| 肝素钠注射液中细菌内毒素的检测 |
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| 引用本文： | 马静芬,陈长水.肝素钠注射液中细菌内毒素的检测[J].华西药学杂志,2003,18(4):304-306. |
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| 作者姓名： | 马静芬 陈长水 |
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| 作者单位： | 1. 宁波市药品检验所,浙江,宁波,315040
2. 宁波市中心血站,浙江,宁波,315040 |
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| 摘 要： | 目的 建立肝素钠注射液中细菌内毒素的检查方法。方法 采用中国药典2000年版附录细菌内毒素检查法。结果 肝素钠注射液在稀释至250倍时对细菌内毒素的检查无干扰。结论 所用方法检查肝素钠注射液中细菌内毒素可行，可用细菌内毒素检查法代替家兔热原检查法。
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| 关 键 词： | 肝素钠注射液 抗凝血药 热原检查 细菌内毒素检查法 |
| 文章编号： | 1006-0103(2003)04-0304-03 |
Study on the bacterial endotoxin test in Heparin sodium injection |
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| MA Jing-fen ,CHEN Zhang-shui . Ningbo Municipal Institute for Drug Control,Ningbo ,China, . Ningbo Centre for Blood Supply,Ningbo ,China.Study on the bacterial endotoxin test in Heparin sodium injection[J].West China Journal of Pharmaceutical Sciences,2003,18(4):304-306. |
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| Authors: | MA Jing-fen CHEN Zhang-shui Ningbo Municipal Institute for Drug Control Ningbo China Ningbo Centre for Blood Supply Ningbo China |
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| Institution: | MA Jing-fen 1,CHEN Zhang-shui 2 1. Ningbo Municipal Institute for Drug Control,Ningbo 315040,China, 2. Ningbo Centre for Blood Supply,Ningbo 315040,China |
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| Abstract: | OBJECTIVE To establish a method for control endotoxin in Heparin sodium injection.METHOD Bacterial endotoxin test approved by Chinese Pharmacopoeia (edition 2000) was adopted. RESULTS The bacterial endotoxin test showed neither inhibition nor enhancement in diluted solution.CONCLUSION These results suggest that the technique of TAL-test could be used to replace the rabbit pyrogen test for Heparin sodium injection. |
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| Keywords: | Heparin sodium injection Bacterial endotoxin test Interfere factors test Tachypleus amebocyte lysate (TAL) |
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