不同来源一次性使用无菌注射器用活塞体外细胞毒性的比较研究

Comparison of in Vitro Cytotoxicity of Different Disposable Sterilized Syringe Piston

目的:对不同来源一次性使用无菌注射器用活塞体外细胞毒性进行评价,为科学监管提供技术支持。方法:将一次性使用无菌注射器用活塞浸提液分别与L929细胞接触培养,采用四唑盐比色法(MTT法)量化细胞毒性,计算相对增殖率,并进行细胞毒性评价。结果:不同厂家相同浸提比例,产品之间细胞毒性均存在差异,同一厂家不同浸提比例的条件下,产品细胞毒性未发现明显变化。结论:不同厂家产品配方及生产工艺不尽相同可能是导致不同厂家的产品的细胞毒性存在差异的原因,建议在产品标准中生物性能技术要求中增加细胞毒性评价项。

Objective：To evaluate the different sources of disposable sterile syringe piston in vitro cytotoxicity,to provide techni-cal support for scientific supervision. Methods：disposable sterile syringe piston leaching solution were cultured in contact with L929 cells, using MTT method quantify cytotoxicity, calculated relative growth rates, and cytotoxicity evaluation. Results：Different manu-facturers in same leaching ratio, cytotoxicity were differences between the product and the same manufacturer, cytotoxicity were no ap-parent change under the conditions of different leaching ratio of same manufacturers products. Conclusion： different manufacturer product formula and production process is not the same may be lead to the product of different manufacturer＇s the reason why there are differences between cytotoxicity, suggest that biological properties in the product standard technical requirements of increased cytotox-icity evaluation items.