动态浊度法定量检测甲磺酸帕珠沙星氯化钠注射液中细菌内毒素

Endotoxin Test for Pazufloxacin Mesilate and Sodium Chloride Injection by Using Kinetic - Turbidimetric Technique

目的:建立甲磺酸帕珠沙星氯化钠注射液细菌内毒素定量检测的方法。方法;采用动态比浊定量法,用BDET—32细菌内毒素测定仪对三批样品进行干扰回收试验及检测。结果:甲磺酸帕珠沙星氯化钠注射液在稀释至16倍时,已无干扰因素影响,内毒素回收率均在50％～200％范围内。结论:使用细菌内毒素动态浊度法定量检测甲磺酸帕珠沙星氯化钠注射液中的内毒素是可行的。

Objective; To establish method for practical qualititative control on a limit of endotoxin in pazufloxacin mesilate and sodium chloride injection. Methods:Using BET-32 instrument and adopting kinetic-turbidimetric technique,interference effects of three batches of production was investigated. Results:. The injection has neither inhibition nor enhancement action as diluted to sixteen times,and endotoxin recovery is in the range of 50%-200%. Conclusion:Kinetic-turbidimetric technique detecting bacterial endotoxin in this injection was feasible.