三种冲洗剂的细菌内毒素检验方法探究

Study on method of bacterial endotoxin test for 3 washing agent

目的:探究呋喃西林溶液、硫酸新霉素溶液和醋酸氯已定溶液细菌内毒素检查的干扰试验,建立三种冲洗剂的细菌内毒素检查法。方法:按照《中国药典》2010年版(二部)附录ⅪE细菌内毒素检查法,对三种冲洗剂进行干扰试验和细菌内毒素检查。结果:呋喃西林溶液和硫酸新霉素溶液分别采用直接和稀释2倍后,再分别采用灵敏度λ为0.5EU/mL和0.25EU/mL的鲎试剂进行试验,供试品不干扰细菌内毒素检查;醋酸洗必泰溶液经碱化后,稀释8倍后,用灵敏度λ为0.06EU/mL的鲎试剂进行试验,供试品不干扰细菌内毒素检查。结论:不同的冲洗剂通过适当的方法可以消除对细菌内毒素的干扰。

Objective：To study the furacillin solution,neomycin sulfate solution and chlorhexidine acetate solution of bacterial endotoxin test interference test,and to establish the bacterial endotoxin test methods for three kinds of washing agent. Methods ：The interference test and the bacterial endotoxin test of three kinds of washing agent were performed in accordance with Appendixes X] E, Volume Two,Chinese Pharmacopoeia 2010 Edition. Results：There was no interfere with the bacterial endotoxin test that furacillin solution and neomycin sulfate solution were used to direct and dilut 2-fold,respectively,using limulus amebocyte lysate test for 0.5 EU/mL and 0.25 EU/mL of the sen- sitivity;the tests of chlorhexidine acetate solution showed no interfere with the bacterial endotoxin test by alkalized, diluted 8-fold and the limulus amebocyte lysate test of the 0. 06 EU/mL sensitivity. Conclusion： The appropriate methods for different washing agents can eliminate the interference to bacterial endotoxin.