基于人用经验医疗机构中药制剂向新药转化的药学变更考虑

Pharmaceutical changes and countermeasures for transformation of traditional Chinese medicine preparations in medical institutions into new drugs based on human use experience

医疗机构中药制剂作为我国特有的重要制剂形式,拥有较为丰富的人用经验,是临床经验方和中药新药复方制剂之间的重要桥梁,国家鼓励医疗机构制剂向中药新药转化,强调其“孵化器”作用。随着“三结合”中药注册审评证据体系的建设推进,基于人用经验的医疗机构制剂新药转化的思路日益受到广大药品研发单位的重视。在医疗机构中药制剂向新药转化的过程中,需要关注药学变更的多个方面。该文从制剂处方中的辅料、剂型、生产工艺、生产规模、包装材料和容器、制剂生产场地和注册标准等方面,论述基于人用经验医疗机构中药制剂向新药转化的药学变更与对策。强调变更过程需要根据药品的特性和临床需求进行科学决策,保证药品质量的稳定性,并通过恰当的评价指标和检测方法客观评估药学变更对药品质量的影响;提前进行布局,力求制剂关键药学信息保持稳定,从而为基于人用经验医疗机构中药制剂向新药转化打下良好的基础。

Traditional Chinese medicine(TCM) preparations in medical institutions,as a unique and important form of preparations in China,have a long history of human use and serve as a bridge between clinical experience prescriptions and new Chinese medicine preparations.The state encourages medical institutions to transform their preparations into new traditional Chinese medicines,emphasizing their role as "incubators".Since the proposal of the traditional Chinese medicine registration and evaluation evidence system with the integration of TCM theory,human use experience(HUE),and clinical experience,the idea of transforming preparations used in medical institutions into new drugs based on HUE has been increasingly valued by drug research and development organizations.In the transformation process,pharmaceutical changes should be concerned from multiple aspects.This paper discusses the pharmaceutical changes and countermeasures based on the transformation of traditional Chinese medicine preparations in medical institutions into new drugs based on HUE from the aspects of excipients,dosage forms,production technology,production scale,packaging materials and containers,production sites,and registration standards.It is emphasized that scientific decisions should be made according to the characteristics and clinical needs of drugs to ensure the stability of drug quality.The impacts of pharmaceutical changes on drug quality should be objectively assessed based on appropriate evaluation indexes and detection methods.The layout should be carried out in advance,and the key pharmaceutical information of the preparations should be kept stable,so as to underpin the transformation of traditional Chinese medicine preparations in medical institutions into new drugs based on HUE.