北京生物医学工程

生物医学拉曼光谱质控方法研究

Study on the quality control methods of biomedical Raman spectroscopy

作者：王浩孟祥峰刘艳珍任海萍

单位：中国食品药品检定研究院光机电室(北京100050)

分类号：R318.51; TN818; TH773

出版年·卷·期（页码）：2016·35·5（527-532）

摘要：

目的评价生物医学拉曼光谱设备的关键性能参数，为开展不同厂家产品的一致性比对和建立拉曼光谱类医疗器械的检测规范做准备。方法开发通用的拉曼光谱实验平台，测量化学参考物质，开发光谱分析方法，对实验系统的分辨率、波长校正、信噪比、系统响应等进行分析，并使用几种常见的生物分子进行测试验证。结果根据化学参考物质的拉曼光谱提取了实验系统的光谱分辨率、波长校正、信噪比、系统响应等信息，在测试中可有效地将生物分子的原始拉曼谱还原为可比对的标准拉曼谱。结论本文方法可有效提取和评价拉曼系统的性能参数，这对于拉曼光谱和其他相关光谱医疗器械的质控具有积极意义。

Objective To assess the key performance parameters of Raman spectroscopy medical device, and prepare for the testing of consistency between different Raman products and the establishment of quality control criterion. Methods A general Raman experimental platform was built to measure chemical reference materials. Spectral analysis methods were developed to evaluate the performance parameters of the Raman system including spectral resolution, wavelength calibration, signal-to-noise ratio and system response. Certain common biomolecules were tested as validation. Results Wavelength calibration, signal-to-noise ratio and system response were extracted from the Raman spectra of the chemical reference materials. The standard spectra of certain biomolecules were effectively reconstructed from the raw spectra in the test, which can be used for comparison. Conclusions This method was demonstrated the capability to acquire the performance parameters of Raman systems, which were beneficial for the quality control of Raman and other related spectroscopy medical devices.

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