紫杉醇注射液配套输液器中邻苯二甲酸二辛酯的溶出性考察

Investigation of Dissolution of DEHP in Packaged Infusion Sets of Paclitaxel Injection

目的:考察紫杉醇注射液配套输液器及聚氯乙烯(PVC)输液器中邻苯二甲酸二辛酯(DEHP)的溶出情况,评价紫杉醇临床用输液器的安全性。方法:收集重庆市9家"三甲"医院紫杉醇包装中配备的输液器,模拟临床紫杉醇输注的浓度、时间,用8种(其中7种为配套输液器)不同输液器滴注3h,用高效液相色谱法测定收集液中DEHP的峰面积,计算含量;并考察时间对DEHP溶出的影响。结果:紫杉醇通过8种输液器的DEHP溶出总量分别为1408、9393、6576·5、2412·6、8194·4、0、8477·2、8037·4μg;输注时间越长,DEHP溶出越多。结论:目前临床使用的紫杉醇配套输液器绝大部分为PVC输液器,由于DEHP溶出后可直接进入人体,不能保证紫杉醇的用药安全,故应高度重视其危害性。

OBJECTIVE ： To investigate the dissolution of DEHP in PVC infusion set and the packaged infusion sets of the Paclitaxel injection so as to evaluate the safety of clinical infusion sets for paclitaxel. METHODS： The packaged infusion sets of Paclitaxel injection were collected from 9 Three- A grade hospitals in Chongqing. Paclitaxel injections were prepared as per actual concentration needed by the clinic and dripped through eight different infusion sets （in which 7 were packaged infusion sets） for 3 h. The peak area of the collected solution was measured and its content was determined by HPLC, and the effect of infusion time on the dissolution of DEHP was investigated as well. RESULTS： The dissolution of DEHP dripped through eight infusion sets were 1 408, 9 393, 6 576.5, 2 412.6, 8 194.4, 0, 8 477.2, and 8 037.4 μg, respectively. The dissolution increased with the prolonging of infusion time. CONCLUSION： At present, the majority of packaged infusion sets of Paclitaxel injection were made form PVC materials. The safe medication of Paclitaxel can＇t be ensured for the dissolved DEHP can enter the blood directly, thus its hazardness should be given great attention.