[关键词]
[摘要]
通过对中药制剂关键质量属性确认中应重点考虑的问题分析,提出药品关键质量属性的确定应全面考虑药物的有效性、安全性、药用物质本身的性质等方面的因素,同时还应关注中药制剂成型的要求,体现药物质量控制的整体性要求,以提取完整的能表征药品性质的质量控制指标,为企业生产过程控制和药品质量标准建立提供依据。
[Key word]
[Abstract]
In this paper, through the analysis of the key issues in the confirmation of the critical quality attributes (CQAs) of traditional Chinese medicine preparations, it is proposed that the determination of the CQAs should fully consider factors such as the efficacy, safety, nature of the drug substance, requirements of formulation and overall requirements of drug quality control. Complete quality control items that can characterize the properties of drugs should be extracted to provide a basis for the establishment of process control and drug quality standards.
[中图分类号]
[基金项目]