基于中药质量标志物的饮片质量控制研究

饮片是中药配方颗粒、中药汤剂、中成药的原料药,其质量好坏直接影响了三大中药产品的质量。作为"中药材-饮片-中成药"产业链的中间环节,饮片质量至关重要。然而,近几十年来,中药质量控制一直以药材为主,饮片的质量控制虽逐渐被行业内重视,但仍不能体现其本身特性,缺乏科学性、有效性、合理性,严重影响了中药产业的健康发展。刘昌孝院士于2016年首次提出了"中药质量标志物"的质量控制新概念,在行业内引起了强烈反响。对目前大中药产业质量标准的现状进行综述与分析,将"中药质量标志物"的研究思路与饮片本身特点相结合,形成具有饮片特色的"饮片质量标志物"质量控制新思路,旨在引发饮片领域内专家同行的思考与共鸣,推动中药饮片质量控制方法的发展与完善,保证中药产品行业的快速稳步发展。

Study on quality control of Chinese herbal pieces based on Q-marker of Chinese materia medica

Decoction pieces are the crude materials of Chinese medicinal granule, herbal decoction, and Chinese patent medicine. Its quality directly affects the quality of the three major traditional Chinese medicine products. As the intermediate link of "traditional Chinese medicinal materials-Decoction pieces-Chinese patent medicine" industry chain, the quality is very important. However, the quality control of Chinese materia medica (CMM) products has been dominated by traditional Chinese medicinal materials in recent decades. Though the quality control of Chinese herbal pieces is paid gradually more attention in the industry, it still can not reflect its own characteristics. The lack of scientificity, effectiveness, and rationality seriously affects the healthy development of CMM industry. Academician Chang-xiao Liu first proposed the new concept of "quality marker of CMM" in 2016, which caused a strong reaction. This paper reviewed and analyzed the current situation of the quality standard of CMM industry in detail, combined the research approach of "quality marker of CMM" with the characteristics of decoction pieces, in order to form the new idea of "quality marker of decoction pieces". The purpose is to stimulate thinking and resonance of the experts in the field of Chinese herbal pieces, to promote the improvement of quality control methods of Chinese herbal pieces, and to ensure the rapid development of CMM products industry.