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Standardisation of
the red vine leaf |
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Compared with chemically
produced pharmaceuticals, herbal medicines are produced from heterogeneous
organic raw material. They are nevertheless subject to the same high
quality requirements as synthetic medicines. For this reason, the
production, quality assurance and proof of efficacy and tolerability of
high-quality herbal medicines has to be based on the standardisation of
herbal extracts. Standardisation means guaranteeing the minimum content of
certain active ingredients in the extract. Clinical studies will only
provide reproducible results if the active ingredient combination and the
effect of each individual dose remain constant. Standardisation is
necessary in order to ensure the quality and safety of the herbal medicine
for the consumer. AS195® red vine leaves extract contained in ANTISTAX® is
based on very careful standardisation - a solid base for its consistent
quality.
Obtaining active ingredient from red vine leaves
´The leaves for ANTISTAX® red vine leaf extract come
from vines of Vitis vinifera Linné.
These grapevines have blackish-blue grapes with a red pulp. In the autumn
they bear strikingly red-coloured leaves. On fermentation, the grapes
yield deep-red wines. In earlier times, they used to be blended with
light-red varieties in order to make the colour more attractive. This is
the origin of the term "dyer's" or "teinturier" grapes
which can occasionally be seen in connection with the origin of the red
vine leaf.
The red-leaved vines are cultivated in warm and dry regions of Europe,
Africa and in South America. The red vine leaf is harvested following the
grape harvest. It is at this time that the leaves have the highest content
of the quality-determining ingredients, the anthocyans (colouring agents)
and flavonoids.
The selection of the red vine leaves which are to be used in the
production of the red vine leaf extract is performed on the basis of the
French Pharmacopoeia which describes the quality of the raw material to be
used in medicines. According to the French Pharmacopoeia, the leaves which
are suitable show a minimum content of anthocyans and flavonoids. The
latter are separately identified and quantitatively determined according
to in-house procedures.
The requirements of the European Pharmacopoeia and other European
directives on residues also apply with respect to purity tests on the
natural products, e.g. the test for heavy metals and pesticides.
The red vine leaf extract
After being harvested, the leaves are sparingly dried
and then extracted using purified water in what is referred to as a drip
process which is dependent upon precise temperature control. In this
process, the extracting agent perfuses the comminuted leaves and dissolves
out the ingredients in several stages. The liquid phase is separated from
the raw material residue and dried, leaving the active ingredients
extracted from the leaves.
Quality assurance
The selection of the raw material with quality
requirements in accordance with the French and European Pharmacopoeias,
the consistent, scientifically valid manufacturing process for formulation
of the extract and the control of the flavonoid content of starting
material and extract are in accordance with the quality guideline of the
Working Party on Herbal Medicinal Products of the EMEA (European Medicines
Evaluation Agency) for Phytopharmaceuticals.
Boehringer Ingelheim GmbH, April 2001. |
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Tips
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Help yourself: Our tips for healthy legs. |
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 more |
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Efficacy
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Learn more about the efficacy of the red vine leaves! |
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more |
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Dosage forms
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Something for everybody. Learn more about the dosage forms of Antistax®. |
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more |
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