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EHP:药品中邻苯二甲酸添加剂是否影响健康仍是谜

来源:生物谷 2012-02-28 09:05

邻苯二甲酸

邻苯二甲酸盐类主要用于制取染料、聚酯树脂、涤纶、药物及增塑剂等。邻苯二甲酸是合成树脂、纤维、药物等的原料,是重要的有机工业产品。

近日,波士顿大学与哈佛大学的研究者证实大量药品中含有邻苯二甲酸盐类,有100多种处方药、非处方药以及食品添加剂中含有邻苯二甲酸盐类物质。邻苯二甲酸盐只是作为不具活性功能的辅料成分,并不发挥药物的作用。

在该项研究中,研究人员监测了自1995年开始,在美国和加拿大地区出售的所有药品以及食品中添加剂里的非活性物质成分。结果发现多种药品和食品添加剂中都含有邻苯二甲酸盐类物质。其中邻苯二甲酸二丁酯和邻苯二甲酸二乙酯是常使用的两种邻苯二甲酸盐添加剂。

研究中还鉴定的其他一些邻苯二甲酸盐类添加剂,虽然邻苯二甲酸盐类物质对人是不是存在潜在的健康危险这一点还不明确,但早些年的动物实验已经显示这类化学物质会影响动物的生长发育进程。因此在这种未知情况下,我们也应该关注邻苯二甲酸盐类物质对健康可能的影响,要尽快开展临床试验弄清楚邻苯二甲酸盐类物质的潜在致病风险。(生物谷Bioon.com)

Identification of Phthalates in Medications and Dietary Supplement Formulations in the U.S. and Canada

Katherine E. Kelley, Sonia Hernández-Díaz, Erica L. Chaplin, Russ Hauser, Allen A. Mitchell

Background: In experimental animals, some ortho-phthalates, including di(2-ethylhexyl) phthalate (DEHP) and di-n-butyl phthalate (DBP), are demonstrated reproductive and developmental toxicants. Human studies show widespread population exposure to background levels of phthalates. Limited evidence suggests that particularly high exposure levels may result from orally ingested medicinal products containing phthalates as excipients.

Objective: The objective of this study was to identify and describe the scope of prescription (RX) and non-prescription (OTC) medicinal products and dietary supplements marketed in the United States and Canada since 1995 that include phthalates as excipients.

Methods: Lists of modified-release drug products were used to identify potential drug products. Inclusion of phthalates was verified using available electronic databases, print references, published package inserts, product packages, and direct communication from manufacturers. Additional products were identified using Internet searches utilizing keywords for phthalates.

Results: Labeling information for 6 RX drug products included DBP as an excipient, while 45 labels specified the use of diethyl phthalate (DEP). Phthalate polymers with no known toxicity, hypromellose phthalate (HMP), cellulose acetate phthalate (CAP), and polyvinyl acetate phthalate (PVAP), were noted in 75 RX products. Three OTC drug and dietary supplement products listed DBP, 64 listed DEP, and over 90 indicated inclusion of polymers.

Conclusions: Numerous RX and OTC drug products and supplements from a wide range of therapeutic categories may use DBP or DEP as excipients in oral dosage forms. The potential effects of human exposure to these phthalates through medications are unknown and warrant further investigation.

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