关于口服多维元素制剂质量研究的一些考虑

Some considerations on the study of multivitamins and minerals preparation for oral administration

口服多维元素制剂为多种维生素和矿物质组成的复方制剂,鉴于该类品种处方组成较为复杂,质量研究的方法需要进一步探索和提升。本文结合品种特点、审评经验和现行国内外的法规要求提出一些考虑,旨在为此类品种后续的研发提供一些参考。

Multivitamins and minerals preparation for oral administration contains a variety of vitamins and minerals.Considering the complexity of the prescription,further exploration methods of quality research are needed.Based on the preparation characteristics,review experience and guidance released in many countries,this paper expounds some considerations on the study of multivitamins and minerals preparation,in order to provide some references for future research.