Talja M, Saarela K, Ruutu M, Andersson L C, Alfthan O
Department of Surgery, Päijät-Häme Central Hospital, Lahti, Finland.
Ann Chir Gynaecol Suppl. 1993;206:74-9.
The cytotoxicity of latex urinary catheters has been earlier documented. During the manufacturing process tens of chemicals are added to the natural rubber base. Several of the accelerators and other chemicals used have carcinogenic and acute toxic effects. Some of the accelerators are zinc compounds. In the present study, the cytotoxicity and zinc concentration of 68 latex catheter extracts were analysed. The siliconized latex catheters were the most toxic, and a correlation was seen between the IC50 values and the zinc concentration. The good manufacturing practice (GMP) has to some extent resolved the cytotoxicity problem of latex urinary catheters. There is, however, still a need to reformulate the manufacturing process and to find new catheter materials to meet the new EN standards concerning the biological safety of urinary catheters.
乳胶导尿管的细胞毒性早已被记录在案。在制造过程中，数十种化学物质被添加到天然橡胶基质中。所使用的几种促进剂和其他化学物质具有致癌和急性毒性作用。一些促进剂是锌化合物。在本研究中，分析了68种乳胶导尿管提取物的细胞毒性和锌浓度。硅化乳胶导尿管毒性最大，并且在半数抑制浓度（IC50）值和锌浓度之间存在相关性。良好生产规范（GMP）在一定程度上解决了乳胶导尿管的细胞毒性问题。然而，仍然需要重新制定制造工艺并寻找新的导管材料，以符合关于导尿管生物安全性的新欧洲标准。
