齐娅汝+李远辉+韩丽+伍振峰+岳鹏飞+王学成+熊耀坤+杨明

[摘要] 中药丸剂的干燥品质是目前丸剂研究的热点难点，其品质对疗效及剂型的发展有至关重要的作用。该文通过文献调研统计分析，综述丸剂干燥存在的问题，围绕中药丸剂评价体系，分析探讨常见干燥设备及工艺的特点及其对丸剂品质的影响，探讨干燥设备及工艺和品质存在的问题并提出相应的策略，以期为中药丸剂品质的改善及质量标准的提高提供新思路和新方法。

[关键词] 中药丸剂；研究现状；干燥设备及工艺；品质；调控

[Abstract] The dry quality of traditional Chinese medicine pills is the hot spot of pills research，because their quality has a crucial effect on the efficacy and development of dosage forms. Through literature research and statistical analysis，we would review the current problems on the drying of traditional Chinese medicine pills in this paper，and surrounding the evaluation system for traditional Chinese medicine pills，analyze the characteristics of common drying equipment and processes as well as their effect on quality of pills，discuss the problems in drying equipment and process as well as quality，and put forward the corresponding strategies，hoping to provide new ideas and new methods for the quality improvement of traditional Chinese medicine pills and quality standards.

[Key words] traditional Chinese medicine pills；research status；drying equipment and process；quality；regulation

中药丸剂是指饮片细粉或提取物加适宜的黏合剂或其他辅料制成的球形或类球形制剂，其按辅料不同主要分为水丸、蜜丸、水蜜丸、浓缩丸、糊丸、蜡丸等。中药丸剂始于先秦延至现代，是具有中国特色的传统而经典的剂型，我国较早的医方集《五十二病方》中所记载药物剂型最常用的是丸剂，《新编中成药药典》中一共收录丸剂1 358种，《中国药典》2015年版一部[1]共收录单位药及中药成方制剂1 493种，其中丸剂466种，约占31.21%。其特点药效持久、缓和，可减缓药物的挥发或掩盖气味，及防止氧化、变质、受潮；对毒性、刺激性药物可因延缓吸收而减少毒性和不良反应[2]。中药制剂的品质评价及其调控是中医药研究领域的热点与难点，其品质的优劣对中药丸剂成品的质量起着举足轻重的作用。但在丸剂的制备过程中影响中药丸剂品质的因素众多，如药粉的性质、黏合剂的类型、制备丸剂的方法、制药设备、制备工艺、干燥及质量标准，也直接影响丸剂成品的质量，丸剂干燥是影响丸剂有效性及安全性的重要因素。……