文章信息/Info

Title:

Current Status of the Safety Evaluation and Regulation for Nanosilver-containing Materials

作者:

許海燕; 郭花

中國醫(yī)學(xué)科學(xué)院基礎(chǔ)醫(yī)學(xué)研究所 北京協(xié)和醫(yī)學(xué)院基礎(chǔ)學(xué)院

Author(s):

XU Haiyan; GUO Hua

關(guān)鍵詞:

納米銀; 毒理; 標準; 監(jiān)管

DOI:

10.7502/j.issn.1674-3962.2016.01.05

文獻標志碼:

A

摘要:

納米銀具有顯著優(yōu)于銀離子化合物的殺菌性能，近年來，產(chǎn)業(yè)界和學(xué)術(shù)界對利用納米銀提高生物醫(yī)藥、電子、家用產(chǎn)品的抗菌性能方面進行了廣泛的探索和開發(fā)。但是，隨著納米銀生產(chǎn)數(shù)量的增加和各種醫(yī)用與日用產(chǎn)品進入市場，人們接觸納米銀機會也隨之增多，納米銀對于健康、環(huán)境和安全的影響受到了學(xué)術(shù)界及政府管理機構(gòu)的密切關(guān)注。納米銀的生物安全性、臨床應(yīng)用必要性和有效性、在產(chǎn)品中的結(jié)合方式與結(jié)合穩(wěn)定性的檢測與評價標準、以及含納米銀醫(yī)療器械的管理規(guī)范是需要認真而慎重考慮的關(guān)鍵問題。本文概要介紹了納米銀的毒理學(xué)研究進展，總結(jié)和評述了國際上對于納米銀及其他納米材料用于生物醫(yī)藥和日常生活用品的安全性評價標準和監(jiān)管政策現(xiàn)狀。

Abstract:

The nanosilver has been widely explored for being used as a powerful antibacterial agent in medical healthcare, electronic and household products due to its much stronger antimicrobial performance than conventional silver compounds. Meanwhile, the increasing exposure of nanosilver raises the serious concern with impacts upon the health, safety, and environment of the nanosilver-containing products. In the development of nanosilver-containing products, the bio-safety, necessity and effectiveness in clinical practices, and standardization and regulation should be carefully considered. In this article, the antimicrobial mechanism and the research progress in nanosilver toxicology was introduced. The standardization for physicochemical characterization and safety evaluation for nanomaterials as well as the regulation was addressed.