| 两种生物材料细菌内毒素检查和热原检查方法比较的研究 |
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| 引用本文： | 温庭民,祝君梅,姜华,史弘道. 两种生物材料细菌内毒素检查和热原检查方法比较的研究[J]. 生物医学工程与临床, 2001, 5(4): 193-194 |
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| 作者姓名： | 温庭民 祝君梅 姜华 史弘道 |
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| 作者单位： | 天津市医药科学研究所, |
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| 摘 要： | 目的本试验对样品管腔支架(镍钛)和支架输送系统进行热原检测.方法采用细菌内毒素检查和家兔检查法.结果细菌内毒素试验表明,两样品不合格;热原试验表明,两样品合格.结论导致鲎试剂凝集不一定就能引起生物体的热原反应.出现这种不相一致结果的原因很多.所以在评价生物材料和医疗器械时,建议做热原试验.
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| 关 键 词： | 生物材料 细菌内毒素试验 热原试验 生物学评价 |
| 文章编号： | 1009-7090(2001)04-0193-02 |
| 修稿时间： | 2001-04-12 |
Comparative Study on Bacterial Endotoxin Test and Pyrogen Test in Evaluation of Two Bionaterials |
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| WEN Ting-min,ZHU Jun-mei,JIANG Hua,SHI Hong-dao Tianjin Institute of Medical and Pharmaceutical Sciences,Tianjin. Comparative Study on Bacterial Endotoxin Test and Pyrogen Test in Evaluation of Two Bionaterials[J]. Biomedical Engineering and Clinical Medicine, 2001, 5(4): 193-194 |
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| Authors: | WEN Ting-min ZHU Jun-mei JIANG Hua SHI Hong-dao Tianjin Institute of Medical Pharmaceutical Sciences Tianjin |
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| Affiliation: | WEN Ting-min,ZHU Jun-mei,JIANG Hua,SHI Hong-dao Tianjin Institute of Medical and Pharmaceutical Sciences,Tianjin 300070 |
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| Abstract: | Objective The pyrogen test was performed in NiTi stent and its delivery system.Methods Bacterial endotoxin test and rabbit test were adopted in this experiment.Results It was demonstrated the two samples that had passed pyrogen test but both were not qualified by bacterial endotoxin test.Conclusion The result of agglutination in limulus lysate test for a biomaterial is not associated with the positive pyrogen test. The reasons in causing the inconsistent result are various. Thus the pyrogen test is suggested in evaluation biomaterials and medical instruments. |
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| Keywords: | biomaterial bacterial endotoxin test pyrogen test biological evaluation |
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