d) Qualitative chemical tests

•According to the type of AC present→general tests should carried out

herbal
medicine
 Introduction and Orientation
Contribution of herbal products in global market
 In the raw form:
Over all international trade in medicinal plants and their products was US$ 60
billion in 2010.e.g. waters as sea water, thermal water and rose water.

 Pure compounds:
Pravastatin (US$ 3.6 billion per year), is made through different
biotransformation processes from compactin by Streptomyces carbophilus and
Actinomadura sp.
 Intermediates for drug:
Simvastiatin: A semi-synthetic derivative of lovastatin is simvastatin, a major
hypocholesterolemic drug, selling for US$ 7 billion per year before becoming
generic.

Traditional Chinese Phytopharmaceuticals

and Indian medicine e.g. active fraction or
CAM
or herbal tea standardized extracts

New drugs and Natural products Nutraceuticals

intermediates e.g.Medicinal
plants

Cosmeceuticals Functional food or

Dietary healthy food or
supplement food additives
s
What is herbal medicine?
 Herbal medicine , phytomedicine or herbalism is a type of alternative and
complementary medicine (CAM) that uses plants or their crude products for
the treatment of diseases. It may include also animal, fungi or bacteria
products (≠ conventional medicine, which uses pure chemicals regardless of
their origin, natural or synthetic).
Other types of CAM
• Physical therapy
• Vacuum cups (cupping)
• Acupuncture
• Aromatherapy
Crude Drug: It’s a medically useful drug of plant or animal origin without any
further processing or modification.
Natural product : is biosynthetic substances produced by living cells.
Herbal medicine is the use of plants or plant extracts for medicinal purposes
(especially plants that are not part of the normal diet).
Phytonutrient or nutraceutical or functional food
Natural substances that aid the body to maintaining health and combating
disease such as anthocyanidins, isoflavones and carotenoids.
Phytopharmacuticals; Is the natural biologically active fraction or standerdized
extracts formulated in certain pharmaceutical dosage form and legally
approved for intended use and user
Extraction
Extraction is the obtaining of a mixture of compounds from herbal materials by
using adequate solvents
-Standardized extract: this is extract with relatively well- established chemical,
pharmacological and clinical profiles
-Non - standardized extract: extract with little information about quality,
chemical composition and efficacy.
Differences between Herbal drugs, purified and single compound
medicinal agents (i.e. conventional drugs)
1) They are generally safer with fewer side effects
-with moderate use in crude from because of (active compounds are
present in lower concentrations than in conventional drugs).
2) Many of them are used in the form of extract to concentrate the active
compound(s).
3) They contain a wide variety of different compounds (active and inactive).
4) The concentration and composition of their active compounds (mostly
secondary metabolites) vary with many factors (amount of sunlight,
rainfall, temperature, soil and season).
5) They contain mixture of components that may have active, synergistic or
antagonistic compounds, which determines their mode of use.
6) They couldtreat certain chronic and self-limiting diseases that could be
responsive to self-treatment such as headache, constipation, diarrhea,
cough, skin infections,….
7) Certain herbs are used as remedies and foods at the same time e.g. garlic,
citrus, grapes, green and black tea
8) They may support the general health and offer prophylaxis against certain
diseases e.g. antioxidants, antihepatotoxics (protect against cancer and
liver diseases), antihyperlipidemics and antihypercholesterolemics
(protect against atherosclerosis and cardiovascular diseases )
9) They are generally cheaper than conventional medicines
10) due to complexity of the mixture of the herbal products it may be
exert multiplicity of mechanisms
 Major therapeutic categories in which Herbal medicine were prescribed
Cardiovascular system.
Nervous system.
Digestive system.
Immune system.
Urological system
Respiratory system.
Rheumatic conditions.
Skin diseases.
Wounds, and sprains.
Some metabolic and endocrinal conditions.
Gynecological conditions and diseases of the breast.
Cancer.
* Herbs and herb materials refers to whole plants and/or plant parts, or their
derived chemically complex products (e.g., oleoresin capsicum), but not single
chemical entities (e.g., capsaicin, the primary active ingredient in capsicum
oleoresin, approved as both an Rx and OTC drug, but not considered "herbal"
although it is plant-derived). Further, pure compounds from herb-derived oils,
although approved for OTC drug use, are not considered "herbal;" these
include eucalyptol from eucalyptus leaf, menthol from peppermint leaf oil,
and thymol from thyme leaf oil.
 Quality control of herbal medicine
Aspects must be considered in herbal medicine
1 Identity
Macroscopical, microscopical, chemical investigation.
2 Purity
Detection of adulterants and pollutants
3 Efficacy
Cell, tissue and organ cultures, Animal and clinical studies.
4 Safety

1- Identity
Investigation of herbal medicine drugs involves several points, include the
following:
a) Macroscopical examination:

N. B. For pharmaceutical preparations, suitable tests are done (e.g. for

tinctures, extracts: clarity, specific gravity, pH.)
b) Microscopical examination:

This is very useful, especially for herbal medicines present in the powdered
forms. Microscopical examinations aims at:
- Identifying, or confirming the identity of herbal ingredients through
presence of their diagnostic elements.
- Confirming purity, through absence of foreign elements (presence of
which indicates adulteration).
- Distinguishing between closely related species usually by determining
certain microscopical numerical values such as stomatal index, palisade
ratio, vein islet number and veinlet termination number.
- Determination of percentage of some adulterants that contain certain
characteristic elements by the lycopodium method.
c) Histochemical tests

d) Qualitative chemical tests

According to the type of active coustitents present, general tests should carried
out:

e) Quantitative chemical analysis

This is carried out depending on the type of active constituents
present.
The amount of active constituents should be within
the official or required limits.
f) Chromatographic detection of active constituents in different
extracts.
 2- Purity
Detection of adulterants and pollutants
The following types of potential contaminants will be considered:
A- Toxic botanicals
B- Micro-organisms and microbial toxins C- Pesticides and fumigation agents
D- Radioactivity E-Toxic metals
F- Synthetic and animal drug substances

3- Efficacy
a) Cell, tissue and organ cultures
-It is modern alternative to animal experimentation.
-It is used for in vitro preliminary screening in drug discovery programs.
-Its advantages are direct observation of the action of agent on target cells and

with reduced ethical difficulties.

-Its disadvantage, it is impossible to predict the balance of plant constituents

that will actually reach internal tissue (after digestion, absorption, and first pass
hepatic effect.
b) Animal experiments
c) Clinical trials
 4- Safety
a) Investigation of acute and chronic toxicity.
b) Determination of the duration of administration.
c) Identification of therapeutic and toxic doses.
d) Studying the effects during lactation and pregnancy.
e) Postmarketing surveillance. (Phase 4 clinical trial = Pharmacovigilance)
-adverse reaction reports.
-drug interaction reports.
-phototoxicity reports.
-hypersensitivity reports.
Dosage forms in herbal medicine