新型沸石止血纱布的生物安全性研究

Biosafety study on new zeolite hemostatic gauze

目的研究新型沸石止血纱布的生物安全性。方法参照GB/T 16886医疗器械生物学评价标准和GB/T 14233.2-2005《中华人民共和国药典》对新型沸石止血纱布进行安全性研究,采用CCK8法进行体外细胞毒性试验、溶血试验、热原试验、急性全身毒性试验、皮内反应试验和致敏试验。结果新型沸石止血纱布细胞毒性等级均在0~1,溶血率为3.37%,热原试验、急性全身毒性试验、皮内反应和致敏试验均呈阴性。结论新型沸石止血纱布生物安全性较好。

Objective To study the biosafety of new zeolite hemostatic gauze.Methods According to GB/T 16886 biological evaluation standard for medical devices and GB/T 14233.2-2005“Pharmacopoeia of the People’s Republic of China”,the safety of the new zeolite hemostatic sponge was studied.CCK8 method was used for in vitro cytotoxicity test,hemolysis test,pyrogen test,acute systemic toxicity test,intradermal reaction test and sensitization test.Results The cytotoxicity grade of the new zeolite hemostatic gauze was 0-1.The hemolysis rate was 3.37%.The pyrogen test,acute systemic toxicity test,intradermal reaction and sensitization test were all negative.Conclusions The new zeolite hemostatic gauze is characterized by better biosafety.