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5540627 
Journal Article 
Occurrence of phthalate esters in over-the-counter medicines from China and its implications for human exposure 
Jia, LL; Lou, XY; Guo, Y; Leung, KS; Zeng, EY 
2017 
Yes 
Environment International
ISSN: 0160-4120
EISSN: 1873-6750 
Elsevier Ltd 
OXFORD 
98 
137-142 
English 
Food, air, personal care products and indoor dust have been recognized as the main routes of exposure to phthalates in Chinese population, but other sources may have been overlooked, e.g., medicines. To fill the knowledge gap, phthalate esters were measured in 96 over-the-counter medicines made in China, including selected 71 Chinese patented medicines and 25 western medicines. It was found that none of the medicines was free of phthalates. The mean concentrations of individual phthalates ranged from 0.001μg/g (dicyclohexyl phthalate) to 5.85μg/g (diethyl phthalate). Among 9 targeted phthalates, di-n-butyl phthalate was the dominant congener, accounting for > 65% of the total phthalates in all medicine samples, followed by di-(2-ethylhexyl) phthalate and diethyl phthalate. Phthalates in medicines appeared to derive from gastroresistant film coatings, plastic packing materials or phthalate contaminated rural herbal plants (especially for Chinese patented medicines). Daily human exposure to phthalates was estimated for local patients for one treatment cycle (e.g., one week) based on suggested consumption dosage and phthalate concentrations. Almost all exposure levels were below the guidelines suggested by the United States Environmental Protection Agency or European Food Safety Authority, indicating low health risk with phthalates from consumption of the medicines. In addition, concentration levels of phthalates in patients would increase upon administration but are expected to decrease to the same values as those in patients before they took medicines in several days. Because the number of medicine samples was limited and the concentrations of phthalates varied in a large range, further investigations are needed to acquire more data for better assessment of human health effects for Chinese population. Capsule: Distribution of phthalate esters in over-the-counter medicines and related exposure for Chinese population are examined. 
China; Dibutyl Phthalate/analysis; Dust/analysis; Environmental Exposure/analysis; Esters/analysis; Nonprescription Drugs/chemistry; Phthalic Acids/analysis; Plastics; Chinese population; Di-n-butyl phthalate; Human exposure; Over-the-counter medicine; Phthalate esters; 2286E5R2KE; 6O7F7IX66E; CGD15M7H2N; UF064M00AF 
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