صفحه 1:
Lb ae
صفحه 2:
"OF MEDICINAL PLANTS PRODUCTS 35
ZAINAB, U. SHARIFF (MRS)
MANAGING DIRECTOR,
NIGERIAN MEDICINAL PLANTS DEVELOPMENT COMPANY
(NMPDC), ASOKORO, ABUJA
PRESENTATION AT
IPAN WORKSHOP, 2011
In Collaboration with
NMPDC, NAFDAC & NIPRD
صفحه 3:
The World Health Organization (WHO) estimates
that about 80% of the world populations rely
totally on herbal medicine for some aspect of
primary health care. WHO notes that between 25
- 40% of pharmaceutical medicines are derived
from plants. It is also noted that 40 - 50% of
medicines are direct or synthetic copies of plant
ingredients. (Shariff, Z, 2000)
Roughly 50,000 species of higher plants (about 1 in 6 of all
species) have been used medicinally
There are over 400,000 vegetable species on planet earth
(Encyclopedia of Med. Plants, Vol. 1)
صفحه 4:
India is currently the largest producer of medicinal plants
with 15,000 - 20,000 species of medicinal plants
documented in Traditional Medicine. Today, the list of
plants with known medicinal properties is around 5,800 in
Chinese material medica.
The demand for such plants is rising in the
industrialized world where people are resorting to
natural health remedies more and more.
According to the WHO, the global market for
medicinal herbs and herbal products is estimated to
touch US $ 5 trillion by 2050 and is currently worth
over US $80 billion. This indicates the tremendous
potential and demand in this sector which should be
harnessed through improved formulation,
manufacturing and commercialization efforts in
Nigeria so as to tap from the huge source of foreign
exchange for any country.
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صفحه 5:
Herbal Medicine: Herbal Medicines are according to WHO
finished labeled medicinal products that contain as active
ingredients aerial or underground parts of plants or the plant
material or combination thereof, whether in the crude state or
as plant preparations. Plant materials include juices, gums,
fatty oils, essential oils and any other substances of this
nature. Herbal medicine may contain excipients in addition to
the active ingredients.
Med al Plants: These are large groups of plants used in
medicine or veterinary practice for therapeutic or prophylactic
purposed due to the presence in their organs of active
substances, such as alkaloids, flavonoids, glycosides, vitamins,
tannins and coumarin compounds which physiologically affect
the bodies of humans and animals or which are biologically
active in relation to the causative agents of various diseases.
صفحه 6:
ne
with thera value using a combination of one
or more medicinal plants parts. The formulator must study the
formulation to be manufactured or processed, combination of
herbal drugs to be used, clinical and long term usage.
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Number of herbal ingredients for efficacy plus safety
Dosage: Minimum therapeutic dosage by any pharmacopela or scientific work.
Safety and Efficacy of Formulation.
Cost Management.
Category of Formulation.
Type of product and market needs.
Good book on formulation should be consulted.
Quality parameters of formulation must be determined before marketing. Regulatory
requirement must be determined before marketing of the products.
Market Acceptability.
Formulation Procedures.
Forensic Considerations and legal aspects involved for marketing and sales. =“
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PLANT PARTS USED IN MED PLANT FORMULATION.
Stems
Seeds
Roots
Flowers
Berries
And bark of herbs.
Etc.
صفحه 9:
Types of Dosage Form
Pills
~ Syrups
* Juices
* creams and ointment
* oils
* infusions
* suppositories
* liniment
* extracts
« tinctures
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Preparation
Herbs are available in a variety of forms, including fresh, dried, in tablets or
capsules, or bottled in liquid form. You can buy them individually or in
mixtures formulated for specific conditions.
Whatever type of product you choose, the quality of an herbal preparation-
be it in capsule, tablet, tea, tincture, bath, compress, poultice, or ointment
form-is only as good as the quality of the raw herb from which it was made.
To produce top-quality products, herb farmers require a great deal of
specialized knowledge. For maximum potency, it is important that different
ways of preparing medicinal herbs for use all aim at;
Making administration of the plant easier.
To increase the concentration of any active component of the plant,
putting into consideration its physical-chemical properties.
To favor the presentation of the plant or its preparations, depending on
the stability.
do
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Methods & Types of Formulations.
‘Compresses are used by socking a cloth in a warm or cool herbal solution and applied directly to the
affected area e.g. green tea, while fomentations are applied by socking a cloth in very hot water, for
respiratory tract infections, throat and trachea inflammations, etc
Decoction
Can be made from the bark, root, seed or berry of a plant. A decoction fs made by simmering the
part in water (do not boil)for 5 to 10 minutes even up to 30 minutes if materials is very hard
Extracts
Are obtained by pressing herbs with a heavy hydraulic pressure, and soaking them in alcohol or
water. The excess alcohol or water is allowed to evaporate, yielding a concentrated extract. They are
suitable for people with severe illness or mal-absorption problems. Herbal extracts are generally
diluted before use, example includes celery, ginger, garlic, and pumpkin etc. of particular importance
is the emersion of herbs into apple cider vinegar or malt vinegar and left to stand for two or more
weeks.
Infusions
Parts of the leaves, flowers or the delicate parts of plants are grinded and cut _into pieces for
twigs, stem or other larger parts and steeped, not boiled for 5-10 minutes in hot water to allow for
active ingredients in the herb to diffuse into water. E.g. herbal tea. such as Artemisa tea, Morigvite
tea, The aromatic volatile ingredients, vitamins and essences are removed by infusion averagely.
‘One and the half-one ounce of herb in a pint of water is usually applied or 1-3 tea spoonful of dried
herb in a cup of boiling water. The infusion is allowed to set and carefully strained into a cup of water
for drinking as directed.
1
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Methods of Formulations (Contd)
Tinctures
Very concentrated extract of a herb in a alcoholic solutions. They are well
preserved form of previously fresh herbs. Tinctures are prepared by putting a
well-dried, ground plant in alcohol at room temperature for two or three days, or
even up to 15 days, such as in the case of arnica.
Ointments and creams
The base used here are mostly Vaseline, oil, lanolin, or animal fats. The ointment
is obtained simply by addition of extract, infusion, or pressed juice or powdered
herb to the base. A thorough mix of this gives an ointment which can be applied
to the affected areas, e.g. henbane and monkshood, used as calming substances
for neuralgia, persistence headache. Ointments are solid at room temperatures
and soften when rubbed on the skin. Creams are prepared with other fatty
substances currently produced by Pharmaceutical companies.
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Methods of Formulations (Contd)
Poultices
Is the application of powdered or granulated herbs in a hot, soft, moist or mass
of herbs, flowers, mustard or other substances spread on muslin or loosely
woven cloth and applied for 20-30 minutes on a sore or inflamed area of the
body to relieve pain and inflammation. A poultice must not be allowed to
become cold, replace with a second one after removing the first one. E.g. of
herbs used in uncle gum Arabic, hyssop, chickweed, are excellent for distinct
organs or protrusions such as breast, groins, prostates, eruptions, boils e.t.c.it
is advisable to clean the area before applying poultice also of note is the use
of onions and carrot poultice. Applied to stimulate indolent sores and boils that
are slow to heal.
The preparation involves boiling the onions/carrots until soft or used as raw
mash to pulp and some vegetable oil to keep them from hardening, spread
over a cloth for application.
© Powdered herbs
® The part of the herbs containing the active ingredient is dried and grounded
into powder or made into capsules, tablets or solutions.
9
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a cup of
0 يك si merughiy sas”
Steve before batting, €9, lemon [ulce Is prepared by boling one part of lemon julee for 10min,
strain, add three parts of sugar and boil a little longer. Honey and brown sugar preferably must be
‘employed in the preparation of syrups. E.g. onion, Ipecaccuana, barberry, raspberry etc.
Salves
Fresh leaves, flowers, roots, bark and dried powders are used here. They are cut into fine pieces; a
pound of herbs is added to one and a half pounds of pure. Vegetable oil, 4 ounces of bees wax, mix
thoroughly, cover and place in hot sun or oven turn (low hours; strain and leave to cool. This will
produce a firm preparation ready to use.
Liniments
Liniments are an emulsion (mixture) of medicinal herb extracts with oil and/or alcohol. They have a
constituency, and are applied to the skin by gentle rubbing. The active substances penetrate through
the skin into deeper tissues and therefore used for rheumatic and muscular symptoms.
Juices
‘Are made from fresh plants, soon after they are picked by mashing them in a mortar and then filtering
them. Electric blenders may be used to make them. Juices are made from herbaceous plants or from
leaves and fruits E.g. Aloe juice, orange juice. Some juice preparation need to be diluted with water
before administration and some taken in small doses.
age
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ی
as
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Zingiber officinale
Syzygium aromaticum
Hibiscus Sp
Moringa oleifera
Allium sativum
For the management of the following:
* Digestion
* Diabetic Support
* Hypertensive Support
صفحه 17:
PROCES
5۱۱1» )
MANUFACTURE) OF
CATEGORIZED AS FOLLOWS;
= Pre-Production Processes.
= Production Processes.
" Post Production Processes.
we
صفحه 18:
Pre-Production Processes
hie eile oll ke عطاقت حرط prior to caer produciza ۱
رس سس سح
عم( مط) لو )۱06۳(۰
( لو( Wervesiey Provices (BWR).
O. Pretevicary Orvices (Oxvnily by oust or cir drvicr)
>. Pickiog ond Gortiog oF Iwpuriiies Prow biowuss.
S. Deighiegy.
. Bood Gtorage Practices usicy opproprice ]جا سومج
pope. ao
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JR PRODUCTION PROCESS
This major production processess required for herbal
preparations depends on;
The nature of the raw materials (i.e plant part in use).
ll. Desired nature of the finished products.
E.G if the intention is to process a particular herb (leaves) into
tea (infusion), or standardized extract and or powder, then
the major production processes required is represented in
the processing chart below
صفحه 20:
JALITY ASSURANCE
BE TAKEN DURING ENTIRE
PRE- RESEARCH &
PRODUCTION | ~\
بو و ZS 1
Vv 5
‘APPROPRI چ
E> CMEC 2 ۱
EXTRACTIO بات
STORAGE
MILLI ee OF DISTRIBUTI
CRUSHI
NG INTO FINISHED ON
8 tes
SEIVING SATCHET
FILLING ۶
INTO TEA
BAGS 1
1
NOTE THAT PROCESSES DEPEND ON
مج NATURE OF FINISHED PRODUCTS
STORAGE
‘OF OTHER PROCESSING TECHNOLOGIES:
۳ + Manufacturing Of Standardized
Extracts.
لنت سما + Extraction Of Essential اه
DISTRIBUTI + Extraction Of Phyto-Chemicals.
‘ON + Extraction Of Natural Colours.
لوعهيها Extraction Of Oleo-re:
Ll. Other للب ههنومامصطعم+
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۳۳۴۲( (۹0: بت
Includes all activities immediately succeeding
major production processes like;
* Haulage of the finished products with the
appropriate delivery vehicle to storage site.
* Storage of the finished products in a standard
prescribed storage facility.
* Distribution of the finished products into desired
sales channels.
ed
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THIS INCLUDE THE PRODUCTION SITE
AND THE PRODUCTION EQUIPMENTS.
ALL THESE MUST BE IN LINE WITH
NAFDAC REQUIREMENTS AND MUST
SUPPORT GOOD MANUFACTURING
PRACTICE (GMP)
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QUALITY PERSONNEL IS REQUIRED TO HAVE APPROPRIATE SKILLS,
QUALIFICATION AND EXPERIENCE. THEY INCLUDE;
QUALITY CONTROL ANALYST.
*
SUPERVISORY PHARMACIST (WHERE REQUIRED)
SCIENTISTS (MICROBIOLOGISTS, ENVIRONMENTALISTS, ETC)
TECHNOLOGIST/ENGINEERS
OTHER ATTENDANTS, ETC.
NOTE: ALL PERSONNEL ARE TO BE WELL AND DECENTLY DRESSED IN AN
OVERALL COAT DURING PRODUCTION PROCESS TO AVOID CROSS
CONTAMINATION OF THE PRODUCTS.
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QUALITY CONTROL
* THIS IS CARRIED OUT IN ALL THE STAGES OF
PRODUCTION TO GUARANTEE STANDARD
AND QUALITY CONTROL.
er
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COMMERCIALIZATION OF MEDICINAL
DEFINITION:
Commercialization is defined as a process or
cycle of introducing a new product into the
market. The actual launch of a new product into
the market is the final stage of a new product
development and the one where the most
money will be spent for advertising, sales
promotion and other marketing efforts.
es
صفحه 26:
GLOBAL MARKET FOR MEDICINAL PLANTS
India makes about USD $ 6billion from Moringa oleifera with annual purchase of
1.3million tons.
Nigeria regrettably is not in the picture.
The botanical market which include those of herbs & medicinal plants is worth an
estimated USD $1.6billion per annum.
China exports over 120,000 tons per annum and India exports some 32,000 tons
per annum hence dominating the international markets.
Europe annually imports an estimated 400,000 tons of medicinal plants with an
average market value of USD $1billion from Africa and Asia.
In China, about 40% of the total medicine consumption is attributed to the
indigenous traditional medicines, while in Japan, medicinal plants preparations are
more in demand than the mainstream pharmaceutical products.
eo
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AFRICAN MARKET FOR MEDICINAL PLANTS
USD$40million in 1993 alone. And the seed of Voacanga africana which
is Tae) to contain the alkaloid Jobasonin (a CNS depressant in geriatric
patients).
The major export earner for Madagascar is Catharanthus rosea which is
for anticancer therapy whose constituent are Vincristine and Vinblastine.
Burkinafaso and Mali export Entada africana.
75 - 80 tons of Grafonia simplica seeds are exported to Germany.
Tanzania exports Cadamon and Cloves.
South Africa exports 3 plants out of the 24,000 indigenous species which
are used in traditional remedies thereby generating a revenue of 500
million Rands per annum.
صفحه 28:
Tee) Uae Na) aU) ee oe
Utilization by 80% of population for health care.
Availability of medicinal plants as cheaper alternatives and
acceptability.
Increasing cases of resistance to synthetic version.
Bio-prospecting of new plants derived drugs ( R & D).
Global economic benefit (about $80 billion)
Job and wealth creation.
Environmental sustainability to cope erosion and desertification.
To beautify the environment.
Promotion of commercialization of Agriculture through ‘cash crops” e.g
Moringa Oleifera, Artemisia annua, e.t.c. (of the 1.2 million hectares of
land available for cultivation in Nigeria, only 1/3rd is u'
1.0) Rich Soil
صفحه 29:
WHY COMMERCIALISE MEDICINAL PLANTS.
Traditional medicines.
Herbal teas.
Health foods such as nutriceuticals and galenicals.
Phyto-pharmaceuticals.
Industrially produced pharmaceuticals.
Pharmaceutical fragrances,
flavours, and colour ingredients.
® Cosmetics.
© Food Security.
eo
صفحه 30:
ROLE OF FEDERAL ELAS LAE ILE
Inauguration of the Presidential Initiative Committee
(PICO in 2006 on the development, promotion and
commercialization of Nigerian herbal medicinal plants.
The committee came up with a blue print of IM of
traditional medicine.
Establishment of ARTEMISININ DEVELOPMENT COMPANY
(ADC) now NIGERIAN MEDICINAL PLANTS DEVELOPMENT
COMPANY (NMPDC) under the supervision of the Federal
Ministry of Agriculture and Rural Development. The
company has succeeded in cultivation and
commercialization of Artemisia annua and is currently
working on the commercialization of six plants in six geo-
political zones of the country as shown below.
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صفحه 31:
ROLE OF FEDERAL GOVERNMENT
el WIS) Le
Production of Nigerian herbal pharmacopoeia (1st edition with 42
monographs).
Establishment of a unit of traditional medicine, Foods & Drugs
Services in Federal Ministry of Health.
Establishment of other agencies such as;
RMRDC (Raw Materials Research and Development Council).
NIPRD - Development of the Sickle Cell drug called NICOSAN.
NCAC - National Council for Art and Culture, botanical gardens
in Kano, Ebonyi and Bauchi.
NAFDAC
NAMPDA which established data for medicinal plants in all the
ical zones of the country.
صفحه 32:
ZONE
SE& SW
NW & NE
SW & SS
SE&SS
NW & NC
NW & NW
NMPDC COMMERCIALISATION
5 BOTANICAL NAME COMMON & LOCAL NAMES
1 Vernonia amygdalina. Bitter leaf (Shuwaka, Ewuro &
Onugbu)
2 Moringa oleifera Drumstick (Zogale, Ewe-iye &
Okweoyibi)
3 Occimum species ( Bassil & Scent leaf (effirin, nchanwu &
Grassissimum) dodoya)
4 Telifeira occidentalis Pumpkin leaves (Ugwu, egusi-
iroko)
5 Zingiber officinalis Ginger (junja, Aje/atale & Citta)
6 Hibiscus sabdarifera Sorrel, Roselle (Zobo, Isapa &
Ojo)
Raw materials Research and Development Council (RMRDC)
recently held a
Moringa oleifera.
Ministry of Agriculture is also promoting Cocoa and a host of
other
medicinal plants.
صفحه 33:
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]۱ poieutaly aed eovwrwir beurPty oP iradicad wedoe ta her wits DECOS.
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Recker we oP Pore curreuny to koportaton oad prowote exportaiza oP eoecdord phar.
وی ,یی eet by the عابي te: dove, Ongers yet ip ackeve tee desired هروس رتسا
to pose the bil oa iradiod wectoies by «rar set bask. ناموت( the ruby oP the Dutccd
99
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Inadequate support for research institutes (e.g NIPRD,
IAR, Institute of Agricultural Research etc), Poor
collaboration between researcher and industries or
manufacturers for commercialization from laboratory
to the market.
) Inadequate collaboration between government and
stake holders to harmonize policies, programmes and
drive implementation.
) Implementation of the blue print for the establishment
of Nigerian Institute of Traditional Medicine by the
Presidential Committee on Promotion, Development
and Commercialization of herbal medicine in Nigeria.
oF
صفحه 35:
4.Establishment of National Medicinal Plants Database.
In addition to the good efforts by NMDA, Nigerian herbal
pharmacopoeia.
5.Awareness Programmes-continuous need for
sensitization, enlightenment of the populace.
6.Establishment of more industries forcommercialization
and encourage more of public private partnership (PPP)
7.Massive cultivation of medicinal plants with potentials
for commercialization e.g Moringa oleifera, Artemisia
annua and in additon to six medicinal plants of the six
geopolitical zones.
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Issues of standardization, quality control.
Conservation.
Value addition for
© Agricultural products.
® Collaboration with international agencies for
technical assistance and
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صفحه 37:
opn Of Hi | In Th
Developing World Like Nigeria Would Provide Jobs, And
Stimulate Growth Of Local And National Economies. It
Will Also Complement Government Efforts In Meeting
The Health Needs Of Its Populace. Facilitate the
attainment of MDG goals by 2020.
The Nigerian Government Can Therefore Play A Vital
Role In The Development Of Traditional Medicine
Industry By Supporting, Commercialization, R & D Of
Natural Medicinal Products, Through The Execution Of
Carefully Planned And Workable Strategies That Would
Involve Stake Holders, Including Universities, Research
Institutes And Local Manufacturing Industries.