中国医学创新
中國醫學創新
중국의학창신
MEDICAL INNOVATION OF CHINA
2014年
8期
120-121
,共2页
鲎试剂%参麦注射液%细菌内毒素检查法
鱟試劑%參麥註射液%細菌內毒素檢查法
후시제%삼맥주사액%세균내독소검사법
Limulus lysate reagent%Shenmai Injection%Bacterial endotoxin test
目的：考察参麦注射液细菌内毒素检查方法的可行性，加强对参麦注射液的质量监控。方法：采用细菌内毒素检查法，考察参麦注射液对鲎试剂的干扰试验，并检测供试品细菌内毒素的限度。结果：对样品进行1∶4稀释，用0.125 EU/mL鲎试剂无干扰，与家兔热源检查法结果一致。结论：与家兔法检查本品热原相比，细菌内毒素法可行性高，此方法避免了家兔热源检查法操作的复杂性，且灵敏度高、方便快捷。
目的：攷察參麥註射液細菌內毒素檢查方法的可行性，加彊對參麥註射液的質量鑑控。方法：採用細菌內毒素檢查法，攷察參麥註射液對鱟試劑的榦擾試驗，併檢測供試品細菌內毒素的限度。結果：對樣品進行1∶4稀釋，用0.125 EU/mL鱟試劑無榦擾，與傢兔熱源檢查法結果一緻。結論：與傢兔法檢查本品熱原相比，細菌內毒素法可行性高，此方法避免瞭傢兔熱源檢查法操作的複雜性，且靈敏度高、方便快捷。
목적：고찰삼맥주사액세균내독소검사방법적가행성，가강대삼맥주사액적질량감공。방법：채용세균내독소검사법，고찰삼맥주사액대후시제적간우시험，병검측공시품세균내독소적한도。결과：대양품진행1∶4희석，용0.125 EU/mL후시제무간우，여가토열원검사법결과일치。결론：여가토법검사본품열원상비，세균내독소법가행성고，차방법피면료가토열원검사법조작적복잡성，차령민도고、방편쾌첩。
Objective:To investigate the feasibility of bacterial endotoxin test and enhance the quality control for Shenmai Injection. Method:The bacterial endotoxin inspection method was used for the interference test of Shenmai injection to limulus reagent and the LOQ of bacterial endotoxin was tested. Result:The 1:4 diluted sample was test with 0.125 EU/mL tachypleus amebocyte lysate. No interference was found and the result consistent with the rabbit test results. Conclusion:The bacterial endotoxin test is much more feasible,sensitive and fast than rabbit test method for the pyrogen test of Shenmai Injection.
