Herbal Formulations

General Formulations

➤ Objectives of processing
– To increase the concentrations of active principles.
– To eliminate undesirable constituents.
– The pharmacologically active principles of different species of a medicinal
plant genus can differ. The goal is to obtain high-quality extracts from a defined
plant species with the highest possible concentrations of the active principles.
➤ Starting materials
– In some cases the whole plant, but usually only the plant component with
the highest concentration of active principles (i. e., flowers or roots).
– The composition of extracts made from the same plant may vary according
to which part of the plant was used for its preparation (e. g., nettle leaf extract
vs. nettle root extract ).
➤ Traditional dosage forms (result of processing of the herb)
– Tea (species)
– Decoction (decoctum)
– Infusion (infusum)
– Maceration (maceratio)
– Juice (succus)
– Syrup (sirupus)
– Tincture (tinctura)
– Extract (extractum)
➤ Modern pharmaceutical preparations (made with pharmaceutical excipients)
– Capsules
– Tablets
– Film-coated tablets
– Sugar-coated tablets
– Ointments
– Creams
Preparations from Fresh Plant Material
➤ Plant juice
– Definition: The liquid obtained by pressing and crushing freshly harvested
plant material (plant parts).
– Preparation: Prepared from freshly harvested plant parts. Expressed juice
primarily contains water-soluble plant constituents.
– Storage: Once opened, the bottle should be closed and stored in a refrigerator
and the rest discarded after one week. The contents should be discarded
after the expiration date specified on the label.
– Medicinal action: Usually relatively weak, except in rare cases (expressed
Echinacea juice, for example).
➤ Distillates
– Definition: Formulations obtained by extracting active principles from fresh
or dried plant material by steam distillation.
– Preparation: Obtained by separating the steam-volatile constituents of
fresh or dried medicinal plants by vaporization.
– Storage: See p. 5.
– Medicinal action: Determined by the water-volatile constituents (e. g., mustard
oils, essential oils) contained in the distillate.

Origins of Medicinal Plants for the Manufacture

of Herbal Products
Wild harvested herbs
– Half of all medicinal plants on the market and two-thirds of all plant species
are harvested from the wild.
– For economic reasons, wild harvested herbs are preferably used in the cases
of certain slow-growing plants and of plants of which there is a naturally
abundant supply.
Cultivated herbs
– Cultivated herbs are used when the natural supply is not sufficient to meet
demand or if a herb required for medicinal purposes is a protected plant
species, such as purple coneflower,
Echinacea purpurea,
and goldenseal,
Hydrastis canadensis
.
Advantages of controlled farming
Uniform seed material, optimal growing conditions and harvesting
times
Reduced risk of mistaken identity or adulteration
Reduction of impurities, microbial contamination, and residues from
pesticides and heavy metals (especially in plants imported from developing
countries)
Organic farming:
Ensures the maintenance of natural growing conditions
and is environmentally friendly.
Cultivation of special crops
– Mainly used to enrich and optimize the primary constituents of medicinal
plants. A way of standardizing active constituent levels.
– Reduces the number and quantity of undesirable substances in the plants.
– Enhances the resistance of the plants to atmospheric influences, diseases,
and pests.
Quality Assurance
Homogeneous starting materials
– Homogeneity is achieved by optimization and wide-scale standardization
of growing conditions (e. g., in cultures), and asexual propagation
Note
:
The concentrations of constituents in a given plant (e. g., ginseng or
arnica) tend to vary according to location of origin, season of harvesting,
and age.
Standardized preparation process
– Manufacturers use exact specifications for analyzing parent substances—
meaning the herbs and their parts used—and herbal extracts made from
them, using solvents such as ethanol. Specifications for assaying the content
of target or primary constituents are just as exact and are designed to
ensure that the chemical composition of the herbal extracts remains consistent
from batch to batch.
– Standardization ensures that the quality of medicinal plants and extracts
made from them are reproducible and consistent.
– Minimum concentrations of active principles in raw (unprocessed) herbs
are specified in sources such as the German and European Pharmacopeias
and, lately, the US Pharmacopeia.

Preliminary Remarks


Herbal medicine is a scientifically recognized complementary and alternative
treatment method with proven efficacy.
In North America, herbal remedies are considered dietary supplements by law
and are considered safe unless proven otherwise. Manufacturing standards are
not as stringent as required for pharmaceutical drugs. While only a few “structure
and function” claims (such as “benefits digestion”) can be made by manufacturers,
many work around that limitation by making extensive use of
“third-party” advertising in magazines and through company representatives.
In Germany, herbal remedies are defined as medicinal products by German
Drug Law.
German legislators regard herbs and herbal remedies as medicinal products
with specific pharmaceutical characteristics. Together with homeopathic and
anthroposophic medicines, herbal medicines are classified as drugs of a special
system of therapeutics.
According to German law, every physician must be knowledgeable about herbal
medicine. North American physicians are not required to have this training,
and few classes are offered in herbs or natural medicine in medical school.
The public interest in alternative therapies for general health maintenance and
supportive treatment of chronic diseases has increased tremendously.

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