摘要
喷雾干燥技术历经100多年发展,技术愈加成熟、使用日益广泛,在中药领域的应用更为突出。喷雾干燥制备的中药粉体是中药配方颗粒的原料药,其粉体学性质对后续成型过程及产品质量有重要影响。配方颗粒作为一种新型饮片形式,已纳入中药饮片管理范畴,预示着更广阔的应用市场,关于中药粉体研究的重要性也已达成共识。基于此,笔者总结了喷雾干燥在中药粉体研究中的应用进展,包括影响喷雾干燥过程的因素,如料液性质、工艺参数和装备因素,以及计算流体力学和热力学模型在喷雾干燥过程模拟仿真中的应用。介绍了部分用于中药粉体改性的常用药用辅料,如采用麦芽糊精或微粉硅胶改善黏壁、提高收率,采用微晶纤维素提高可压性,采用聚维酮或羟丙甲纤维素提高粉体的稳定性等。此外,喷雾干燥技术也可作为微囊、固体分散体等中药新型给药系统的制备技术。梳理后笔者发现中药喷雾干燥技术的后续研究可从基于“药辅合一”共处理辅料的应用规律、喷雾干燥粉体“结构-性质”的关系、计算机模拟和设计的应用等方面开展,以进一步丰富该技术在中药粉体领域的应用。
After more than 100 years of development,spray drying technology has become more mature and widely used,and it is of great importance in the field of traditional Chinese medicine(TCM). TCM powders prepared by spray drying is the raw material of dispensing granules,and the powder properties have an important influence on subsequent molding process and product quality. As a new form of TCM,dispensing granules have been included in the management category of TCM decoction pieces, indicating a broader application market,and a consensus has also been reached on the importance of TCM powder research. Based on this,the author summarized the application progress of spray drying in the study of TCM powders,including the factors affecting spray drying process,such as liquid properties,process parameters and equipment factors,as well as the application of computational fluid dynamics(CFD)and thermodynamic model in spray drying process simulation. Moreover,some commonly used pharmaceutical excipients for the modification of TCM powders were also introduced such as maltodextrin,microcrystalline cellulose and povidone. In addition,spray drying technology can also be used as a preparation technology for new drug delivery systems such as microcapsules and solid dispersions. Through the summary of this paper,the author suggests that the future research direction of spray drying of TCM can be carried out from the aspects of application rule of the coprocessing auxiliary materials based on the "unification of medicines and excipients",the "structure-property" relationship of spray-dried powders and the application of computer simulation and design,so as to further enrich the application of spray drying in the field of TCM powders.
作者
戴胜云
杨茂蕊
李文静
郑健
徐冰
乔延江
DAI Shengyun;YANG Maorui;LI Wenjing;ZHENG Jian;XU Bing;QIAO Yanjiang(National Institutes for Food and Drug Control,Beijing 102629,China;School of Chinese Materia Medica,Beijing University of Chinese Medicine,Beijing Key Laboratory for Production Process Control and Quality Evaluation of Traditional Chinese Medicine,Engineering Research Center of Key Technologies for Chinese Medicine Production and New Drug Development,Ministry of Education,Beijing 102488,China)
出处
《中国实验方剂学杂志》
CAS
CSCD
北大核心
2022年第14期200-208,共9页
Chinese Journal of Experimental Traditional Medical Formulae
基金
国家自然科学基金项目(82074033)
中华中医药学会青年人才托举工程项目(2019-QNRC2-C11)。
关键词
喷雾干燥
质量源于设计(QbD)
物性表征
粉体改性
药用辅料
计算流体力学(CFD)
药辅合一
spray drying
quality by design(QbD)
physical characterization
powder modification
pharmaceutical excipients
computational fluid dynamics(CFD)
unification of medicines and excipients
