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艾迪注射液细菌内毒素检查方法探讨
引用本文:王丽华.艾迪注射液细菌内毒素检查方法探讨[J].生物技术通讯,2011,22(6):870-872.
作者姓名:王丽华
作者单位:解放军总医院药品保障中心,北京,100853
摘    要:目的:建立艾迪注射液细菌内毒素检查方法。方法:根据《中华人民共和国药典》2005年版Ⅱ部收载的细菌内毒素检查法进行。结果:将艾迪注射液稀释至1/6后可消除干扰因素,用标示灵敏度为0.25 EU/mL的鲎试剂检测细菌内毒素是有效的。结论:细菌内毒素检查法准确、可靠,适用于检测艾迪注射液中的内毒素。

关 键 词:艾迪注射液  细菌内毒素  干扰试验  鲎试剂

Bacterial Endotoxins Test in Aidi Injection
WANG Li-Hua.Bacterial Endotoxins Test in Aidi Injection[J].Letters in Biotechnology,2011,22(6):870-872.
Authors:WANG Li-Hua
Institution:WANG Li-Hua Department of Pharmacy in PLA General Hospital,Beijing 100853,China
Abstract:Objective: To establish a method for testing the bacterial endotoxin in Aidi injection by using tachypleus amebocyte lysate.Methods: The experiment was implemented according to the loacterial test endotoxins in China Pharmacopoeia(Ⅱ,2005ed).Results: The results showed that the interference elements could be excluded by diluting glycerol and fructose injection 6 times,and the endotoxin could be tested by amebocyte lysate with accuracy of 0.25 EU/mL.Conclusion: Bacterial endotoxin test is suitable for the detection of bacterial endotoxin in Aidi Injection.
Keywords:Aidi injection  bacterial endotoxin  interference test  tachypleus amebocyte lysate  
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