中药复方制剂质量控制与评价的监管科学

Regulatory Science of Quantity Control and Evaluation of Compound Preparations of Traditional Chinese Medicine

中药复方制剂质量控制的核心在于量质传递,即指在中药制剂的生产过程中,可量化或质量可控的药用植物从饮片或提取物、中间体到制剂的传递过程,以全链条质量控制为目的确保中药安全与疗效。本文基于中药质量控制、评价研究现状及监管挑战,探讨符合中药特点的质量控制与评价的监管新方法,并以古代经典名方新药转化实践案例,提出建立符合中药特点的复方制剂质量评价新工具、新标准、新方法在中药复方制剂质量控制和生产实践中的应用前景,为进一步推进中药监管科学在中药质量可控性和安全监管,解决中药质量监管中的基础性和关键性问题提供参考。

The core of quality control of compound preparations of traditional Chinese medicine(TCM)lies in quality transfer,which refers to the transfer process of medicinal substances with controllable quantity or quality from decoction pieces,extracts,intermediates,to preparations in the production process of TCM preparations.The purpose is to ensure the safety and effectiveness of TCM by quality control throughout the whole chain.Based on the current status of TCM quality control and evaluation research,as well as regulatory challenges,this paper discussed the new regulatory methods of quality control and evaluation in line with the characteristics of TCM.The paper investigated the practice case of transforming ancient famous prescriptions into new drugs and put forward the application prospect of establishing new tools,new standards,and new methods for quality evaluation of compound preparations in line with the characteristics of TCM in the quality control and production practice of TCM compound preparations.The results can provide a reference for promoting the quality controllability and safety regulatory of TCM by TCM regulatory science and solving the basic and key problems in TCM quality regulatory.