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给药装置中他克莫司在聚氯乙烯(PVC)管和非PVC管上的吸附评估:泵注法与滴注法。

Evaluation of tacrolimus sorption to PVC- and non-PVC-based tubes in administration sets: Pump method vs. drip method.

作者信息

Jin Su-Eon, Jeon Seungho, Byon Hyo-Jin, Hwang Sung-Joo

机构信息

College of Pharmacy, Yonsei University, Incheon, 21983, Republic of Korea; College of Medicine, Yonsei University, Seoul, 03722, Republic of Korea; Yonsei Institute of Pharmaceutical Sciences, Incheon, 21983, Republic of Korea.

Polyscientech Co. Ltd, Anseong, 17508, Republic of Korea.

出版信息

Int J Pharm. 2017 Aug 7;528(1-2):172-179. doi: 10.1016/j.ijpharm.2017.05.040. Epub 2017 May 23.

Abstract

Tacrolimus sorption to tubes was evaluated using pump and drip methods For tubes, polyvinylchloride (PVC)- and non-PVC-based (polyurethane [PU] and polyolefin [PO]) tubes were used. First, inner surface properties of tubes were analyzed using field emission scanning electron microscopy and X-ray photoelectron spectroscopy. Tacrolimus was quantitatively analyzed using high-performance liquid chromatography with UV detection. For kinetic sorption analysis, diluted tacrolimus to 10μg/mL was passed through 1-m-long tubes at 10mL/h. Samples were collected at 1-4h. The inner surface of PO-based tubes was relatively smooth and soft compared with those of PVC- and PU-based tubes. Atomic compositions of tubes matched chemical formulas of polymers excluding low-level impurity in PVC-based tubes. Tacrolimus was successfully analyzed and linearly determined at 2.5-20μg/mL. From both methods, PVC- and PO-based tubes exhibited the highest and the lowest (<10%) sorption levels to tacrolimus, respectively. Tacrolimus was stably delivered using the pump method. Results suggested that the pump method can estimate tacrolimus sorption in administration set tubes and evaluate other sorptional drugs used at low concentrations. PO-based tubes also have promising potential as an alternative for administration set tubes.

摘要

采用泵注法和滴注法评估他克莫司在管道中的吸附情况。对于管道,使用了聚氯乙烯(PVC)基和非PVC基(聚氨酯[PU]和聚烯烃[PO])管道。首先,使用场发射扫描电子显微镜和X射线光电子能谱分析管道的内表面性质。采用高效液相色谱-紫外检测法定量分析他克莫司。对于动力学吸附分析,将他克莫司稀释至10μg/mL,以10mL/h的流速通过1米长的管道。在1-4小时收集样品。与PVC基和PU基管道相比,PO基管道的内表面相对光滑且柔软。管道的原子组成与聚合物的化学式相符,但PVC基管道含有低水平杂质。他克莫司在2.5-20μg/mL范围内成功分析并呈线性测定。从两种方法来看,PVC基和PO基管道对他克莫司的吸附水平分别最高和最低(<10%)。采用泵注法可稳定输送他克莫司。结果表明,泵注法可估算给药装置管道中他克莫司的吸附情况,并评估其他低浓度使用的吸附性药物。PO基管道作为给药装置管道的替代品也具有广阔的应用前景。

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