摘要
目的了解医疗器械和生物材料的浸提液能否过滤或离心后再进行热原实验。方法采用《中国药典》2010年版(二部)附录检测细菌内毒素的动态浊度法,进行定量测定浓度为0.2 EU/mL的原液中的细菌内毒素含量,并在过滤和离心后分别测定溶液中细菌内毒素的含量。结果溶液中的细菌内毒素含量过滤后大大减少,甚至小于0.040 EU/mL。离心则不会影响溶液中的细菌内毒素含量,与原液中含量相近,为0.260 EU/mL。结论为除去医疗器械和生物材料的浸提液中的悬浮颗粒,可以离心后再进行热原实验。
Objective To confirm the influence of filtration or centrifugation on pyrogen test.Methods Kinetic turbidity test was performed to detect bacterial endotoxin concentration in the solution after filtration or centrifugation according to the 2010 Edition of Chinese Pharmacopoeia.The endotoxin concentration in the primary solution（0.2 EU/mL） was detected after filtration and centrifugation,respectively.Results The bacterial endotoxin concentration in the solution were reduced after filtration（less than 0.040 EU/mL remaining）,whereas centrifugation didn’t influence the endotoxin concentration in the solution（0.260 EU/mL remaining）.Conclusion It is demonstrated that centrifugation could be utilized to eliminate particles in the solution for pyrogen test.
出处
《生物医学工程与临床》
CAS
2011年第5期417-419,共3页
Biomedical Engineering and Clinical Medicine
关键词
热原实验
动态浊度法
过滤
离心
pyrogen test
kinetic turbidity method
fihration
centrifugation
