乳酸依沙吖啶溶液(冲洗剂)细菌内毒素的检测

Detection of Bacterial Endotoxins in Ethacridine Lactate Solution by Tachypleus Amebocyte Lysate Test

目的:建立乳酸依沙吖啶溶液(冲洗剂)细菌内毒素的检测方法。方法:按照《中国药典》2010年版(二部)附录ⅪE和附录ⅠS对5批乳酸依沙吖啶溶液进行干扰试验和细菌内毒素检查。结果:质量浓度为1 mg·ml^(-1)的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,5个批号的样品细菌内毒素检查均符合规定。结论:建立的鲎试剂方法可用于乳酸依沙吖啶溶液细菌内毒素的检查,方法具有简便、快捷、可靠等优点。

Objective： To establish a method for the detection of bacterial endotoxins in ethacridine lactate solution. Method： The interference experiment and bacterial endotoxins test for 5 batches of ethacridine lactate solution were carried out according to the guideline and procedures specified in appendix Ⅺ E and I S, Volume two, Chinese pharmacopoeia 2010 edition. Result： It was proved that the samples with the concentration of 1 mg·ml^-1 had no inhibition effect on the congregating reaction between bacterial endotoxins and taehypleus amebocyte lysate. The results of bacterial endotoxins test for 5 batches of ethaeridine lactate solution complied with the required standard. Conclusion： The established method of taehypleus amebocyte lysates test is feasible for detecting the bacterial endotoxins in ethacridine lactate solution, and the method is simple, rapid and reliable.