摘要
目的研究甘油果糖注射液细菌内毒素检查(BET)的干扰实验,建立用(BET)代替热原检查(PT)。方法根据《中国药典》2005年版Ⅱ部收载的细菌内毒素检查法的要求进行实验。结果将甘油果糖注射液经2倍稀释可消除干扰因素,用标示灵敏度为0.25EU.ml-1的鲎试剂检测细菌内毒素检查是有效的。结论可以用细菌内毒素检查法代替家兔法来控制甘油果糖注射液的质量。
Objective To study the interference factors of BET for glycerol and fructose injection and establish a method for bacterial endotoxin test（BET） instead of the pyrogen Test（PT）. Methods The experiment was implemented according to the loacterial test endotoxins in China Pharmacopoeia （Ⅱ ,2005ed）. Results The test showed that the interference elements could be excluded by diluting glycerol and fructose injection 2 times, and it was effective that endotoxin could be tested by amebocyte lysate with accuracy of 0.25EU/ml. Conclusion Bacterial endotoxin test can be used in place of rabbit method for pyrogen monitor of glycerol and fructose injection.
出处
《时珍国医国药》
CAS
CSCD
北大核心
2007年第2期359-360,共2页
Lishizhen Medicine and Materia Medica Research
关键词
甘油果糖注射液
细菌内毒素
热原
Glycerol and Fructose Injection
Bacterial endotoxin
Pyrogen
