碘化钠注射液细菌内毒素检查方法的研究

Application of bacterial endotoxin test to sodium iodide injection

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。

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 Appendix Ⅺ E,Pharmacopoeia of the People＇s of China（Vol. Ⅱ,2010）. 3 batches of samples were detected by bacterial endotoxin test. Results By using tachypleus amebocyte lysates with the sensitivity λ of 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.