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目的:考察吲哚美辛(IDM)肠溶滴丸中IDM存在的状态及与基质聚乙二醇6000(PEG 6000)的相互作用。方法:分别采用差示扫描量热法(DSC)、红外光谱法(IR)、X-射线衍射法及扫描电镜(SEM)观察对IDM、PEG 6000、两者的物理混合物及IDM肠溶滴丸进行研究。结果:DSC图谱中,IDM肠溶滴丸在164℃处的吸热峰消失,而57℃处的PEG 6000吸热峰发生了前移;IR图谱中,IDM肠溶滴丸中IDM的羰基伸缩振动峰消失,而在1 680 cm~(-1)处出现了新峰;X-射线衍射图谱中,IDM肠溶滴丸无衍射峰存在;SEM下IDM以更细小的状态分布于基质中。结论:IDM肠溶滴丸中IDM以无定形或分子形式分散于基质中,且IDM与PEG 6000发生了以氢键为主的化学作用。
OBJECTIVE: To investigate the presence of IDM in indomethacin (IDM) enteric dripping pills and the interaction with matrix PEG-6000. Methods: Differential scanning calorimetry (DSC), infrared spectroscopy (IR), X-ray diffraction and scanning electron microscopy (SEM) were used to observe the physical properties of IDM, PEG 6000, research. Results: The endothermic peak disappeared at 164 ℃ in IDM enteric dripping pills and the endothermic peak of PEG 6000 shifted forward at 57 ℃. In the IR spectra, the carbonyl stretching The vibrational peak vanished and a new peak appeared at 1 680 cm -1. In the X-ray diffraction pattern, there was no diffraction peak of IDM enteric dropping pills. The IDM was distributed in the matrix in a finer state under SEM. Conclusion: The IDM in IDM enteric drip pills is dispersed in the matrix in amorphous or molecular form, and hydrogen bond-based chemical interaction occurs between IDM and PEG 6000.