10%氯化钠注射液的细菌内毒素检查  

The bacterial endotoxin test of 10% Sodium chloride injection

作　　者：鱼爱和[1] 刘泉生[1] 张兰华[1] 

机构地区：[1]解放军261医院药剂科,北京100094

出　　处：《华西药学杂志》2005年第3期251-253,共3页West China Journal of Pharmaceutical Sciences

摘　　要：目的建立10%氯化钠注射液的细菌内毒素检查方法。方法确定10%氯化钠注射液的细菌内毒素限值,并进行干扰试验。结果10%氯化钠注射液对细菌内毒素检查有抑制作用,原液在稀释4倍(2.5%,最大不干扰浓度),使用λ为0.25EU·ml-1的鲎试剂可消除此干扰。结论10%氯化钠注射液的热原检查可用细菌内毒素检查法替代。OBJECTIVE To establish a bacterial endotoxin testing method of 10% NaCl injection(NI). METHODS The limit value of bacterial endotoxin test(BET) and the maximal undisturbed concentration for NI were determined. RESULTS The diluted solution(1:4,~2.5% )of NI(the maximal undisturbed concentration ) could not disturb the BET,with 0.25 EU·ml^-1 of tachypleus amebocyte iysate(TAL). CONCLUSION The BET for NI could replace the pyrogen test.

关 键 词：氯化钠注射液 细菌内毒素检查方法 细菌内毒素检查法 细菌内毒素限值 干扰试验 抑制作用 热原检查 鲎试剂 

分 类 号：R927.2[医药卫生—药学] R978.1