Key Laboratory of Eco-Environment-Related Polymer Materials, Ministry of Education of China, Lanzhou 730070, China.
Key Laboratory of Polymer Materials of Gansu Province, College of Chemistry and Chemical Engineering, Northwest Normal University, Lanzhou 730070, China.
Molecules. 2022 Nov 26;27(23):8266. doi: 10.3390/molecules27238266.
In this study, Na-attapulgite was explored as an excipient to prepare domperidone sustained-release tablets and test them in accordance with United States Pharmacopoeia requirements. Fourier transform infrared spectroscopy (FTIR), X-ray powder diffraction (XRD) and differential scanning calorimetry (DSC) were employed to explore the compatibility between Na-attapulgite and domperidone. The XRD and DSC show no interaction between the drug and Na-attapulgite. The FTIR spectrum indicates a shift in the absorption of N-H in the drug molecule, which can be explained by the hydrogen bonding interaction between the N-H in the DOM molecule and the -OH on the surface of Na-ATP. The diameter, hardness, friability and drug content of the tablets were measured, and they all met the relevant requirements of the United States Pharmacopoeia. In addition, the tablets with Na-attapulgite as excipient exhibit a better release performance within the release time of 12 h. These results demonstrate that the domperidone sustained-release tablets have been successfully prepared by using Na-attapulgite as an excipient. The doping of Na-ATP in domperidone sustained-release tablets improves the cytocompatibility. Moreover, with the increase of Na-ATP content, cells proliferate remarkably and cell activity is significantly enhanced.
在这项研究中，我们探索了钠基凹凸棒石作为辅料来制备多潘立酮缓释片，并按照美国药典的要求对其进行了测试。傅里叶变换红外光谱（FTIR）、X 射线粉末衍射（XRD）和差示扫描量热法（DSC）被用来研究钠基凹凸棒石和多潘立酮之间的相容性。XRD 和 DSC 表明药物与钠基凹凸棒石之间没有相互作用。FTIR 谱表明药物分子中 N-H 的吸收发生了位移，这可以用 DOM 分子中的 N-H 与 Na-ATP 表面的 -OH 之间的氢键相互作用来解释。对片剂的直径、硬度、脆碎度和药物含量进行了测量，它们均符合美国药典的相关要求。此外，含有钠基凹凸棒石作为辅料的片剂在 12 小时的释放时间内表现出更好的释放性能。这些结果表明，多潘立酮缓释片已成功地使用钠基凹凸棒石作为辅料进行了制备。在多潘立酮缓释片中掺杂钠基凹凸棒石提高了细胞相容性。此外，随着钠基凹凸棒石含量的增加，细胞增殖显著，细胞活性明显增强。
