German Commission E Monograph

The use of phytomedicines in Germany is well integrated into conventional medicine and the 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 therapies. The German Federal Health Agency established the Commission E, which consists of physicians, pharmacists, toxicologists, pharamacognosists, and others who are familiar with medicinal plant research. The Commission E has published 410 monographs covering 324 herbs and combinations. To date, 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 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.

BioGinkgo Products

Ginkgolides are unique constituents found only in the ginkgo tree. Their unique chemical structures were first described in 1967 by Professor Koji Nakanishi of Columbia University, world-renowned in the science of natural products. Ginkgolides are potent platelet activating factor (PAF) antagonists, and ginkgolide B is considered the most potent ginkgolide. Numerous scientific studies have demonstrated the beneficial effects of ginkgolides, especially ginkgolide B, in blood circulation, and brain function enhancement.* Pharmanex has developed an advanced proprietary GBE formulation based on the most recent scientific findings related to ginkgolide B. BioGinkgo 27/7 Extra Strength has been developed to provide the highest concentration of all active compounds as specified by the German Commission E Monograph.

Furthermore, it is specifically concentrated through proprietary methods to provide at least 80% more ginkgolide B than other standardized GBE products.

In a recent pharmacokinetic study performed in rabbits at dosages of 40 mg/kg, BioGinkgo 27/7 was shown to provide an average of 24% higher plasma concentrations of the active ingredients than the leading brand of GBE as measured by ginkgolide B activity. Further BioGinkgo 27/7 was also shown to have a faster onset and longer duration of action as measured by ginkgolide concentration in the plasma over a 12-hour period.

These findings provide the additional support for BioGinkgo's two times per day dosage at 60 mg GBE/tablet, rather than three times per day at 40 mg GBE/tablet.

Proprietary Processing

Research conducted by Pharmanex reveals that concentrations of active components in Ginkgo biloba 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 on-site harvest management and testing so that only fresh, clean leaves of highest quality are procured.

BioGinkgo™ products are manufactured to GMP (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 (High Performance Liquid Chromatography) 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 absence of heavy metals, residual solvent, ginkgolic acid, and undesirable microbes.

Scientific Support

The extensive body of scientific studies for GBE supports the following benefits:

Circulation: Ginkgo biloba extract helps maintain normal, healthy circulation in the body, including the brain and the extremities, without a borrowing effect from adjacent areas of normal flow.* It also promotes efficient circulation by helping maintain the tone and elasticity of both large blood vessels (arteries) and smaller blood vessels (capillaries).* This makes it easier for blood and oxygen to reach the brain and extremities or other places characterized by fine capillaries like the eyes and ears. The brain (constituting approximately 2% of body weight, but requiring some 20% of total body-resting oxygen consumption) is very sensitive to oxygen deprivation. In a series of scientific studies conducted in France and Germany, in which animals and human subjects with specific conditions such as cerebral insufficiency were tested, standardized Ginkgo biloba extract was shown to increase the brain's tolerance for oxygen deficiency.* Terpene Lactones, which are specific to Ginkgo biloba extract, inhibit platelet activating factor (PAF).* In particular, ginkgolide B has been shown to bind to PAF receptors; it is considered the most active constituent in Ginkgo biloba and the most sustainable scientifically.*

Stimulates Memory and Concentration:* In more than forty scientific studies involving human subjects, standardized Ginkgo biloba extract was shown to have a positive effect on electroencephalograph (EEG) activity, short-term memory and speed of information processing, resulting from its ability to increase blood flow to the brain and Central Nervous System (CNS).*

Antioxidant activity: The brain and CNS have a high lipid content in their cell membranes. This characteristic makes them vulnerable to attack and damage by free radicals. Oxidized lipids, such as lipid peroxides, may alter cells and membrane integrity leading to a gradual loss of semipermeability. Flavonoid glycosides and proanthocyanidins in Ginkgo biloba extract have potent antioxidant activities that help support the body's antioxidant defense system fight free radicals.

Recommended Usage

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

Adverse Effects

The adverse reactions that have been reported include mild gastrointestinal discomfort in less than 1% of persons in studies conducted, as well as rare reports of allergic skin reactions. Ginkgo biloba extract appears to be well-tolerated. There have not been any reports of significant adverse reactions to Ginkgo biloba extract at the recommended dosages or in patients ingesting as much as 600 mg of the extract in one dose. Some people may experience a mild, transient headache for the first two or three days of use.

Warnings

Keep out of reach of children. If you are pregnant or lactating, please consult your physician before taking this product. No known drug interactions; contact your physician if you are taking a prescription medication.

Order # 01 003298, box (30 day supply)

Order # 01 003442, bottle (30 day supply)