摘要
目的:建立测定多西他赛注射液中细菌内毒素含量的方法。方法:采用动态浊度法。确立细菌内毒素检查的标准曲线及稀释倍数,通过测定供试液中外加内毒素的回收率进行干扰试验,确定样品检测浓度线性范围,并定量测定样品中的细菌内毒素。结果:内毒素检测浓度线性范围为0.03125～2.0EU·mL-1(r=-0.9999);样品在稀释12～96倍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:动态浊度法可用于多西他赛注射液中细菌内毒素的定量检测。
OBJECTIVE：To establishment a method for determine the concentration of bacterial endotoxin in Docetaxel injection.METHODS：Kinetic turbidimetric method was adopted to generate the standard curve and dilution rate of test sample.Bacterial endotoxin was added into test sample for interference test.Linear range and bacterial endotoxin in samples were determined.RESULTS：The linear range of bacterial endotoxin was 0.031 25～2.0 EU·mL -1 （r=-0.999 9）.The endotoxin test wasn＇t interfered by 12～96 times diluted solution.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 kinetic turbidimetric method is suitable for bacterial endotoxin test of Docetaxel injection.
出处
《中国药房》
CAS
CSCD
北大核心
2011年第1期54-55,共2页
China Pharmacy
关键词
多西他赛注射液
细菌内毒素
动态浊度法
含量测定
Docetaxel injection
Bacterial endotoxin
Kinetic turbidimetric method
Content determination
