纳米生物材料标准化检测和评价的现状与展望

Research progress and prospects of standardized testing and assessment for nanobiomaterials

近年来,纳米生物材料被广泛应用于药物靶向递送、医学成像、组织工程、生物传感、化妆品等生物医学领域.纳米材料的特殊性质使其在提高材料性能的同时也带来潜在的生物安全性风险.目前,我国的纳米科技水平已处于世界前沿,然而纳米技术的转化仍旧是短板.纳米生物材料要实现生物医药产品的转化应用,围绕“质量控制”和“安全性评估”两个主要方面,尚有很多关键问题急需解决.本文将综述纳米生物材料及其产品的理化性质表征和生物安全性评价的标准化现状、存在的问题及发展趋势等,为纳米生物材料的转化应用提供参考.

Nanobiomaterials, as nanotechnology-derived biomaterials, are referred to those biomaterials whose structures orcomponents exhibit novel and significantly changed properties when their dimensions are at the nanoscale (1–100 nm).Hence, due to the unique features, nanobiomaterials have been extensively applied to targeted drug delivery, medicalimaging, tissue engineering, biosensing as well as cosmetics over the past few decades. Meanwhile, the new characteristicsof nanobiomaterials can also bring potential risks in biological safety together with performance. Currently, China hasplayed a large role in the development of nanoscience and nanotechnology in the world in quite a lot of benefits relatedfields since there are the most abundant nano-related publications. Additionally, since National Technical Committee 279on Nanotechnology of Standardization Administration of China was founded in 2005, China has released more than 100national standards in the field of nanobiomaterials and over 30 related national standard plans are under development.Moreover, the industry standards for medical devices containing nanomaterials in China have been vigorously pushedforward. In the past China tended to publish scientific papers for original research, but now analytic data have shown anexponential growth in the nanobiomaterials related patents, about more than 1700 cases.However, nanotechnology translation is far behind in our country. There are very few real nano-products in thebiomedical field. As for the translation from nanobiomaterials to biomedical applications, there are still so many criticalissues which need to be addressed urgently, mainly including quality control and biosafety evaluation. The majorchallenges consist in the accurate measurement of physicochemical properties for nanobiomaterials and the setup of nanobiosafetyknowledge system. Although some advanced techniques can give a valuable understanding of nanobiomaterials,especially for some special scenarios involving the presence of nanobiomaterials in complex matrices to confirm nanocontentlabeling as well as nanobiomaterial release from medical devices and so on. The repeatability and applicability ofthese measurements based on advanced techniques are still limited so far, which can be improved by standardized testing.In addition, there is still a lack of standardized biological assays as well as experimental animal models for biosafetyevaluation. Standardization is the bridge of innovation-driven development as an indispensable way to achieving therepeatability and reproducibility of new technologies and large-scale production. It can also push the marketization andinternationalization of these new advanced technologies and be very helpful to promote China transformation from “Madein China” to “Chinese Standards”. Therefore, the standardized testing will definitely provide much more accurate andreliable information regarding the characterization of physicochemical properties and risk-benefit evaluation ofnanobiomaterials.In order to offer a strong support and reference for nanobiomaterial development and nanotechnology translation in ourcountry, this review summarizes the current situation of standardized testing, existing issues and development trend ofphysicochemical characterization and biosafety evaluation for nanobiomaterials as well as the related products. As newstrategic and cutting-edge materials around the world, the development and application of nanobiomaterials will be boundto further improve the overall medical efficiency and support the national strategy of healthy in China in the future.