杨岩涛+陶叶琴+唐闻汉+李森+石继连+周逸群+刘文龙+贺福元

[摘要] 控缓释制剂是创新药物的重要来源，但由于中药成分复杂，理化性质体现表观性等一系列关键问题尚未完全廓清，故真正成熟上市、能体现中药精髓的复方控缓释制剂基本没有，限制了中药控缓释制剂的研发。结合中药复方用药多成分协同作用的特点，通过对中药复方控缓释制剂制备过程中的一系列瓶颈问题的分析，结合多成分“整体受控、同步溶蚀”的中药控缓释制剂制备指导原则，在前期利用超分子化学诠释中医药理论的基础上，借鉴单成分精确控制技术，运用超分子化学理论，系统探讨中药缓控释制剂多成分整体受控的超分子机制，阐明中药复方多成分体系中超分子体存在所带来的影响，探讨中药控缓释制剂多成分整体受控、同步释放的超分子机制，为中药复方缓控释制剂的研制与开发提供有益的学术参考和借鉴，进而为制备中药控缓释制剂奠定理论与技术基础。

[关键词] 中药；多成分；控缓释制剂；超分子；印迹模板；整体受控

[Abstract] Controlled sustained-release preparation （CSRP） is a definitely important source of innovative medicines，however，its further researches and development are limited due to the complexity of Chinese medicine （CM） compositions，and a series of unclear key problems like the apparent properties from physical and chemical aspects. Combined with the CM characteristics of the multiple components and synergistic effect，a series of bottleneck problems in the preparation of CSRP were analyzed. Then the mechanism and influences of supermolecular chemical theory in the CSRP about the multiple-components overall-control were explored under the guideline of "overall control，synchronous dissolution" in CSRP，based on the previous explications about supramolecular chemistry theories and with the application of single component precision controlling technologies. The supermolecular mechanism of multi-component overall control and synchronous release of the CSRP was investigated，providing an useful academic reference for the research and development of the CSRP and laying the theoretical and technical foundation for the manufacturing process of CSRP.

[Key words] Chinese medicine；multi component；controlled sustained-release preparation；supramolecular；imprinting template；overall control

doi：10.4268/cjcmm20162430

控緩释制剂通过制剂学手段调整药物的动力学行为，使临床顺应性差的药物得到合理的应用[1]。单成分的控缓释制剂技术成熟，上市产品众多。而中药成分复杂，其理化性质体现表观性，兼之一系列关键问题尚未完全廓清，故真正成熟上市、能体现中药精髓的复方控缓释制剂基本没有。单成分制剂发挥治疗作用的……