Ikarashi Y, Tsuchiya T, Nakamura A
Division of Medical Devices, National Institute of Health Sciences, Tokyo, Japan.
Biomaterials. 1995 Feb;16(3):177-83. doi: 10.1016/0142-9612(95)92115-m.
A new sterilization system using vapour-phase hydrogen peroxide (VPHP) was recently developed. The cytotoxicity of various medical materials sterilized by the VPHP sterilization system was investigated. After VPHP sterilization, polystyrene, polyurethane (PU8), blend material of silicone and polyurethane (Sil/PU6), poly(methyl methacrylate) (PMMA), fluorosilicone acrylate and poly(2-hydroxyethyl methacrylate) (HEMA) showed strong cytotoxicity, whereas polyethylene and polypropylene did not. Although the cytotoxic potential of most materials is reduced by extension of the aeration time, HEMA and PMMA still retained strong cytotoxicity after 12 h aeration. Addition of catalase to the cell culture eliminated the cytotoxicity of sterilized polystyrene and PU8. Hydrogen peroxide (H2O2) residues remaining in the sterilized materials were determined. Large amounts of H2O2 (5.1-186 micrograms) were detected in HEMA, PU8, Sil/PU6 and PMMA. In contrast, silicone and polyethylene contained low levels of H2O2. The amounts of residual H2O2 in the materials decreased with increasing aeration time, but the elimination rate of H2O2 differed among the test materials. The cytotoxic potential of the VPHP-sterilized materials correlated with the amounts of residual H2O2 present. These results indicated that the cytotoxicity of VPHP-sterilized materials was caused by the residual H2O2. To generalize the developed VPHP sterilization system for various medical devices, it is important to validate the aeration of materials for removal of cytotoxic residuals.
最近开发了一种使用气相过氧化氢（VPHP）的新型灭菌系统。研究了经VPHP灭菌系统灭菌的各种医用材料的细胞毒性。VPHP灭菌后，聚苯乙烯、聚氨酯（PU8）、硅酮与聚氨酯的混合材料（Sil/PU6）、聚甲基丙烯酸甲酯（PMMA）、氟硅酮丙烯酸酯和聚甲基丙烯酸2-羟乙酯（HEMA）表现出很强的细胞毒性，而聚乙烯和聚丙烯则没有。尽管大多数材料的细胞毒性潜力会随着通气时间的延长而降低，但HEMA和PMMA在通气12小时后仍保留很强的细胞毒性。向细胞培养物中添加过氧化氢酶消除了灭菌后的聚苯乙烯和PU8的细胞毒性。测定了灭菌材料中残留过氧化氢（H2O2）的含量。在HEMA、PU8、Sil/PU6和PMMA中检测到大量H2O2（5.1-186微克）。相比之下，硅酮和聚乙烯中的H2O2含量较低。材料中残留H2O2的量随着通气时间的增加而减少，但不同测试材料中H2O2的消除率不同。VPHP灭菌材料的细胞毒性潜力与存在的残留H2O2量相关。这些结果表明，VPHP灭菌材料的细胞毒性是由残留的H2O2引起的。为了将开发的VPHP灭菌系统推广应用于各种医疗器械，验证材料通气以去除细胞毒性残留物非常重要。
