首页|凝胶剂前处理在胶原蛋白祛疤凝胶敷料检测中的应用

凝胶剂前处理在胶原蛋白祛疤凝胶敷料检测中的应用

Application of Gel Pretreatment in the Detection of Collagen Scar Removal Gel Dressing

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凝胶类医疗器械产品近年来发展迅速,针对市场蓬勃的凝胶类产品,国家也陆续针对特定凝胶产品推出相关的技术标准,用以规范和约束凝胶类产品的性能指标,但凝胶类产品的前处理一直是行业难题.硅酮类凝胶剂作为凝胶类产品的一种,同样缺乏系统科学的前处理方法,这也严重影响了硅酮凝胶剂的质量检测稳定性.本项目将有机溶剂萃取法和强酸沉淀法有机组合,对高硅酮体系的凝胶剂进行了前处理,有效解决了胶原蛋白祛疤凝胶中蛋白含量的检测和硅酮含量检测的一致性和准确性问题,降低了检测难度,也为类似高硅酮体系凝胶剂的检测提供了参考.
Gel medical devices have developed rapidly in recent years.For the booming gel products,the state has also launched relevant technical standards for specific gel products to regulate and restrain the performance indicators of gel products.However,the pre-processing of gel products has always been a difficult problem in the industry.As one of gel products,silicone gel agents also lack systematic scientific pretreatment methods,which also seriously affects the quality detection stability of silicone gel agents.This project will combine organic solvent extraction and strong acid precipitation method to pre-process the high silicone system gel,which effectively solves the collagen remove scar gel protein content detection and silicone content detection consistency and accuracy,reduce the detection difficulty.This project also provides a reference for similar high silicone system gel detection.

gel agentsilicone systemextractionacid sink

周齐洋、高静贤、金玉、徐松泉、徐林

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江苏省医疗器械检验所 (江苏 南京 210019)

南京天纵易康生物科技股份有限公司 (江苏 南京 210031)

凝胶剂 硅酮体系 萃取 酸沉

江苏省市场监督管理局

苏市监标[2023]173号

2024

中国医疗器械信息
中国医疗器械行业协会

中国医疗器械信息

影响因子:0.375
ISSN:1006-6586
年,卷(期):2024.30(13)
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