[关键词]
[摘要]
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。
[Key word]
[Abstract]
Object To prove the feasibility of bacterial endotoxin test (BET ) in Shenmai Freeze-dried Powder In jection by in terference test. Methods In terference primary screening test and in terference test were conducted in BET of Shenmai Freeze-dried Powder In jection to detect whether the interference existed or not and to explore the method of removing the in terference. Results There was inhibition on BET with 0.5 EU ?mL tachyp leu s amebocyte lysate (TAL ). In terference cou ld be excluded by u sing 0125 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 F reeze-dried Powder In jection.
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[基金项目]
国家新药基金开发项目 (92-11-10);国家科技部科技型中心企业技术创新基金资助项目 (00C26215110425)