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.
出处
《药物分析杂志》
CAS
CSCD
北大核心
2001年第4期293-295,共3页
Chinese Journal of Pharmaceutical Analysis
