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Standardization of Medicinal Herbs
The Problem
Herbal
medicines and supplements can provide a cornucopia of health benefits to
mankind. Unethical business practices (e.g. adulteration), ignorance
(e.g. misidentifications) as well as the variable quality of the herbs
themselves have unfortunately led to deaths and health problems in
unsuspecting consumers, but also to products with essentially no
beneficial effect and have created a general awareness that
standardization measures have to be introduced in order to ensure both
safety and efficacy of herbal products. Current practices of
standardization (quantification of one or few supposedly active or
marker compounds via HPLC analysis), however, even though highly
effective tools for quality control of single-ingredient western
prescription medicines, do not appropriately address the problems of
medicinal herbs which represent complex mixtures of chemical compounds,
often acting together in a synergistic manner. For scientific details on
the problem, click here.
Our solution:
TQP™
TQP ™ applies high field
hydrogen nuclear magnetic resonance spectroscopy (1H-NMR) to
create the most concise, non-reductive, high-resolution total chemical
profile of a medicinal herb currently possible, representing all, not
only one or a few compounds (NMR fingerprinting) – knowledge on active
compounds is thus not required to obtain the desired results. After
spectrum acquisition, statistical tools are used to compare the 1H-NMR
spectrum of a sample with the specification settings for a particular
medicinal herb and yes/no answers to whether or not the particular
sample is within those specifications (and thus fulfills the
requirements for chemical consistency) can be obtained.
TQP™
is a very sensitive technique that can detect minimal levels of
contamination or adulteration and can enable predictions on bioactivity
or toxicity of a sample (if this spectrum exists within the species),
but is at the same time fast (1H-NMR analysis requires ca.
10% of the time of a standard HPLC analysis) and simple and can be
automated to a great extent. Per sample analysis costs are not much
higher than e.g. for HPLC tests. TQP™ can be applied to herbs,
extracts and final products and can be used in addition as a means of IP
protection e.g. in the case where clinical trials are being conducted
with herbal medicines.
Patent applications for TQP™
have been filed worldwide. The US patent has been allowed recently,
other countries (incl. Malaysia) are expected to follow shortly. The
patent and license also cover the combination of NMR fingerprinting with
a proteomics approach to assess bioactivity of e.g. final products on
relevant human cell-lines in an overall, multi-mechanism way, addressing
the potentially synergistic activities of the components of a medicinal
herb to create an integrated tool for the appropriate standardization
and quality control of herbal products from the herb in the field to the
final product on the shelf. For scientific details on standardization of
medicinal herbs using TQP™, click
here.
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