BioGinkgo

Extra Strength

Healthcare Professional Product Guide

Natural Dietary Supplement for the Maintenance of Healthy
Cognitive Performance and Circulatory Health.*

BioGinkgo 27/7 Extra Strength is a dietary

supplement being sold by Pharmanex as an
advanced concentration and memory formula,
to stimulate memory and concentration, and to
promote circulation to the brain, arms, and legs.
This is an educational publication provided to
help licensed healthcare practitioners understand
the science upon which BioGinkgo 27/7 is
based and the mechanism of action by which
BioGinkgo 27/7 works. This pamphlet should
not be used to sell BioGinkgo 27/7, and it
should be distributed only to licensed healthcare practitioners.
The only claims that can be made for
BioGinkgo are those that have been approved
by the Company.

Memory and Circulation Enhancer*

STANDARDIZED GINKGO BILOBA EXTRACT

A Scientific Product Review

by Michael Chang, Ph.D.

Official Sponsor
36 USC 220506
* These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.

BioGinkgo

STANDARDIZED GINKGO BILOBA EXTRACT

Summary
As modern medicine enhances its ability to fight disease, the human population is expected to live longer. The
quality of life, however, may be compromised with age if
mental acuity and physical well being decrease sharply.
As baby boomers age and approach retirement, there is a
growing need for products that counteract the decline in
mental acuity often seen during aging.
Recently, there is scientific evidence to suggest that
herbal medicines and dietary supplements can improve
cognitive functions and conserve mental sharpness. One
of the best-studied herbal extracts is Ginkgo biloba.
This review surveys the published scientific work that
pertains to this intriguing herb. It also provides the scientific rationale behind the formulation of BioGinkgo 27/7.
This product has been formulated by Pharmanex, Inc. to
provide the maximal benefits that can be derived from
Ginkgo biloba extract while complying with guidelines
defined by European health authorities.

What is BioGinkgo 27/7

Ginkgo biloba extract (GBE), with its beneficial effects
on cognitive functions, has become one of the most
widely used of the traditional
supplements. Extracts
from the leaves of the
Ginkgo biloba tree (the
maidenhair tree) have
been used medicinally
for thousands of years and
Ginkgo biloba is still one of the
most widely used herbal products in China for breathing problems.1
In the West, Ginkgo biloba extract is increasingly prescribed in Europe2 and has recently been approved by the
German Commission E, Europes most respected herbal
standards authority, for treating a variety of symptoms often
found in the aging population.3
Perhaps the most important age-related condition
affected by GBE is a group of symptoms usually referred
to as cerebral insufficiency.*4 These symptoms include:
difficulties in concentration and memory, absent-mind-

edness, confusion, lack of energy, tiredness and decreased

physical performance. GBE, therefore, has the potential to
greatly improve the quality of life during aging.

German Commission E Monograph

The use of phytomedicines in Germany is well integrated into conventional medicine and pharmacy. The
German government has established a regulatory mechanism whereby herbs and phytomedicines are reviewed for
their safety and efficacy for approval as over-the-counter
(OTC) therapies. The German Federal Health Agency
established the Commission E, which consists of physicians, pharmacists, toxicologists, pharmacognosists, and
others who are familiar with medicinal plant research.
The Commission E has published 410 monographs
covering 324 herbs and combinations. Of these, more than
200 herbs are approved for OTC use, including GBE. The
Commission E Monograph for GBE describes, in detail, its
health-related benefits, pharmacology, toxicology, active
component composition, manufacturing requirements,
and quality control standards.
The Monograph defines the two key active components
of Ginkgo biloba 50:1 extract as:
22% to 27% flavonoid glycosides, determined as
quercetin and kaempferol including isorhamnetin
(via HPLC).
5 to 7% terpene lactones, as measured by the
percentage of ginkgolides A, B and C, as well as
bilobalide content.

Constituents of Ginkgo biloba Extracts

The most important bioactive ingredients in GBE are
the terpene lactones (ginkgolides and bilobalide) and the
ginkgo flavone glycosides.1 The ginkgo flavonone glycosides
are a group of small molecules that are derived from flavone
(2-phenyl-benzopyrene); the major flavonoid glycosides are
kaempferol, quercetin and isorhamnetin linked to sugar
residues. The terpene lactone ginkgolides are unique to
the ginkgo tree and are not found elsewhere in nature. They
are diterpenes and are divided into types A, B, C, and J,
which differ slightly in structure;5 ginkgolide B has the
greatest PAF bioactivity. The terpene lactone bilobalide has
a sesquiterpenoid structure.
The amounts of flavone glycosides and terpene lactones in GBE, and thus their health promoting properties,
vary according to the source of the ginkgo leaves and the
extraction and enrichment procedures used to prepare the
extract.6 Therefore, the extracts are usually standardized
in terms of their flavone glycoside and terpene lactone

* These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.

content and typically contain from 22% to 27% w/w

(weight of active compound/total weight of extract) flavone
glycosides and from 5% to 7% w/w terpene lactones.
BioGinkgo 27/7, the Pharmanex version of GBE,
contains significant concentrations of ginkgolides, especially ginkgolide B, the most potent and long-acting PAF
(platelet activating factor) antagonist. A recent bioavailability study7 in rabbits has shown that after a single dose,
a higher concentration of ginkgolides was maintained for
a longer duration time with BioGinkgo 27/7 than with
another commercially available Ginkgo biloba 24/6 extract.

(PAF).*12 PAF, a small molecule that binds to specific

receptors on platelet surfaces, initiates platelet aggregation,
one of the first steps in blood clotting. Studies have shown
that ginkgolides, by inhibiting binding of PAF to its receptors, improve blood flow to the brain and other tissues.*
Ginkgolide B has been shown to be the most potent
PAF-inhibitor12 (ten times more potent) with the longest
duration of action in comparison to all the other ginkgolides.
Current scientific evidence supports the notion that the
antioxidant properties of the flavone glycosides and the
antagonism of PAF by ginkgo extracts, particularly terpene
lactones, act in concert to produce a health related effect.

Clinical Studies

Mechanism of Action
The effects of GBE are due to the sum of its bioactive
components since the flavone glycosides and terpene lactones act in different ways. Each bioactive constituent alone
would not be as effective nor can explain the total health
related effect of GBE. Many studies suggest that the health
promoting effects of the ginkgo flavone glycosides result
mainly from their antioxidant properties,8 particularly their
ability to act as scavengers of oxygen free-radicals.*9 The
accumulation of oxygen free-radicals (which are highly
reactive and harmful, and damage many types of biomolecules by a process called peroxidation) is an important
contributor to several age-related ailments. Ginkgo flavone
glycosides have also been shown to protect against the
deleterious peroxidation of lipids,10 which are important
components of cell membranes and are essential for
maintaining membrane fluidity.* Importantly, the radical
scavenging potency of GBE is comparable to other wellknown antioxidants such as vitamin E and vitamin C.*11
The pharmacology of GBE, particularly the terpene
lactones, the ginkgolides and bilobalide, may also be related
to antagonism of the actions of platelet activating factor

GBE is primarily used to affect the relatively slow

decline in cognitive functions, a condition referred to as
cerebral insufficiency in Europe.* There have been several
controlled clinical trials7 using different extracts of Ginkgo
biloba to test the effectiveness of ginkgo extracts in mitigating symptoms characteristic of cerebral insufficiency,
i.e., difficulties of concentration and memory, absent
mindedness, confusion, lack of energy, tiredness and
decreased physical performance. These symptoms are
also often found in people suffering from age-associated
memory impairment (AAMI), a condition that may also
be alleviated by GBE.*
One double-blinded, placebo-controlled trial13 involved
99 patients with an average age of 59 years who had
shown symptoms of cerebral insufficiency for an average
of 26 months; 50 patients received GBE and 49 received
placebo for 12 weeks. The overall effect on the well-being
of the patients and on the severity of each of the symptoms
listed above were rated by both the patients and their
doctors on a four-point scale. After treatment, significant
improvement was reported in a majority of the symptoms
listed above. By patient self-assessment, 70% of the GBE
group felt improvement compared to 14% of the placebo
group. The doctors assessment showed similar results:
72% of the GBE group showed improvement compared
with 8% of the placebo group.
In another study,14 110 patients received GBE for 12
weeks and 99 were treated with placebo. These patients had
an average age of 69 years and had experienced symptoms
of cerebral insufficiency for an average of 46 months. After
treatment, significant improvements in 8 of the 12 symptoms were reported on a four-point or three-point scale
by patients and doctors, respectively. By patient selfassessment, 83% of the GBE group reported improved
cognitive functions compared with 53% of the placebo

* These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.

group; by the doctors assessment, 71% of the GBE group

were improved compared with 32% of the placebo group.
GBE has been approved by the German health
authorities to help with leg problems often experienced
by the elderly when walking. In one trial,4 79 patients were
randomized into two well-matched groups, one receiving
GBE and the other placebo for 6 months. There was a
greater improvement in both the total distance walked and
the distance walked before the onset of leg problems in the
GBE group. The relative increase in the relative distance
walked was 117% in the GBE patients compared with 16%
in the placebo group. The increase in the distance walked
without pain was 110% in the GBE group compared with
42% in the placebo-treated patients.

Health Benefits
Tissue damage. Because of its radical-scavenging ability,11
GBE may protect both nerve and heart cells against damage by free radicals.* GBE may also enhance the ability of
the body to repair free radical tissue damage.*15
Cognitive Function. Important neuro-transmitters such
as dopamine and 5-hydroxytryptamine16 are key players
in central nervous system activity. Since ginkgo flavonoids
protect against membrane damage, GBE can maintain
the normal interaction of nerve cells with these neurotransmitters.* By inhibiting PAF-induced platelet aggregation17 and reducing the resulting viscosity or stickiness of
the blood, the ginkgolides may increase cerebral blood flow
and contribute to the improvement in cognitive function
seen after GBE treatment.*
Circulatory Benefits. Peripheral circulation is improved
after GBE treatment, resulting in an increased supply of
oxygen to the muscles.* GBE has been demonstrated to help
with leg problems often experienced by the elderly when
walking.*18 GBE has also been shown to improve peripheral blood circulation (e.g., hands, feet, inner ear, eyes).*
Lung Function. In addition to platelets, PAF binds to
cells involved in maintaining the healthy functioning of
the airways. PAF is believed to narrow airways, and the
antagonism of the action of PAF by the ginkgolides may,
therefore, improve lung function in those individuals where
breathing is hindered.*19
Vision Benefits. The macular area of the retina is responsible for fine reading and is particularly sensitive to damage
by lipid free-radicals. GBE may help promote eye health
in the elderly through its antioxidant properties.*15

BioGinkgo 27/7 Proprietary Processing

Research conducted by Pharmanex reveals that con-

centrations of active components in Ginkgo biloba leaves

can vary by as much as 300% depending on location, season
and method of harvest. To ensure the best quality and
consistency of finished product, Pharmanex employs onsite harvest management and testing so that only fresh, clean
leaves of the highest quality are procured. BioGinkgo 27/7
is manufactured to GMPs (Good Manufacturing Practices)
standards using a proprietary 23-step extraction and
washing process requiring approximately 50 pounds of
leaves to yield just one pound of extract.
Active components of each batch are stringently analyzed by HPLC to control the concentrations of flavonoid
glycosides (as measured by the percentage of kaempferol,
quercetin and isorhamnetin content) and terpene lactones
(as measured by the percentage of ginkgolide A, B, C,
and bilobalide content). Furthermore, each batch is then
tested against fifteen additional quality criteria including
heavy metal and residue solvent, ginkgolic acid and
microbial content.

Side Effects
An important finding with GBE is that no serious
side effects have been reported in any GBE trials and the
frequency of side-effects is low. Mild gastrointestinal disorders, headache, and allergic skin reactions are the only
side effects that have been reported.1

Safety and Toxicology Data

Both the acute and chronic toxicity level is very low for
Ginkgo extracts studied: the LD50 for oral administration
to mice is 7,725 mg/kg body weight. Very large doses in
humans may cause restlessness, diarrhea, nausea, vomiting
and other unpleasant effects, usually of a relatively mild
nature. If these occur, discontinue use or reduce the dosage.

* These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.

Drug Interactions

About the Author

No drug interactions have been identified, even in

reports where elderly patients are taking multiple medications simultaneously. Due to Ginkgos mechanisms of
actions, persons taking anticoagulants that affect platelet
aggregation should consult with a physician.

Michael Chang, Ph.D., Senior Vice President of Research

and Development and Chief Scientific Officer, leads
Pharmanexs R&D team efforts. Dr. Chang has a strong
pharmaceutical background, with more than 15 years in
the industry, first as Deputy Director of Medicinal
Chemistry at Merck Sharpe and Dohme and then as
Director of Medicinal Chemistry at Rhone Poulenc Rorer.
All Pharmanex Research and Development efforts are
coordinated at our state-of-the-art facilities in the United
States and China under Dr. Changs leadership.

Directions for Use

As a dietary supplement, take one tablet two times
per day (morning and evening) with food and drink. Do
not chew tablet. Tablet is coated for ease of swallowing.
Although some people will notice benefits in as little as
two to three weeks after daily supplementation with
BioGinkgo 27/7, users should allow up to 12 weeks for
optimum benefits.

How Supplied
BioGinkgo 27/7 tablets (60 mg each) are supplied in
a one-month supply of 60 tablets.

Storage
Store in dry, cool place. Avoid excessive heat. Protect
from light.

Shelf Life
Expiration date and lot code numbers are imprinted
on the bottom of the box or bottle.

Warnings
Keep out of reach of children. If you are pregnant or
lactating, please consult your physician before taking this
product. Contact your physician if you are taking a prescription medication. Persons taking anticoagulants that
affect platelet aggregation should consult their physician
before using a GBE product.

Do not use if
You are taking anticoagulants;
You are taking aspirin on a daily basis;
You are taking monoamine oxidase (MAO)

inhibitors;
You are allergic to the Ginkgo biloba plant or

its products.
Note: If you have a known medical condition or are taking a
medication stated above, please consult with a doctor before
taking BioGinkgo .

Key References
1. DeFeudis F. Ginkgo biloba Extract (EGb 761): Pharmacological
Activities and Clinical Applications. Paris: Elsevier, 1991.
2. Grunwald J. The European phytomedicines market: figures, trends,
analyses. Herbal Gazette 1995;34:6065.
3. Bundes A. Ginkgo biloba leaves: Bundes Anzeiger, 1994.
4. Kleijnen J, Knipschild P. Ginkgo biloba for cerebral insufficiency.
Br J Clin Pharmacol 1992;34:352 8.
5. Maruyama, M.; Terahara, A.; Itagaki, Y.; Nakanishi, K. The Structure
of Ginkgolides. Tetrahedron Lett 1967;1:299, 303, 315, 321.
6. Sticher, O. Quality of Ginkgo preparations. Planta Medica
1993;59:211.
7. Li CL, Wong YY. The Bioavailability of Ginkgolides in Ginkgo
biloba Extracts. Planta Medica 1997;63:5635.
8. Marcocci L, Packer L, Droy-Lefaix MT, Sekaki A, Gardes-Albert M.
Antioxidant action of Ginkgo biloba extract (EGb 761). Methods
Enzymol 1994;234:46275.
9. Pincemail J, Dupuis M, Nasr C, et al. Superoxide anion scavenging
effect and superoxide dismutase activity of Ginkgo biloba extract.
Experientia 1989;45:708 12.
10. Maitra I, Marocci L, Droy-Lefaix MT, Packer L. Peroxyl radical
scavenging activity of Ginkgo biloba extract (EGb 761). Biochem
Pharmacol 1995; 49:1649 55.
11. Kose K, Dogan P. Lipoperoxidation induced by hydrogen peroxide
in human erythrocyte membranes. 1. Protective effect of Ginkgo
biloba extract (EGb 761). J Int Med Res 1995;23:1 8.
12. Braquet P, Spinnewyn B, Braquet M, et al. BN 52021 and related
compounds: A new series of highly specific PAF-acether receptor antagonists isolated from the Ginkgo biloba. Blood Vessels
1985;16:559 572.
13. Schmidt U, Rabinovici K, Lande S. Einfluss eines Ginkgo-bilobaSpezialextraktes auf die Befindlichkeit bei cerebraler Insuffizienz.
Munchener Medizinische Wochenschrift 1988;133:S15S18.
14. Bruchert E, Heinrich SE, Ruf-Kohler P. Wirsamkeit von LI1370
bei alteren Patienten mit Hirnleistungsschwache Multizentrische
Doppelblindstudie des Fachverbandes deutscher Allgemeinzartze.
Munchener Medizinische Wochenschrift 1991;133:S9S14.
15. Lebuisson DA, Leroy L, Rigal G. Treatment of senile macular
degeneration with Ginkgo biloba extract. A preliminary doubleblind drug versus placebo study. Presse Med 1986;15:1556 8.
16. Huguet F, Drieu K, Piriou A. Decreased cerebral 5-HT1A receptors during aging: Reversal by Ginkgo biloba extract (EGb 761).
J Pharm Pharmacol 1994;46:316 8.

17. Guinot P. Tanakan inhibits platelet-activating aggregation in

healthy male volunteers. Homeostasis 1989;19:219 223.
18. Bauer U. Six-month double-blind randomised clinical trial of
Ginkgo biloba extract versus placebo in two parallel groups in
patients suffering from peripheral arterial insufficiency.
Arzneimittelforschung [Drug Research] 1984;34:716 20.
19. Chiu C-P, Hsieh K-H. Pulmonary response to platelet-activating
factor (PAF) and PAF antagonist BN 52021 in allergic asthmatic
children. In: Braquet P, ed. Ginkgolides-Chemistry, Biology,
Pharmacology and Clinical Perspectives Barcelona, Spain: J. R.
Prous Science Publishers, S. A., 1989;877 878.
20. LeBars PL, Katz MM, Berman N, et al. A placebo-controlled,
double-blind, randomized trial of an extract of Ginkgo biloba for
dementia. JAMA 1997;278:132732.

The Pharmanex 6S Quality Process

Central to the Pharmanex mission of transforming time-honored, traditional preparations into health promoting botanical products with known
content and consistent activity is the Pharmanex 6S Quality Process.

Selection

Exhaustive scientific review of research and databases is conducted.

Authenticity, usefulness, and safety standards are determined.

Sourcing

Teams of experts investigate potential sources and evaluate quality.

Comprehensive botanical and chemical evaluations are completed.

Structure

Structural analyses of natural compounds are determined.

Active ingredients are isolated and studied.

Standardization

Strict standardization to at least one relevant marker molecule is required.

Proprietary processing methods to increase consistency and ensure measured dose

effectiveness are developed.

Safety

Safety is assessed from available research.

Microbial test, chemical, toxin, and heavy metal analyses are conducted.

Substantiation

Documented pre-clinical and clinical studies are reviewed.

Pharmanex sponsored studies are initiated when appropriate.

Visit Your Local Bookstore:

Ginkgo, A Practical Guide
by George Halpern, M.D., Ph.D.

For More Information:

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