浅谈纳米晶药物的药学研究与评价

A Brief Analysis of Pharmaceutical Research and Evaluation of Nanocrystal Pharmaceutical Products

纳米晶药物可显著改善药物的溶解度和生物利用度。目前已有多个纳米晶药物在全球上市,但国内外监管机构尚未针对纳米晶药物形成明确、统一的监管评估方案。该文对国内外纳米晶药物的监管及上市情况进行了介绍,从纳米晶药物的原料药、辅料、生产工艺、质量研究与控制、包材与稳定性等方面,对纳米晶药物的药学研究与评价进行探讨,并结合案例进行分析,以期为纳米晶药物的药学研究与评价提供参考。

Nanocrystal pharmaceutical products can significantly improve drug solubility and bioavailability.Several products have been marketed globally,but domestic and foreign regulatory agencies have not yet formed a clear and unified regulatory assessment program for them.This review introduces the regulation and listing of some nanocrystal pharmaceutical products marketed at home and abroad,discusses the pharmaceutical research and evaluation from the aspects of API,excipients,production process,quality research and control,packaging materials and stability,and analyzes them with case studies,in order to provide a reference for the pharmaceutical research and evaluation of nanocrystal pharmaceutical products.