劳海燕,罗宇芬,林秋晓
LAO Hai yan; LUO Yu fen; LIN Qiu xiao (The Pharmaceutical Department of Guangdong Provinicial People's Hospital;

• 1:广东省人民医院药学部
• 2:广东省人民医院药学部
• 3:广东省人民医院药学部 广东广州510080
• 4:广东广州510080

摘要(Abstract)：

目的定量测定注射用头孢噻肟中的细菌内毒素含量。方法应用动态比浊法鲎试验 ,通过对样品中定量添加标准内毒素的干扰预试验 ,将头孢噻肟 (B0 0 1 0 0 1 )制备成 1 0、5、2、1、0 5、0 3mg/mL溶液 ,定量添加标准内毒素 ,测定样品中所添加标准内毒素量 ,从中筛选出最佳的检测浓度 0 3mg/mL ,进行 3个批号头孢噻肟 ( 990 4 0 8、B0 0 1 0 0 1、B0 0 1 0 0 5 )正式干扰试验。结果样品中定量添加标准内毒素 ,干扰预实验其回收率分别为 1 7 2 2 %、31 74 %、4 8 2 7%、5 2 1 5 %、6 3 1 2 %、1 1 9 1 % ;正式干扰实验 ,其回收率分别为 1 31 3%、1 1 9 1 %和 77 30 %。标准内毒素使用 5 0 0、0 5 0 0、0 0 5 0 0Eu/mL ,将头孢噻肟制备成浓度为 0 3mg/mL,样品中定量添加标准内毒素 ,回收率均为 5 0 %～ 2 0 0 %。结论动态比浊法鲎试验可以高效地测定头孢噻肟的细菌内毒素。
Objective The kinetic turbidimetric limulus test was used in the endotoxin assay of cefotaxime for the injection.Methods The validation test was fulfiled ,when the amount of endotoxin spiked in cefotaxime for the injection sample(Lot No.B001001)in which the concentrations of its dilution solution were 10, 5, 2, 1, 0 5, 0 3 mg/mL.They were recovered in 17 22%, 31 74%, 48 27%, 52 25%, 63 12%, 119 1%; with the amount of endotoxin spiked in the cefotaxime sample (Lot No 990408, B001001, B001005),their 0 3mg/mL dilution were recovered in 131 3%, 119 1% and 77 30%.Results With the standard endotoxin the working curves are 5 00,0 500, 0 0500 Eu/mL .The 0 3 mg/mL solution to cefotaxime is effective in eliminating the interference in the limulus test.Conclusion The kinetic turbidimetric limulus test provided a new way to the detection of endotoxin in the cefotaxime for injection.

关键词(KeyWords)： 动态比浊法鲎试验;头孢噻肟;细菌内毒素;干扰试验
kinetic turbidimetriclimulus test; cefotaxime; inhibition enhancement test; bacterial endotoxin

Abstract:

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基金项目(Foundation): 广东省重点科技攻关项目 ( 2KM0 5 4 0 6 3)

作者(Authors): 劳海燕,罗宇芬,林秋晓
LAO Hai yan; LUO Yu fen; LIN Qiu xiao (The Pharmaceutical Department of Guangdong Provinicial People's Hospital;

参考文献(References)：

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• [2]夏振民.药品细菌内毒素检查的限值[J].药物分析杂志,1995,15(3):54.