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- Ginkgo (Ginkgo biloba, Ginkgoaceae)
- Adulteration
- Quality
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Date:
01-13-2017 | HC# 061652-560
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Re: Study Finds over 90% of Ginkgo Products Adulterated or of Poor Quality
Booker
A, Frommenwiler D, Reich E, Horsfield S, Heinrich M. Adulteration and poor
quality of Ginkgo biloba supplements.
J Herb Med. June 2016;6(2):79-87.
Globally,
the market for ginkgo (Ginkgo biloba,
Ginkgoaceae) leaf products is estimated to be over $850 million annually. A clinically
proven, standardized ginkgo extract is expensive to produce, which has led to a
situation where fraudulent suppliers have added pure flavonoids (e.g., rutin or
quercetin) or flavonol-glycoside-rich extracts from less-expensive plant
materials to ginkgo extracts in order to obtain materials that contain the
required 24% of flavonol glycosides. The purpose of this study was to evaluate
the authenticity of 35 commercial ginkgo products, using nuclear magnetic
resonance (NMR) with subsequent statistical analysis by soft independent
modeling of class analogy (SIMCA), and high-performance thin-layer
chromatography (HPTLC).
Ginkgo
products (n = 35) were purchased from health food stores, supermarkets, and pharmacies
in Central London, United Kingdom, and from the internet. Product formulations included
tablets (22), hard capsules (11), and caplets (2). A detailed description of
all investigated products is provided in the supplementary data section of the
article.
The
reference standards used were as follows: quantified ginkgo leaf extract EGb
761® (Tebofortin® intense; Dr. Willmar Schwabe GmbH &
Co. KG; Karlsruhe, Germany) and ginkgo extract tablets (LI 1370 extract;
Lichtwer Pharma AG; Berlin, Germany) purchased from a pharmacy [Note: Lichtwer
Pharma no longer exists, and the company that purchased most of the business is
Klosterfrau Vertriebsgesellschaft mbH; Cologne, Germany. However, it is not
known if they have the rights to this extract.]; ginkgo tablet (S1312) and
ginkgo leaf (S1310) from the National Institute of Standards and Technology;
ginkgo leaf samples (S11311, S15564) and powdered ginkgo leaf extracts (S10925
and S15571) from the American Herbal Pharmacopoeia; ginkgo chemical reference
standard supplied by the European Pharmacopoeia for peak
identification; and quercetin, chlorogenic acid, rutin, and ginkgo terpene
lactones (mixture) from Sigma-Aldrich.
The
NMR analyses showed that some samples had a similar chemical composition to the
ginkgo reference extracts, while others were more similar to the rutin standard
with only small concentrations of all other ginkgo constituents. One spectrum suggested
that the product was composed primarily of a compound with structural
similarity to 5-hydroxytryptophan (5-HTP). Some products had chemical
compositions that were very different from those of the ginkgo reference
standards. Only two of the 35 products had HPTLC fingerprints equivalent to EGb
761.
The
claims on the product labels were evaluated in relation to the NMR and HPTLC
findings. The label claims were categorized into seven categories, ranging from
extracts standardized to 24% flavonol glycosides/6% terpene lactones, products
listing a drug extract ratio of 50:1, all the way to products with no
information; some products were listed in more than one category. All labels
claimed the product contained ginkgo leaf or extract. The results of the label
claims analyses were as follows:
- Category
1: Eighteen products claimed to contain standardized extract (24% flavonol
glycosides and 6% terpene lactones). Fifteen of the 18 products had HPTLC
fingerprints in compliance with the authentic ginkgo references, although the
intensity of the quercetin band was much greater than those of the references.
Three products had fingerprints that did not match authentic ginkgo extract at
all.
- Category
2: Four products claimed to be standardized to 24% flavonol glycosides. The
fingerprints of all four products complied with the acceptance criteria for
identification.
- Category
3: Twenty-two product labels claimed to have a 50:1 drug extract ratio; of
those, eight provided no further information, 12 claimed to be standardized,
one declared 24% flavonol glycosides, and one claimed ginkgo leaf and extract.
None of the 22 samples had fingerprint intensities equal to that of the
reference standards, indicating they contained lower concentrations of ginkgo.
- Category
4: Two products claimed to contain ginkgo leaf and extract; however, both
contained constituents not found in ginkgo.
- Category
5: Four product labels gave no specification about the extract, just the amount
of extract in each dosage unit.
- Category
6: One product claimed to be enhanced with rutin; however, the fingerprint
showed it was enhanced with quercetin, not rutin.
- Category
7: Two products claimed to contain only ginkgo leaf; however, the fingerprints were
different from those of the leaf references.
In
summary, 32/35 (91%) of the ginkgo products were adulterated or of poor
quality. The results of this study suggest that the main ginkgo product quality
problems are low concentrations of ginkgo constituents, addition of pure compounds
(rutin) to increase flavonol-glycoside contents, and addition of other compounds,
such as 5-HTP-type derivatives. Based on HPTLC fingerprints, only two products were
equivalent to EGb 761, three products were of bad quality (contained no ginkgo
at all or were not in compliance with labeling), and 30 products had a quality
different from that described in the pharmacopeias (elevated levels of rutin and/or
quercetin, or low levels of ginkgo constituents). The elevated levels of rutin
and quercetin suggest adulteration, while low levels of ginkgo compounds may be
due to adulteration or poor extraction methods. However, from a consumer safety
and reliability perspective, only five products were not in compliance with
their labeling. The authors point out that based on their data, price is not
always a reliable indicator of quality; while most of the cheap products were
of poor quality, some of the expensive products also were of poor quality.
The
authors state, "There seems little other recourse than to draw the conclusions
that these companies are either being sold sub-standard material from third
parties or are using poor quality and adulterated material intentionally in
order to maximise profits. … Future investigations into the ratio of different flavonoids
e.g. quercetin and kaempferol using NMR spectroscopy and HPTLC will provide
further evidence as to the kind and degree of adulteration of gingko [sic] supplements and provide a measure
of product quality that helps overcoming supplement adulteration."
—Heather S. Oliff,
PhD
Editor's Note:
"The initial idea for this project was developed
with researchers (Matt Barrett, Fay Finlay and Chris van Tulleken) for the BBC
programme 'Trust Me I'm a Doctor' (BBC2) and many of the samples included were purchased
with funds provided by the BBC. The initial results were broadcast on
15.07.2015. Anthony Booker's research position was funded through a charitable
donation by Dr. Willmar Schwabe GmbH & Co. KG, Germany."
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