血液透析器生产工艺对聚乙烯吡咯烷酮洗脱的影响研究

Study on the Production Process Parameters Affecting the Elution of Polyvinylpyrrolidone in Hemodialyzer

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2 d)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2 d)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。

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.