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Metabolite profiling
sebagai kontrol kualitas
obat fitofarmasi
Dr. Wahjo Dyatmiko, Apt.

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GOOD AGRICULTURE PRACTICE [ G A P ]

GOOD LABORATORY PRACTICE [ G L P ]
GOOD MANUFATURE PRACTICE [ G M P ]
GOOD CLINICAL PRACTICE [ G C P ]
GOOD DISTRIBUTION PRACTICE [ G D P ]

Center for phytopharmaceutical development

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SAFETY EFFICACY
QUALITY

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AUTHENTICATION OF SPECIES
QUALITY EVALUATION
DISTINGUISHING THE ADULTERANT
MONITORING RATIONALITY`OF
DOSAGE FORMS
MONITORING THE DYNAMIC CHANGE
DUE TO INTERACTION DURING
EXTRACTION

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BASIC FOR
MODERNISATION

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Center for phytopharmaceutical development

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Center for phytopharmaceutical development

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Center for phytopharmaceutical development

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Role of Biodiversity
in Medicine
1.75 million known species of animals,
plants, fungi, & micro-organisms
Estimated to be 10 million species on
earth
Each species contains 100s - 1,000s
of chemicals
1 billion - 1 trillion chemicals
SD Hines & S Valscic:From Plant to Drug

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Lucia DApote : Clarification on THP & fast track registration process

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Lucia DApote : Clarification on THP & fast track registration process

Center for phytopharmaceutical development

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Center for phytopharmaceutical development

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In general, quality control is based

on three important pharmacopoeial
definitions:
1. Identity: Is the herb the one it should be?
2. Purity: Are there contaminants, e.g., in the form
of other herbs which should not be there?
3. Content or assay: Is the content of active
constituents within the defined limits?

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Several problems not applicable to synthetic

drugs influence the quality of herbal drugs:
1. Herbal drugs are usually mixtures of many
constituents.
2. The active principle(s) is (are), in most cases unknown.
3. Selective analytical methods or reference compounds
may not be available commercially.
4. Plant materials are chemically and naturally variable.
5. The source and quality of the raw material are variable.
6. The methods of harvesting, drying, storage,
transportation, and processing (for example, mode of
extraction and polarity of the extracting solvent,
instability of constituents, etc.) have an effect
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In the first category, true

true standardization, a definite
phytochemical or group of constituents is known to have
activity. Ginkgo with its 26% ginkgo flavones and 6%
terpenes is a classic example.
These products are highly concentrated and no longer
represent the whole herb, and are now considered as
phytopharmaceuticals. In many cases they are vastly more
effective than the whole herb.

The other type of standardization is based on manufacturers

guaranteeing the presence of a certain percentage of
marker compounds; these are not indicators of therapeutic
activity or quality of the herb
Center for phytopharmaceutical development

There are two types of standardization

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Dr. Arthur M Presser : Herbal-Drug Interaction

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Target analysis

Metabolite profiling

Metabolomics

Metabolic fingerprinting

few metabolites

some selected metabolites

scope

accuracy

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all metabolites

classifying samples

Comp.Funct. Genom. 2 (155-168) 2001

Plant Mol. Biol. 48 (155-171) 2002

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Dr. Shin Li Yang :QC oF TCM

Center for phytopharmaceutical development

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Dr. Shin Li Yang :QC oF TCM

Center for phytopharmaceutical development

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Dr. Shin Li Yang :QC oF TCM

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Dr. Shin Li Yang :QC oF TCM

Center for phytopharmaceutical development

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Dr. Shin Li Yang :QC oF TCM

Center for phytopharmaceutical development

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Dr. Shin Li Yang :QC oF TCM

Center for phytopharmaceutical development

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Dr. Shin Li Yang :QC oF TCM

Center for phytopharmaceutical development

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Dr. Shin Li Yang :QC oF TCM

Center for phytopharmaceutical development

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Center for phytopharmaceutical development

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Chromatogram dari simplisia yang diekstraksi

dengan pelarut yang berbeda-beda

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Center for phytopharmaceutical development

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CONCLUSION
Therapeutic activity not depend on one
single compound but there are any
interaction all constituents consisted in
product
So, the quality of the product determine
by metabolite finger printing not only
marker compound

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