国际医药卫生导报
國際醫藥衛生導報
국제의약위생도보
INTERNATIONAL MEDICINE & HEALTH GUIDANCE NEWS
2010年
8期
970-973
,共4页
参芎葡萄糖注射液%凝胶限量法%细菌内毒素
參芎葡萄糖註射液%凝膠限量法%細菌內毒素
삼궁포도당주사액%응효한량법%세균내독소
Shenxiong Glucose Injection%Gel limit method%Bacterial endotoxins
目的 建立凝胶限量法检杳参芎葡萄糖注射液细菌内毒素的方法.方法 参照中国药典中细菌内毒素检查法和细菌内毒素检杳法应用指导原则要求进行实验设计,确定参芎葡萄糖注射液的细菌内毒素限值.用不同厂家的鲎试剂对三个批号的参芎葡萄糖注射液进行干扰试验,考察确立其内毒素的检查方法.结果 参芎葡萄糖注射液经6倍稀释后能消除干扰,可用标示灵敏度为0.25 EU/ml的鲎试剂检测其细菌内毒素.结论 可用凝胶限量法代替家兔热原法检查参芎葡萄糖注射液的致热物质.
目的 建立凝膠限量法檢杳參芎葡萄糖註射液細菌內毒素的方法.方法 參照中國藥典中細菌內毒素檢查法和細菌內毒素檢杳法應用指導原則要求進行實驗設計,確定參芎葡萄糖註射液的細菌內毒素限值.用不同廠傢的鱟試劑對三箇批號的參芎葡萄糖註射液進行榦擾試驗,攷察確立其內毒素的檢查方法.結果 參芎葡萄糖註射液經6倍稀釋後能消除榦擾,可用標示靈敏度為0.25 EU/ml的鱟試劑檢測其細菌內毒素.結論 可用凝膠限量法代替傢兔熱原法檢查參芎葡萄糖註射液的緻熱物質.
목적 건립응효한량법검묘삼궁포도당주사액세균내독소적방법.방법 삼조중국약전중세균내독소검사법화세균내독소검묘법응용지도원칙요구진행실험설계,학정삼궁포도당주사액적세균내독소한치.용불동엄가적후시제대삼개비호적삼궁포도당주사액진행간우시험,고찰학립기내독소적검사방법.결과 삼궁포도당주사액경6배희석후능소제간우,가용표시령민도위0.25 EU/ml적후시제검측기세균내독소.결론 가용응효한량법대체가토열원법검사삼궁포도당주사액적치열물질.
Objective Set up the gel limit method for testing the Bacterial Endotoxins of the Shenxiong Glucose Injection.Method The experiments were designed according to the bacterial endot-oxins test methed and the guide for application of the bacterial endotoxins test method in the Chinese pharmacopoeia.The limit value of the bscterial endotoxins of the Shenxiong Glucose Injection was determined.The interference tests were carried out with three batches of the Shenxiong Glucose Injection that was tested by tachypleas amebocyte lysate of different manufacturers,and the bacterial endotoxins test method was then investigated and established.Results The inteference would be eliminated by 6-fold dilution of the Shenxiong Glucose Injection,and the tachypleus amebocyte lysate with sensitivity of 0.25EU/mL can be used to test the bacterial endotoxins.Conclusion The gel limit method can be used to substitute the rabbit pyrogen method to test the pyrogen of the Shenxiong Glucose,Injection.
