道地性和生产规范性是中药材质量属性形成的关键

Daodi Attribute and Production Standardization are the Key to the Formation of the Quality Attributes of Chinese Materia Medica

中药材是中医药事业传承和发展的基石,道地药材是我国传统优质药材的代表。由于近年来中药产业发展迅速,药材生产环节对道地性和规范性坚守不够,出现了不少质量问题。道地性和生产规范性是中药材质量属性形成的关键,强化道地性和规范生产(人工种植/养殖或野生抚育)操作,并建立与之相关的体现重要质量属性的标准,进而对中药材生产全过程进行有效控制,是保证中药材质量稳定、可控,保障中医临床用药安全有效的重要措施;同时对促进中药材生产的规模化、规范化发展,加快发展现代中药产业具有重要意义。

Chinese materia medica is the material basis for the inheritance and development of traditional Chinese medicine,and Daodi attribute is the representative of Chinese traditional high-quality medicinal materials.A lot of quality problems have arisen,because the production link of crude drugs does not adhere to the Daodi authenticity and standardization(artificial planting/breeding)of the manufacture process,along with the rapid development of traditional Chinese medicine industry in recent years.Daodi attribute and good manufacturing practice are the key to the formation of the quality attributes of Chinese materia medica,and relevant standards that embody important quality attributes should be established,which are important measures to ensure the safety and efficacy of traditional Chinese medicine products.At the same time,it is of great significance to promote the large-scale and standardized development of traditional Chinese medicine production and accelerate the development of modern traditional Chinese medicine industry.