摘要
目的比较两种医疗器械中环氧乙烷残留量的测定方法。方法分别用比色分析法和气相色谱法测定不同材质医疗器械的环氧乙烷残留量,比较其测定结果。结果对于塑料材质的一次性使用医疗器械,两种方法的测定结果不存在显著差异(P>0.05);对于敷料敷贴等医疗器械,两种方法的测定结果存在显著差异(P<0.01)。结论比色分析法不适合于测定敷料敷贴等医疗器械的环氧乙烷残留量。
OBJECTIVE To compare two method for the determination of ethylene oxide in medical instruments. METHODS The ethylene oxide in different medical instruments was determined by colorimetry and GC.RESULTS In medical instruments made from plastic, the results determined by two method are similar(P 〉0.05). And in medical instruments such as adhesive bandage, the results determined by two method are absolutely different(P 〈 0.01). CONCLUSION The colorimetry is unsuitable for the determination of ethylene oxide in medical instruments such as adhesive bandage.
出处
《海峡药学》
2010年第8期83-84,共2页
Strait Pharmaceutical Journal