以交联聚维酮为载体的吲哚美辛固体分散体稳定性和溶出行为研究
Stability and Dissolution Study of Indomethacin Amorphous Solid Dispersion Using Crospovidone as Carrier
任沁 1刘怡 1王伟芳 2蔡挺2
作者信息
- 1. 上海亚什兰化工技术开发有限公司,上海 200233
- 2. 中国药科大学药学院,南京 210009
- 折叠
摘要
目的 以交联聚维酮为载体,通过喷雾干燥方法制备吲哚美辛固体分散体粉末和片剂.方法 采用调试差示扫描量热、粉末X射线衍射和傅里叶转换红外光谱法,确定药物在载体中的物理状态和药物与载体之间可能存在的相互作用.结果 当载药量低于20％时,药物在交联聚维酮中以无定形态存在,且药物与载体之间存在氢键相互作用.加速稳定性实验结果表明,固体分散体载药量低于20％时,以交联聚维酮为载体的固体分散体中物理稳定性良好.结论 与聚维酮或共聚维酮相比,以交联聚维酮为载体的固体分散体片剂具有更快的片剂崩解速度和更高的药物溶出速率.
Abstract
OBJECTIVE To prepare the powders and tablets of indomethacin solid dispersion by spray drying method with crospovidone as carrier.METHODS Modulated differential scanning calorimetry,powder X-ray diffraction analysis and Fourier transform infrared were used to investigate the physical state of the drug in carriers and to detect the possible interactions between the drug and carriers in the solid dispersions.RESULTS Indomethacin remained amorphous in the presence of crospovidone when the drug loading was below 20％,and the hydrogen bonds between the drug and carriers were formed in the solid dispersion.Accelerated stability tests demonstrated that the amorphous solid dispersions using crospovidone as carrier were stable when the drug loading was less than 20％.CONCLUSION The solid dispersion tablets prepared with crospovidone exhibited shorter disintegration time and fas-ter dissolution rate compared with the tablets using povidone or copovidone.
关键词
吲哚美辛/交联聚维酮/固体分散体/喷雾干燥/稳定性/溶出Key words
indomethacin/crospovidone/solid dispersion/spray drying/stability/dissolution引用本文复制引用
出版年
2024
NETL
NSTL
万方数据