STANDARDIZED EXTRACTS
Siti Muslichah,S.Si., M.Sc.,Apt.
STANDARDIZED EXTRACTS
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• Standardized botanical extracts contain a
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guaranteed and quantified amount of
certain constituents.
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• Although the most obvious aspect of
Help standardization is the guaranteed content of
one or more active constituents or marker
compounds, standardization involves much
more than guaranteed levels of
constituents.
STANDARDIZED EXTRACTS
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• Standardization refer to the body of the information
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and controls that guarantees the consistency of
composition-and therefore consistency of activity-of
Next botanical extract
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• Standardization involves the collation of information
and application of stringent quality control
measures at every step of the process from the
growing of a medicinal plant to the finished
therapeutic substance
STANDARDIZED EXTRACTS
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• A standardized extract is standardized with
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respect to one or more specific constituents
or group of constituents. In most cases the
Next standardization is done to one or more key
active constituents.
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• In cases where the most important active
constituents have not been identified,
standardization may be done to a marker
compound
STANDARDIZED EXTRACTS
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• Other important aspects include the
Previous growing and harvesting of the plants, post
harvest treatment (drying, storage),
extraction method, extraction solvent,
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Help particle size, concentration process, the use
of an recipient to achieve the desired level
of active constituents or marker
compounds, and efforts to ensure the
stability of the extract
STANDARDIZED EXTRACTS
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• Chemical analysis,using appropriate
Previous techiques such as HPLC, GLC, and TLC is
a key aspect on standardization
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ADVANTAGES OF STANDARDIZED EXTRACTS
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• Standardized extracts retain the chemical
Previous complexity typical of the natural plant, but
offer the added advantage of guaranteed
levels of certain key constituent
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• An increasing number of botanical
medicines have had their clinical efficacy
confirmed in clinical trials
ADVANTAGES OF STANDARDIZED EXTRACTS
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• The vast majority of clinical trials involving
Previous botanical medicines have used
standardized extracts
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• The reason is simple : standardized
extracts offer consistent and reproducible
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theraupetic effects and the highest degree
of safety. Accordingly, standardized
extracts produce the best clinical results
Why standardized botanical extracts?
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• Because botanical extracts are made
Previous directly from crude plant material, they can
show very substantial variation in
composition, quality and therapeutic
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Help effects
Why standardized botanical extracts?
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• The variation and diversity of life is
Previous enormous, even within a species. In other
word, two medicinal plants of the same
species may look similar, yet be
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Help substancially different in the levels of active
contituents they contain
Why standardized botanical extracts?
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• Botanical medicines made from plants that
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differ markedly in their chemical
constituents cannot produce the same
Next therapeutic effects
Help • Because the practitioner or comsumer will
be unable to asses the difference, the
cannot compensate for it
• The consequence will be inconsistent
clinical result
STANDARDIZED EXTRACTS are:
Home • High quality extracts containing levels of specified
compounds
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• Broad spectrum extracts containing recognized
Next active constituents as well as variety of other plant
constituents ( some of which may contribute to the
Help overall therapeutic quality of the extract)
• Extracts subjected to rigorous quality controls
during all phases of the growing, harvesting and
manufacturing process
CLINICAL ADVANTAGES
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• High quality extracts with consistent activity
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• Consistent activity allows for more accurate
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• Consistent activity allows for consistent
clinical results
• Extensive quality control ensure the quality
and safety of standardized extracts
QC ensures:
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• That the correct botanical species is used
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• That no other plant material has been used
• That the plant material is not contaminated with
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pesticides, heavy metals or other noxious agents
• That the final extract comply with international
limits for mikrobial content
• That the final product is consistent high standard
Standardized extracts are not:
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• Isolated constituents
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• Do not contain added isolated constituents
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• Do not contain synthetic or semi synthetic
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Factors causing variation in medicinal plant
composition
Home • Genetic variation within spesies
• Climatic factors (temperature, rainfall)
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• Soil type
• Plant nutrient availability
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• Aspect amount of sunlight received
Help • Geographical origin (usually a combination of the above
factors)
• Age of plant when harvested
• Time of harvest
• Methode of drying
• Post-harvest storage
• Time since harvest
PROCESS FLOW CHART
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• It is essential that the seed sown is of the
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• The process begin with cultivation of the
medicinal plant under homogenous growing
conditions. Some species are wild crafted
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due to the nature of the plant. Crop
management and testing determines the
optimal time for harvesting
PROCESS FLOW CHART
Home • After harvesting, the crude plant material is tested
and clearly identified. The part of the plant used for
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medicinal purposes is separated from the rest of
the plant
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• This is regarded as one of the most important
Help stages. Improper drying can result in the loss or
degradation of active components. Most plants
have a moisture content of 60-80 % and cannot be
stored without drying. The dried plant material is
analized for pesticides and heavy metals.
Different techniques involved in standardization
of crude drugs
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• Macroscopic methods
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• Microscopic methods
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• Physical methods
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• Chemical methods
• Biological methods
PHYSICAL STANDARDIZATIONOF HERBAL
DRUGS:
Home • Viscosity
• Melting point
Previous • Solubility
• Moisture content and volatile matter
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• Specific gravity
• Density
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• Optical rotation
• Refractive index
• Bitterness value
• Hemolytic activity
• Swelling index
• Foaming index
• Ash value
• Astringency
CHEMICAL EXAMINATION
Home • Detection of alkaloids
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• Detection of carbohydrates and glycosides
• Detection of phytosterols
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• Detection of fixed oils and fats
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• Detection of saponins
• Detection of phenolic compounds and tannins
• Detection of protein and free amino acids
• Detection of gums and mucilage
• Detection of volatile oils
BIOLOGIAL/ TOXICOLOGIAL STANDARDIZATION
Home • Drugs which cannot be assayed by chemical, or
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physical means are evaluated by biological methods
INDICATION FOR BIOLOGICAL EVALUATION
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• When quantity is too small.
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• No specific chemical test is available
• When the action of drug is due to a mixture of
substance
• Purification of drug is not possible
Referensi
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• Depkes RI, Materia Medika
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• Dirjen POM, Parameter Standar Ekstrak
Next Tumbuhan Obat
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• WHO, Research Guidelines for Evaluation
the Savety and Efficacy of Herbal
Medicinal.
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