摘要
针对目前尚缺乏符合中药复方缓控释制剂特征的体内外评价方法,对近年来中药复方缓控释制剂体内外评价的研究进行总结,分析了现有评价模式的优势及不足,并强调中药多成分缓控释制剂体内外评价模式应体现整体特色。因此,尝试探讨基于总量统计矩理论的中药缓控释制剂体内外评价方法,以不同时段缓释制剂与全溶样品指纹图谱的相似度情况表征中药多成分体外释放研究,以总量药动学探讨其整体总量生物等效性,并结合总量统计矩相似度法将两者关联,期望建立一种能反映中药缓控释制剂体内外整体释放动态变化特征的评价模式,使之能够符合中药复方缓释制剂"总量均衡、整体溶散、随方释放"的总体要求,为中药多成分缓控释制剂的开发提供支撑。
At present, due to the lack of in vivo and in vitro evaluation methods that conform to the characteristics of traditional Chinese medicine(TCM) compound preparations for sustained and controlled release, the in vivo and in vitro evaluation of TCM compound preparations for sustained and controlled release in recent years is summarized in this paper, and the advantages and disadvantages of the existing evaluation model are analyzed, and the overall characteristics are emphasized to be reflected in the in vivo and in vitro evaluation model for the sustained and controlled release of TCM compounds. Therefore, an in vivo and in vitro evaluation method of TCM sustained and controlled release preparations based on the total statistical moment theory was attempted. The in vitro release of multiple components of TCM is characterized by the similarity of the fingerprints of slow-release preparations and total dissolved samples at different time periods. Total pharmacokinetics was used to investigate the total bioequivalence. Combined with the aggregate statistical moment similarity method, the two mentioned above are correlated. An evaluation model that can reflect the overall release dynamics in vitro and in vivo is expected to be established. So that it can meet the overall requirements of the balanced total amount of the TCM compound sustained-release preparation and the release of the whole dissolved powder with the prescription, which provides support for the development of TCM multi-component sustained-release preparation.
作者
肖佳妹
杨岩
贺福元
杨岩涛
XIAO Jia-mei;YANG Yan;HE Fu-yuan;YANG Yan-tao(College of Pharmacy,Hunan University of Chinese Medicine,Changsha 410208,China;Laboratory of Supramolecular Mechanism and Mathematic-Physics Characteristic of Chinese Materia Medica,Hunan University of Chinese Medicine,Changsha 410208,China;Hunan Key Laboratory of Druggability and Preparation of Chinese Medicine,Changsha 410208,China)
出处
《中草药》
CAS
CSCD
北大核心
2021年第4期909-916,共8页
Chinese Traditional and Herbal Drugs
基金
湖南省重点研发计划项目(2018NK2041)
湖南省教育厅优秀青年基金项目(2015B172)
湖南省中医药科研基金项目(201494)
湖南省教育厅一般项目(2015C1039)
湖南省“十二五”省级药学重点学科开放基金项目(1007)
湖南中医药大学化学工程与技术一流学科建设项目
湖南省研究生创新项目(CX2018B505)。
关键词
缓控释制剂
总量统计矩
体内外评价
中药
多成分
sustained-release preparations
total quantum statistical moment
in vivo and in vitro evaluation
traditional Chinese medicine
multicomponent