微球制剂的研究进展

Progress in Microsphere Preparations

近年来,因生物可降解高分子材料制备的载药微球制剂可以进行缓控释放给药而备受关注,是当前高端新型药物制剂的研究热点。制备微球制剂的关键因素在于选择合适的高分子材料和生产工艺技术。然而,微球的制备工艺繁杂、质量控制困难,至今只在少数产品上应用,现在越来越多的口服难吸收的生物药物开始产品化,缓释微球在提高患者依从性方面备受瞩目。通过文献研究,对目前较为经典的微球制备技术和一些制备微球的新技术进行了综述分析,并总结了微球制剂的形态、大小及颗粒分布,载药量和包封率,释放度等质量评价相关成果,以期为微球制剂的研究提供一定的参考价值。

In recent years,drug-loaded microsphere preparation prepared by biodegradable polymer materials can be slowly controlled release,which is a research hotspot of high-end new pharmaceutical preparations.The key factor in the preparation of microsphere preparations lies in the selection of suitable polymer materials and production technology.However,the preparation process of microspheres is complicated and the quality control is difficult,which is only applied in a few products.Now more and more oral biological drugs are difficult to absorb,and slow-release microspheres are much attention in improving patient compliance.This review analyzes the classic microsphere preparation technology and some new techniques of microsphere preparation,and summarizes the morphology,size,particle distribution,drug loading,sealing rate and release degree of microsphere preparations,in order to provide some reference value for the research of microsphere preparations.