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。
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.
出处
《生物技术通讯》
CAS
2011年第6期870-872,共3页
Letters in Biotechnology
关键词
艾迪注射液
细菌内毒素
干扰试验
鲎试剂
Aidi injection
bacterial endotoxin
interference test
tachypleus amebocyte lysate
