现代仪器与医疗2024,Vol.30Issue(6) :44-50.DOI:10.11876/mimt202406007

医疗器械用压敏胶的生物学危害及安全风险研究

Study on the biological hazards and safety of pressure sensitive adhesive for medical devices

叶小惠 周宙 张磊 章亚兵 施超 黎秀梅 吕彤彤 王彦蕲
现代仪器与医疗2024,Vol.30Issue(6) :44-50.DOI:10.11876/mimt202406007

医疗器械用压敏胶的生物学危害及安全风险研究

Study on the biological hazards and safety of pressure sensitive adhesive for medical devices

叶小惠 1周宙 2张磊 1章亚兵 1施超 1黎秀梅 1吕彤彤 1王彦蕲1
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作者信息

  • 1. 安徽省食品药品检验研究院生物学评价检测室,合肥 230051
  • 2. 安徽省科技成果转化促进中心科技研发部,合肥 230091
  • 折叠

摘要

目的 研究不同类型的医疗器械用压敏胶的生物相容性,为压敏胶的规范使用提供理论支撑.方法 按参照GB/T 16886医疗器械生物学评价标准,对不同类型的医疗器械用压敏胶进行细胞毒性试验、中性红摄取试验、溶血试验和凝血试验等生物相容性评价试验研究.结果 YP1、YP3和YP4在厚度40μm时细胞存活率<70%,YP1、YP3和YP4在20μm和40μm厚度时中性红吞噬率均下降超过50%,YP3和YP4在10μm、20μm和40μm 厚度时的溶血率均>5%,YP3和YP4在厚度20μm和40μm时的PTT值与空白对照相比的百分比均<80%.结论 在本次试验条件下,部分厂家的丙烯酸酯压敏胶,尤其是YP3和YP4,在一定厚度时具有潜在细胞毒性,抑制细胞的吞噬功能,具有溶血反应和凝血反应,在医疗器械的使用时应慎重考虑.

Abstract

Objective To evaluate the biocompatibility of different types of pressure sensitive adhesive for medical devices,which provides theoretical support for scientific supervision of the pressure-sensitive adhesive.Methods Based on a series of GB/T 16886 medical equipment biology evaluation standards,Pressure sensitive adhesive for medical devices were subjected to a series of tests,including MTT cytotoxicity test in vitro,neutral red uptake test,and hemocompatibility test and Partial thromboplastin time.Results The cell survival rates of the YP3 and YP4 were less than 70%at 40μm thicknesses,The neutral red phagocytosis rates of theYP1,YP3 and YP4 were reduced to<50%of the blank.at thicknesses of 20μm and 40μm.The hemolysis rates of theYP1,YP3 and YP4 were more than 5%at thicknesses of 10μm,20μm and 40μm.The partial thromboplastin time of YP3 and YP4 compared with blank control were less than 80%at thicknesses of 20μm and 40μm.Conclusion Under the current test conditions,the acrylic emulsion pressure sensitive adhesive showed a potential biocompatibility with potential cytotoxicity,inhibition of cellular phagocytic functionhemolytic effect and blood coagulation effect,especially for YP3 and YP4 at some thicknesses.

关键词

压敏胶/医疗器械/生物相容性/厚度

Key words

Pressure sensitive adhesive/Medical devices/Biological compatibility/Thickness

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出版年

2024
现代仪器与医疗
中国科学器材公司

现代仪器与医疗

影响因子:1.47
ISSN:2095-5200
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