动态浊度法定量检测替硝唑注射液中内毒素研究  

Measurement of endotoxin in tinidazole injection using the kinetic-tur bidimetric technique

作　　者：苑庆华[1] 芮菁[1] 华晓东[1] 唐元泰[1] 

机构地区：[1]天津市药品检验所,天津300070

出　　处：《中国药学杂志》2003年第12期952-954,共3页Chinese Pharmaceutical Journal

基　　金：天津市科委自然基金项目 (No .0 0 0 2 61)

摘　　要：目的　对替硝唑注射液进行细菌内毒素动态浊度法检查实验 ,建立定量检测替硝唑注射液中细菌内毒素实验方法。方法　采用中国药典 2 0 0 0年版附录检测细菌内毒素动态比浊法。结果　替硝唑注射液用定量鲎试剂检测无干扰因素影响 ,内毒素回收率在 5 0 %～ 2 0 0 %范围内。OBJECTIVE: To establish the kinetic-turbidimetric technique for practical quality control on endotoxin content in tinidazole injection. METHODS: The kinetic-turbidimetric technique in Chinese pharmacopoeia 2000 edition was used. Interfence factors were investigated. RESULTS: Endotoxin spiked to tinidazole injection was recovered in a quantitative manner and neither inhibition nor enhancement effect was found. The endotoxin recovery was more than 50 percent and less than 200 percent. CONCLUSION: These results suggested that the kinetic-turbidimetric technique for bacterial endotoxin test was suitable for the detection of endotoxin in tinidazole injection.

关 键 词：动态浊度法 定量检测 替硝唑 注射液 内毒素 

分 类 号：R927.12[医药卫生—药学]