盐酸左氧氟沙星注射液中细菌内毒素的定量检查

Measurement of endotoxin in Levofloxacin hydrochloride injection using the kinetic-turbidimetric technique

目的 建立定量检测盐酸左氧氟沙星注射液中细菌内毒素的方法。方法 采用中国药典 2 0 0 0年版附录检测细菌内毒素的动态比浊法。结果 盐酸左氧氟沙星注射液在稀释至 4倍时检测可排除干扰因素的影响 ,内毒素回收率在 5 0 %～ 2 0 0 %范围。结论 细菌内毒素动态比浊法定量检查盐酸左氧氟沙星注射液中的内毒素可行。

OBJECTIVE To establish the kinetic-turbidimetric technique for practical quality control on endotoxin content in Levofloxacin hydrochloride injection.METHODS Accoding to Chinese Pharmacopoeia (2000 edition), the kinetic-turbidimetric technique and eliminated interfere factors was adopted.RESULTS Endotoxin added to Levofloxacin hydrochloride injection was recovered in a quantitative manner showing neither inhibition nor enhancement in diluted solution at the 4 times, and the endotoxin recovery was 50%-200%.CONCLUSION These results suggested that the kinetic-turbidimetric technique of LAL-test was suitable for the detection of endotoxin in Levofloxacin hydrochloride injection.