Details of quality control methods and quality of herbal crude drugs

1. Dr.J.S.Suryawanshi
Asst. Professor and Head,
Dept. of Pharmacognosy,
Satara College of Pharmacy, Satara
UNIT I
Quality control of Drugs of Natural Origin

2. Herbal Raw material
 This is the crude herb or substance freshly collected from
either plant ,animals or microorganisms that have all
medicinal benefits but not been processed (Drying,
pulverization, extraction etc.)
 It includes flower, leaf, root, bark, fruit, and seed, plant
exudates ,resins ,juices, oils etc
 A major share of raw materials is of plant origin.
 It includes herbs, shrubs, leaves, barks, heartwood, flowers,
seeds, fruits, fruit kernel, oils, gums, resins etc.
 Animal origin: Animal byproducts like ghee,
milk, honey ,fish oils etc

3.  Quality of a herbal material is described in terms
of…
 Identity Correct botanical identification
 Purity WithoutAdulteration
 Potency Phytochemicals
 Safety Without any hazardous material
What is Quality of a Herbal drug..??

4. Quality of a herbal material is described in terms of…
Identity
Purity
Potency
Safety
Q

5.  First step in the research on plants/herbs
 Most important.
 The herb under examination must be the authentic and
botanically identified correctly.
 Identity can be achieved by macro- and microscopical
examinations.
 Voucher specimens are reliable reference sources.
Identity

6.  Purity is linked with limited or no contamination of the herb
with other similar looking herb or part.
 No deterioration/spoilage of herbal drug.
 NoAdulteration
 No presence of Foreign Organic Matter
 Drug should be as per the Pharmacopoeial standards.
 For better quality, the herb must be pure.
Purity

7.  It depends on the presence of active chemical constituents in
the herb.
 Number and quantity of constituents matters for the desired
therapeutic effect.
 For better quality and potency ,the herb must contain
appropriate quantity of chemicals.
Potency/Efficasy

8.  If the herb is said to be safe, then it is free from microbial
load, pesticide residue, heavy metals etc.
 WHO has given guidelines for the presence of these unsafe
materials in the herb.
 For better quality and potency ,the herb must
be safe, free from hazardous effects.
Safety

9.  It means confirmation of its purity ,potency and safety by various
parameters like morphological, microscopical, physical, chemical
and biological observations.
 The finished Herbal formulation must contain a phytoconstituent
or a group of phytoconstituent with known therapeutic activity.
What is Quality Evaluation of herbal formulations …??

11.  QC is an essential step in the development and production of
herbal medicines in order to assure the reproducibility of quality,
efficacy and safety.
 The attainment of quality of herbal materials remains a challenge,
due to the influence of several factors such as:
 Biological variability
 Drug processing (drying/grinding/storage).
Adulterations, contaminations
Deterioration (physicochemical and chemical)
Why Need of QC…??

12. Adulteration of drugs of
natural origin

13.  The adulteration and substitution of herbal drugs is the burning problem in
herbal industry and it has caused a major effect in the commercial use of
natural products.
 Adulteration in market samples is one of the greatest drawbacks in
promotion of herbal products.
 Adulteration is a practice of substituting the original crude drug partially
or fully with other substances which is either free from or inferior in
therapeutic and chemical properties or addition of low grade or spoiled
drugs or entirely different drug similar to that of original drug substituted
with an intention of enhancement of profits.
  An adulteration means a process of addition of impure, cheap and
filthy substances to genuine drug in order to get more profits .The
adulterants may not have pharmacological or therapeutic properties.

14.  Adulteration is a practice of substituting
original crude drug partially or whole with
other similar looking substances but the latter
is either free from or inferior in chemical and
therapeutic properties.
O
R

15.  Adulteration in simple words is
the debasement of an article.
OR
 Adulteration is broadly defined as admixture
or substitution of original or genuine article/
drug with inferior, defective or
otherwise useless or harmful substances.

16. Examples of Adulteration
1)Substitution using inferior commercial varieties
 In this type, the original drugs are substituted using inferior
quality drugs that may be similar in morphological
characters, chemical constituents or therapeutic activity.
 Eg. Hog gum or hog tragacanth forTragacanth gum,
 Eg.Arabian senna and Dog senna are used to adulterate
Indian senna,
 Ginger being adulterated with Cochin Ginger,African ginger
and Japanese ginger

17.  2)substitution of superficially similar inferior
natural substance.
 The substituents used may be morphologically similar but
will not be having any relation to the genuine drug in their
constituents or therapeutic activity.
 Eg.Ailanthus leaves are substituted for belladonna,
 Saffron admixed with saff flower,
 Peach kernels and apricot kernel for almonds .

18.  3)Adulteration using the vegetative part of the same
plant.
 The presence of vegetative parts of the same plant with the
drug in excessive amount is also an adulteration.
 Eg. Excessive amount of stems in drugs like lobelia,
stramonium.
 Eg. Clove with clove stalk
 Fennel fruit with stalk
 Senna leaves with stalk.

19.  4)substitution using exhausted drugs
 In this type of substitution, the active medicaments of the main
drugs are extracted out and are used again.
 This could be done for the commodities that would retain its
shape and appearance even after extraction,
 This technique is frequently adopted for the drugs containing
volatile oil, such as clove, Fennel, etc.
 Eg.After extraction, Saffron and red rose petals are recoloured
by artificial dyes.
 The bitterness of exhausted gentian is restored by adding aloes.

20.  5) Addition of toxic materials
 In this type of adulteration, the materials used for
adulteration would be toxic in nature.
 Eg.A big mass of stone was found in the centre of a bale of
liquorice root.
 lime stone pieces with asafoetida, lead shot in opium, amber
coloured glass pieces in colophony.