浅谈微球制剂的药学研究与评价

Discussion on the Pharmaceutical Research and Evaluation of Microspheres

微球属于复杂的长效缓控释注射剂,目前国内外均无针对微球药学研究的技术指南。分析国内外微球上市及申报现状发现,无论是新药还是仿制药,国内微球药学研究仍有待完善。本文结合药品审评工作,从释放机制、处方工艺、质量控制等方面,提出微球药学评价的特殊关注点。

Microspheres are complex long-acting sustained-release injections.At present,there is a lack of technical guidelines for microsphere pharmaceutical researches in China and abroad.By analyzing current status of approved microspheres,new or generic drugs,the domestic microsphere pharmaceutical researches still need to be improved.Based on the practice of drug review,from the aspects of release mechanism,formulation process,quality control,etc.,special concerns are put forward for the pharmaceutical evaluation of microspheres.