doi:10.16597/j.cnki.issn.1002-154x.2023.03.001
血液透析器生产工艺对聚乙烯吡咯烷酮 洗脱的影响研究
戴鹏1 刘炳荣1 汪毅1 沈美兰1 鄢杰1 刘峰2∗
(1. 江西三鑫医疗科技股份有限公司,江西 南昌 330200; 2. 南昌大学 化学化工学院,江西 南昌 330031)
Study on the Production Process Parameters Affecting the Elution of Polyvinylpyrrolidone in Hemodialyzer
Dai Peng 1 Liu Bingrong 1 Wang Yi 1 Shen Meilan 1 Yan Jie 1 Liu Feng 2∗
(1. Jiangxi Sanxin Medical Science and Technology Co. , Ltd. , Jiangxi Nanchang 330200; 2. School of Chemistry and Chemical Engineering, Nanchang University, Jiangxi Nanchang 330031)
摘要:
聚乙烯吡咯烷酮( PVP)从膜表面的洗脱是血液透析器使用过程中的重要问题之一。 本研究旨在探讨 电子束灭菌及储存时间对血液透析器中 PVP 洗脱的影响。 选取同一批号自制聚醚砜中空纤维血液透析膜,组 装成血液透析器,依次编为 A ~ G 组,分别进行电子束灭菌和室温储存。 然后模拟临床血液透析标准操作,用 500 mL灭菌注射用水替代血液,以 200 mL·min-1的流速于 37 ℃ 下循环 5.5 h,用高效液相色谱法测定循环液 中 PVP 的量。结果表明,A 组(未灭菌、储存 2 d)透析器产品的 PVP 洗脱量约为 40.184 mg·支-1 ,B 组( 电子束灭菌、储存 2d)透析器产品的 PVP 洗脱量为 90. 895 mg·支-1,电子束灭菌后产品的 PVP 洗脱量为前者的 2.3 倍。 B ~ G 组透析器产品均采用电子束灭菌,但室温储存时间依次增加,PVP 洗脱量由 B 组( 电子束灭菌、储存2d)的 90.895 mg·支-1 ,上升至 G 组( 电子束灭菌、储存 720 d) 的 181.005 mg·支-1 ,增长速率逐渐变缓。 因此,电子束灭菌及储存时间等均会导致聚醚砜透析膜上 PVP 的洗脱量增加,而 PVP 被认为是影响血液透 析器生物相容性的潜在因素。 本研究可为优化血液透析器生产工艺,减少 PVP 洗脱量,提升国产血液透析器生物相容性提供相关理论依据。
关键词：聚乙烯吡咯烷酮 聚醚砜 透析器 电子束灭菌 储存时间；
Abstract：
The elution of polyvinylpyrrolidone(PVP) from the membrane surface is one of the important issues for hemodialyzer. The purpose of this study was to investigate the effect of irradiation sterilization and storage time of hemodialyzer on the elution of PVP in hemodialyzers. In this study, self-made polyethersulfone hollow fiber hemodialysis membranes were selected from the same batch number, assembled into hemodialysis machines, numbered as group A - G, and subjected to electron beam sterilization and room temperature storage operations respectively. Then simulate the standard operation of clinical hemodialysis, which was replaced blood with 500 mL sterile water for injection, circulate at 37 ℃ for 5. 5 h at a flow rate of 200 mL·min - 1 , and measure the amount of polyvinylpyrrolidone eluted in the circulating fluid with high performance liquid phase. Results The PVP elution amount for per branch in group A(non sterilized, stored for 2 d) was about 40. 184 mg, and that in group B(electron beam sterilization, stored for 2 d) was 90. 895 mg. The PVP elution amount of products after electron beam sterilization is 2. 3 times that of the former. All dialyzer products in group B - G were sterilized by electron beam, but the storage time at room temperature increased in turn. The elution amount of PVP for per branch increased from 90．895 mg in group B(electron beam sterilization, storage for 2 d) to 181. 005 mg·branch - 1 in group G( electron beam sterilization, storage for 720 d), and the growth rate gradually slowed down. Electron beam sterilization and storage time will increase the elution amount of polyvinylpyrrolidone(PVP) on polyethersulfone dialysis membrane. PVP was considered to be a potential factor affecting the biocompatibility of hemodialyzer, and this operation process was an essential key process for the production of hemodialyzer. The results of this study could provide relevant theoretical basis for optimizing the production process of hemodialyzer, reducing the elution amount of PVP and improving the biocompatibility of domestic hemodialyzer.
Keywords：polyvinylpyrrolidone; polyethersulfone; hemodialyzer; electron beam sterilization; storage time;