CAJ | 학술논문

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。
목적：대불동래원일차성사용무균주사기용활새체외세포독성진행평개，위과학감관제공기술지지。방법：장일차성사용무균주사기용활새침제액분별여L929세포접촉배양，채용사서염비색법(MTT법)양화세포독성，계산상대증식솔，병진행세포독성평개。결과：불동엄가상동침제비례，산품지간세포독성균존재차이，동일엄가불동침제비례적조건하，산품세포독성미발현명현변화。결론：불동엄가산품배방급생산공예불진상동가능시도치불동엄가적산품적세포독성존재차이적원인，건의재산품표준중생물성능기술요구중증가세포독성평개항。
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.