摘要
目的:考察常用的5种注射剂表面活性剂对聚氯乙烯(PVC)输液器中邻苯二甲酸二辛酯(DEHP)溶出的影响。方法:分别配制吐温-80、吐温-40、吐温-20、聚氧乙烯蓖麻油、卵磷脂溶液,加入5%葡萄糖注射液中,模拟临床输注方式,用PVC输液器滴注,以高效液相色谱法测定收集液中DEHP峰面积,计算含量,以此考察加入表面活性剂的种类、浓度、输液时间及输液管长度对DEHP溶出的影响。结果:5种表面活性剂对DEHP的溶出能力为吐温-80>吐温-40>吐温-20>聚氧乙烯蓖麻油>卵磷脂,卵磷脂未见溶出DEHP。在表面活性剂种类一定的情况下,DEHP的溶出与其浓度、输液时间以及输液管长度成正相关。结论:本研究可为含有表面活性剂的注射剂选择安全的输液器及药厂生产注射剂时选择表面活性剂提供参考。
OBJECTIVE： To investigate the effects of common surfactants on the dissolution of dioctyl phthalate （DEHP） when flowed through the polyvinyl chloride（PVC） infusion sets. METHODS： Solutions of Tween- 80, Tween- 40, Tween- 20, Cremophor EL and lecithin were prepared respectively, which were then added into 5% glucose and flowed though the PVC infusion sets, with the peak area and content of DEHP in the collected solutions determined by HPLC so as to investigate the effects of the kinds and concentration of the added surfactants and the infusion time and the length of the infusion tube on the dissolution of DEHP. RESLUTS： The dissolution of DEHP in 5 different surfactants in a descending order were Tween- 80〉 Tween-40〉Tween-20〉Cremophor EL〉 lecithin. No dissolution of DEHP was noted in lecithin. In a certain kind of surfactant, the dissolution of DEHP was positively correlated with the concentration of surfactant and the infusion time and the length of the infusion tube. CONCLUSIONS： The results serve as reference for the choice of safe infusion set when surfactants is contained in the injection and the choice of surfactant in the production of injection in pharmaceutical facoties.
出处
《中国药房》
CAS
CSCD
北大核心
2008年第34期2664-2666,共3页
China Pharmacy
