문

目的：建立碘化钠注射液细菌内毒素检查方法。方法采用《中国药典》2010版二部附录细菌内毒素检查法，以不同厂家的鲎试剂进行干扰试验，并对3批样品进行细菌内毒素检查。结果将碘化钠注射液稀释为20倍稀释液，用灵敏度为0．25 EU/mL的鲎试剂进行干扰试验，进行不干扰细菌内毒素检查。结论本研究的方法简便、准确、可靠，可用于碘化钠注射液的细菌内毒素检查。
목적：건립전화납주사액세균내독소검사방법。방법채용《중국약전》2010판이부부록세균내독소검사법，이불동엄가적후시제진행간우시험，병대3비양품진행세균내독소검사。결과장전화납주사액희석위20배희석액，용령민도위0．25 EU/mL적후시제진행간우시험，진행불간우세균내독소검사。결론본연구적방법간편、준학、가고，가용우전화납주사액적세균내독소검사。
Objective To establish a method for detecting bacterial endotoxin in sodium iodide injection. Methods The beforehand confirming interference test were carried out according to The Guideline and Procedure Specified in AppendixⅪE,Pharmacopoeia of the People′s of China (Vol.Ⅱ,2010). 3 batches of samples were detec-ted by bacterial endotoxin test. Results By using tachypleus amebocyte lysates with the sensitivityλof 0. 25 EU/mL, the sample did not interfere when sodium iodide injection was diluted to 20 times with bacterial endotoxin examination water. Conclusion The established method is simple,rapid,reliable and feasible for detecting the bacterial endotoxin in sodium iodide injection.