注射用丹参酮Ⅱ_A磺酸钠细菌内毒素检查法

Application of the Bacterial Endotoxin Test for Sodium Tanshinone IIA Sulfonate Injection

目的建立检测注射用丹参酮ⅡA磺酸钠中内毒素的试验方法。方法运用干扰初筛法对供试品进行干扰试验,采用鲎试剂法对样品中的内毒素进行检测。结果注射用丹参酮ⅡA磺酸钠在药液稀释浓度为0.016 8 mg.m l-1以下时,与鲎试剂反应无干扰。结论所采用的细菌内毒素检查法可用于注射用丹参酮ⅡA磺酸钠的内毒素检查。

Objective To establish a method for detection of bacterial endotoxin in sodium tanshinone IIA sulfonate injection.Methods After interfering experiment,tachypleus amebocyte lysate（TAL） was performed to detect the bacterial endotoxin in sodium tanshinone IIA sulfonate injection.Results Sodium tanshinone IIA sulfonate injection did not interfere with limulus agent when the injection was diluted to the concentration lower than 0.016 8 mg·ml-1.Conclusion The bacterial endotoxin test is suitable for the detection of bacterial endotoxin in sodium tanshinone IIA sulfonate injection.