中国医疗器械信息
中國醫療器械信息
중국의료기계신식
CHINA MEDICAL DEVICES INFORMATION
2015年
2期
45-49
,共5页
范春光%孙立魁%刘成虎%李娜%侯丽
範春光%孫立魁%劉成虎%李娜%侯麗
범춘광%손립괴%류성호%리나%후려
热原检测%IL-1β%体外法%医疗器械
熱原檢測%IL-1β%體外法%醫療器械
열원검측%IL-1β%체외법%의료기계
pyrogen test%IL-1β%in vitro%medical devices
目的：探讨人全血IL-1β试验在医疗器械热原体外检测中应用的可行性。方法：该研究采用梯度稀释的内毒素O113与人新鲜全血孵育，检测上清所含I L-1β的量并建立标准曲线；采用脂磷壁酸（LTA）溶液与新鲜人全血孵育，检测上清所含I L-1β的量并根据回归方程计算出LTA溶液的内毒素当量。结果：成功建立标准曲线，并计算出LTA溶液的内毒素当量。结论：经分析比较，该研究认为人全血IL-1β试验可用于医疗器械热原检测并能弥补传统方法的诸多不足。
目的：探討人全血IL-1β試驗在醫療器械熱原體外檢測中應用的可行性。方法：該研究採用梯度稀釋的內毒素O113與人新鮮全血孵育，檢測上清所含I L-1β的量併建立標準麯線；採用脂燐壁痠（LTA）溶液與新鮮人全血孵育，檢測上清所含I L-1β的量併根據迴歸方程計算齣LTA溶液的內毒素噹量。結果：成功建立標準麯線，併計算齣LTA溶液的內毒素噹量。結論：經分析比較，該研究認為人全血IL-1β試驗可用于醫療器械熱原檢測併能瀰補傳統方法的諸多不足。
목적：탐토인전혈IL-1β시험재의료기계열원체외검측중응용적가행성。방법：해연구채용제도희석적내독소O113여인신선전혈부육，검측상청소함I L-1β적량병건립표준곡선；채용지린벽산（LTA）용액여신선인전혈부육，검측상청소함I L-1β적량병근거회귀방정계산출LTA용액적내독소당량。결과：성공건립표준곡선，병계산출LTA용액적내독소당량。결론：경분석비교，해연구인위인전혈IL-1β시험가용우의료기계열원검측병능미보전통방법적제다불족。
Purpose: To investigate the feasibility of applying human whole blood test for IL-1β into in vitro pyrogen test for medical devices. Methods: Gradient diluted endotoxin O113 was incubated in human fresh blood and the content of IL-1β in supernatant was assayed to found standard curve. Lipoteichoicacid (LTA) solution was incubated in human fresh blood and the content of IL-1β in supernatant was also assayed to calculate its endotoxin equivalent weight according to regression equation.Results: standard curve was founded successfuly and endotoxin equivalent weight of LTA solution was gained.Conclusions: According to the analysis and comparison, human whole blood test for IL-1β could be applied into in vitro pyrogen test for medical devices, which could make up the shortages of traditional methods.
