MacDonald B F, Prebble K A
Burroughs Wellcome Co., Analytical Development Laboratories, Greenville, NC 27835-1887.
J Pharm Biomed Anal. 1993 Nov-Dec;11(11-12):1077-85. doi: 10.1016/0731-7085(93)80085-f.
A non-comprehensive overview of near-infrared (NIR) reflectance analysis in the pharmaceutical industry is presented. This survey will include background information defining NIR (i.e. spectral region and spectral features), the spectroscopic measurement, and the merits of this technique. This presentation comprises selected pharmaceutical applications of NIR used within Wellcome. One use of NIR is for the identification of tablets in bulk and non-invasively inside individual blister pack cells using several sample presentations including a fibre-optic probe. NIR has been used to determine moisture in freeze-dried parenterals by non-invasively measuring spectra through the bases of product vials. The viability of transferring moisture measuring equations between different instruments within the same site and between two different sites is examined. Another application of NIR involves a rapid assay of the active in whole tablets without any sample preparation. Finally, the use of NIR to validate blending processes for solid formulations is briefly discussed. There are many other applications of NIR in the pharmaceutical industry which are beyond the scope of this presentation. The applications presented here are those being pursued within our company, and provide an indication of the capabilities of NIR.
本文对制药行业中的近红外（NIR）反射率分析进行了非全面概述。本次综述将包括定义近红外的背景信息（即光谱区域和光谱特征）、光谱测量以及该技术的优点。本报告涵盖了在威康公司内部使用的近红外在制药领域的选定应用。近红外的一种用途是使用包括光纤探头在内的多种样品呈现方式，对散装片剂以及单个泡罩包装单元内的片剂进行非侵入式识别。近红外已被用于通过对产品小瓶底部进行非侵入式光谱测量来测定冻干肠胃外给药制剂中的水分。研究了在同一地点的不同仪器之间以及两个不同地点之间转移水分测量方程的可行性。近红外的另一个应用是在无需任何样品制备的情况下对整片剂中的活性成分进行快速分析。最后，简要讨论了使用近红外验证固体制剂混合过程的情况。近红外在制药行业还有许多其他应用，超出了本报告的范围。这里介绍的应用是我们公司正在进行的，展示了近红外的能力。
