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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。
Chinese medicine has been making some progress in the formulation of sustained-release drug delivery systems, and the study on the synchronization of component release is becoming a hot spot in the field. However, the complexity of the components has given rise to some difficulties in the study on the synchronization of component release in Chinese medicine. In recent years, the related literature about the synchronization study of the release of oral sustained-release preparation of Chinese traditional medicine has been collated and analyzed. The technologies for controlling simultaneous release mainly include solid dispersion technology, layered compression technology, multivariate coating technology, The main evaluation methods of pump technology and release synchronization are similarity factor method and similarity factor - fingerprinting method. The synchronous release control technology at the present stage has achieved some results, but the degree of synchronization of component release is not high enough. The evaluation method of release synchronization has certain value, but the system is still not complete and systematic. Carrying out the study on the simultaneous release of components of TCM preparations can emulate the advantages of simultaneous transfer of components of TCM decoction in order to simulate the efficacy of the original prescription to the maximum extent and at the same time it is necessary to compare the efficacy studies on the release of synchronicity and asynchrony to confirm the synchronization study Necessity and importance. The study of sustained-release preparation of traditional Chinese medicine, while pursuing good sustained-release effect, should also seek simultaneous release of its multiple components in order to achieve the overall, synchronous and comprehensive effect of traditional Chinese medicine.