中成药上市后质量控制研究进展

Research Progress on Post-marketing Quality Control of Traditional Chinese Patent Medicine

中成药是我国中医药的组成部分,在临床疾病治疗中发挥着不可替代的作用。目前我国尚存在着中医药发展不平衡不充分、中药材质量良莠不齐、中成药上市后再评价质量控制标准亟待规范等问题。中成药质量控制标准能否满足临床需求是影响中医药产业发展的重要问题。随着我国各地中药注射剂安全性再评价及风险评估工作方案的陆续出台,中成药上市后再评价研究的投入和发展日益加强,影响日益深远。中成药上市后再评价是以需求为驱动,逐步深入的过程,也是相关法规逐渐健全的过程。中成药质量控制研究是保障中药产业高质量发展、提高中药市场竞争力的关键。鉴于此,本研究梳理了中成药质量控制研究相关政策背景,从药效和安全性两个维度,并通过分析实际案例,重点分析符合中医药临床特点的中成药质量控制升级策略,探讨中成药上市后质量控制研究成果转化要点,强调应将基础研究与实际生产、应用相结合,旨在为我国中医药卫生体系的发展提供科学客观的依据。

Traditional Chinese patent medicine is an integral part of traditional Chinese medicine(TCM)and plays an irreplaceable role in the treatment of clinical diseases.There are many problems in the development of traditional Chinese patent medicine in China,such as unbalanced and insufficient development,uneven quality of Chinese herbal medicine,and the urgent need to standardize the quality control standards of traditional Chinese patent medicine after they are marketed.Whether the quality control standard of traditional Chinese patent medicine can meet the clinical demand is an important issue affecting the development of Chinese medicine industry.With the introduction of safety re-evaluation and risk assessment of TCM injections in China,the investment and development of post-marketing research on traditional Chinese patent medicine has been increasingly strengthened,and the impact has become increasingly far-reaching.The post-marketing evaluation of proprietary Chinese medicine is a demand-driven and progressive process,and it is also a process in which relevant laws and regulations are gradually improved.The research on quality control of traditional Chinese patent medicine is the key to guarantee the high-quality development of Chinese medicine industry and to improve the competitiveness of traditional Chinese medicine market.In view of this,this study sorted out the relevant policy background of the quality control research of traditional Chinese patent medicine,and through the analysis of actual cases,from the two dimensions of efficacy and safety,focused on analyzing the upgrading strategies of traditional Chinese patent medicine quality control in line with the clinical characteristics of Chinese medicine,and discussed the main points of the transformation of post-marketing quality control research results of traditional Chinese patent medicine,and emphasized that basic research should be combined with actual production and application,in order to provide a scientific and objective basis for the development of traditional Chinese medicine health system in China.