标题：Systemic toxicity and toxicokinetics of a high dose of polyethylene glycol 400 in dogs following intravenous injection
作者：Bao-qiu Li;Xin Dong;Shi-hong Fang
作者机构：[Li, B.-Q] Department of Pharmacology, School of Pharmaceutical Sciences, Shandong University, 44 Wen Hua Xi Road, Jinan, Shandong 250012, China;[ Don 更多
通讯作者地址：[Li, BQ]Shandong Univ, Dept Pharmacol, Sch Pharmaceut Sci, 44 Wen Hua Xi Rd, Jinan 250012, Shandong, Peoples R China.
来源：Drug and Chemical Toxicology
关键词：Polyethylene glycol 400;pharmaceutical excipient;toxicity;toxicokinetics
摘要：Polyethylene glycol 400 (PEG-400) has been used in injections. However, limited data are available concerning the toxicity of a high dose of PEG-400 following intravenous (i.v.) injection. The aim of the present study was to estimate the systemic toxicity and toxicokinetics of a high dose of PEG-400 in dogs following i.v. injection. Twenty-four dogs were divided into four groups: a control group receiving normal saline and three test groups receiving 4.23, 6.34, and 8.45 g/kg of PEG-400, respectively, by i.v. injection once a day for 30 days. The repeated-dose toxicity of PEG-400 was assessed. Toxicokinetic parameters of PEG-400 in dogs were estimated on days 1 and 30. Dry mouth and dry nasal mucus membrane were observed in dogs treated with 6.34 and 8.45 g/kg of PEG-400. Cloudy swelling of kidney cell and increased glomerular volume were observed in dogs treated with 8.45 g/kg of PEG-400 when the animals were sacrificed 24 hours after the last injection. No significant histological changes were found 21 days later. Repeated dosing did not affect the toxicokinetic profile of PEG-400 in dogs. This study has shown that the toxicity of a high dose of PEG-400 following repeated intravenous injections is low, and alterations produced are reversible.