Virtanen Satu, Antikainen Osmo, Yliruusi Jouko
Division of Pharmaceutical Technology, 00014 University of Helsinki, P.O. Box 56, Helsinki, Finland.
Int J Pharm. 2008 Aug 6;360(1-2):40-6. doi: 10.1016/j.ijpharm.2008.04.022. Epub 2008 Apr 22.
In the present study, the Raman spectroscopy technique was used as a non-invasive, rapid analytical method for measuring the crushing strength of tablets. The compressed tablets were individually detected, using Raman spectroscopy, and the respective crushing strength values were measured, using a tablet hardness tester as a reference method. The tablets were compressed from a granule mass containing theophylline anhydrate as an active substance. For measuring the crushing strength of the tablets, Raman spectra were recorded from the tablets. Partial least squares (PLS) regression models were constructed to obtain information from the spectra. The correlation between measured and predicted crushing strength values for the tablets was shown to be very favorable. With Raman spectroscopy, shifting of the baseline was observed as the crushing strengths of tablets (and the smoothness of the tablet surface) were increased. Consequently, correlation between the crushing strength data on the present tablets and Raman spectra was observed. Multiple scanning electron (SEM) and non-contact laser profilometry (LP) micrographs from the surfaces of the tablets were taken to describe the surfaces and applied as supportive information for the proposed spectroscopy approach. In conclusion, Raman spectroscopy is a promising alternative for established off-line/at-line tablet-testing methods for some tablet formulations.
在本研究中，拉曼光谱技术被用作一种非侵入性的快速分析方法来测量片剂的抗压强度。使用拉曼光谱对压制片剂进行逐个检测，并使用片剂硬度测试仪作为参考方法测量各自的抗压强度值。片剂由含有无水茶碱作为活性物质的颗粒物料压制而成。为了测量片剂的抗压强度，从片剂上记录拉曼光谱。构建偏最小二乘（PLS）回归模型以从光谱中获取信息。结果表明，片剂的实测抗压强度值与预测抗压强度值之间的相关性非常良好。使用拉曼光谱时，随着片剂抗压强度（以及片剂表面的光滑度）增加，观察到基线发生偏移。因此，观察到当前片剂的抗压强度数据与拉曼光谱之间存在相关性。拍摄了片剂表面的多次扫描电子显微镜（SEM）和非接触激光轮廓仪（LP）显微照片以描述表面情况，并将其用作所提出的光谱方法的辅助信息。总之，对于某些片剂配方，拉曼光谱是现有离线/在线片剂测试方法的一种有前景的替代方法。
