色谱Issue(5)：522-529,8.DOI:10.3724/SP.J.1123.2014.12029
邻苯二甲酸二（2-乙基）己酯和偏苯三酸三辛酯在临床不同药液中溶出量的比较
Comparison of the release behaviors of di(2-ethylhexyl) phthalate and tri(2-ethylhexyl)trimellitate from the polyvinyl-chloride infusion set into pharmaceutical solutions
摘要
Abstract
Polyvinyl-chloride(PVC)with plasticizers of di(2-ethylhexyl)phthalate(DEHP)and tris(2-ethyl-hexyl)trimellitate( TOTM)is widely used in medical and paramedical appliances. However,such plasticizers can leach from PVC products into contact solutions. The aim of this study is to investigate the release behaviors of DEHP and TOTM from the PVC intravenous infusion set into various pharmaceutical solutions under the sim-ulated clinical conditions,such as the lipophilic substances( paclitaxel),parenteral nutrition( fat emulsion injection),acid and alkali pharmaceutical solution( levofloxacin hydrochloride injection,pH 3. 0-5. 0 and furo-semide,pH 8. 0-9. 0). A simple and rapid high-performance liquid chromatographic method with UV detection ( HPLC-UV)for the determination of DEHP or TOTM released from PVC medical devices into the above intrave-nous preparations was developed. The cumulative amounts of DEHP or TOTM released in 24 h were in the same following order:paclitaxel>fat emulsion injection>levofloxacin hydrochloride> furosemide solution. From a comparison of the cumulative amounts of released DEHP and TOTM from the above solutions,we found that the cumulative amount of TOTM is far less than that of DEHP,under the same conditions. The cumulative amount of the DEHP released in 24 h in the paclitaxel solution was 21. 14 mg,while under the same conditions, the cumulative amount of TOTM was only 0. 078 mg. The cumulative amount of DEHP is assumed to be about 270 times that of the released TOTM. Thus TOTM could be a superior alternative to DEHP for use in medical de-vices because of its potential lower leachability.关键词
高效液相色谱-紫外检测/邻苯二甲酸二(2-乙基)己酯/偏苯三酸三辛酯/聚氯乙烯/溶出行为/药液Key words
high-performance liquid chromatographic method-ultraviolet detection( HPLC-UV)/di( 2-ethylhex-yl)phthalate(DEHP)/tris(2-ethylhexyl)trimellitate(TOTM)/polyvinyl-chloride(PVC)/release behavior/pharmaceutical solution分类
化学化工引用本文复制引用
张虹,杨凤敏,沈刚,杨月阳,唐亚林..邻苯二甲酸二（2-乙基）己酯和偏苯三酸三辛酯在临床不同药液中溶出量的比较[J].色谱,2015,(5):522-529,8.基金项目
National Natural Science Foundation of China（ Grant No．21302188）． （）
