RESUMO
This paper introduces the general information of Japanese Kampo preparations, including the catalogue, classification, approval, production and so on, and summarizes their quality characteristics on medicinal materials, formulation, productive process, and quality control. It is suggested that classical representative prescriptions should be selected in combination with clinical application, and the research of classical prescription preparations should follow the guidance of traditional Chinese medicine (TCM) theories and the characteristics of clinical application of TCM, attach important to the research after listed, and strengthen studies on the quality control. Moreover, the reassessment of post-marketed "classical representative famous prescription" preparations should be paid more attention to. The research of new Chinese materia medica (CMM) should strengthen quality control of medicinal materials/pieces source, and new CMM compound preparation research should base on the history of human use. Quality control study of new CMM should base on "quality by design" ideas and concepts, and strengthen process control research and quality standard research.
RESUMO
Chinese materia medica (CMM) compound is the quintessence of traditional Chinese medicine culture, the main form and method of clinical medicine of CMM, the main categories and direction of the research and registration of new CMM products, the important part of “inheritance and development” of CMM culture, and mainly reflects the characteristics of CMM. According to the evaluation practice for many years, the research path and the knowledge of the research rules for new drugs of CMM compound were discussed, and the requirements for pharmaceutical research works of new CMM compound preparation. The pharmaceutical research on new CMM compound preparation is a process of quality design and quality improvement. The evaluation requirements of different stages for new CMM compound preparation were elaborated. It is the conclusion that the discussion of R&D path, R&D law, and R&D strategy on new CMM compound preparation will improve the technical evaluation standard system with the characteristics of CMM, increase the ability of R&D for CMM new products, promote the innovation of CMM, and accelerate the new CMM products to go on market.
RESUMO
The effective components are the material basis for efficacy of Traditional Chinese Medicine (TCM), also the core of its quality control. This paper focused on two key scientific issues that how do the effective components form?, How can we improve the effective components?, combining with examples of our group's research, to dis-cuss the research thoughts, technical methods for TCM quality-design. This paper provided a methodological refer-ence for the study of TCM quality-control.