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邻苯二甲酸二乙基己酯从多层输液管中浸出至依托泊苷输注液中。

Leaching of diethylhexyl phthalate from multilayer tubing into etoposide infusion solutions.

作者信息

Bagel-Boithias Sandrine, Sautou-Miranda Valérie, Bourdeaux Daniel, Tramier Violaine, Boyer Anne, Chopineau Jean

机构信息

Department of Pharmacy, Gabriel-Montpied Hospital, Clermont-Ferrand, France.

出版信息

Am J Health Syst Pharm. 2005 Jan 15;62(2):182-8. doi: 10.1093/ajhp/62.2.182.

DOI:10.1093/ajhp/62.2.182
PMID:15700892
Abstract

PURPOSE

The extent of leaching of diethylhexyl phthalate (DEHP) from various polyvinyl chloride (PVC), polyethylene (PE), coextruded (PVC and PE), and triple-layered (PVC, ethyl vinyl acetate, and PE) i.v. extension tubing into etoposide infusion solutions was studied.

METHODS

Different lengths of tubing (25, 50, and 80 cm) were tested in two types of experiments: (1) static, in which the etoposide solution was left in contact inside the tubing for various times and then removed, and chromatography was used to quantify the DEHP content of the effluate, and (2) dynamic, in which infusion was simulated using syringe reservoirs, and three flow rates were tested to assess the effect of flow rate on the quantities of DEHP leached.

RESULTS

The static study showed that large quantities of DEHP were leached from all tubing types except the PE tubing. The dynamic study confirmed that leaching occurred, although the values were below the threshold limit of 5 microg/mL. The values varied depending on flow rate, tubing length, and etoposide concentration. The coextruded and triple-layered i.v. tubing did not provide the inertness and safety they are intended to have, as DEHP not only leached out but did so in quantities almost equivalent to those found with tubing made of PVC only.

CONCLUSION

DEHP leached rapidly from PVC, coextruded, and triple-layered i.v. tubing into etoposide infusion solution. The quantity of DEHP found in the infusion solution was influenced by the length of the tubing and concentration of etoposide.

摘要

目的

研究邻苯二甲酸二(2-乙基己基)酯(DEHP)从各种聚氯乙烯(PVC)、聚乙烯(PE)、共挤(PVC和PE)及三层(PVC、乙烯-醋酸乙烯共聚物和PE)静脉输液延长管中溶出到依托泊苷输注溶液中的程度。

方法

在两种类型的实验中测试了不同长度(25、50和80厘米)的延长管:(1)静态实验,将依托泊苷溶液留在延长管内不同时间后取出,用色谱法对流出液中的DEHP含量进行定量;(2)动态实验,使用注射器储液器模拟输注,测试三种流速以评估流速对DEHP溶出量的影响。

结果

静态研究表明,除PE延长管外,所有类型的延长管均有大量DEHP溶出。动态研究证实了溶出的发生,尽管其值低于5微克/毫升的阈值。这些值因流速、延长管长度和依托泊苷浓度而异。共挤和三层静脉输液管并未具备其预期的惰性和安全性,因为DEHP不仅会溶出,而且溶出量几乎与仅由PVC制成的延长管相当。

结论

DEHP从PVC、共挤及三层静脉输液管中迅速溶出到依托泊苷输注溶液中。输注溶液中DEHP的含量受延长管长度和依托泊苷浓度的影响。

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