通过粉末X射线衍射、红外光谱、差示扫描量热分析和拉曼光谱法测定了不同工艺制备的雷贝拉唑钠样品,获得了无定形雷贝拉唑钠的特征光谱图。通过考察工艺过程中样品的拉曼光谱,对固体口服制剂生产过程中无定形雷贝拉唑钠的稳定性进行监测。结果表明,拉曼光谱法能快速便捷地鉴别原料药和固体制剂中的无定形雷贝拉唑钠,准确度高,可应用于无定形雷贝拉唑钠制剂工艺的质量控制。 The characteristic spectra of amorphous rabeprazole sodium were obtained by powder X-ray diffraction, infrared spectroscopy, differential scanning calorimetry and Raman spectroscopy. The stability of amorphous rabeprazole sodium during the manufacture of solid oral preparations was monitored by examining the Raman spectra of the samples during the process. The results show that Raman spectroscopy can quickly and conveniently identify amorphous rabeprazole sodium in bulk drugs and solid preparations with high accuracy and can be applied to the quality control of amorphous sodium rabeprazole preparations.