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The Commission E Monographs |
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THE COMPLETE GERMAN COMMISSION E MONOGRAPHS
THERAPEUTIC GUIDE TO HERBAL MEDICINES
Copyright © 1999 American Botanical Council
Part One Introduction
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Quality Standards and
Phytoequivalence
In addition to the therapeutic parameters noted in each of the monographs,
every monograph includes implied standards for quality, according to the current
issue of the German Pharmacopoeia ( DAB ). However, a few of the
more recently published Commission E monographs contain specific standards for
assessing the quality of the herbal drug (Busse, 1996). These include the
monographs for Ginkgo Biloba leaf dry extract, Horse Chestnut seed extract, and
Lecithin. Since the early 1990s Commission E has issued an increasing number of
monographs on specifically defined plant preparations. "This was due to
further improvements in the analytical procedures applied for quality control of
plant preparations (e.g., extracts). It was shown that differing methods of
manufacturing (e.g., the use of different solvents for extraction, purification
steps) resulted in extracts of different quality. The results from
pharmacological and clinical trials with one extract could thus not
automatically be transferred to another preparation." (Busse, 1996). A good
example of this process is the Commission E monograph on Ginkgo Biloba leaf dry
extract, based on several patented, standardized extracts of a 50 to 1 average
concentration, with chemically defined standardization for ginkgolides (6
percent) and ginkgo flavonglycosides (24 percent), and a maximum level of
ginkgolic acid (max. 5 ppm). In spring of 1997, the Bf ArM sent a letter to
manufacturers of phytomedicines requiring proof that all ginkgo extracts have
less than 5 ppm ginkgolic acid in order for products to receive license
renewals, due to concerns about the potential allergenic effects of ginkgolic
acid (Thiele, 1997).
Regarding research conducted on proprietary preparations like the ginkgo
extracts described above, if a manufacturer is able to document the same
bioequivalence (or phytoequivalence , as it is often called for plant
medicines) in addition to the chemical profile, then these results may be
transferable to a claim for a preparation (Schilcher, 1997b). No new
pharmacological or clinical studies are required; however, the documentation
must demonstrate phytoequivalence via in vitro pharmacokinetic studies
(Schilcher, 1998a).
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