Low Molecular Weight Leachables from Medical Grade Polymers

摘要

Four medically important polymeric materials (silicone polymer from mammary prostheses, polyurethane, polyethylene, and polycarbonate) were placed in contact with water for time periods ranging from four hours to seven days. Substances leaching into water wereseparated by extraction with methylene chloride, or by evaporation of water, and identification of species in the leachate was attempted by a number of analytical techniques, with extensive use of combined gas chromatography/mass spectrometry (GC/MS). Low molecular weight fragments of dimethylsiloxane were identified from mammary prosthesis gel. Spectra are also included for leachate from the other three polymers; identification of these compounds is still in process. Prolyl hydroxylase and tritium-labeled protocollagen substrate were prepared from chick embryos, and an enzyme activity assay system was developed with use of Bio-Rad AG 50W-X8 cation exchange resin. No effect on enzyme activity was seen when silicone gel leachate was added to the assay mixture.