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目的:建立呋喃西林溶液细菌内毒素的检查方法。方法:按照《中国药典》2005年版(二部)附录ⅠS和附录ⅪE进行试验及结果判定。结果:呋喃西林溶液稀释两倍后,对市售标示灵敏度(λ)为0.25EU·ml~(-1)的鲎试剂凝集无干扰作用,3个批号的供试品细菌内毒素均符合规定。结论:细菌内毒素检查法中的凝胶法可控制呋喃西林溶液的细菌内毒素限度。
Objective: To establish a method for the detection of bacterial endotoxin in nitrofurazone solution. Methods: According to the “Chinese Pharmacopoeia” 2005 edition (two) Appendix Ⅰ S and Appendix XIE to test and determine the results. Results: After the solution of nitrofurazone was diluted twice, there was no interference effect on the agglutination of limulus reagents with commercially available labeling sensitivity (λ) of 0.25EU · ml -1. The bacterial endotoxins of the three batches were all in accordance with the regulations. CONCLUSIONS: The gel method in the bacterial endotoxin test controls bacterial endotoxin limits for nitrofurazone solution.