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目的:定量检测国产氨甲环酸小容量注射剂中细菌内毒素含量,考察该品种的内毒素污染情况。方法:建立动态浊度法,检测了13家企业15批样品中的内毒素含量。结果:样品≤6.25 mg·ml~(-1)时,对检测不存在干扰作用,且所有批次产品的内毒素含量远低于其限值。结论:动态浊度法可有效检测氨甲环酸小容量注射剂中内毒素含量,13家生产企业该品种的内毒素污染很轻微,可供临床安全使用。
Objective: To quantitatively detect the content of bacterial endotoxin in domestic tranexamic acid small volume injection and investigate the endotoxin contamination of this species. Methods: The dynamic turbidity method was established to detect the endotoxin content in 15 batches of samples from 13 enterprises. Results: No interference was detected when the sample was ≤6.25 mg · ml -1, and the endotoxin content of all batch products was much lower than its limit. Conclusions: The dynamic turbidity method can effectively detect the content of endotoxin in the small volume injection of tranexamic acid. The endotoxin contamination of the 13 manufacturers is slight, which is safe for clinical use.