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利用隐形纳米信标通过片剂包衣过程中的表面增强拉曼散射实现片剂追溯保证。

Application of stealth nanobeacon for traceability assurance in pharmaceutical tablets via surface-enhanced Raman scattering during the tablet coating process.

作者信息

Yasunaga Toshiya, Fukuoka Takao, Yamaguchi Akinobu, Ogawa Noriko, Yamamoto Hiromitsu

机构信息

Laboratory of Pharmaceutical Engineering, School of Pharmacy, Aichi Gakuin University, 1-100 Kusumoto-cho, Chikusa-ku, Nagoya, 464-8650 Japan.

Archilys Corporation, Advanced Science, Technology and Management Research Institute of Kyoto, 8E09, 8F134, Chūdōji Minamimachi, Shimogyo-ku, Kyoto, 600-8813, Japan.

出版信息

Int J Pharm. 2024 Dec 5;666:124810. doi: 10.1016/j.ijpharm.2024.124810. Epub 2024 Oct 10.

Abstract

Microtaggant technologies for on-dose authentication have garnered significant interest for use in the anti-counterfeit activities and traceability of pharmaceutical dosage forms. Previously, we proposed a stealth nanobeacon (NB) comprising self-assembled colloidal gold nanoparticles with reporter molecules that demonstrated characteristic surface-enhanced Raman scattering (SERS) activity. However, the integration of such microtaggants into standard production lines remains underexplored. In this study, we demonstrate the incorporation of NB into tablet coatings using a simple mixing method with conventional coating solutions. Rapid and discernible SERS responses from the NB-coated tablets were observed in response to laser excitation at 785 nm for 0.1s, implying that it is an advanced and efficient method for counterfeit detection. In addition, the SERS intensity of NB increased with coating time, suggesting that NB can be used as a tracer for the real-time monitoring of coating thickness. Furthermore, NB-coated tablets were indistinguishable from NB-free tablets, even during colorimetric analysis. These results suggest that the NB possesses stealth properties and can be easily incorporated into counterfeit detection products.

摘要

用于剂量验证的微标记技术在药品剂型的防伪和可追溯性方面引起了极大的关注。 此前,我们提出了一种由自组装胶体金纳米粒子组成的隐形纳米信标 (NB),其中包含具有特征表面增强拉曼散射 (SERS) 活性的报告分子。 然而,将此类微标记物集成到标准生产线中仍未得到充分探索。 在这项研究中,我们使用常规涂层溶液的简单混合方法将 NB 掺入片剂涂层中。 在以 785nm 的激光激发 0.1s 后,从 NB 涂层片剂中观察到快速且可辨别的 SERS 响应,这表明它是一种先进且高效的防伪检测方法。 此外,NB 的 SERS 强度随涂层时间的增加而增加,表明 NB 可作为涂层厚度实时监测的示踪剂。 此外,即使进行比色分析,NB 涂层片剂也与无 NB 片剂无法区分。 这些结果表明,NB 具有隐形特性,可以很容易地融入防伪检测产品中。

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