中药配方颗粒标准化研究现状分析

摘要

For many years, TCM formula granules, as a new form of decoction pieces reform, have been favored by people with its three features—"Three Efficacy", "Three Small" and "Five Conveniences". As a result, it has become the ideal product in the course of TCM internationalization. In the face of growing sales, to formulate its standard becomes imminent. Therefore, how to establish a system that is unique to standardization of TCM formula granules has become a research hotspot of scholars. This article summarized Results of recent research on the preparation, quality control, pharmacology studies and clinical evaluation of TCM formula granules, with a purpose to put forward relevant suggestions, and provide references for standardization of TCM formula granules.%中药配方颗粒作为饮片改革的一种新形式,多年来以其"三效""三小"及"五方便"的特点受到患者青睐,是中药国际化的优质产品.随着中药配方颗粒用量不断增加,有关企业统一标准的制定迫在眉睫.为此,如何建立一个专属于中药配方颗粒的规范化体系就成了学者们的研究热点.本文就近年来中药配方颗粒的制备工艺、质量控制、药理学及临床评价等方面的研究成果进行总结,并提出相关建议,为配方颗粒的标准化提供参考.