中国药师
中國藥師
중국약사
CHINA PHARMACIST
2015年
4期
674-676
,共3页
于海洲%都婧%于风平
于海洲%都婧%于風平
우해주%도청%우풍평
叔丁醇%细菌内毒素%鲎试剂%干扰试验
叔丁醇%細菌內毒素%鱟試劑%榦擾試驗
숙정순%세균내독소%후시제%간우시험
Tertiary butyl alcohol%Bacterial endotoxins%Tachypleus amebocyte lysate%Interference experiment
目的：建立叔丁醇细菌内毒素检查方法。方法：采用2个不同厂家的鲎试剂和3批样品，进行预干扰试验和干扰试验。结果：供试品溶液对鲎试剂与细菌内毒素之间的凝集反应无干扰；样品的细菌内毒素限值确定为0.25 EU·ml-1。结论：所建立的方法可行，可用于叔丁醇的细菌内毒素检查。
目的：建立叔丁醇細菌內毒素檢查方法。方法：採用2箇不同廠傢的鱟試劑和3批樣品，進行預榦擾試驗和榦擾試驗。結果：供試品溶液對鱟試劑與細菌內毒素之間的凝集反應無榦擾；樣品的細菌內毒素限值確定為0.25 EU·ml-1。結論：所建立的方法可行，可用于叔丁醇的細菌內毒素檢查。
목적：건립숙정순세균내독소검사방법。방법：채용2개불동엄가적후시제화3비양품，진행예간우시험화간우시험。결과：공시품용액대후시제여세균내독소지간적응집반응무간우；양품적세균내독소한치학정위0.25 EU·ml-1。결론：소건립적방법가행，가용우숙정순적세균내독소검사。
Objective:To establish a method for the detection of bacterial endotoxins in tertiary butyl alcohol. Methods:The in-terference experiment and bacterial endotoxins test for 3 batches of the products from 2 companies were carried out with tachypleus ame-bocyte lysate. Results:There was no interference in the bacterial endotoxins test. The limit of bacterial endotoxins was 0. 25 EU/ml. Conclusion:The established method of bacterial endotoxins test is feasible for tertiary butyl alcohol.
