中国药房2011，Vol.22Issue(1)：54-55,2.
动态浊度法测定多西他赛注射液中细菌内毒素的含量
Content Determination of Bacterial Endotoxin in Docetaxel Injection by Kinetic Turbidimetric Method
祝清芬 1魏霞1
作者信息
- 1. 山东省药品检验所药理室,济南市,250101
- 折叠
摘要
Abstract
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 Docetaxei injection.关键词
多西他赛注射液/细菌内毒素/动态浊度法/含量测定分类
医药卫生引用本文复制引用
祝清芬,魏霞..动态浊度法测定多西他赛注射液中细菌内毒素的含量[J].中国药房,2011,22(1):54-55,2.
