以质量一致性为导向的中药混批勾兑技术研究概况与展望

Overview and prospects of traditional Chinese medicine blending technology oriented by quality consistency

药品质量一致性关乎临床疗效与安全,受到国家和相关行业的高度重视。与化学药相比,中药源于天然,受产地、栽培加工技术、气候等自然因素影响较大,质量一致性差。质量一致性已成为中药产业发展的痛难点,严重影响中医临床疗效的稳定可控及现代研究结果的可重复、被认可,也是中成药走向国际市场亟待解决的瓶颈问题。混批勾兑技术是其他行业与学科保障质量一致性的有效方法,在酿酒行业、烟草行业与香水行业广泛应用。在国外,混批勾兑技术在保障银杏叶制剂金纳多的质量一致性方面取得巨大成功,在日本汉方制剂生产应用30余年。近年来,混批勾兑技术被引入中药学领域,用于保障中药质量一致性,并取得了一定进展。该文回顾了混批勾兑技术在其他学科的应用概况,综述了国内外中药学或天然药物领域混批勾兑的算法原理与软件系统,阐述了混批勾兑技术的具体实施过程,展望了人工智能等新技术解决中药复杂物质体系质量一致性的应用前景,以期抛砖引玉,为解决中药质量一致性难题,推动中药产业在新时代高质量高水平发展提供新的思路与技术。

The consistency of drug quality is related to the clinical efficacy and safety,which is highly valued by the government and relevant industries. Compared with chemical medicine,traditional Chinese medicine originates from the nature,and is greatly influenced by natural factors,such as the place of origin,cultivation and processing technology,climate. The quality consistency of traditional Chinese medicine is poor. The quality consistency has become the pain point and difficulty of the development of the traditional Chinese medicine industry,which seriously affects the stability and controllability of clinical efficacy and the reproducibility or recognition of modern research results. It is also a bottleneck for Chinese patent medicine to enter the international market. Mixed batch blending technology is an effective method for the scientific guarantee of the quality consistency in other industries and disciplines,and widely applied in liquor making industry,tobacco industry and perfume industry. Overseas,mixed batch blending technology has been successfully applied in guaranteeing the quality consistency of Ginkgo biloba preparations Jinnado. It has been used in the production of Chinese formulations in Japan for more than 30 years. In recent years,mixed batch blending technology has been introduced into the pharmaceutical field to ensure the quality consistency of traditional Chinese medicine,and relevant research has gradually increased.This manuscript reviews the application of blending technology in other disciplines,summarizes the algorithm principles and software systems of mixed batch blending in traditional Chinese medicine or natural medicine,explains the specific implementation process of mixed batch blending technology,and looks forward to the application prospects of artificial intelligence and other new technologies,in the hope of providing new ideas and technologies for breaking through the problem of quality consistency,and boosting the high-quality and high-level development of Chinese medicine industry in the new era.