【摘要】 目的 对硫辛酸注射液进行细菌内毒素检查研究，建立检测硫辛酸注射液中内毒素的试验方法。方法 采用《中国药典》2000年版附录细菌内毒素检查法。结果 硫辛酸注射液用鲎试剂检查其细菌内毒素并无干扰因素的影响。结论 用细菌内毒素检查法检查硫辛酸注射液中内毒素是可行的。

    【关键词】 硫辛酸注射液；细菌内毒素检查法；鲎试剂；干扰试验

    【Abstract】 Objective To establish bacterial endotoxin test for thioctic acid injection using limulus lysate agent. Methods The maximum valid dilution (MVD) was determined according to inhibition test, the bacterial endotoxin test was based on the method from Chinese pharmacopeia 2000 edition.Results Thioctic acid injection has no interference to the bacterial endotoxin. Conclusion The results suggest that the bacterial endotoxins test is suitable for the detection of endotoxin in thioctic acid injection.

    【Key words】 thioctic acid injection; bacterial endotoxins test; limulus lysate reagent; interfere test

    α- 硫辛酸是在人全身细胞中存在的一种脂肪酸 ......