缓/控释药物制剂作为一种新药剂是药学研究的热点。本文对近年来超临界流体技术在缓/控释药物系统制备中的研究成果进行了回顾和总结,重点对以超临界流体为溶剂、无机介孔材料为载体制备缓/控释药物系统的方法进行了阐述和评价,内容包括:技术原理、工艺流程、主要影响因素、药效试验、与传统方法比较等。分析了各种工艺流程的优缺点,并指出超临界流体输运技术在缓/控释药物系统制备中所具有的优势。在此基础上,提出药物溶于超临界二氧化碳后所形成的超临界二氧化碳溶液在多孔材料纳米级孔道内的渗透、扩散以及表面物理化学吸附机理、在特定环境氛围下的控制释放机制、药物超临界溶液热力学模型以及制备过程动力学研究等是应该重点关注的理论问题。
Among the research of new pharmaceutic dosage forms, controlled-release drug delivery system is a very important issue nowdays. In this field, processes using supercritical fluid technology are mostly " clean" process leading to " clean" products. Meanwhile, inorganic porous materials are emerging as a new category of host/guest systems due to some interesting features such as their biological stability and their drug-releasing properties. This review summarizes the applications of supereritical fluid transport technology in preparation of controlled-release drug delivery system in recent years and pays more attention on the method using supercritical fluid as the solvent and inorganic mesoporous materials as the support to prepare this controlled-release drug delivery system. The technical principle, development of technological process and the main influence factors are discussed here besides the drug release experiments and the comparison with the traditional methods. It shows clearly the advantages and disadvantages of various processes, and sums up the superiority of the supercritical transport technology in preparing controlled-release drug delivery system. Although this technique has lots of advantages, as for the papers delivered at present, the research on supercritical fluid transport technology is just at its initial stage of development because there are so many factors influencing the experimental resuhs and these factors are sometimes link-coupled. It is still challenging to make the preparation controllable. It indicates that the diffusion and penetration of the supercritical carbon dioxide drug solution in porous materials, the surface chemical and physical adsorption mechanism should be focused on as well as the controlled drug release mechanism, thermodynamic model and process dynamic.