海峡药学
海峽藥學
해협약학
STRAIT PHARMACEUTICAL JOURNAL
2015年
4期
50-52
,共3页
红花注射液%细菌内毒素检查%动态浊度法
紅花註射液%細菌內毒素檢查%動態濁度法
홍화주사액%세균내독소검사%동태탁도법
Honghua Injection%Bacterial endotoxins test%Kinetic turbidimetric limulus test
目的：建立动态浊度法测定红花注射液中细菌内毒素的含量。方法采用动态浊度法，通过测定供试液中外加内毒素的回收率进行干扰试验，确定样品无干扰浓度，并定量样品中细菌内毒素。结果内毒素检查质量浓度线性范围为0．03125～2．0EU? mL －1（r＝0．9966），样品在稀释10倍以上对试验无干扰，细菌内毒素回收率在50％～200％范围内，样品中内毒素可定量测定。结论动态浊度法可用于红花注射液中细菌内毒素的含量检测。
目的：建立動態濁度法測定紅花註射液中細菌內毒素的含量。方法採用動態濁度法，通過測定供試液中外加內毒素的迴收率進行榦擾試驗，確定樣品無榦擾濃度，併定量樣品中細菌內毒素。結果內毒素檢查質量濃度線性範圍為0．03125～2．0EU? mL －1（r＝0．9966），樣品在稀釋10倍以上對試驗無榦擾，細菌內毒素迴收率在50％～200％範圍內，樣品中內毒素可定量測定。結論動態濁度法可用于紅花註射液中細菌內毒素的含量檢測。
목적：건립동태탁도법측정홍화주사액중세균내독소적함량。방법채용동태탁도법，통과측정공시액중외가내독소적회수솔진행간우시험，학정양품무간우농도，병정량양품중세균내독소。결과내독소검사질량농도선성범위위0．03125～2．0EU? mL －1（r＝0．9966），양품재희석10배이상대시험무간우，세균내독소회수솔재50％～200％범위내，양품중내독소가정량측정。결론동태탁도법가용우홍화주사액중세균내독소적함량검측。
OBJECTIVE To establish a method for determining the content of bacterial endotoxin in Honghua Injection.METHODS Using Kinetic Turbidimetric Limulus Method, sample was confirmed without interference, and bacterial endotoxin in the sample was quantitated by interference test with measuring the endotoxin additional in test liquid.RESULTS The linear range of bacterial endotoxin detection concentration was 0.31~2.0 EU? mL-1 ( r=0.9981 );the sample under Diluted 10 times had no interference to test.The recovery rate of bacterial endotoxin was within the range of 50%~200%.The bacterial endotoxin content in the sample could be quantitatively deter-mined.CONCLUSION The kinetic turbidimetric limulus method can be used to the quantitative determination of bacterial endotoxin in Honghua Injection.
