摘要
目的:探讨次氯酸伤口抗菌液体敷料的细菌内毒素检测方法。方法:依据《中华人民共和国药典》2015年版1143细菌内毒素检查法,考察次氯酸伤口抗菌液体敷料对细菌内毒素检查的干扰作用,确定其最大不干扰浓度。结果:次氯酸伤口抗菌液体敷料在稀释8倍时对细菌内毒素试验无干扰作用,其细菌内毒素限值符合规定。结论:使用鲎试剂检查次氯酸伤口抗菌液体敷料的细菌内毒素是可行的。
Objective:To research the reviewed method of bacterium endotoxin test method for hypochlorite wound antisepti dressing.Method:The bacterium endotoxintests were performed to detect valid dilution concentration and limit value according to the Chinese Pharmacopoeia2015edition.Result:The diluent of samplewhich was diluted8times didn’t disturb the bacterium endotoxin test and the limit value accord with demand.Conclusion:This method of bacterial endotoxindetection can ensure that hypochlorite wound antisepti dressing meet the requirements.
作者
刘茜
刘兴辰
严小莉
高静贤
LIU Qian;LIU Xing-chen;YAN Xiao-li;GAO Jing-xian(Jiangsu Province Institute for MedicaL Equipment Testing,Jiangsu Nanjing 210022)
出处
《中国医疗器械信息》
2017年第11期61-63,共3页
China Medical Device Information