头孢曲松钠注射液细菌内毒素的鲎试验研究

Study of tachypleus amebocyte lysate test for bacterial endotoxins in ceftriaxone sodium injection

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:应用凝胶法堂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(1g/50mL)的细菌内毒素限值为3.OEU/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。

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, the limit of bacterial endotoxins in ceftriaxone sodium injection (1 g/50mL) was confirmed to be 3. 0 EU/mL, after 24 times of dilution, three batches of ceftriaxone sodium injection showed no interference with the test; the content of bacterial endotoxins in all samples tested were not more than 3. 0 EU/mL. Conclusion: TAL test provides a new way to detect the content of bacterial endotoxins in ceftriaxone sodium injection, samples can be diluted by 24 times to avoid their interfering effects on routine bacterial endotoxins test.