[Establishment and application of "multi-dimensional structure and process dynamic quality control system" in...

Appropriate dosage forms of traditional Chinese medicine (TCM) preparation products, improve effectively drug efficacy and reduce side effects, and also facilitate the use in clinic. In addition, it may also promote the development of the modernization of TCM. TCMs were developed to finish products which possessed suitable dosage form characteristics through multiple steps from raw herbs to preparation. In this paper, we discussed other two key technologies of "multi-dimensional structure & process dynamic quality control system": (1) The dosage form is an important factor affecting the efficacy and safety for the prevention and treatment of diseases. Therefore, the control of the quality of the formulation characteristics is more important. (2) Process dynamic quality control: the dynamic quality control in the production process is particularly critical because drugs are produced rather than testing. In this paper, the paper demonstrates the important role of the system in the quality control of TCM for strengthening the quality control of the production process of TCM preparation, and then further providing a theoretical basis for improving the efficacy of TCM products.