中药配方颗粒的现状与发展新思路

Current situation and new ideas on future trends of Chinese materia medica granules for prescriptions

中药配方颗粒是传统中药饮片、汤剂的改良产品,其最突出的优点是使用方便,但缺乏统一的质量标准、一致性基础研究不系统、难以评价单煎的配方颗粒与合煎的传统汤剂的等效性是最突出的问题和争议。因此,建立统一、完善的国家标准,实现全程质量控制和规范管理,开展系统的合煎和分煎等效性对比研究,开发经方(复方)颗粒,加强中医药传统理论指导,实现产地化提取将有利于保证中药配方颗粒的安全有效,有利于促进产业持续健康发展,有利于中医药走向世界。通过了解中药配方颗粒的历史和发展现状,对其优点及存在的问题和争议进行深入分析,有针对性地提出今后发展的新思路。

Chinese materia medica（CMM） granules for prescriptions is one of the improved products of decoction pieces,which is easy to use its most prominent advantage.However,lack of unified quality standards,non-systematic basic research on equivalences that is difficult to evaluate the equivalence on ingredients and treatment outcome between granules for prescriptions from single decocting and traditional decoction from combined decocting,which are the most prominent problems and controversial issues.Therefore,establishing unified and perfect national standards,achieving quality control and standardized management throughout the whole process,carrying out systematic treatment outcome equivalence comparison research between combined decoction and single decoction,developing（compound） granules of classical prescriptions,strengthening treatment guidance by traditional Chinese medicine（TCM） theory,and realizing extraction on the place of origin will be conducive in ensuring safety and efficacy of CMM granules for prescriptions,promoting healthy and sustainable development of the industry,and leading TCM into the world.Through understanding the history and present situation of CMM granules for prescriptions,analyzing deeply its advantages,existing problems and controversies,the new ideas for future development are proposed.