Projects Profile
Project Title
Analytical approaches to the quality control of Compounds Danshen Dripping Pill, a traditional Chinese medicine
Partnership
Prof Peter Hylands from King's College London
Prof Yongping Wu from Zhejiang University
Project Aim
In this project, King’s College London and Zhejiang University are partnering up to investigate novel analytical methodologies and to demonstrate its feasibility for TCM analysis, as well as assess its suitability as a novel TCM QA/QC technology to produce data satisfying western regulatory requirements for marketing approval.
The project aims to drawn on the pharmaceutical analysis expertise from King’s College London and TCM know-how from Zhejiang University to form a joint research partnership and to evaluate the feasibility of a new analytical approach to the TCM QA/ QC analysis and to assess its potential to address regulator’s concerns on the issue.
Inspiration for the projects
Due to the major difference of the Traditional Chinese Medicine (TCM) from the modern western medicines in medical theory, medication formations, etc., the long established TCM medicines, practice and many of its proven medical benefits are still not accessible by the people in the western world as normal medication for disease treatment. A critical obstacle for this is due to the lack of suitable GLP/GMP complianced methodologies for QA/QC of TCMs to satisfy the stringent regulatory requirement established in the western countries for granting marketing licences.
To overcome this obstacle, new analytical methodology suitable for analysis of TCM and also complying with the western drug regulator’s QA/QC requirements is crucial.
Commercial Potential and Further Development
The project will carry out a preliminary analysis of selected TCMs using novel analytical approaches. The effectiveness of the novel method for TCM QA/QC analysis will be demonstrated and evaluated. The comparative advantage of the new analytical approach for TCM QA/QC will be assessed and its fitness as a tool to produce TCM product data satisfactory to regulatory requirement.
The project could potentially open up a new opportunity for TCM QA/QC, and resolve the obstacle for TCM market approval, and to allow its medical benefits to become accessible by the people living in the western countries.
