RESUMO
In this paper,the design and development of sustained and controlled release preparations in traditional Chinese medicine( TCM) based on quality by design( QbD) was put forward,aiming at the current situation that the final product quality is affected by multiple factors during the development of sustained and controlled release preparations in TCM. The important development of sustained and controlled release preparations in western medicine in recent years was summarized. According to the complex process of TCM,the concept of QbD was proposed to design and develop sustained and controlled release preparations in TCM. QbD concept was used to analyze the complex factors affecting sustained and controlled release preparations in TCM,and determine the high risk factors affecting the quality of the final product. The high risk factors were controlled from the process to achieve the goal of quality control.This article could provide research ideas for the sustained and controlled release preparations with complex components in TCM,so as to promote the research and development of sustained and controlled release preparations in TCM.