摘要
目的 建立盐酸倍他司汀注射液的细菌内毒素检查法。方法 采用凝胶法进行盐酸倍他司汀注射液的细菌内毒素检查,根据药品剂量拟定该产品的细菌内毒素检查限值,进行方法学验证,确认该方法是否存在干扰因素影响。结果 确定细菌内毒素限值(L)为4 EU/mg;干扰试验结果显示将盐酸倍他司汀注射液稀释至0.125 mg/ml时,对灵敏度为0.5 EU/ml的鲎试剂无干扰作用。结论 本文建立的细菌内毒素检查方法可替代热原检查法用于盐酸倍他司汀注射液的致热性物质检查。
Objective To study the feasibility of bacterial endotoxin test for Betahistine Hydrochloride Injection.Methods The bacterial endotoxin test of Betahistine Hydrochloride Injection was carried out by gel method.The bacterial endotoxin limit(L) of Betahistine Hydrochloride Injection was proposed according to the drug dose,and the methodological validation was conducted to confirm whether the method was affected by interfering factors.Results L value was determined as 4 EU/mg.Interference test results showed that Betahistine Hydrochloride Injection diluted to 0.125 mg/ml had no interference on TAL reagent with sensitivity of 0.5 EU/ml.Conclusion The bacterial endotoxin test method established in this paper can replace the pyrogen test method for the examination of pyrogenic substances in Betahistine Hydrochloride Injection.
作者
钮晓淑
王燕妮
蒋惠源
NIU Xiao-shu;WANG Yan-ni;JIANG Hui-yuan(Taizhou Institute for Drug Control,Taizhou 225300,China)
出处
《食品与药品》
2025年第2期122-126,共5页
Food and Drug
基金
泰州市科技计划项目(编号:SSF20230159)。
