MA Yue1,2, ZHANG Ying1, SUN Qi1,2, SHI Zhenwei1,2, HUANG Zhuanqing1,2, YANG Fei1,2, SHI Haoyuan1,2, YANG Yalong1,2, XU Fenghua1
1. Pharmaceutical Sciences Research Division, Department of Pharmacy, Medical Supplies Centre of Chinese PLA General Hospital, Beijing 100853,China; 2. Medical School of Chinese PLA, Beijing 100853,China
Abstract：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.
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MA Yue, ZHANG Ying, SUN Qi, SHI Zhenwei, HUANG Zhuanqing, YANG Fei, SHI Haoyuan, YANG Yalong, XU Fenghua. Biosafety study on new zeolite hemostatic gauze. Med. J. Chin. Peop. Armed Poli. Forc., 2023, 34(4): 301-304.
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