家兔法与内毒素法检查生物材料热原的适用性研究

药品与生物材料在生物安全性评价方法上有着很大的区别。临床上广泛运用内毒素法检查药品热原,然而,运用细菌内毒素法进行部分组成成分较为复杂的生物材料的热原试验是否适当有待明确。本研究在2005版药典的基础上,分别运用内毒素法和家兔法对两种组织工程支架材料进行热原试验的比较研究,实验结果表明运用内毒素法得到的试验结果为阴性,运用家兔法得到的试验结果为阳性。这两种方法分别测定每种材料所得到的热原试验结果不相符合,表明对组成成分复杂的生物材料,含热原的因素较为复杂,用家兔法进行试验检测热原可能更加灵敏。

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

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.The pyrogen test result was not accord with the two methodes.The result indicated the pyrogen for the product of some biomaterials was complicated.The rabbit test method is more safe and reliable than the bacteria endotoxin test method.