| 特异性鲎试剂检查生脉注射液细菌内毒素 |
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| 引用本文： | 黄东燕,章丽佳,罗梓河,黄俊斌. 特异性鲎试剂检查生脉注射液细菌内毒素[J]. 中国现代应用药学, 2005, 22(4): 325-328 |
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| 作者姓名： | 黄东燕 章丽佳 罗梓河 黄俊斌 |
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| 作者单位： | 汕头市中心医院,广东,汕头,515031 |
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| 摘 要： | 目的建立生脉注射液的细茵内毒素检查方法，以控制药品质量。方法按中国药典2000年版二部检查法，考察生脉注射液对细茵内毒素检查法的干扰。结果确定生脉注射液细茵内毒素限值为3．75EU／mL，最佳检测条件为供试品稀释10倍，特异性鲎试剂灵敏度为0．25EU／mL。结论用特异性鲎试剂检查生脉注射液细茵内毒素，方法简便、灵敏、准确、重现性好．可替代家兔法用于生脉注射液的热原检查。
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| 关 键 词： | 特异性鲎试剂 生脉注射液 抑制增强试验 细菌内毒素 |
| 文章编号： | 1007-7693（2005）04-0325-04 |
| 收稿时间： | 2003-10-20 |
| 修稿时间： | 2003-10-20 |
Detection of bacterial endotoxins of Shengmai injection with TAL ES-TEST |
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| HUANG Dong-yan,ZHANG Li-ji,LUO Zi-he,HUANG Jun-bin. Detection of bacterial endotoxins of Shengmai injection with TAL ES-TEST[J]. The Chinese Journal of Modern Applied Pharmacy, 2005, 22(4): 325-328 |
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| Authors: | HUANG Dong-yan ZHANG Li-ji LUO Zi-he HUANG Jun-bin |
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| Abstract: | OBJECTIVE To establish a method for the test of bacterial endotoxins in order to replace the test for pyrogen in Shengmai injection. METHODS The inhibition and enhancement test were carried out by tachypleus amebocyte lysate ES-Test according to the bacteria endotoxin content by Chinese Pharmacopoeia (2000). RESULTS The bacterial endotoxins limit value of Shengmai injection was 3.75EU/mL and the experiment showed that the interference elements could be excluded by diluting Shengmai injection 10 times. CONCLUSION The method is convenient,sensitive,accurate and can replaces the pyrogen test of Shengmai injection. |
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| Keywords: | tachypleus amebocyte lysate ES Test (TAL ES Test) Shengmai injection inhibition and enhancement test bacterial endotoxins |
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