Occurrence of phthalate esters in over-the-counter medicines from China and its implications for human exposure.
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.
School of Environment, Guangzhou Key Laboratory of Environmental Exposure and Health, Guangdong Key Laboratory of Environmental Pollution and Health, Jinan University, Guangzhou 510632, China.
Lu-Lu
LL
Jia
The Frist Affiliated Hospital of Jinan University, Guangzhou 510632, China.
Xiang-Ying
XY
Lou
School of Environment, Guangzhou Key Laboratory of Environmental Exposure and Health, Guangdong Key Laboratory of Environmental Pollution and Health, Jinan University, Guangzhou 510632, China. Electronic address: yingguo2004@jnu.edu.cn.
Ying
Y
Guo
Department of Chemistry, Hong Kong Baptist University, Hong Kong Special Administrative Region & HKBU Institute of Research and Continuing Education, Shenzhen Virtual University Park, Kowloon Tong, Shenzhen, China. Electronic address: s9362284@hkbu.edu.hk.
Kelvin Sze-Yin
KS
Leung
School of Environment, Guangzhou Key Laboratory of Environmental Exposure and Health, Guangdong Key Laboratory of Environmental Pollution and Health, Jinan University, Guangzhou 510632, China.
Eddy Y
EY
Zeng
D002681:China; D003993:Dibutyl Phthalate / Q000032:analysis; D004391:Dust / Q000032:analysis; D004781:Environmental Exposure / Q000032:analysis; D004952:Esters / Q000032:analysis; D006801:Humans; D004366:Nonprescription Drugs / Q000737:chemistry*; D010795:Phthalic Acids / Q000032:analysis*; D010969:Plastics
D004391:Dust; D004952:Esters; D004366:Nonprescription Drugs; D010795:Phthalic Acids; D010969:Plastics; D003993:Dibutyl Phthalate; C032279:phthalic acid; C036042:dicyclohexyl phthalate; C007379:diethyl phthalate
Chinese population; Di-n-butyl phthalate; Human exposure; Over-the-counter medicine; Phthalate esters