北京生物醫(yī)學工程

生物醫(yī)學拉曼光譜質控方法研究

Study on the quality control methods of biomedical Raman spectroscopy

作者：王浩孟祥峰劉艷珍任海萍

單位：中國食品藥品檢定研究院光機電室(北京100050)

分類號：R318.51; TN818; TH773

出版年·卷·期（頁碼）：2016·35·5（527-532）

摘要：

目的評價生物醫(yī)學拉曼光譜設備的關鍵性能參數(shù)，為開展不同廠家產(chǎn)品的一致性比對和建立拉曼光譜類醫(yī)療器械的檢測規(guī)范做準備。方法開發(fā)通用的拉曼光譜實驗平臺，測量化學參考物質，開發(fā)光譜分析方法，對實驗系統(tǒng)的分辨率、波長校正、信噪比、系統(tǒng)響應等進行分析，并使用幾種常見的生物分子進行測試驗證。結果根據(jù)化學參考物質的拉曼光譜提取了實驗系統(tǒng)的光譜分辨率、波長校正、信噪比、系統(tǒng)響應等信息，在測試中可有效地將生物分子的原始拉曼譜還原為可比對的標準拉曼譜。結論本文方法可有效提取和評價拉曼系統(tǒng)的性能參數(shù)，這對于拉曼光譜和其他相關光譜醫(yī)療器械的質控具有積極意義。

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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