摘要
目的建立丙泊酚中细菌内毒素定量测定的动态浊度法。方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,定量测定样品中的细菌内毒素含量。结果内毒素检测浓度线性范围为0.031 25~2.0 EU/m L(r=-0.995 4);样品在稀释成1.25 g/L及以下时对试验无干扰作用,细菌内毒素回收率为50%~200%;3批样品的内毒素定量测定结果符合规定。结论丙泊酚中细菌内毒素的定量检测用动态浊度法可行。
Objective To establish a kinetic turbidimetric assay （ KTA ） method for determine the concentration of bacterial endotoxin in propofol. Methods Bacterial endotoxin was added into test sample for interference test, and the recovery rate was determined, no inter-ference concentration was determined for the sample. The linear range and bacterial endotoxin in samples were determined. Results The linear range of bacterial endotoxin was 0. 03125-2. 0 EU/mL （ r= -0. 9954 ） . The sample had no interference to the test when it is diluted to 1. 25 g/L and below. The recovery rate of bacterial endotoxin was 50% -200%. The concentration of endotoxin in the 3 batches of samples met the requirements for bacterial endotoxins. Conclusion The KTA method is suitable for the content determination of bacterial endotoxin in propofol.
作者
杨柳
Yang Liu(Chongqing Institute for Food and Drug Control, Chongqing Engineering Research Center for Pharmaceutical Process and Quality Control, Chongqing, China 401121)
出处
《中国药业》
CAS
2017年第13期28-30,共3页
China Pharmaceuticals
关键词
丙泊酚
细菌内毒素
动态浊度法
含量
propofol
bacterial endotoxin
kinetic turbidimetric assay
content
