基于总量统计矩的中药多成分缓控释制剂整体释放体内外评价研究

Evaluation of total release of Chinese medicine multicomponent sustainedrelease preparations based on total statistical moment in vivo and in vitro

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.