口服中药缓释制剂组分释放同步性的研究进展

中药缓释给药系统的剂型研究已经取得一定进展,其组分释放同步性研究正成为领域热点,而成分的繁杂又赋予了中药制剂组分释放同步性研究带来了一定的难度。通过对近年来的口服中药缓释制剂组分释放同步性研究的相关文献进行了整理和分析,分析控制同步释放的技术主要有固体分散体技术、分层压片技术、多元包衣技术、渗透泵技术,释放同步性评价方法主要为相似因子法和相似因子-指纹图谱结合法。现阶段的同步释放控制技术已取得了一定成果,但组分释放的同步性程度还不够高;释放同步性评价方法具有一定的评估价值,但该体系仍不够完整和系统。开展中药制剂组分同步释放研究可效仿中药汤剂成分同步转运的优势,以最大限度地模拟原方疗效,同时还需比较释放同步性与非同步性的药效研究,以证实同步性研究的必要性和重要性。中药缓释制剂研究在追求良好缓释效果的同时,还应力求其多组分的同步释放,以期达到中药的整体、同步、综合作用。

Advance in Studies on Synchronized Release of Multiple Components from Sustained-release Preparations of Chinese Materia Medica for Oral Administration

Formulations study of sustained-release drug delivery system has made some progress for Chinese material medica, it is becoming a hotspot issue that to study synchronicity of multiple components release, but complex compositions of Chinese material medica make it difficult to study synchronicity of release.In this paper, recent related literature of studies in synchronous release of multiple components has been collected and analysed for Chinese medicine sustained-release preparations for oral administration, solid dispersion technology, layered preforming technology, multiple coating technology and osmotic pump technology are main technology to control synchronous release, synchronicity evaluation method mainly includes release similarity factor method and combination method of similarity factor and fingerprints.At this stage, control technology of synchronous release has made some achievements, but the degree of synchronous release is not high enough, synchronicity evaluation method is valuable at a certain extent, but not complete and systematic.Research on synchronous release is to absorb advantage of synchronous transport of Chinese material medica decoctions, in order to simulate original maximum effectiveness.At the same time, contrast research of synchronous release with non-synchronous release is still needed to confirm necessity and importance of synchronicity for achieving overall, synchronization and comprehensive action.