七款喷涂类新型医用敷料的生物安全性评价研究  

Study on Biosafety Assessment of Seven New Spray-on Medical Dressings

作　　者：陈小青 李冰 付燕 朱康达 罗吉 王斌 于志强 马中春 王燕 CHEN Xiao-Qing;LI Bing;FU Yan;ZHU Kang-Da;LUO Ji;WANG Bin;YU Zhi-Qiang;MA Zhong-Chun;WANG Yan(Ningbo International Travel Health Care Center(Ningbo Customs Port Outpatient),Ningbo 315012;Ningbo Customs District Technology Center,Ningbo 315012;Ningbo No.2 Hospital,Ningbo 315012)

机构地区：[1]宁波国际旅行卫生保健中心(宁波海关口岸门诊部),宁波315012 [2]宁波海关技术中心,宁波315012 [3]宁波市第二医院,宁波315012

出　　处：《中国口岸科学技术》2024年第1期69-74,共6页China Port Science and Technology

基　　金：海关总署科研项目(2019HK072,2021HK227)。

摘　　要：本文对7款喷涂类新型医用敷料的生物安全性进行评价,旨在为医用敷料的安全使用提供科学依据。采用皮肤刺激试验、皮肤致敏试验和体外细胞毒性试验对7款喷涂类新型医用敷料的生物安全性进行评价。研究结果显示,这7款喷涂类新型医用敷料均无皮肤刺激反应和皮肤致敏反应。体外细胞毒性试验显示,医用皮肤修复敷料、医用湿性修复敷料2个受试物细胞毒性反应级别为0级,无细胞毒性;医用冷敷凝胶、医用修护敷料2个受试物细胞毒性反应级别为2级,细胞毒性反应程度为轻度;医用聚乙二醇敷料、医用创面修复敷料、医用生物玻璃皮肤护理敷料3个受试物细胞毒性反应级别为3级,细胞毒性反应程度为中度。本研究结果提示,喷涂类新型医用敷料因材质不一,对健康的影响也不尽相同,建议有关部门加强监管,确保产品质量和安全性,从而进一步保障使用者的健康安全。This study evaluates the biological safety of seven new types of spray-on medical dressings to provide a scientific basis for their safe use.Dermal irritation tests,dermal sensitization tests,and in vitro cytotoxicity tests were conducted to assess the biosafety of these medical dressings.The results showed that all seven spray-on medical dressings did not induce dermal irritation or sensitization.In the in vitro cytotoxicity tests,two of the test materials,medical dermal repair dressings and medical wet repair dressings,exhibited no cytotoxicity(level 0),while two others,medical cold compress gels and medical repair dressings,showed mild cytotoxicity(level 2).Three of the test materials,medical polyethylene glycol dressings,medical wound repair dressings,and medical bioactive glass dermal care dressings,exhibited moderate cytotoxicity(level 3).These results imply that the impact of spray-on medical dressings on health varies due to differences in materials.Therefore,it is recommended that relevant authorities enhance supervision to ensure product quality and safety,further safeguarding the health and safety of users.

关 键 词：医用敷料 皮肤刺激试验 皮肤致敏试验 体外细胞毒性试验 生物安全性评价 

分 类 号：R318.08[医药卫生—生物医学工程]