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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 understand whether the leaching solution of medical devices and biomaterials can be filtered or centrifuged before pyrogen experiments. Methods The bacterial endotoxin content in the original solution with a concentration of 0.2 EU / mL was determined by the dynamic turbidity method of detecting the bacterial endotoxin in the appendix of Chinese Pharmacopoeia (2010 Edition) (Part 2). After the filtration and centrifugation, the solution In bacterial endotoxin content. Results The bacterial endotoxin content in the solution was greatly reduced after filtration, even less than 0.040 EU / mL. Centrifugation will not affect the bacterial endotoxin content of the solution, and the content of the stock solution is similar, 0.260 EU / mL. Conclusion In order to remove suspended particles from the leaching solution of medical devices and biomaterials, the pyrogen test can be performed after centrifugation.