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首页> 外文期刊>Regulatory Toxicology and Pharmacology: RTP >Human health risk assessment of carbamazepine in surface waters of North America and Europe
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Human health risk assessment of carbamazepine in surface waters of North America and Europe

机译:卡马西平在北美和欧洲地表水中的人体健康风险评估

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摘要

A human health risk assessment was carried out for environmental exposures to carbamazepine (CBZ) and its major human metabolites, carbamazepine diol (CBZ-DiOH) and carbamazepine N-glucuronide (CBZ-N-Glu). Carbamazepine is an active pharmaceutical ingredient (API) used worldwide as a medicine for treating epileptic seizures and trigeminal neuralgia. Carbamazepine tends to be detected in surface water more frequently, and at relatively higher concentrations, than most other APIs.Predicted no effect levels (PNECs) for CBZ and its major human metabolites were developed for surface waters to be protective of human health from environmental exposures from drinking water and fish consumption. These PNECs were compared to both measured (MEC) and predicted (PEC) environmental concentrations for North America and Europe. PECs were calculated using the geo-referenced models PhATE~(TM)for North America and GREAT-ER for Europe.The combined PNEC for drinking water and fish consumption for CBZ is 226,000 ng/L Ninetieth percen-tile MECs ranged from 150 to 220 ng/L, while 90th percentile PECs ranged from 333 to 658 ng/L Calculated margins of safety (MOS) therefore range from 340 to 1500. MOS for the major metabolites are significantly higher. This assessment indicates that CBZ and its major metabolites have high MOS (>1) and thus should have no appreciable risk to human health through environmental exposures based on available human data.
机译:对卡马西平(CBZ)及其主要人体代谢物,卡马西平二醇(CBZ-DiOH)和卡马西平N-葡糖醛酸(CBZ-N-Glu)的环境暴露进行了人类健康风险评估。卡马西平是一种活性药物成分(API),在世界范围内用作治疗癫痫发作和三叉神经痛的药物。与大多数其他API相比,卡马西平在地表水中的检出率更高,且浓度较高。从饮用水和鱼类消费。将这些PNEC与北美和欧洲的实测(MEC)和预测(PEC)环境浓度进行了比较。 PEC是使用针对北美的地理参考模型PhATE〜(TM)和针对欧洲的GREAT-ER计算的.CBZ饮用水和鱼类消费的PNEC组合为226,000 ng / L九十个百分点的MEC,范围为150至220 ng / L,而第90个百分位数的PEC范围为333至658 ng / L,因此计算得出的安全性(MOS)范围为340至1500。主要代谢物的MOS明显更高。该评估表明,CBZ及其主要代谢产物的MOS含量较高(> 1),因此根据现有的人类数据,通过环境暴露,对人体健康没有明显的危害。

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