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目的制备氧氟沙星/蒙脱土(OFLO/MMT)插层化复合物,为寻求新型药物载体材料及氧氟沙星新剂型提供依据。方法采用溶液离子交换法制备OFLO/MMT复合体系,利用单因素法考察药物浓度、反应温度、时间等因素对蒙脱土载药量的影响,优化插层反应条件,通过紫外光谱、傅立叶变换红外(FTIR)、DTA曲线手段对插层复合体进行表征。并进一步研究OFLO/MMT纳米复合物在不同p H值释放介质中的释放行为。结果在初始浓度2.60 mg·m L?1,25℃反应2 h时药物载药量最大,体外释放实验表明OFLO/MMT插层药物在释放介质中具有缓释作用,且OFLO/MMT在酸性和碱性条件下的释放动力学明显不同,复合体更倾向于在盐酸溶液(p H 1.2)中进行释放。结论插入蒙脱土层间的氧氟沙星具有明显的缓释作用,且具有一定p H值敏感性,蒙脱土可作为一种非常好的缓释制剂载体材料。
OBJECTIVE To prepare OFLO / MMT intercalation complexes, and to provide evidences for seeking novel drug delivery materials and ofloxacin new dosage forms. Methods The OFLO / MMT composite system was prepared by solution ion exchange method. The effects of drug concentration, reaction temperature and time on the drug loading of montmorillonite were investigated by single factor method. The conditions of intercalation reaction were optimized. The UV-vis, Fourier transform infrared (FTIR) and DTA curves were used to characterize the intercalated complex. And to further investigate the release behavior of OFLO / MMT nanocomposites in different p H release mediators. Results The drug loading was the highest when the initial concentration was 2.60 mg · mL-1 at 1,25 ℃ for 2 h. In vitro release experiments showed that the OFLO / MMT intercalation drug had sustained release in the release medium, and the OFLO / The release kinetics differ significantly under alkaline conditions, and the complexes are more prone to release in hydrochloric acid solution (p H 1.2). CONCLUSION: Ofloxacin inserted into the montmorillonite layer has obvious sustained release effect and certain p H value sensitivity. Montmorillonite can be used as a very good sustained-release preparation carrier material.