| Article ID | Journal | Published Year | Pages | File Type |
|---|---|---|---|---|
| 2575398 | World Science and Technology | 2009 | 8 Pages |
With the analysis of opportunities and challenges for the drug innovation, this research proposed a definition of the composite drug, which means a compatible combination of multiple compounds or multi-group compounds developed under the guidance of multiple therapeutic principles and mechanisms in order to achieve an optimal holistic efficacy. Composite drugs may consist of composite Traditional Chinese Medicine (TCM) and composite synthetic drugs or the combination of the both. The characteristics of composite drug innovation system are the followings: first, its target is the patient, not just a particular disease. Second, it requires the collaboration from physicians and the combination of iatrology and pharmacology. Third, it requires an R&D procedure of clinical experience to animal experiment to clinical trial. Fourth, it requires the development of a comprehensive assessment system for the clinical efficacy. Fifth, it requires developing an integrative system for screening of composite drugs. Sixth, it requires a development of an integrative system with both holistic characterization and specific characterization of the pharmaceutical components group. The current key issues for the innovation of composite TCM drugs are to develop a comprehensive assessment system for the clinical efficacy of TCM, to develop an integrative system for screening of composite drugs according to the characteristics of TCM and to standardize the approaches for the integrative characterizing of composite drugs. As in some demonstrative studies, this research has developed a new approach, Chemomics-integrated Global System Biology based on which a few composite drugs have been developed: one for treatment of ischemic apoplexy using TCM Qingkailing, and another one for treatment of ischemic cardiopathy using TCM Shuanglongfang. The current key issues for the innovation of composite synthetic drugs should focus on how to innovate the notions in order to establish an acknowledged model for the innovation of composite synthetic drugs, to attract physicians to participate in the composite drug innovation in order to establish an R&D procedure of clinical experience to animal experiment to clinical trial, and to strengthen the research of the composite drugs combining TCM and synthetic drugs.
