[关键词]
[摘要]
中药片剂的溶出度对其质量一致性评估及生物利用度预测具有重要意义。然而,关于中药片剂溶出行为的系统研究仍较为匮乏。通过对近年来中药片剂溶出行为的研究进展进行总结,涵盖了溶出度的检测指标、新兴研究方法、评价体系及当前研究中存在的挑战,重点阐述了测定中药片剂溶出度的新技术及测定中药片剂溶出度过程中遇到的问题。基于以上进展,提出了进一步研究的建议,为中药片剂溶出行为的研究提供参考,以便将溶出度纳入中药片剂质量评价体系,进一步提升中药质量控制水平。
[Key word]
[Abstract]
The dissolution of traditional Chinese medicine (TCM) tablets plays a significant role in the assessment of their quality consistency and the prediction of bioavailability. However, systematic research on the dissolution behavior of TCM tablets remains relatively scarce. This review synthesizes recent advances in dissolution studies of TCM tablets, including key evaluation parameters, emerging methodologies, current assessment frameworks, and persistent challenges. Particular attention is given to innovative dissolution testing technologies and methodological obstacles encountered during experimental processes. Based on these advancements, suggestions for further research are proposed to provide a reference for the study of dissolution behavior in TCM tablets, aiming to incorporate dissolution rate into the quality evaluation system of TCM tablets and further enhance the quality control of TCM.
[中图分类号]
R282
[基金项目]
国家重点研发计划项目(2023YFC3504500,2023YFC3504503)