头孢曲松钠注射液细菌内毒素的鲎试验研究
头孢曲松钠注射液,,头孢曲松钠注射液；细菌内毒素；鲎试验；干扰试验,1材料和仪器,2方法与结果,3讨论
摘 要 目的：考察头孢曲松钠注射液进行细菌内毒素检查的可行性。方法：应用凝胶法鲎试验进行头孢曲松钠注射液的细菌内毒素检查。 结果：根据最大临床用量确定头孢曲松钠注射液(1 g/50 mL)的细菌内毒素限值为3.0 EU/mL，3批样品经24倍稀释后对细菌内毒素检查无干扰作用；样品中细菌内毒素的含量均未超过限值。结论：可建立头孢曲松钠注射液的细菌内毒素检查法，日常细菌内毒素检查时可将样品稀释24倍以排除其干扰作用。关键词 头孢曲松钠注射液；细菌内毒素；鲎试验；干扰试验
Study of tachypleus amebocyte lysate test for bacterial endotoxins in ceftriaxone sodium injection
XIAO Guinan, WU Zhaodi，LI Jinfei，CHEN Xiaofang
(Guangdong Institute for Drug Control, Guangzhou, Guangdong 510180 )
Abstract Objective：To investigate the feasibility of bacterial endotoxins test for ceftriaxone sodium injection. Methods：Gel-clot method of tachypleus amebocyte lysate (TAL) test was applied to detect bacterial endotoxins in ceftriaxone sodium injection. Results：According to the maximal dose of clinical administration ......
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