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Quality Control of Herbal Drugs

Presentation · December 2011

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Hesham I. El-Askary
Cairo University
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 ‫ﺑﺳم ﷲ اﻟرﺣﻣن اﻟرﺣﯾم‬

Quality Control of Herbal

Drugs
Dr. Hesham El-Askary
Prof. of Phytochemistry & Medicinal Plants

Pharmacognosy Department - Faculty of Pharmacy

Cairo University

International Conference
Total Quality Management of Herbs & Medicinal Plants
& their Products

Ministry of Agriculture & Land Reclamation

6 - 8 December 2011
Quality Control is a term refers to
processes involved in maintaining
the quality or validity of a manufactured product.
* some degree of quality control should exist, Regardless of
the form of herbal preparation,

Without proper quality control,

there is no assurance that
the herb contained in the package is the same as
what is stated on the outside label.

Improvements in analytical methods led to improvements in

** harvesting schedules,
** cultivation techniques,
** storage,
** Activity & stability of active compounds
** product purity.
 Factors contribute to variation in
the content and composition of raw materials.
These factors can be grouped in four categories:

1 - Climatic factors
(prevailing temperature,
rainfall,
humidity,
daylight
& altitude of the growing region).
2 - Nutritional factors
(affect the
health of a growing plant and are reflected in the
production of biomass and its composition)

several soil factors (availability of micro- & macronutrients,

pH & cation exchange capacity are
important for optimal growth of plants.
 Factors contribute to variation in
the content and composition of raw materials.
3 - Collection factors
(control the content of active components by giving
attention to the - age,
- season,
- collection time &
- the plant organ.

4 - Post-harvest factors
(the enzymatic processes continue after collection until
they are deactivated by drying or other suitable treatment)

as the collected material is still live and carries out

metabolic processes and respires;
 Factors contribute to variation in
the content and composition of raw materials.

All or some of these factors

can affect

the Safety, Efficacy & quality

of any herbal drug.

 The World Health Organization (WHO)
in its volume Quality control methods for medicinal plant materials,

* Listed several parameters which are valuable in assuring

quality of plant drugs. These include:
identification, visual inspection, sensory characters,
macro- and microscopic characteristics,
moisture content, foreign matter, fingerprint by TLC,
ash values, extractive values, volatile matter,
microbial load, heavy metals, pesticide residues,
radioactive contaminants.

* Also, according to the nature of the drug, one or more

determinations for : bitter value, tanning test,
foaming, hemolytic and swelling indices.
 The European Medicines Agency’s
“Guideline on quality of herbal medicinal products”
& “Guideline on specifications”
more precisely
describe the quality-related issues of medicinal plants.

These documents define and differentiate:

- herbal substances (equivalent to herbal drugs),
- herbal preparations (equivalent to herbal drug preparations)
- herbal medicinal products (equivalent to traditional herbal
medicinal products).
The guidelines :
- Emphasize the quantification of active or analytical markers.
- Describe procedures to ensure quality of
- raw material,
- semi finished and
- finished products.
 The quality of a plant product
Can be assured by
* assuring the quality of the raw material.
* in-process control,
* quality control of the finished product,
* good manufacturing practice (GMP) controls &
* process validation.

• It is important to
define specifications of raw materials
to minimize variations in the quality of finished
products and to achieve consistency.

• The expected results of these tests and

measurements are
presented as numerical limits or as a range or
discretely observable result.
 Standardized Botanical Extract
Botanical extracts present in different forms:
* Powder or
* Liquid).
The Standardized botanical / herbal extracts
should guarantee
* the defined amount of active ingredients
* the assurance that the quality and the active
ingredient are consistent.

Certificate of Analysis
Should be provided with

every standardized extract.

 Assessment of quality of plant preparation

** Plant preparations (powdered, extracts, tinctures, fatty or

essential oils, expressed juices and fractionated, purified or
concentrated preparations).

** The manufacturing procedure should be described in detail.

** The added substances (excipients) should be mentioned in the

manufacturing procedures.

** A method for identification and assay (where possible) of

the plant preparation should be added.

If identification of an active principle is not possible,

it should be sufficient to identify a characteristic substance or
mixture of substances (e.g. “chromatographic fingerprint”)
to ensure consistent quality of the preparation.
- A fingerprint chromatogram of the extract or preparation
obtained by
- HPLC,
- Gas Chromatography (GC), or
- Thin Layer Chromatography (TLC)

* It is the most suitable way to proof the identity and

batch-to-batch conformity.

* It is applied when the active principles are unknown or

when a mixed preparation contains several raw drugs or
extracts

* This fingerprint should:

* demonstrate identity and purity of a drug
* guarantee the therapeutic equivalence of
extracts from the same herbal drug.
Fingerprints of EtOAc & But. Extract of Passiflora
 Simultaneous HPLC Analysis of
Tocotrienols, Tocopherol & Gamma Oryzanol
 HPLC Chromatographic fingerprint of
different DGL extracts (DGL-Ev, DGL-Ge & DGL-Ph)
140 140
UV UV UV
DGL (EVA) DGL (Gemini) DGL (phyto)
051DGL (EVA).dat 049DGL (Gemini).dat 050DGL (phyto).dat

120 120

100
Liquiritigenin 100

80 80
mAU

mAU
60 60

40 40

DGL-Ev
20 20

DGL-Ge

0 DGL-Ph 0

0.0 2.5 5.0 7.5 10.0 12.5 15.0 17.5 20.0 22.5 25.0 27.5 30.0
Minutes
 If a phyto-preparation contains
more than four or five drugs or extracts,

it is more reliable to
characterize the individual drugs or extracts
by HPLC
before mixing them.
 Currently, only a few manufacturers
adhere to

complete quality control &

good manufacturing procedures (GMP)

Companies supplying
standardized drugs and/or extracts
currently offer

the greatest degree of quality control,

hence

Its products typically offer the highest quality.

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