医药前沿
醫藥前沿
의약전연
YIAYAO QIANYAN
2014年
18期
124-125
,共2页
王正凤%翟灵妍%吴军%陈家香
王正鳳%翟靈妍%吳軍%陳傢香
왕정봉%적령연%오군%진가향
伊立替康注射液%细菌内毒素检查%干扰试验
伊立替康註射液%細菌內毒素檢查%榦擾試驗
이립체강주사액%세균내독소검사%간우시험
Irinotecan Injection%Bacterial endotoxin test%Interference test
目的：建立伊立替康注射液细菌内毒素检查方法。方法：按照《中国药典》2010年版二部附录细菌内毒素检查法，采用2个不同厂家的鲎试剂对伊立替康注射液进行研究。结果：本品稀释20倍以后，可消除对鲎试剂与细菌内毒素凝集反应的干扰；按拟定标准检验，采用2个厂家的鲎试剂分别对3批伊立替康注射液的细菌内毒素检查，其结果和家兔热原检查结果均符合规定。结论：可用细菌内毒素检查法对伊立替康注射液进行热原检查。
目的：建立伊立替康註射液細菌內毒素檢查方法。方法：按照《中國藥典》2010年版二部附錄細菌內毒素檢查法，採用2箇不同廠傢的鱟試劑對伊立替康註射液進行研究。結果：本品稀釋20倍以後，可消除對鱟試劑與細菌內毒素凝集反應的榦擾；按擬定標準檢驗，採用2箇廠傢的鱟試劑分彆對3批伊立替康註射液的細菌內毒素檢查，其結果和傢兔熱原檢查結果均符閤規定。結論：可用細菌內毒素檢查法對伊立替康註射液進行熱原檢查。
목적：건립이립체강주사액세균내독소검사방법。방법：안조《중국약전》2010년판이부부록세균내독소검사법，채용2개불동엄가적후시제대이립체강주사액진행연구。결과：본품희석20배이후，가소제대후시제여세균내독소응집반응적간우；안의정표준검험，채용2개엄가적후시제분별대3비이립체강주사액적세균내독소검사，기결과화가토열원검사결과균부합규정。결론：가용세균내독소검사법대이립체강주사액진행열원검사。
Objective This paper established a method study for bacterial endotoxin test of irinotecan injection. Methods: The experiment was carried out acccroding to the AppendixⅡ of Chinese Pharmacopeia (2010 edition, 2 volume) to test bacterial endotoxin. Then, using the different tachypleus amebocyte lysate from 2 manufacturers tested the bacterial endotoxin for irinotecan injection. Results: When the sample was diluted 40 times, this method could eliminate the interference for tachypleus amebocyte lysate and bacterial endotoxin agglomeration reaction. According to the laying standard, the bacterial endotoxin test and rabbit pyrogen test results were accorded with the regulation for 2 manufacturers tachypleus amebocyte lysate testing 3 batch irinotecan injection samples. Conclusion: The bacterial endotoxin test method can be applied in pyrogen test for irinotecan injection.
