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作 者:韩亮[1] 田英[1] 张孟佑[1] 覃贝[1] 符旭东[1]
出 处:《中国药师》2009年第4期462-464,共3页China Pharmacist
摘 要: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 bacterial endotoxins test for Furacilin Solution. Method: The experiment was performed, and the results were assessed in accordance with Appendixes IS and XI E, Volume Two, Chinese Pharmacopoeia 2005 Edi-tion. Result: The tests showed that there was no interference with the agglutination reactions between tachypleus amebocyte lysate ( λ 0.25EU·ml^-1 ) and endotoxin in twofold diluted Furacilin Solution, and the bacterial endotoxins of the three samples accord with the define. Conclusion : The method can control the limit of bacterial endotoxins in Furacilin Solution.
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