This study focused on the development of an effective method to determine the spatial distribution and content of acetaminophen in intact tablets. We scanned tablets by confocal micro-Raman spectroscopy using live video imaging with a microscope to identify the three ingredients of the tablet formulation, acetaminophen, starch, and hydrated magnesium silicate. Tablets with five different acetaminophen concentrations (5.0–37.5%) were scanned at a spectral resolution of 1000 × 1000 μm. Imaging of tablet surface scans generated characteristic Raman spectra, which were used to rapidly and accurately characterize acetaminophen tablets. The spatial distribution of the drug in the tablet was used to assess the homogeneity of the drug formulation. The tablet composition was determined using single-peak spectra of the raw materials of the tablet formulation as references. Characteristic Raman scanning patterns of acetaminophen tablets were used to determine the composition of different formulations. Importantly, we found that acetaminophen was homogeneously distributed in tablets with low drug concentration. Thus, we developed a confocal micro-Raman spectroscopy method to evaluate the spatial distribution and content of each ingredient in intact acetaminophen tablets. Our new method can be used for the validation of the drug preparation process, the verification of the drug dose, and the authentication of the drug.

这项研究的重点是确定完整片剂中对乙酰氨基酚的空间分布和含量的有效方法的开发。我们通过共焦显微拉曼光谱法使用实时视频成像仪和显微镜对片剂进行了扫描，以识别片剂配方的三种成分：对乙酰氨基酚，淀粉和水合硅酸镁。以1000×1000μm的光谱分辨率扫描具有5种不同对乙酰氨基酚浓度（5.0–37.5％）的片剂。片剂表面扫描的成像产生特征性的拉曼光谱，该光谱用于快速而准确地表征对乙酰氨基酚片剂。片剂中药物的空间分布用于评估药物制剂的均匀性。使用片剂制剂原料的单峰光谱作为参考来确定片剂组成。对乙酰氨基酚片剂的特征拉曼扫描模式用于确定不同制剂的组成。重要的是，我们发现对乙酰氨基酚均匀分布在低药物浓度的片剂中。因此，我们开发了一种共聚焦显微拉曼光谱法，以评估完整对乙酰氨基酚片剂中每种成分的空间分布和含量。我们的新方法可用于药物制备过程的验证，药物剂量的验证以及药物的验证。我们发现对乙酰氨基酚在药物浓度低的片剂中均匀分布。因此，我们开发了一种共聚焦显微拉曼光谱法，以评估完整对乙酰氨基酚片剂中每种成分的空间分布和含量。我们的新方法可用于药物制备过程的验证，药物剂量的验证以及药物的验证。我们发现对乙酰氨基酚在药物浓度低的片剂中均匀分布。因此，我们开发了一种共聚焦显微拉曼光谱法，以评估完整对乙酰氨基酚片剂中每种成分的空间分布和含量。我们的新方法可用于药物制备过程的验证，药物剂量的验证以及药物的验证。