鲎试剂法检测硫辛酸注射液细菌内毒素的研究

Study on tachypleus amebocyte lysate test for detecting bacterial endotoxin in thioctic acid injection

目的探讨采用鲎试剂方法检测硫辛酸注射液中细菌内毒素的可行性。方法选择两个厂家生产的不同批号的鲎试剂,对5个批次不同稀释倍数的供试品系列溶液进行干扰试验和细菌内毒素检查。结果稀释倍数≤10的硫辛酸注射液对鲎试剂与细菌内毒素之间的凝集反应有抑制现象,稀释至20倍后干扰作用消失。结论鲎试剂方法可用于硫辛酸注射液中细菌内毒素的检测,并且具有简便、快捷、可靠等优点。

Objective To investigate the feasibility of tachypleus amebocyte lysate（TAL） test for detecting bacterial endotoxin in thioctic acid injection. Methods The interference experiment and bacterial endotoxin detection in five batches of samples at different diluting times were carried out using tachypleus amebocyte lysates produced by two manufactories. Results The samples at low diluting times（not more than 10 times） had inhibitive effects on the agglutination reaction between bacterial endotoxin and TAL.However,this interference was eliminated when it was diluted 20 times. Conclusion Bacterial endotoxin in thioctic acid injection can be detected by tachypleus amebocyte lysate test and the established method is simple,rapid and reliable.