摘要
目的 :建立注射用磷霉素钠的细菌内毒素检查法。方法 :按中国药典 2 0 0 0年版二部附录规定进行鲎试剂复核、样品干扰试验和样品测定。结果 :75mg·ml- 1 的样品稀释 4倍后 ,可用标示灵敏度为 0 .2 5EU·ml- 1 的鲎试剂检测其细菌内毒素 ,实验结果与临床应用情况相符。结论 :鲎法检测注射用磷霉素钠的细菌内毒素方法可行、结果可靠 ,可代替兔法检测其热原。
Objective: To study a detection methods of bacterial endotoxins in fosfomycin sodium for injection.Methods: According to the rules of the ‘Chines Pharmacopoeia’, sensitivity test for tachypleus amebocyte lysate(TAL) and sample test for fosfomycin sodium for injection were carried out. Results: 75 mg·ml -1 of sample concentration diluted up to 4 times could be tested by TAL of which a sensitivity was 0.25 EU·ml -1 , the laboratorial and clinical resultes werer conformable between laboratorial result and clinical application.Conclusions: The TAL may be used for detection of bacterial endotoxins in fosfomycin sodium for injection. This method is sensitive and rapid, it may be used instead of the pyrogen test of fosfomycin sodium for injection.
出处
《中国药师》
CAS
2003年第4期213-214,共2页
China Pharmacist
关键词
注射用磷霉素钠
鲎试剂
细菌内毒素
Fosfomycin sodium for injection
Tachypleus amebocyte lysate
Bacterial endotoxins
