Herbal Product Quality
Herbal Product Quality
Herbal Product Quality
Quality :
the status of a drug that is determined by identity,
purity, content, and other chemical, physical, or
biological properties, or by the manufacturing processes.
In general, all medicines, whether they are of synthetic
or of plant origin, should fulfill the basic requirements of
being efficacious and safe, and this can be achieved by
suitable clinical trials.
QUALITY ?
phytoequivalent
Composition Reprodusibility
chemical in effetivity
content and safety
Standardized extracts are high-quality
extracts containing consistent levels of
specified compounds,
and they are subjected to rigorous quality
controls during all phases of the growing,
harvesting, and manufacturing processes.
GENERAL PROTOCOL FOR STANDARDIZED
PRODUCTION OF PLANT DRUGS
STANDART
PARAMETER
FOR HERBAL
DRUGS
•Residual solvent
•Heavy metal
•Pesticide residue
•Mycrobial level
Parameters for Quality Control
of Herbal Drugs
Macroscopic Examination
Organoleptic evaluation
• Organoleptic evaluation of drugs :
Evaluation of a drug by colour, odour, size, shape, taste and
special features including touch, texture etc.
Primary importance before any further testing can be carried
out.
• For this purpose authentic specimen of the material under study
and samples of pharmacopoeial quality should be available to
serve as a reference.
• However judgment based on the sensory characteristics like
odour, taste etc., may vary from person to person and time to
time based on individual's nature. So the description of this
features are very difficult so that often the characteristic like
odour and taste can only described as 'characteristic' and
reference made to the analyst's memory.
Microscopic Evaluation
At other times, microscopic analysis is needed to determine
the correct species and/or that the correct part of the
species is present. For instance :
pollen morphology may be used in the case of flowers to
identify the species
leaf stomata can be used to identify the plant part used.