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Volume 29 Issue 2
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Article Navigation >  Journal of Pharmaceutical Practice and Service  > 2011  >  29(2): 120-121,148

FU Cong, GAO Jin, JI Yang, NIE Yu-qiong, CHENG Yang, FU Xiao-fei. Research on bacterial endotoxin test for compound sodium lactate injection No.3[J]. Journal of Pharmaceutical Practice and Service, 2011, 29(2): 120-121,148.
Citation: FU Cong, GAO Jin, JI Yang, NIE Yu-qiong, CHENG Yang, FU Xiao-fei. Research on bacterial endotoxin test for compound sodium lactate injection No.3[J]. Journal of Pharmaceutical Practice and Service, 2011, 29(2): 120-121,148.
shu

Research on bacterial endotoxin test for compound sodium lactate injection No.3

  • 1.

    No. 307 Hospital of PLA ,Beijing 100071,China

  • 2.

    Institute for Drug and Instrument Control of Health Department of PLA ,Beijing 100071,China

  • Received Date: 2010-12-22
  • Rev Recd Date: 2011-01-18
  • Objective To establish the method of bacterial endotoxin test for compound sodium lactate injection No.3. Methods The method based on the bacterial endotoxin test in Chinese pharmacopoeia 2005 edition was used. Results Neither inhibition nor enhancement was found in the bacterial eddotoxin interfere factors test after the drug was diluted and the sensitivity of TAL was 0.25 EU/ml. Conclusion The results suggested that bacterial endotoxin test was suitable for the detection of endotoxin in compound sodium lactate injection No.3 and the bacterial endotoxin limit is 0.5 EU/ml.
  • [1] 中国人民解放军总后勤部卫生部.中国人民解放军医疗机构制剂规范2002年版[S].北京:人民军医出版社,2002:302.
    [2] 中国药典.2005年版二部[S]. 化学工业出版社,附录,2005:85,88.
    [3] 高 锦,付 聪,嵇 扬,等.甲硫酸新斯的明注射液细菌内毒素检查方法的研究[J].药物分析杂志,2008,28(7):1141.
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  • 1. 

    沈阳化工大学材料科学与工程学院 沈阳 110142

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Research on bacterial endotoxin test for compound sodium lactate injection No.3

  • 1. No. 307 Hospital of PLA ,Beijing 100071,China
  • 2. Institute for Drug and Instrument Control of Health Department of PLA ,Beijing 100071,China
  • Received Date: 2010-12-22
  • Rev Recd Date: 2011-01-18

Abstract: Objective To establish the method of bacterial endotoxin test for compound sodium lactate injection No.3. Methods The method based on the bacterial endotoxin test in Chinese pharmacopoeia 2005 edition was used. Results Neither inhibition nor enhancement was found in the bacterial eddotoxin interfere factors test after the drug was diluted and the sensitivity of TAL was 0.25 EU/ml. Conclusion The results suggested that bacterial endotoxin test was suitable for the detection of endotoxin in compound sodium lactate injection No.3 and the bacterial endotoxin limit is 0.5 EU/ml.

FU Cong, GAO Jin, JI Yang, NIE Yu-qiong, CHENG Yang, FU Xiao-fei. Research on bacterial endotoxin test for compound sodium lactate injection No.3[J]. Journal of Pharmaceutical Practice and Service, 2011, 29(2): 120-121,148.
Citation: FU Cong, GAO Jin, JI Yang, NIE Yu-qiong, CHENG Yang, FU Xiao-fei. Research on bacterial endotoxin test for compound sodium lactate injection No.3[J]. Journal of Pharmaceutical Practice and Service, 2011, 29(2): 120-121,148.
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