A train of thoughts on research development and the direction
Of the modern traditional Chinese medicine preparations
Yang Ming, Chen Chao-min and Luo Heng
(The Key Labs of
ABSTRACT. The traditional Chinese medicine (TCM) preparations are those patented drug formulations prepared under the guidance of the pharmacological theory of TCM. They are being processed under specified conditions and administered in different forms of drug delivery systems.
1. Research ideas of modern TCM preparations.
Preserving the excellent features combined with the long standing theories and experiences of the existing preparations, the modern TCM formulations are being processed with advanced technologies in order to fulfill the increasing needs of the society.
It’s also important to develop and manufacture better formulations with higher quality, efficacy, safety, better compliance and product stability.
The TCM preparations, with a long history, have proven to induce long-term clinical efficacies. They consist of multi-ingredients, which exert actions at several targets and multiple-stages of regulatory activities of whole body system. By rationale compounding and screening of existing formulae, integrated with the advanced drug delivery systems (DDS), a unique way of the modernization of TCM preparations can be attained.
2. The direction to the modernization studies on TCM preparations
2.1. Contemporary research on the TCM material bases
There are several factors which seriously hinder the modernization of TCM preparations. They are: 1) TCM preparations have not been paid proper attention, 2) lack of understanding of the action mechanisms, 3) difficulty in quality control of the product, and 4) lack of understanding of the pharmacodynamic of the materials involved. There are two problems associated the chemical investigations of the compositional materials. First, after compounding, were there any newly produced compounds? Secondly, with various contents in the compositions, were there any resulting forms of synergistic efficacies? The studies of chemical composition in the TCM preparations are significant. They not only facilitate the elucidation of mechanisms of actions, theories of prescriptions, and dispensing principles, but also benefit the process optimization and formulating the quality control standard of the final preparations.
2.2. Modernization of the production process of the TCM preparations
There is a number of process development technologies applied to the field of TCM preparations. They are, for examples, supercritical fluid extraction, supersonic extraction, microwave extraction, enzymatic extraction, macroporous reticular resin absorption, membrane separation, ultra-filtration, flocculent precipitation, solid sispersion, occlusion, lyophlization, microencapsulation technique etc.
2.3. The modernization of DDS of the TCM preparations
There are two approaches that we can follow to speed up the DDS modernization of TCM preparations. One is the application of new technologies, new devices and new auxiliaries to modify or enhance development of the existing ones in order to improve the comprehensive characteristics. The other is to strengthen the basic research and the development of advanced DDSs, including those of sustained and/or controlled released, transdermal and targeting technologies etc.
2.4. The modernization of quality standard and control of the TCM preparations
To establish an independent intellectual property right of quality standard and control systems which combined with the multi-item, qualitative/quantitative analysis of the composition, and to incarnate the profound intension connotation of the theory of TCM, as well as to underline the integrality quality standard system of ingredients in the preparations. By fingerprint analysis of the ingredients combined with the multi-item quail-quantitative analyses, a scientific, objective and innovative standard and control systems can be realized.
2.5. The modernization of packaging of TCM preparations
The safety and potential chemical interactions of package materials with the drug, and diversity of presentation and the specification requirements had also to be considered.
“Return to Nature” has become trendy and people are putting more and more efforts on studying products derived from natural sources. China not only possesses abundant resources of natural products, but also holds a long history of profound knowledge of traditional medical theory in dealing with chronic, refractory, senile and other hard-to-treat diseases. By integrating the unique TCM theories with advanced technologies and resources, the modernization of the TCM preparations would be attained.
KEY LABORATORY OF MODERN PREPARATION OF TCM OF MINISTRY OF EDUCATION
ADD: JIANGXI UNIVERSITY OF CHINESE MEDICINE yunwan road
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