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。
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.
关键词
沸石 /
止血 /
生物安全性
Key words
zeolite /
hemostasis /
biosafety
{{custom_sec.title}}
{{custom_sec.title}}
{{custom_sec.content}}
参考文献
[1] Granville J, Jacobs N, Midwinter M J. Pre-hospital haemostatic dressings: a systematic review [J]. Injury, 2011, 42(5): 447-459.
[2] Pourshahrestani S, Zeimaran E, Djordjevic I, et al. Inorganic hemostats: the state-of-the-art and recent advances [J]. Mater Sci Eng C Mater Biol Appl, 2016, 58(1): 1255-1268.
[3] Vilardo N, Feinberg J, Black J,et al. The use of QuikClot combat gauze in cervical and vaginal hemorrhage [J]. Gynecol Oncol Rep, 2017, 21(8): 114-116.
[4] Yu L, Shang X, Chen H,et al. A tightly-bonded and flexible mesoporous zeolite-cotton hybrid hemostat [J]. Nat Commun, 2019, 10(1): 1932.
[5] Wang J, Zhang H, Wang J, et al. Efficacy of new zeolite-based hemostatic gauze in a gunshot model of junctional femoral artery hemorrhage in swine [J]. J Surg Res, 2021, 263: 176-185.
[6] GB/T16886.12-2005.医疗器械生物学评价.第12部分:样品制备与参照样品[S].北京:中国标准出版社, 2005:03.
[7] 施高强,罗高兴,陈希炜,等.3D打印的多聚甲醛硅氧烷仿生纳米银复合材料及性能研究[J].解放军医学杂志,2018,43(10):840-848.
[8] 张文云,沈 毅,李 南,等.牙科纤维/树脂复合材料的生物安全性研究[J].解放军医学杂志, 2004, 29(4): 345-347.
[9] 国家药典委员会.中华人民共和国药典四部[S].2015年版.北京:中国医药科技出版社, 2015:153-154.
[10] Hamada H, Bruze M, Zimerson E,et al. Sensitization and cross-reactivity patterns of contact allergy to diisocyanates and corresponding amines: investigation of diphenylmethane-4,4′-diisocyanate, diphenylmethane-4,4′-diamine, dicyclohexylmethane-4,4′-diisocyanate, and dicylohexylmethane-4,4′-diamine [J]. Contact Dermatitis, 2017, 77(4): 231-241.
[11] Li Y, Liao X, Zhang X, et al. In situ generated thrombin in the protein corona of zeolites: relevance of the functional proteins to its biological impact [J]. Nano Research, 2014, 7(10): 1457-1465.
[12] Arnaud F, Tomori T, Saito R, et al. Comparative efficacy of granular and bagged formulations of the hemostatic agent QuikClot[J/OL]. J Trauma, 2007, 63(4): 775-782.
[13] Arnaud F, Tomori T, Carr W, et al. Exothermic reaction in zeolite hemostatic dressings: QuikClot ACS and ACS+ [J]. Ann Biomed Eng, 2008, 36(10): 1708-1713.
PDF(1658 KB)
