Design of Chinese materia medica compound preparation based on clinical value and inheritance and innovation
10.7501/j.issn.0253-2670.2019.17.001
- Author:
Chang-Ming YANG
1
Author Information
1. Center for Drug Evaluation, National Medical Products Administration
- Publication Type:Journal Article
- Keywords:
Clinical value;
Design of Chinese materia medica compound preparation;
Inheritance and innovation;
Quality by design;
Traditional Chinese medicine
- From:
Chinese Traditional and Herbal Drugs
2019;50(17):3997-4002
- CountryChina
- Language:Chinese
-
Abstract:
Chinese materia medica (CMM) compound is the quintessence of traditional Chinese medicine culture, the main form in clinic of traditional Chinese medicine, the main categories and direction of research and registration of new CMM products, and an important carrier for traditional Chinese medicine inheritance and innovation. Due to the characteristics of complicated chemical constituents, weak research foundation, unclear effective components and multi-target effects, coupled with the limitations of research methods and evaluation of CMM compound preparation, how to scientifically carry out the design of CMM compound preparation has become a difficult question to answer. In this paper, from the basic attributes and requirements of drugs, combined with the discussion of research and development path, rule, strategy of new CMM compound preparation, it is proposed that the design of CMM compound preparation should be based on clinical value and inheritance and innovation, in the principle of the safety and effectivity of preparations, respecting traditional medicine experience, quality by design, whole quality evaluation, and quality uniformity and stability, etc. The pretreatment, dosage, process, dosage form, formulation design, equipment selection and industrial production in the CMM compound preparation design are also discussed.
