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替加氟注射液的细菌内毒素检查
引用本文:李琪波.替加氟注射液的细菌内毒素检查[J].海峡药学,2010,22(11):81-82.
作者姓名:李琪波
作者单位:浙江省奉化市人民医院药剂科,奉化,315500
摘    要:目的建立检测替加氟注射液中细菌内毒素的实验方法;方法按2005年版《中国药典》二部附录ⅪE细菌内毒素检查法进行试验;结果替加氟注射液在稀释浓度30倍(1.67mg·mL-1)下对细菌内毒素检查法无干扰作用,其细茵内毒素限值L为0.15EU·mg-1;结论采用细菌内毒素检查法检测替加氟注射液的细菌内毒素是可行的。

关 键 词:替加氟注射液  细菌内毒素  干扰试验

Tegafur injection of bacterial endotoxin detection method
LI Qi-bo.Tegafur injection of bacterial endotoxin detection method[J].Strait Pharmaceutical Journal,2010,22(11):81-82.
Authors:LI Qi-bo
Institution:LI Qi-bo(Department of Pharmacy,Fenghua People's Hospital,Zhejiang,Fenghua 315500,China)
Abstract:OBJECTIVE To establish a method for the bacterial endotoxins test of Tegafur injection.METHODS The test was operated according to the method for examination of the bacterial endotoxin test in Ch.P(2005)Vol Ⅱ.RESULTS Tegafur injection in diluted concentrations(1.67mg·mL-1)under the bacterial endotoxin test for the role of non-interference,its bacteriological endotoxin limit of L=0.15EU·mg-1.CONCLUSION Use of bacterial endotoxin detection method checks Tegafur injection of bacterial endotoxin is feasible.
Keywords:Tegafur injection  Bacterial endotoxin  Interference experiment
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