中药药理与临床2025，Vol.41Issue(6)：2-5,4.
《中药制剂稳定性研究技术指导原则(试行)》解读
Interpretation of the Guideline for Stability Studies of Traditional Chinese Medicine Preparations(Interim)
摘要
Abstract
Developing technical requirements for stability studies tailored to the characteristics of traditional Chinese medicine(TCM)preparations is critically important for ensuring the consistent quality,accelerating the R&D and marketing authorization,and promoting the high-quality de-velopment of TCM preparations.This article outlines the revision background and rationale for the Guideline for Stability Studies of TCM Prep-arations(Interim).It is concluded that stability studies should adopt a holistic quality assessment approach,reflecting the latest research ad-vances in TCM quality control and the current industry needs.Objective and accurate presentation of stability data provides a reliable founda-tion for quality control and stability studies of TCM preparations,demonstrating the essential requirements and value of such studies while pro-moting targeted studies to enhance the quality of TCM preparations.Additionally,clarified technical requirements for TCM compound prepara-tions originated from classical formulas and the conversion of hospital-manufactured preparations will accelerate research in these areas.Re-fined requirements for"determining packaging materials and containers"further facilitate related studies.Through conducting stability studies from multiple perspectives and dimensions to characterize the holistic quality attributes and quality variations of TCM preparations,coupled with implementation of targeted studies,marketing authorization holders will drive the continuous quality improvement of TCM preparations.关键词
中药制剂/稳定性研究/考察指标/评价方法/中药质量/中药监管科学Key words
Traditional Chinese medicine(TCM)preparations/Stability studies/Assessment indicators/Assessment methods/Quality of TCM preparations/TCM regulatory science引用本文复制引用
申向荣,阳长明,韩炜,曲建博,赵晓霞,李计萍,宋菊,唐溱,顾宇凡..《中药制剂稳定性研究技术指导原则(试行)》解读[J].中药药理与临床,2025,41(6):2-5,4.基金项目
2023年药品监管科学全国重点实验室第一批课题(编号:2023SKLDRS0132) （编号:2023SKLDRS0132）
2024年药品监管科学全国重点实验室第二批课题(编号:2024SKLDRS0221). （编号:2024SKLDRS0221）
