中药生药粉直接入药是中药制剂的特色形式，在保留药材全成分、体现“药辅合一”理念方面具有独特优势，但也面临微生物污染、制剂成型性差、有效成分溶出度低及质量控制困难等挑战。统计了《中国药典》2025年版中含生药粉制剂的分布情况，分析生药粉入药的应用特点，系统梳理现存关键问题，并从灭菌技术、粉体改性、超微粉碎及在线检测等维度探讨解决策略，并对未来研究方向进行展望，以期为生药粉制剂的工艺优化与质量提升提供参考。

The direct incorporation of crude drug powders into traditional Chinese medicine preparations represents a distinctive approach. While this method has unique advantages in preserving the full spectrum of herbal constituents and embodying the principle of “drug-excipient combination”, it also presents challenges such as microbial contamination, poor formulation formability, low dissolution rates of active ingredients, and difficulties in quality control. This paper statistically analyzes the distribution of crude drug powder formulations in the 2025 edition of the Chinese Pharmacopoeia, examines the application characteristics of crude drug powders in pharmaceuticals, and systematically reviews existing key issues. Furthermore, it explores solution strategies from dimensions including sterilization technology, powder properties modification, ultrafine grinding (particle design), and online detection. It also outlines future research directions, aiming to provide references for process optimization and quality enhancement of crude drug powder formulations.

R282

江西省重点研发计划-重点项目（定向委托）（20243BCC31010）；中药制剂技术与装备创新团队（CXTD22006）