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透射拉曼光谱技术在药物固体口服制剂在线、高通量和无损定量分析方面的发展。

Development of Transmission Raman Spectroscopy towards the in line, high throughput and non-destructive quantitative analysis of pharmaceutical solid oral dose.

作者信息

Griffen Julia A, Owen Andrew W, Matousek Pavel

机构信息

Cobalt Light Systems Ltd, 174 Brook Drive, Milton Park, Abingdon, Oxfordshire OX14 4SD, UK.

出版信息

Analyst. 2015 Jan 7;140(1):107-12. doi: 10.1039/c4an01798f.

DOI:10.1039/c4an01798f
PMID:25360447
Abstract

Transmission Raman spectroscopy (TRS) is a recently introduced analytical technique to pharmaceutical analysis permitting volumetric sampling by non-destructive means. Here we demonstrate experimentally, for the first time, the enhanced speed of quantification of pharmaceutical tablets by an order of magnitude compared with conventional TRS. This is achieved using an enhancing element, "photon diode", avoiding the loss of laser photons at laser coupling interface. The proof-of-concept experiments were performed on a complex mixture consisting of 5 components (3 APIs and 2 excipients) with nominal concentrations ranging between 0.4 and 89%. Acquisition times as short as 0.01 s were reached with satisfactory quantification accuracy for all the sample components. Results suggest that even faster sampling speeds would be achievable for components with stronger Raman scattering cross sections or with higher laser powers. This major improvement in speed of volumetric analysis enables high throughput deployment of TRS for in line quality control applications within the batch or continuous manufacturing process and facilitating non-destructive analysis of large fractions.

摘要

透射拉曼光谱(TRS)是一种最近引入到药物分析中的分析技术,它允许通过非破坏性手段进行体积采样。在此,我们首次通过实验证明,与传统TRS相比,药物片剂的定量速度提高了一个数量级。这是通过使用一种增强元件“光子二极管”实现的,避免了激光光子在激光耦合界面处的损失。概念验证实验是在一种由5种成分(3种活性药物成分和2种辅料)组成的复杂混合物上进行的,标称浓度范围在0.4%至89%之间。对于所有样品成分,采集时间短至0.01秒,且定量精度令人满意。结果表明,对于具有更强拉曼散射截面或更高激光功率的成分,甚至可以实现更快的采样速度。体积分析速度的这一重大改进使得TRS能够在批次或连续制造过程中进行在线质量控制应用的高通量部署,并便于对大部分样品进行非破坏性分析。

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