应用鲎试剂法检测盐酸左氧氟沙星注射液热原

Studies on the Feasibility of Applying TAL Test Method on the Pyrogen Test of Levofloxacin Injection

分别采用鲎试剂检查法及家兔升温度法对盐酸左氧氟沙星注射液中的热源进行检测。结果鲎试剂法检查盐酸左氧氟沙星注射液热源合格,家兔升温度法检查盐酸左氧氟沙星注射液热源合格。两种方法比较得出应用鲎试剂法检查盐酸左氧氟沙星注射液热源操作简单易行,试验费用低,结果迅速可靠,灵敏度高,可用于该制剂的质量控制。

The pyrogen in the Levofloxacin Injection was tested by TAL test method and Rabbits method. The results from the TAL test method were qualified and the results from Rabbits method were qualified. Compared with Rabbits method, TAL test method is more sensitive and convenient. It can be used for the quality control of the Pyrogen test of Levofloxacin Injection.