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不同振荡速率制备阳性对照在医疗器械生物学评价中的应用 被引量:2
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作者 孙晓霞 黄经春 +3 位作者 王鸾鸾 王昕 侯丽 王瑾晔 《中国医疗设备》 2017年第2期5-8,共4页
医疗器械生物学评价中试验样品制备的标准化是保证其试验结果具有可靠性和可比性的关键。为了进一步明确样品制备过程中振荡速率对浸提液溶出物的影响,本研究以国际标准ISO10993-12:2007中推荐的阳性标准物质(SPU-ZDEC)为试验样品,检测... 医疗器械生物学评价中试验样品制备的标准化是保证其试验结果具有可靠性和可比性的关键。为了进一步明确样品制备过程中振荡速率对浸提液溶出物的影响,本研究以国际标准ISO10993-12:2007中推荐的阳性标准物质(SPU-ZDEC)为试验样品,检测了不同振荡速度下浸提液的细胞毒性。结果表明,医疗器械生物学实验中不同的样品振荡速率对检测结果具有显著影响,本研究对于今后标准制定中规定样品制备的标准化问题提供可靠的实验依据,有着重要的参考意义。 展开更多
关键词 二乙基二硫代氨基甲酸锌 细胞毒性 振荡速率 恒温培养振荡器 酶标仪
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Human urinary occurrence of dithiocarbamate vulcanization accelerators and their exposure estimation
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作者 Zhenling Fu Hangbiao Jin +1 位作者 Ruyue Guo Weili Mao 《Emerging Contaminants》 2025年第2期374-380,共7页
Dithiocarbamate vulcanization accelerators (DVAs) are widely used in rubber manufacturing, yet their potential human exposure and associated health risks remain poorly understood. Previous studies have identified DVAs... Dithiocarbamate vulcanization accelerators (DVAs) are widely used in rubber manufacturing, yet their potential human exposure and associated health risks remain poorly understood. Previous studies have identified DVAs in various environmental matrices, such as dust and sediments, but their occurrence in human biological samples has not been investigated. This study aims to fill this critical research gap by conducting the first comprehensive biomonitoring assessment of DVAs in human urine, providing direct evidence of human exposure. A total of 263 urine samples were collected from Chinese adults and analyzed for eight DVAs. Seven out of eight target compounds were detected, with detection frequencies ranging from 14 % to 94 %. Zinc diethyldithiocarbamate (ZDEC) was the predominant compound, with a mean concentration of 1.6 ng/mL (range: <LOD–12 ng/mL). Notably, males exhibited significantly higher urinary levels of ZDEC (1.7 ± 0.28 ng/mL vs. 1.3 ± 0.33 ng/mL;p = 0.021) and zinc dibutyldithiocarbamate (ZDBC;0.78 ± 0.18 ng/mL vs. 0.50 ± 0.10 ng/mL;p = 0.017) compared to females, while urinary concentrations of ZDEC and zinc dibenzyldithiocarbamate (ZBEC) were inversely correlated with age. Daily exposure (DE) estimation revealed that ZDEC had the highest mean DE value at 48 ng/kg bw/day, followed by ZEPC (29 ng/kg bw/day) and ZDBC (21 ng/kg bw/day). These findings provide essential insights into human exposure patterns to DVAs, offering a scientific basis for future risk assessment and regulatory considerations. Given the widespread detection of these compounds and their potential toxicity, further research is warranted to elucidate their health implications and major exposure pathways. 展开更多
关键词 ZDBC zdec Dithiocarbamate vulcanization accelerators Urinary concentration Human daily exposure
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