硼酸冲洗剂的细菌内毒素检查方法研究

Study on Bacterial Endotoxin Test Method of Boric Acid Rinse

目的:建立硼酸冲洗剂的细菌内毒素检查方法。方法:根据《中国药典》2005年版二部附录收载的细菌内毒素检查方法,采用鲎试剂法对硼酸冲洗剂进行干扰预试验及干扰试验,以确定样品无干扰浓度、pH值及鲎试剂的灵敏度。结果:样品经2倍稀释并调节pH值为稍高于6时对鲎试剂与内毒素的反应无干扰作用,可用灵敏度为0.25EU的鲎试剂进行细菌内毒素检查。结论:鲎试剂法可用于硼酸冲洗剂的细菌内毒素检查。

OBJECTIVE：To establish a method for bacterial endotoxin test of Boric acid rinse.METHODS：According to appendix volumeⅡof Chinese Pharmacopoeia（2005 edition）,the tachypleus amebocyte lysate（TAL）method was applied for the pre-inference test and interfence test to investigate non-inference concentration,pH value and sensitivity of TAL.RESULTS：Boric acid did not interfere with TAL and the reaction of bacterial endotoxin at 2 times diluted concentration with pH value adjusted above 6.The sensitivity 0.25 EU·mL^-1 of TAL was available.CONCLUSION：The TAL method can control the limit of bacterial endotoxins in Boric acid rinse.