A survey of parabens in commercial pharmaceuticals from China and its implications for human exposure
A survey of parabens in commercial pharmaceuticals from China and its implications for human exposure
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中国商品药品中对羟基苯甲酸酯的调查及其对人体暴露的影响
DOI：
10.1016/j.envint.2016.07.013
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发表时间：
2016-10-01
影响因子：
11.8
通讯作者：
Li, Yi-Fan
中科院分区：
文献类型：
--
作者：
Ma, Wan-Li;Zhao, Xue;Li, Yi-Fan
对羟基苯甲酸酯广泛用作药品生产中的抗菌防腐剂。然而，关于商业药品中对羟基苯甲酸酯的存在及其对人体暴露的影响的信息很少。采用超高效液相色谱-串联质谱法对100种市售药品中6种常用的对羟基苯甲酸酯进行了分析。几乎所有的药物样品都含有至少一种。对羟基苯甲酸酯类的检出率为97%。对羟基苯甲酸西格玛（6）酯（6种对羟基苯甲酸酯的总和）的浓度范围为低于MDL至1256 ng/g，平均值和中位值分别为94.8和119 ng/g。对羟基苯甲酸甲酯（MeP）、对羟基苯甲酸乙酯（EtP）和对羟基苯甲酸丙酯（PrP）是主要的化合物。MeP和PrP的浓度之间存在显著的正相关性，表明它们在药物中的共同应用。对羟基苯甲酸西格玛（6）酯的水平在不同类别的药物中有所不同，并随着其保质期的增加而增加。根据测定的药物浓度和每日摄入率，计算对羟基苯甲酸酯的估计每日摄入量（EDI）。成年男性、成年女性和儿童的EDI药物中位值分别为4.05、4.75和9.73纳克/千克体重/天，比食品和个人护理产品低三个数量级。首次报告中国成年女性通过食品、PCP和药物的总暴露剂量为0326 mg/kg-bw/d。(C)2016爱思唯尔有限公司版权所有
Parabens are widely used as antimicrobial preservatives during pharmaceutical production. However, little information is available regarding the occurrence of parabens in commercial pharmaceuticals and their implications for human exposure. In this study, six commonly used parabens were analyzed by ultra-performance liquid chromatography-tandem mass spectrometry with 100 commercial pharmaceuticals collected from China. Almost all of the pharmaceutical samples contained at least one kind. of parabens with the detection frequency of 97%. The concentrations of Sigma(6)parabens (sum of the six parabens) ranged from below MDL to 1256 ng/g, with mean and median values of 94.8 and 119 ng/g, respectively. Methyl paraben (MeP), ethyl paraben (EtP) and propyl paraben (PrP) were the predominant compounds. Significant positive correlation was observed between concentrations of MeP and PrP, indicating their co-applications in pharmaceuticals. Levels of Sigma(6)parabens varied in different categories of pharmaceuticals and increased with their shelf lives. Based on the measured concentrations and daily ingestion rates of pharmaceuticals, the estimated daily intake (EDI) of parabens was calculated. The median values of EDIpharmaceutical for male adults, female adults and children were 4.05, 4.75 and 9.73 ng/kg-bw/day, respectively, which were three orders of magnitude lower than those from foodstuffs and personal care products (PCPs). It was firstly reported that the total exposure dose was 0326 mg/kg-bw/day via foodstuffs, PCPs, and pharmaceuticals for Chinese female adults. (C) 2016 Elsevier Ltd. All rights reserved.