右旋糖酐20葡萄糖注射液中细菌内毒素定量检查研究  

Application of the Turbidimetric-kinetic Method for the Measurement of Endotoxin in Dextran 20 Glucose Injection

作　　者：苑庆华[1] 唐元泰[1] 赵海山[2] 贡立青[2] 

机构地区：[1]天津市药品检验所,300070 [2]天津大学无线电厂,300072

出　　处：《药物分析杂志》2001年第4期293-295,共3页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的 :对右旋糖酐 2 0葡萄糖注射液进行细菌内毒素回收干扰试验 ,建立定量检测右旋糖酐 2 0葡萄糖注射液中污染内毒素试验方法。方法 :采用中国药典 2 0 0 0年版附录检测细菌内毒素的动态浊度法。结果 :右旋糖酐 2 0葡萄糖注射液用细菌内毒素定量检测无干扰因素影响 ,内毒素回收率在 5 0 %～ 2 0 0 %范围内。结论 :使用内毒素动态浊度法定量检测右旋糖酐 2 0葡萄糖注射液的污染内毒素是可行的 。Objective:Application of the turbidimetric-kinetic method for practical quality control on endotoxin content in dextran 20 glucose injection.Methods:Accoding to the turbidimetric-kinetic method and eliminated interfere factors approved by Chinese pharmacopoeia 2000 edition.Results and Conclusions:Endotoxin added to dextran 20 glucose injection was recovered in a quantitative manner showing neither inhibition nor enhancement,the endotoxin recovery is more than 50 per cent and less than 200 per cent.These results suggest that the LAL-test could be used as an alternative method for the rabbit pyrogen test to dextran 20 glucose injection.

关 键 词：右旋糖酐20葡萄糖注射液 细菌内毒素 动态浊度法 干扰试验 定量检查 

分 类 号：R973.5[医药卫生—药品] R927.12[医药卫生—药学]