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中国市售药品中对羟基苯甲酸酯的调查及其对人体暴露的影响。

A survey of parabens in commercial pharmaceuticals from China and its implications for human exposure.

机构信息

International Joint Research Center for Persistent Toxic Substances (IJRC-PTS), State Key Laboratory of Urban Water Resource and Environment, Harbin Institute of Technology, Harbin 150090, China.

International Joint Research Center for Persistent Toxic Substances (IJRC-PTS), State Key Laboratory of Urban Water Resource and Environment, Harbin Institute of Technology, Harbin 150090, China; State Nuclear Electric Power Planning Design & Research Institute, Beijing 100091,China.

出版信息

Environ Int. 2016 Oct;95:30-5. doi: 10.1016/j.envint.2016.07.013. Epub 2016 Jul 29.

DOI:10.1016/j.envint.2016.07.013
PMID:27476643
Abstract

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 Σ6parabens (sum of the six parabens) ranged from below MDL to 1256ng/g, with mean and median values of 94.8 and 119ng/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 Σ6parabens 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 9.73ng/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 0.326mg/kg-bw/day via foodstuffs, PCPs, and pharmaceuticals for Chinese female adults.

摘要

对羟基苯甲酸酯作为一种抗菌防腐剂,被广泛应用于药物生产中。然而,有关其在市售药物中的存在情况以及对人类暴露的影响的信息却很少。本研究采用超高效液相色谱-串联质谱法,对中国市场上采集的 100 种市售药物中的 6 种常用对羟基苯甲酸酯进行了分析。几乎所有药物样本都至少含有一种对羟基苯甲酸酯,检出率为 97%。Σ6 对羟基苯甲酸酯(6 种对羟基苯甲酸酯的总和)的浓度范围为检测限以下至 1256ng/g,平均值和中位数分别为 94.8ng/g 和 119ng/g。其中,甲基对羟基苯甲酸酯(MeP)、乙基对羟基苯甲酸酯(EtP)和丙基对羟基苯甲酸酯(PrP)是主要的化合物。MeP 和 PrP 的浓度之间存在显著的正相关,表明它们在药物中共同应用。Σ6 对羟基苯甲酸酯的浓度在不同类别的药物中存在差异,且随药物的保质期而增加。基于所测量的浓度和药物的日摄入量,计算了对羟基苯甲酸酯的估计日摄入量(EDI)。男性成年人、女性成年人和儿童的 EDIpharmaceutical 中位数分别为 4.05、4.75 和 9.73ng/kg-bw/day,这三个数值均比来自食品和个人护理产品(PCPs)的摄入量低三个数量级。本研究首次报道了中国成年女性通过食品、PCPs 和药物摄入的总暴露剂量为 0.326mg/kg-bw/day。

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