中药缓控释制剂研究进展  

Research progress of sustained and controlled release preparations of Chinese medicine

作　　者：孙莉 谢彬 徐艳琴[2] SUN Li;XIE Bin;XU Yanqin(China National of Traditional Chinese Medicine Co,Ltd.Beijing 100195,China;School of Pharmacy,Jiangxi University of Chinese Medicine,Nanchang Jiangxi 330004,China)

机构地区：[1]中国中药有限公司,北京100195 [2]江西中医药大学药学院,江西南昌330004

出　　处：《中国药物警戒》2024年第8期949-954,共6页Chinese Journal of Pharmacovigilance

基　　金：国家自然科学基金资助项目(82060684);国家中药特色技术传承人培养项目(人教函[2023]96号)。

摘　　要：目的归纳中药缓控释制剂研究进展,为了解中药缓控释制剂制备工艺、处方和质量评价提供参考。方法通过文献检索,对不同缓控释制剂新类型的优缺点,中药缓控释制剂制备工艺、质量评价体系进行分析。结果缓控释制剂新类型涉及固体脂质纳米粒缓控释制剂、口服渗透泵缓控释制剂、胃滞留给药缓控释制剂、生物黏附微球、固体分散体,制备工艺采用多种筛选方法得出最佳工艺,中药缓控释制剂的质量评价方法包括体外释放度研究、体内释药和体内外相关性研究等。结论中药缓控释制剂研究主要集中在中药单体成分、中药提取物或有效部位、中药多个单体成分组合开发的中药制剂,质量评价体系主要有体内释放度、体外释放度和体内外相关性研究,可为中药缓控释制剂发展提供参考。Objective To summarize the research progress on the slow and controlled release preparations of traditional Chinese medicine,and provide a basis for understanding the preparation process,prescription and quality evaluation of slow and controlled release preparations of traditional Chinese medicine.Methods Through literature search,the advantages and disadvantages,preparation process,and quality evaluation system was summarized from different new types of sustained and controlled release formulations.Results The new types of sustained and controlled release formulations involve solid lipid nanoparticles sustained and controlled release formulations,oral osmotic pump sustained and controlled release formulations,gastric retention delivery sustained and controlled release formulations,bioadhesive microspheres,and solid dispersions,and the preparation process uses multiple screening methods to arrive at the optimal process,and the quality evaluation methods for the sustained and controlled release formulations of traditional Chinese medicines include in vitro release studies,in vivo release,and in vitro and in vivo correlation studies.Conclusion The research on slow and controlled release preparations of traditional Chinese medicine mainly focuses on the single component of traditional Chinese medicine,traditional Chinese medicine extracts or active parts,and combination of several single components of traditional Chinese medicine,and the quality evaluation system mainly includes in vivo release,in vitro release and in vitro and in vivo correlation studies,which can provide reference basis for the future development of slow and controlled release preparations of traditional Chinese medicine.

关 键 词：中药缓控释制剂 制备工艺 质量评价 处方 

分 类 号：R969.1[医药卫生—药理学] R944[医药卫生—药学]