中药质量源于设计方法和应用:全过程质量控制

Chinese Medicine Quality Derived from Design Methods and Applications for-(Ⅷ): Holistic Quality Control

质量控制经历了检验质量控制、统计质量控制和全面质量控制3个阶段。为实现全面质量控制,Juran提出质量源于设计(Quality by Design,QbD),将质量的概念扩展到产品质量活动的各个领域和环节。中药全过程质量控制与质量源于设计等全面质量控制理念的内涵具有内在一致性,为QbD在中药研发和生产中的应用奠定了良好基础。本文提出并阐释了中药全过程质量控制的2个维度,即从研发到生产的产品生命周期维度和从原料到产品的中药产业链维度。总结了中药全过程质量控制在中药材种植加工过程、中药制剂生产过程和中药产品流通过程的应用。

Quality control has experienced three stages： inspection quality control,statistical quality control and total quality control. In order to achieve total quality control,Juran proposed the quality by design（ Qb D）,which extends the concept of quality to various fields and stages of quality related activities. The content of holistic quality control of Chinese medicine and quality by design is inherently consistent,which lays a good foundation for the application of Qb D in the research and development of Chinese medicine products. This paper presented and explained the two dimensions of quality control in the whole process of Chinese medicine,that was,the product life cycle dimension from RD to commercial production and the industrial chain dimension from raw materials to final products. And this paper had also summarized the application examples of holistic process quality control of Chinese medicine in herbal planting process,the production process of Chinese medicine preparation and the circulation process of Chinese medicine products.