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BackgroundAdverse reactions, such as anaphylactoid shock, have been reported to occur frequently with the use of polysulfone (PSf) membrane dialyzers. Polyvinylpyrrolidone (PVP) elution from the membrane may be a key factor in these reactions. In this paper, we discuss the problems in the evaluation of PVP elution from PSf membrane dialyzers sterilized by gamma-ray irradiation.Methods and ResultsPVP concentrations in the filling solutions in some wet-type PSf membrane dialyzers are measured by Müller’s method as a standard measurement method. The PVP concentrations in autoclave (AC)-sterilized dialyzers were one order of magnitude higher than those in the solutions in dialyzers sterilized by gamma-ray irradiation. Because it is difficult to determine the PVP concentrations in the filling solutions sterilized by gamma-ray irradiation by Müller’s method, single-fractionated-component PVP solutions with fractionated components of PVP (K90 or K30) were prepared and the PVP concentrations of the solutions before and after gamma-ray irradiation were determined. The results indicated that the PVP concentrations in the solutions could be determined by Müller’s method before irradiation, whereas PVP was undetectable in the solution after irradiation. For single-fractionated-component PVP solutions with K90 and K30, the changes in the structure of PVP before and after gamma-ray irradiation were analyzed by high-performance liquid chromatography (HPLC). The single-fractionated-component PVP solutions with K90 and K30 had a broad peak at retention times of 15 and 19 min, respectively, prior to the gamma-ray irradiation, whereas both solutions showed a similar sharp peak at a retention time of 23 min after the irradiation. Based on these results, it is surmised that PVP is degraded by irradiation to yield PVP degradation products of low molecular weight.Furthermore, nuclear magnetic resonance (NMR) spectroscopy for PVP K90 solution was performed to confirm the signals from the vinylpyrrolidone (VP) skeletal structures. Signals from the VP skeletal structures were detected before the gamma-ray irradiation but disappeared after the irradiation. Thus, it appears that the degradation products of PVP without VP skeletal structures cannot be detected by Müller’s method.ConclusionsThe measurement of PVP concentrations by Müller’s method is inappropriate for the evaluation of PVP elution from PSf membrane dialyzers sterilized by gamma-ray irradiation.

Problems in the evaluation of polyvinylpyrrolidone (PVP) elution from polysulfone membrane dialyzers sterilized by gamma-ray irradiation