中国血液流变学杂志
中國血液流變學雜誌
중국혈액류변학잡지
CHINESE JOURNAL OF HEMORHEOLOGY
2013年
3期
561-563
,共3页
乳糖酸阿奇霉素注射液%细菌内毒素%鲎试剂%干扰试验
乳糖痠阿奇黴素註射液%細菌內毒素%鱟試劑%榦擾試驗
유당산아기매소주사액%세균내독소%후시제%간우시험
azithromycin lactobionate injection%bacterial endotoxin%limulus amebocyte lysate(LAL)%inhibition test
目的：对乳糖酸阿奇霉素注射液进行凝胶法干扰试验，检测乳糖酸阿奇霉素注射液细菌内毒素。方法按照中国药典细菌内毒素检查方法（2010年版二部），对2批样品进行干扰试验和细菌内毒素检查。结果浓度为0.83mg/mL的样品稀释液对标示灵敏度为0.25 EU/mL的鲎试剂无干扰作用。结论使用细菌内毒素检查法检查乳糖酸阿奇霉素注射液中的细菌内毒素是可行的，可用细菌内毒素检查法代替家兔热原检查法。
目的：對乳糖痠阿奇黴素註射液進行凝膠法榦擾試驗，檢測乳糖痠阿奇黴素註射液細菌內毒素。方法按照中國藥典細菌內毒素檢查方法（2010年版二部），對2批樣品進行榦擾試驗和細菌內毒素檢查。結果濃度為0.83mg/mL的樣品稀釋液對標示靈敏度為0.25 EU/mL的鱟試劑無榦擾作用。結論使用細菌內毒素檢查法檢查乳糖痠阿奇黴素註射液中的細菌內毒素是可行的，可用細菌內毒素檢查法代替傢兔熱原檢查法。
목적：대유당산아기매소주사액진행응효법간우시험，검측유당산아기매소주사액세균내독소。방법안조중국약전세균내독소검사방법（2010년판이부），대2비양품진행간우시험화세균내독소검사。결과농도위0.83mg/mL적양품희석액대표시령민도위0.25 EU/mL적후시제무간우작용。결론사용세균내독소검사법검사유당산아기매소주사액중적세균내독소시가행적，가용세균내독소검사법대체가토열원검사법。
Objective To establish a method for the determination of bacterial endotoxin of azithromycin lactobionate injection.Method Two batches of samples were used for interference test and bacterial endotoxins test in accordance with AppendixⅪE,Volume 2,2010 Edition of Chinese Pharmacopoeia.Result No interferential effect was under the density 0.83mg/mL of the dilute test solution.The limulus amebocyte lysate reagent with the sensitivity of 0.25EU/mL could be used in the test.Conclusion It is feasible to detect the bacterial endotoxin of azithromycin lactobionate injection by the method of determination of bacterial endotoxin and the method may replace pyrogen test.
