1. Quality control of herbal drugs is important to ensure consistency and that the herb contained is the same as stated. It involves processes to maintain quality during harvesting, cultivation, storage, and manufacturing. 2. Herbal drugs can vary in composition due to climatic, nutritional, collection, and post-harvest factors. Quality control seeks to minimize these variations. 3. Key aspects of quality control include identification testing, active compound quantification, fingerprint analysis by techniques like HPLC and TLC, and adhering to good manufacturing practices (GMP). This helps ensure consistent quality of raw materials and finished herbal products.

1. Quality Control of Herbal
Drugs

2. 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.

3. 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.

4. 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;

5. 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.

6. * 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 World Health Organization (WHO)
in its volume Qualitycontrolmethodsformedicinalplant materials,

7. 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 European Medicines Agency’s
“Guideline on quality of herbal medicinal products”
& “Guideline on specifications”
more precisely
describe the quality-related issues of medicinal plants.

8. 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.

9. 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.

10. 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.

11. - 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.

12. Fingerprints of EtOAc & But. Extract of Passiflora

13. Simultaneous HPLC Analysis of
Tocotrienols, Tocopherol & Gamma Oryzanol

14. HPLC Chromatographic fingerprint of
different DGL extracts (DGL-Ev, DGL-Ge & DGL-Ph)
Minutes
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
mAU
0
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mAU
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UV
DGL (EVA)
051DGL (EVA).dat
UV
DGL (Gemini)
049DGL (Gemini).dat
UV
DGL (phyto)
050DGL (phyto).dat
Liquiritigenin
DGL-Ev
DGL-Ge
DGL-Ph

15. 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.

16. 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.