三种冲洗剂细菌内毒素检查方法的建立

摘要

Objective To establish methods for checking bacterial endotoxins in solution of Compound ethacridine lac-tate, 3% Boric acid and 33% Magnesium sulfate. Methods The methods were based on the bacterial endotoxins test described in AppendixIE of Chinese Pharmacopeia (2010 edition, 2 volume), including the sensititivity of tachypleus amebocyte lysate, preliminary interference test and official interference test of bacterial endotoxins. Results It was proved that the samples with the Compound ethacridine lactate solution had no inhibition effect on the congregating reaction between bacterial endotoxins and tachypleus amebocyte lysate. The interference was eliminated the 3% Boric acid so-lution and 33%Magnesium sulfate solution being diluted 4-fold and diluted 8-fold respectively. Conclusion The meth-ods are simple, rapid and reliable, which can be used for checking bacterial endotoxin in the three Washing Agent.%目的：建立复方乳酸依沙吖啶溶液、3%硼酸溶液及33%硫酸镁溶液的细菌内毒素检查方法。方法按《中国药典》2010年版(二部)附录欲 E细菌内毒素凝胶检查法，对三种冲洗剂分别进行鲎试剂灵敏度复核试验、干扰预试验和正式干扰试验。结果复方乳酸依沙吖啶溶液对鲎试剂与细菌内毒素之间的凝集反应无干扰作用；3%硼酸溶液和33%硫酸镁溶液分别稀释4倍和8倍后，可消除抑制作用。结论本文建立的三种冲洗剂的细菌内毒素凝胶检查法简便、快捷、可靠。