盐酸替罗非班细菌内毒素检查项可行性研究  

Investigation on feasibility of bacterial endotoxin test for tirofiban hydrochloride

作　　者：张广伟[1] 张军霞[1] 范玲玲 石勇志 ZHANG Guangwei;ZHANG Junxia;FAN Lingling;SHI Yongzhi(Henan Institute for Food and Drug control,Zhengzhou 450003,China;Henan Runhong Pharmaceutical Co.,Ltd.,Zhengzhou 451100,China)

机构地区：[1]河南省食品药品检验所,郑州450003 [2]河南润弘制药股份有限公司,郑州451100

出　　处：《中国药品标准》2020年第5期455-458,共4页Drug Standards of China

摘　　要：目的:研究原料药盐酸替罗非班细菌内毒素检查方法,为该品种设立细菌内毒素检查项提供依据。方法:参照《中国药典》2015年版四部通则1143细菌内毒素检查法,计算并设定本品细菌内毒素限值,选择两个厂家的鲎试剂分别对三批样品进行了干扰试验和细菌内毒素检查。结果:盐酸替罗非班对TAL与细菌内毒素的凝集反应有干扰作用,使用Tris缓冲液将供试品稀释至0.25 mg·mL-1可排除干扰。结论:将盐酸替罗非班用Tris缓冲液稀释至0.25 mg·mL-1,即可排除干扰进行细菌内毒素检查,限值拟定为每1 mg盐酸替罗非班中含内毒素的量应小于5.0 EU。Objective:To investigate the method of bacterial endotoxin test for drug substance of tirofiban hydrochloride and to provide the reference for admission bacterial endotoxin test in its specification.Method:The limit of bacterial endotoxin test of tirofiban hydrochloride was set according to general chapter 1143 in ChP 2015.VolⅣ.The interference test was performed for three batches of samples and the bacterial endotoxin was tested with two manufacturers′TAL reagents seperately.Results:Tirofiban hydrochloride had the interference on the reaction between TAL reagent and bacterial endotoxin,and the interference was eliminated by diluting the samples to 0.25 mg·mL-1 with Tris buffer.Conclusion:Tirofiban hydrochloride′s interference on bacterial endotoxin test can be eliminated by diluting the samples to 0.25 mg·mL-1 with Tris buffer,and the limit of bacterial endotoxin content was less than 5.0 EU per mg of tirofiban hydrochloride.

关 键 词：盐酸替罗非班 细菌内毒素 干扰试验 Tris缓冲液 鲎试剂 

分 类 号：R921.2[医药卫生—药学]