肽类微球注射剂释放度实验评价研究进展

Evaluation methods of in vitro release rate of peptide microsphere injections: a review

简述了已经上市的肽类微球注射剂的临床应用与作用机制,概述了微球制剂的体外释放实验;从肽类微球制剂的体内药动学过程分析、体外释放度测定方法的验证、体内体外相关性与预测模型研究等方面,探讨肽类微球注射剂体外释放度的评价策略。为肽类微球注射剂的质量控制与质量评价研究提供参考。

This review sketches the clinical applications and mechanisms of commercial peptide microspherc injections and summarizes the in vitro release characteristic of microsphere formulations. Meanwhile, we investigate the in vitro release rate evaluation tactics for peptide microsphere injections from the aspects of in vivo pharmacokinetic analysis, the validation of in vitro release test methods and in vitro-in vivo correlation （IVIVC） prediction models research, etc. Hopefully, this will provide references for the quality control and quality evaluation of peptide microsphere injections.