摘要
为获得静脉途径镍暴露的NOAEL以便科学高效地评价含镍医疗器械的生物相容性,该研究通过两个阶段,第一阶段4.9、3.7、2.5 mg/(kg·d),第二阶段1.2及0.25 mg/(kg·d),共5个剂量组以连续14 d静脉给予SD大鼠含镍离子(Ni^2+)溶液的方式,研究镍对大鼠的亚慢性全身毒性作用,结果显示当给予镍离子剂量为0.25 mg/(kg·d)时,大鼠未表现出亚慢性全身毒性反应,并经镍钛合金材料验证该结论。由此以100倍安全因子推算,对于体重60 kg成人,镍离子的TTC为150μg/d。
The purpose of this study was to investigate the NOAEL of the nickel ion and provide with basic data for the biological evaluation of those medical devices containing nickel.Five groups SD rats were repeatedly exposed during 14 d respectively to nickel at first stage doses of 4.9,3.7,2.5 mg/(kg.d),and the second stage doses of 1.2,0.25 mg/(kg.d)by the intravenous route.The results showed that the NOAEL of nickel ion is 0.25 mg/(kg.d)for SD rats,and the result was verified by subchronic systemic toxicity test of nickel alloy.The threshold of toxicological concern(TTC)of nickel is 150μg/d(based on application of 100-fold uncertainty factor and a body weight of 60 kg)deduced by these data.
作者
贺学英
汤菊莉
温贤涛
管博
王蕊
王辉
李华
史建峰
曾亚力
毛永建
HE Xueying;TANG Juli;WEN Xiantao;GUAN Bo;WANG Rui;WANG Hui;LI Hua;SHI Jianfeng;ZENG Yali;MAO Yongjian(Beijing Institute of Medical Device Testing,Beijing,101111;Beijing Key Laboratory of Medical Device Testing and Safety Evaluation,Beijing,101111)
出处
《中国医疗器械杂志》
2020年第5期448-452,共5页
Chinese Journal of Medical Instrumentation
基金
首都卫生发展科研专项课题(2011-3001-02)。
关键词
镍
医疗器械
未观察到有害作用剂量
毒理学关注阈值(TTC)
生物相容性
nickel
medical devices
No Observed Adverse Effect Level(NOAEL)
threshold of toxicological concern(TTC)
biocompatibility
