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Risk assessment of phthalates in pharmaceuticals

邻苯二甲酸盐 邻苯二甲酸二乙酯 邻苯二甲酸二丁酯 增塑剂 邻苯二甲酸二甲酯 毒理 污染 化学 健康危害 色谱法 环境化学 环境卫生 医学 有机化学 生物 生态学
作者
Bu Young Chung,Seul Min Choi,Taehyun Roh,Duck Soo Lim,Mi Young Ahn,Yeon Joo Kim,Hyung Sik Kim,Byung-Mu Lee
出处
期刊:Journal of Toxicology and Environmental Health [Informa]
卷期号:82 (5): 351-360 被引量:33
标识
DOI:10.1080/15287394.2019.1598053
摘要

Phthalates are used for industrial plasticizers to impart flexibility and durability to polyvinyl chloride. Despite widespread use of phthalates, reported endocrine-disrupting properties raise safety concerns for consumers. Since phthalates are permitted as excipients in controlled-release capsules and enteric coatings, patients taking drugs containing these chemicals may potentially be at some health risk. In this study, 102 distinct pharmaceutical products were analyzed by gas chromatography/mass spectrometry to determine phthalate content and maximal phthalate exposure rate was calculated. In 102 drug samples, di(2-ethylhexyl) phthalate (DEHP), dibutyl phthalate (DBP), and diethyl phthalate (DEP) were detected in 9.8, 27.45, and 5.88% of cases, respectively. The highest level of DEP was found in extended-release (ER) capsules with concentrations ranging from 935.5 to 1535.37 ppb. The highest levels of DBP (1.32–7.07 ppb) were detected in tablets, whereas highest level (7.07 ppb) of DEHP was found in suspension preparations. The phthalate hazard index (HI) (human exposure tolerable daily intake) was calculated for each sample, but no sample exhibited an HI value exceeding 1; the minimum value taken to indicate a serious health risk. Thus, no apparent serious health risk from phthalate exposure arises from taking these medications. The low HI values suggest that phthalate contamination in pharmaceuticals may not pose an apparent significant risk to humans. However, the sources of phthalate present in pharmaceutical products still needs to be investigated and verified through on-site inspections in manufacturing processes in order to minimize human exposure. It is recommended that measures be taken to prevent phthalate contamination in pharmaceuticals.
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