Medicinal plants can be used to produce pure natural products containing one or few active substances, or herbal medicines which are complex mixtures. Pure natural products like morphine are isolated compounds, while herbal medicines like St. John's Wort contain many active and inactive substances. Both are produced through extraction and formulation processes from botanical starting materials, though pure compounds undergo additional purification steps. Herbal medicines are generally considered medicinal products and are regulated differently than pure natural products. Common herbal medicines include St. John's Wort, turmeric, clove, and devil's claw.

1. MEDICINAL PLANTS,
NATURAL PRODUCTS &
PHYTOTHERAPHY

2. 1-What is
pharmacognosy?
 The term derived from two Greek words :
pharmakon (Remedy) and Giginosco
(knowledge).it generally focus on all
medicinal plants.
 It refers to the science of biogenic or
nature derived pharmaceuticals and
poison.
It focuses on all medicinal plants.
1-complex mixtures which are used in the form of crude
herbs.
2-pure compounds such as morphine.
3-foods having an additional health benefits: Neutraceuticals

3. What is natural products?
Natural product is a small molecule that is
produced by a biological source in the molecular
weight range of 100-2000 Daltons.
Natural product are looked at regarding their
biological origin, extraction or semi synthetic
production, pharmacology, clinical use, and drug
discovery.
Medicines from plants
There are two groups of medicines from plants.
1-pure natural products'.( morphine)
2-herbal medicines or phytomedicines. (St. johns
wort)

4. Comparing pure natural products and
herbal medicines.
HERBAL MEDICINES: A complex mixture of active and in
active substances generally derived from plants.
PURE NATURAL PRODUCTS: it contains one or
very few active substances derived from natural
sources.
Medicinal product.
Legally considered to be medicinal
product or health food supplement.

5. Processof production
The pharmaceutical process of production of both pure
natural products and herbal medicines are
is often similar. The main differences are in the chemical
complexity of the final products
and uncontrolled status of many (but not all) herbal
medicines.
Pure Natural
compounds
Herbal medicines
The botanical starting
material: the living plant
The botanical starting material:
the living plant
Botanical drugs Botanical drugs
 Extraction
 Isolation
 Purification
 Formulation
 Extraction
 Formulation into
phytomedicines

6. Dispensing Uncontrolled sale or
dispensing
Use by patients Use by patients
COMPOSITION
Aspirin St John’s Wort
Aspirin Hyperforin, adhyperforin, hypericin,
pseudohypericin, isohypericin, protohypericin,
protopseudohypericin, kaempferol, quercetin,
luteollin, tannins, other phenols etc.
Excipients Excipients

7. What are botanical drugs? Dried parts of entire plants, plant organs or
parts of plant organs for use as medicines,
aromatics, spices or excipients used in the
production of pharmaceuticals
Isolated products directly obtained from
plants which no longer have an organ
structure, such
as essential and fatty oils, balsams etc.
Botanical drugs are also the basis for the
isolation of pure natural products for the
production of
herbal medicines and for the production
of extracts used in phytomedicines.
Context of pharmacy  Product derived from a plant and transformed into
a drug by drying certain plant parts or
sometimes the whole plant.

8. Product obtained form plants, which no longer
retains the structure of the plant or its organs
but which contains a complex mixture of
biogenic compounds (e.g. fatty and essential
oils,
gums, resins and balms).
EXTRACT:
The European Pharmacopoeia defines an extract as “a concentrated preparation (fluid extract
or tinctures) or intermediate (semi–liquid) or solid (dry extract) consistency, normally produced
from dried botanical or zoological material by a technique involving the use of adequate
solvents for obtaining a mixture of compounds.
• For some preparations, the material to be extracted may undergo preliminary treatment prior to
extraction (e.g., de–fatting, inactivation of enzymes or most commonly simply grinding).
• The drug–extract ratio is the amount of drug obtained from a given amount of dried drug (e.g.
4:1). This is a good marker of ensuring products of reproducible quality (quality assurance).

9. HERBAL MEDICINE PRODUCTS
Herbal medicine product is exclusively contain
as a active ingredient one or more herbal
substances eg:(powdered drug) or one or more
herbal preparations (eg: Aqueous extractor
essential oil)
They are licensed or registered medicines
for which pharmacist need to take the
same responsibility for other medicines.
(a) Echinacea (Echinacea angustifolia)
(b) St John’s Wort (Hypericum
perforatum)
(c) Valerian (Valeriana officinalis)
(d) Devil’s Claw (Harpagophytum
procumbens
Examples of top–selling herbal medical
products include:

10. Preparations Crude herbs often sold by herbalists or in Traditional Chinese
Medicine (TCM) shops
Extracts
Formulations or Dosage
Forms
Solid dosage forms: tablets, capsules
Semi–solid: creams, ointments
Liquid dosage forms: tinctures.
Combination preparations Several herbs (multi herb)
Herb–vitamin or mineral products.
Herbal medicinal products
General Features of Plant–Derived Pharmaceuticals
 They are derived from herb (aerial parts), leaves, fruits, seeds, root/ rhizome (or other
underground organs), bark or other parts of a (higher) plant.
 These “botanicals” may be used as fresh or dried plant material and they may be sold as
such
or as an extract.

11.  Most of these products are on the GSL, some are P only or POM, others do
not have a license.
 Phytomedicines or botanical drugs are generally made up of complex
mixtures of natural products, some of these are the active compounds,
others are considered to be of little or no pharmacological relevance.
This is an essential difference to other pharmaceuticals.
Examples of herbal medicinal
products
Clove:
Scientific name:Syzgium aromaticum
Family:(Myrtaceae)
 It is derived from evergreen tree
 It is widely cultivated in eastern Indonesia.
 The flower buds are particularly rich in
essential oil.
Botanical drug :The unripe flower buds
Also the clove oil is used.
chemistry:The most important compound is
eugenol (C10H12O2), a simple
phenylpropane-derivative.

12. Pharmacology: Eugenol is an effective antiseptic
and bactericidal compound.
• Toxicological risk: Clove oil is stated to be a
membrane irritant, to cause contact dermatitis
and others. Recently some concerns have raised
about the toxicological risk of high doses of
clove oil in babies for teething problems.
Devils claw/wood spider:Harpagophytum procumbens
(Pedaliaceae) or Devil’s claw grows in the Kalahari Desert in
South Africa.
Its name derives from the claw–like structure of the fruit of the
plan
Botanical drug: The secondary storage roots are currently only
collected in the savannahs of
South Africa and Namibia while still fresh, is cut into small
pieces
and dried. It is obtained from the wild (gathered) but attempts
are underway to cultivate it..
 Traditional African uses are as a tonic for “illnesses of
the blood”, fever, problems during
pregnancy and kidney and bladder problems.
 European use of this product is to treat
dyspepsia and loss of appetite due to the presence of
bitter glycosides present in high
concentration.
Harpagophytum zeyerhi, another species common in
southern Africa is considered to be an
adequate substitute. It contains similar products as H.
procumbens.

13. Most pharmacological and clinical research has
however been conducted using standardised
extracts for the treatment of rheumatism, back
pain and degenerative conditions. The
mechanism of action is unknown, and it is a well-
tolerated suitable alternative to NSAIDs, but
not for patients with ulcers. It has minor side
effects (minor GI upsets). Relevant Natural Products
• The bitter iridoids harpagide and harpagoside are relevant
natural products (active
substances). They are considered to be of pharmacological
importance although research
continues. According to the European Pharmacopoeia, the
drug must contain ≥ 1.2%
harpagide and harpagoside, expressed as harpagoside
(analysis is by HPLC).

14. St. Johns wort:
Hypericum perforatum traditional uses:
Nervous afflictions – excitability, menopausal
neurosis, hysteria, nervousness, anxiety,
depression and as a nerve tonic.
Physiological nerve disorders – sciatica,
neuralgia, spinal injuries.
External use – oily preparations for wounds,
bruises, swellings and shingles.
Turmeric :
(Curcuma longa) is a rhizomatous herbaceous perennial
plant of the ginger family
Zingiberaceae.
• Its rhizomes are ground into a dark yellow powder and
have a characteristic taste and colour. It
is used as a spice and colouring agent.
• A related species, Javanese turmeric (Curcuma
xanthorrhiza) is mostly used for dyspepsia
and other gastrointestinal problems.
Curcuminoids:
 The mixture known as curcumin, consisting of several
phenolic diarylheptanoids, including curcumin,
monodemethoxycurcumin and
bisdemethoxycurcumin.
 An essential oil (about 3–5%), containing about 60%
sesquiterpene ketones (tumerones),
including arturmerone, α–atlantone, zingberene with
borneol, α–phellandrene, eugenol and
others.
Polysaccharides such as glycans and the ukonans A–D
(“starch”).

15. Pharmacological effects of the
turmeric extract include:
 Protects against stomach ulcers
in rats.
 Antispasmodic effect.
 Hypoglycaemic (in vivo in
animals)
 Hypocholesterolaemic effects
(both in animal and human
clinical studies)
 Immunostimulant activity, due to
the polysaccharide fraction.
 Anti-asthmatic effects have been
noted, together with anti-
mutagenic and
 anti-carcinogenic effects.
 Antibacterial and antiprotozoal
in vitro.
An example of an issue often encountered in natural product
pharmacology:
strong effects but on multiple targets.
• Toxicology: Turmeric is well tolerated (used as a spice).
• Turmeric is the subject of much current research but detailed
clinical evidence is lacking so far.

16. Identification of phytomedicine
A herbal drug needs to be defined precisely, as have to be the medicines derived from
it.
Information required about
phytomedicine;
 Botanical origin (species
and family).
 Plant part which provides
the drug.
 Type of product used as
a phytomedicine with a
specific health claim:
 Ground plant material
 Uncharacterised extract
 Standardised extract
 Processed (special extract
4. Active constituents (if
known).
5. Phytotherapeutic (and
other) uses.
6. Chemistry.
7. Pharmacological effects
and clinical effectiveness,
side effects and interactions
with other
(botanical) drugs.
8. Legal category (UK)
9. Monographs (e.g.
European Pharmacopoeia)
Lower pharmaceutical quality
Higher pharmaceutical quality

17. HERBAL DRUG
Drying and processing
(Often drying, grinding),
extraction:
Herbal drug preparation
Formulation Formulation
Herbal medical product

18. Production and quality of botanical drugs
Most important medicinal plants are produced under
controlled agricultural conditions. Differences
in quality may be due to:
 Temperature and annual course of temperature.
 Rainfall (if it is not possible to irrigate the fields).
 Soil characteristics and quality.
 Day length and sun characteristics.
 Altitude.
These require detailed studies for each species to be
cultivated.
Often, the production is based on the principles of GMP
and/or ISO–certification, in this case GAP
(Good Agricultural Practice) and the subsequent processing
steps (drying, cutting, grinding,
storage, packaging, transport, etc. which are covered by the
GMP).

19. EUROPEAN PHARMACOPOEIA REGULATIONS FOR BOTANICAL DRUGS
The following information must be supplied with the botanical drug:
 Title:
English name. Latin name is used in
international trade.
 Definition of the drug
Plant part used; whether it is fresh, dried, cut
or powdered and possibly also specifying
constituents typical for the drug, with
minimal amounts required.
 Characteristics:
Organoleptic or other properties of the drug
(smell colour, other similar characteristics,
and
rarely, taste, which is not usually included in
the European Pharmacopoeia for reasons of
safety.
 Identification
Macroscopic and microscopic description
and in some cases TLC characteristics.
 Tests for purity
Proving data on minimum amounts of
foreign matter, i.e. unacceptable
substances, loss on
drying, ash.
 Required level of biological active or lead
compounds.
 Storage
General information about required forms
of storage.

20. Quality of Botanical Drugs
Numerous specific requirements exist for
assuring appropriate quality of botanical
drugs and
extracts. These include:
 Botanical identity (species and drug).
 Purity (maximum level of other
botanical material).
 Moisture levels (of botanical drug only).
 Pesticides (maximum).
 Microbial contaminants (maximum).
Microbiological Contamination
• The maximum number of
microorganisms allowed is regulated by in
the European
Pharmacopoeia:
(a) Up to 105 aerobic microorganisms per g
or mL including:
(i) Up to 103 yeast and fungi per g/mL.
(ii) Up to 103 enterobacteria per g/mL.
 No detectable Escherichia coli in 1 g/mL.
 No detectable Salmonella species in 10g/mL.
 Specific requirements for storage and transportation
of the drug have to be met. In many cases
this is now control via GAP and GMP standards. Similar
requirement relates to microbial
contamination of botanical drugs. Each natural material
naturally harbours a large number of
spores and other microorganisms.

21. REGULATORY FRAMEWORK OF HERBAL MEDICINAL PRODUCTS
The Traditional Herbal Medicinal Products Directive (THMPD) of the EU
This regulatory framework has
been in place for well over ten
years (implemented in October
2005) and regulates the uses
(claims), quality and safety of
herbal medical products sold as
OTC medicines.
• It is an EU–wide binding
regulation based on previous
directives with the goal of
harmonizing
the regulatory framework for
herbal medical products.
Any manufactured herbal product
placed on the marker under Section 12
of the Medicines Act
since April 30, 2004 need not comply
with the requirements of this scheme.
• The THMP scheme is relevant for any
product which follows the following
criteria:
(a) Makes a medical claim (treatment or
prevention of an illness).
(b) Is sold in a form which implies that
it is used medicinally.
(c) Can be only used for minor self–
limiting diseases and generally as
an OTC product.

22. Requirements for Herbal Medicines to be Registered Under the THMPD
 The product must be approved by the MHRA and be fully regulated.
 The product must demonstrate traditional history of use for at least 30 years (of which
15 have
to be within the EU).
 The product must be used for minor self–limiting diseases only.
 The product is mostly OTC.
 The product must be produced under Good Manufacturing Practice (GMP).
 The product must be considered to be (very) safe.
 A full Patient Information Leaflet (PIL) approved by the MHRA must be included.
 The product must have a defined dose and usage.
 The pharmaceutical producer must conduct weekly updates especially with regards to
safety.
 The therapeutic use of the product must be plausible.
 The product name must be included in Braille on the box.
 The MHRA must regularly monitor the product.
 Most products now carry the THR logo.

23. Examples of Single –Ingredient Traditional Herbal Medicines Registered under the
THMPD
Common Name Botanical Name Registered Products
Agnus castus fruit Vitex agnus-castus L. Premherb Tablets
Arnica flowerheads Arnica Montana L. Atrogel Arnica Gel
Black Cohosh
root/rhizome
Cimicifuga racemosa (L.) Menoherb Tablets
Devil’s Claw root Harpagophytum
procumbens D.C. and/or
H. zeyheri L. Decne.
Atrosan Devil’s Claw Tablets.
Flexiherb Tablets.

24. The UK’s Older Regulatory Framework for Herbal Medicines
When the Medicines Act 1968 was enforced,
all existing products were granted Product
Licenses of Right (PLRs).
Traditional medicines used for minor, self–
limiting conditions were
permitted to draw on bibliographic evidence
of efficacy and safety rather than carry out
controlled tests and trials.
These HMPs were each issued a Product
License (PL) number.
• But Section 12 of the Medicines Act 1968
provided two crucial exemptions from
licensing for
herbal medicines:
(a) If they were supplied by a “herbal
practitioner” following request for
treatment.
If the herbs were only subjected to
simple processing, sold under their
common or
botanical name and have no written
uses.
• Consequently more than 5000
herbal products were sold as “food
or dietary supplements”
without direct medical claims. Only
regulated herbal medicines are
required to comply with
regulatory provisions on quality and
pharmacovigilance.

25. 1. Briefly discuss the main similarities and differences between Licensed Medicines (LM) and
Traditional Herbal Medicinal Products (THMPs)?
2. Write an essay discussing safety issues associated with the use of important herbal medicines
sold in community pharmacies. Your answer should focus on examples of safety issues
relating to specific herbal medicines, but should also include discussion of general safety
Issues?
3.The process of formulating a herbal (botanical) drug into a phytomedicine is more complex
than formulating a chemically defined drug into a medicine.
(a) Pharmacognostic (botanical) quality of the starting material
(b) Preventing risks associated with microbiological contamination
(c) The process of extracting herbal medicines

26. 4.Turmeric is a commonly used spice and medicinal plant.
(a) What is the Latin name of the species yielding this drug?
(b) Discuss the pharmacological effects of this herbal medicine and the chemical constituents
responsible for them.
5. The following is an excerpt from a label of a product registered under the THMPD:
X is a traditional herbal medicinal product used for the relief of:
• Rheumatic or muscular pain
• General aches and pains in the muscles and joints
• Backache
This is based on traditional use only.
Ingredients:
1 film–coated tablet contains 480 mg of extract (as dry extract) from Devil’s claw root
(Harpagophytum procumbens D.C. and/ or H. zeyheri L. Decne.) (1.5-3.0 : 1). Extraction
solvent: Ethanol 60% V/V. The other ingredients used for the tablet are lactose, maize
starch, microcrystalline cellulose, precipitated silica, colloidal silica and magnesium stearate
(vegetable source). The tablet coating contains talc, titanium dioxide, macrogol and
hypromellose.
Directions for use:
Adults and the elderly: Take one table twice daily immediately after food. The dose can be
increased to two tablets twice daily if relief is not obtained after 3 to 5 days.
Not for use in children or those under 18. For oral use only. Read leaflet before use. Do not
use if you are allergic to Devil’s claw or any of the other ingredients. This product contains
lactose.
Keep out of the reach and sight of children.