食品与药品
食品與藥品
식품여약품
FOOD AND DRUG
2013年
2期
128-129
,共2页
注射用盐酸吉西他滨%鲎试剂%细菌内毒素
註射用鹽痠吉西他濱%鱟試劑%細菌內毒素
주사용염산길서타빈%후시제%세균내독소
gemcitabine hydrochloride for injection%horseshoe crab agent%bacterial endotoxin
目的考察注射用盐酸吉西他滨的细菌内毒素检查方法的可行性.方法按《中国药典》2010年版二部收载的细菌内毒素检查方法进行试验.结果将注射用盐酸吉西他滨稀释液的pH值调成近中性时,对鲎试剂的凝集反应无抑制作用.结论用细菌内毒素检查法替代家兔热原法控制注射用盐酸吉西他滨的质量是可行的.
目的攷察註射用鹽痠吉西他濱的細菌內毒素檢查方法的可行性.方法按《中國藥典》2010年版二部收載的細菌內毒素檢查方法進行試驗.結果將註射用鹽痠吉西他濱稀釋液的pH值調成近中性時,對鱟試劑的凝集反應無抑製作用.結論用細菌內毒素檢查法替代傢兔熱原法控製註射用鹽痠吉西他濱的質量是可行的.
목적고찰주사용염산길서타빈적세균내독소검사방법적가행성.방법안《중국약전》2010년판이부수재적세균내독소검사방법진행시험.결과장주사용염산길서타빈희석액적pH치조성근중성시,대후시제적응집반응무억제작용.결론용세균내독소검사법체대가토열원법공제주사용염산길서타빈적질량시가행적.
@@@@Objective To test the bacterial endotoxin in gemcitabine hydrochloride for injection. Methods Bacterial endotoxin test of the Chinese pharmacopoeia was used. Results The test showed that inhibitory effect was not shown when the pH value of gemcitabine hydrochloride dilution was adjusted nearly neutral. Conclusion Bacterial endotoxin test can be alternative to rabbit method for pyrogen monitoring of gemcitabine hydrochloride for injection.
