从市场抽验角度探讨中药配方颗粒质量标准相关问题

Discussion on quality standard of traditional Chinese medicine formula granules from perspective of sampling inspection

中药配方颗粒是传统中医药发展的希望所在,发展前途广阔。质量控制一直是其发展过程中业界关注的重点。详述了在中药配方颗粒国家评价性抽检及调研过程中发现的其现行质量标准在标准制定,性状、特征图谱、溶化性检查、浸出物、含量测定、安全性检测等方面的问题,并针对相关问题对其监管和未来发展提出建议,以期为相关科研、产业及管理提供参考,推动中药配方颗粒健康稳定发展。

Traditional Chinese medicine formula granules is the hope of development of traditional Chinese medicine and has a promising future. Quality control of traditional Chinese medicine formula granules has been the focus in the process of its development.In this paper, a series of problems related to its quality standards, including the formulation of standards, character, characteristic spectrum, test for solubility, exudation, content determination, and security detection of Chinese medicine formula granules in the process of sampling and investigation were described in detail, and suggestions on supervision and development were put forward for related problems, hoping to play a reference role in related scientific research, industry and supervision, and promote the healthy and stable development of traditional Chinese medicine formula particles.