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.
YANG MING
KEY LABORATORY OF MODERN PREPARATION OF TCM OF MINISTRY OF
EDUCATION
ADD: JIANGXI UNIVERSITY OF CHINESE MEDICINE yunwan road
No.18 wanli district,
Tel: 86-791-7118658
Fax: 86-791-7118658
Mobile: 13870608983 P.O.:330004
E-mail:yangming16@126.com Web: http://www.jxtcmi.com/zd/
Add.: 2712 San Gabriel
Boulevard
Rosemead, CA 91770 U.S.A.
Tel.:
(626) 288-1199
Fax:
(626) 288-4199