参麦冻干粉针剂中细菌内毒素检查干扰试验

Interference test in bacterial endotoxins detection of Shenmai Freeze-dried Powder Injection

目的 对参麦冻干粉针中细菌内毒素检查干扰试验进行研究 ,证明使用细菌内毒素检查法 (BET)的可行性。方法 用干扰初筛试验和干扰试验考察参麦冻干粉针对 BET有无干扰 ,并寻求排除干扰的方法。结果 使用λ为 0 .5 EU/ m L 的鲎试剂有抑制作用 ,使用 λ为 0 .2 5 EU/ m L 的鲎试剂 ,供试品溶液作适当稀释可消除干扰。结论参麦冻干粉针的细菌内毒素检查应使用灵敏度为 0 .2 5 EU/ m L 或更高灵敏度的鲎试剂。

Object To prove the feasibility of bacterial endotoxin test (BET) in Shenmai Freeze-dried Powder Injection by interference test. Methods Interference primary screening test and interference test were conducted in BET of Shenmai Freeze-dried Powder Injection to detect whether the interference existed or not and to explore the method of removing the interference. Results There was inhibition on BET with 0.5 EU/mL tachypleus amebocyte lysate (TAL). Interference could be excluded by using 0.25 EU/mL TAL and diluting the samples. Conclusion It is feasible to use 0.25 EU/mL TAL or TAL with more sensitivity in BET of Shenmai Freeze-dried Powder Injection.