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家兔法与内毒素法检查生物材料热原的适用性研究

邹文 袁暾 蔡永福 梁洁

生物医学工程研究2011,Vol.30Issue(3):155-158,4.
生物医学工程研究2011,Vol.30Issue(3):155-158,4.

家兔法与内毒素法检查生物材料热原的适用性研究

Applicability Research for the Bacteria Endotoxin Test Method and Rabbit test Method to Detect Pyrogen

邹文 1袁暾 2蔡永福 1梁洁2

作者信息

  • 1. 四川大学国家生物医学材料工程技术研究中心,成都610064
  • 2. 四川医疗器械生物材料和制品检验中心,成都610064
  • 折叠

摘要

Abstract

To evaluate drugs and biomaterials have great difference. Bacteria endotoxin test was widely applied to detect drug pyrogen. However, if it is Appropriate to detect pyrogen by bacteria endotoxin test for some materials which has complex components, this must to be definituded. At the base of pharmacopoeia (2005), pyrogen was detected for each tissue engineering bioamterial to use rabbit method and the bacteria endotoxin method individually. The result was indicated to be negative for the bacteria endotoxin method and positive for the rabbit method. Hie pyrogen test result was not accord with the two methodes. The result indicated the pyrogen for the product of some biomaterialfc was complicated. The rabbit test method is more safe and reliable than the bacteria endotoxin test method.

关键词

生物材料/热原试验/内毒素法/家兔法/温度变化

Key words

Biomateiial/ Pyrogen/ Endotoxin test/Test method for rabbit/Change of temperature

分类

医药卫生

引用本文复制引用

邹文,袁暾,蔡永福,梁洁..家兔法与内毒素法检查生物材料热原的适用性研究[J].生物医学工程研究,2011,30(3):155-158,4.

基金项目

四川大学青年教师科研启动基金资助项目(2900904134002) (2900904134002)

生物医学工程研究

OACSTPCD

1672-6278

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