Environmental assessment of Norwegian priority pharmaceuticals based on the EMEA guideline

Environmental assessment of Norwegian priority pharmaceuticals based on the EMEA guideline
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DOI:
10.1016/j.ecoenv.2007.10.015
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发表时间:
2008-10-01
影响因子:
6.8
通讯作者:
Thomas, Kevin V.
Thomas, Kevin V.
中科院分区:
环境科学与生态学2区
文献类型:
--
作者:
Grung, Merete;Kallqvist, Torsten;Thomas, Kevin V.

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按照欧洲药品评估机构(EMEA)推荐的指南,对11种药品进行了环境风险评估。挪威污染控制局选择了头孢呋辛、环丙沙星、环磷酰胺、双氯芬酸、炔雌醇、布洛芬、美托洛尔、对乙酰氨基酚、磺胺甲恶唑、四环素和甲氧苄啶进行评估。根据EMEA指南和一个常规模型计算了预测环境浓度(PECs)以作比较,其范围从0.0002到45微克/升。从文献中收集了现有的急性和慢性毒性数据,不过环磷酰胺没有相关数据。毒性试验表明环磷酰胺的急性毒性相对较低,对于羊角月牙藻的半数效应浓度(EC50)>100毫克/升,大型溞繁殖无观测效应浓度(NOEC)为56毫克/升。利用这些数据以及文献数据推导出了预测无效应浓度(PNEC)。然后计算了所有11种药物化合物的风险商(PEC/PNEC)。根据EMEA指南,环丙沙星、双氯芬酸、炔雌醇、磺胺甲恶唑和四环素的风险商大于1。实测环境浓度(MECs)证实,在挪威,从污水处理厂排放的环丙沙星可能会对环境产生潜在影响。(c)2007爱思唯尔公司。保留所有权利。
An environmental risk assessment of eleven pharmaceuticals according to the guideline recommended by the European Medicines Evaluation Agency (EMEA) was performed. Cefuroxime, ciprofloxacin, cyclophosphamide, diclofenac, ethinylestradiol, ibuprofen. metoprolol, paracetamol, sulfamethoxazole, tetracycline and trimethoprim were selected for assessment by the Norwegian Pollution Control Authority. Predicted environmental concentrations (PECs) were calculated according to both the EMEA guideline and a conventional model for comparison and ranged from 0.0002 to 45 mu g/L. Available acute and chronic toxicity data were collected from the literature, although no data were available for cyclophosphamide. Toxicity tests showed cyclophosphamide to have relatively low acute toxicity with an EC50 for Pseudokirchneriella subcapitata > 100 mg/L and a Daphnia magna reproduction NOEC of 56 mg/L. These and the literature data were used to derive predicted no effect concentrations (PNEC). Risk quotients (PEC/PNEC) were then calculated for all I I pharmaceutical compounds. Risk quotients greater than I were obtained for ciprofloxacin, diclofenac, ethinylestradiol, sulfamethoxazole and tetracycline according to the EMEA guideline. Measured environmental concentrations (MECs) confirmed that the release of ciprofloxacin from wastewater treatment works may potentially be of environmental concerti in Norway. (c) 2007 Elsevier Inc. All rights reserved.