色谱

色谱 ›› 2015, Vol. 33 ›› Issue (5): 522-529.DOI: 10.3724/SP.J.1123.2014.12029

• 研究论文 • 上一篇    下一篇

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

张虹1, 杨凤敏1, 沈刚1, 杨月阳2, 唐亚林1   

  1. 1. 中国科学院化学研究所, 分子动态稳态国家重点实验室, 北京 100190;
    2. 北京国医械华光认证有限公司, 北京 100011
  • 收稿日期:2014-12-22 发布日期:2015-04-23
  • 通讯作者: 唐亚林
  • 基金资助:

    National Natural Science Foundation of China (Grant No. 21302188).

Comparison of the release behaviors of di(2-ethylhexyl) phthalate and tri(2-ethylhexyl) trimellitate from the polyvinyl-chloride infusion set into pharmaceutical solutions

ZHANG Hong1, YANG Fengmin1, SHEN Gang1, YANG Yueyang2, TANG Yalin1   

  1. 1. State Key Laboratory for Structural Chemistry of Unstable and Stable Species Institute of Chemistry, Chinese Academy of Sciences, Beijing 100190, China;
    2. Beijing Hua Guang Certification of Medical Devices Co., Ltd., Beijing 100011, China
  • Received:2014-12-22 Published:2015-04-23
  • Supported by:

    National Natural Science Foundation of China (Grant No. 21302188).

PDF

319

摘要：

聚氯乙烯(PVC)材质的医疗器械产品中需要加入增塑剂以改善柔韧性,目前最常用的增塑剂是邻苯二甲酸二(2-乙基)己酯(DEHP)和偏苯三酸三辛酯(TOTM)。本文考察了PVC一次性使用输液器产品在脂溶性药液(紫杉醇注射液)、肠外营养液(脂肪乳)、酸性药液(左氧氟沙星,pH 3.0~5.0)和碱性药液(呋塞米,pH 8.0~9.0)中的DEHP和TOTM溶出量,并进行对比分析。先建立了一种高效液相色谱-紫外检测(HPLC-UV)方法测定增塑剂的溶出量,并利用该方法对增塑剂的溶出量进行了分析。实验结果表明,增塑剂在不同药液中均有一定的溶出情况,其中紫杉醇注射液对增塑剂的溶出量要高于脂肪乳,并远高于左氧氟沙星和呋塞米注射液。通过对比DEHP和TOTM的溶出量可以看出,在相同的浸提条件下,TOTM的溶出量远低于DEHP的溶出量。利用紫杉醇注射液浸提24 h,PVC输液器产品DEHP的溶出量为21.14 mg,而TOTM的溶出量仅为0.078 mg。DEHP的溶出量为TOTM溶出量的270倍。因此,TOTM具有的较好耐迁移性,是一种潜在的DEHP替代增塑剂。

关键词: 高效液相色谱-紫外检测, 聚氯乙烯, 邻苯二甲酸二(2-乙基)己酯, 偏苯三酸三辛酯, 溶出行为, 药液

Abstract:

Polyvinyl-chloride (PVC) with plasticizers of di(2-ethylhexyl) phthalate (DEHP) and tris(2-ethylhexyl) 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 simulated 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 furosemide, 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 intravenous 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 devices because of its potential lower leachability.

Key words: di(2-ethylhexyl) phthalate (DEHP), high-performance liquid chromatographic method-ultraviolet detection (HPLC-UV), pharmaceutical solution, polyvinyl-chloride (PVC), release behavior, tris(2-ethylhexyl) trimellitate (TOTM)

中图分类号: