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CONCEPT OF AYURVEDA,
AYURVEDIC
FORMULATIONSAND
THEIR QUALITY CONTROL
DR. SIDDHI UPADHYAY
H.O.D. & ASSOCIATE PROFESSOR
Dept. of Pharmacognosy and Phytochemistry
SIGMA INSTITUTE OF PHARMACY
CONTENT
■ The holistic concept of Ayurvedic system of medicine.
■ A study on different types ofAyurvedic formulations like Churna,
Kwath, Gutika,Taila,Ghrita,Avaleha,Asavas,Arista, Bhasma and
Pisti.
■ Evaluation of Ayurvedic formulations
THE HOLISTIC CONCEPT OF
AYURVEDIC SYSTEMOF MEDICINE
Ayu
+
Veda
LIFE: The unified State of
Body, Mind & Soul
SCIENCE
(Knowledge)
Ayurveda = Science of Life
What is Ayurveda?
•Is a system of traditional medicine native to the Indian
Subcontinent
•Practiced in other parts of the world like USA, Europe,
Australia, New Zealand, Singapore, Malaysia etc as a
form of complementary and alternative medicine
•Involves use of herbs, therapies and Yoga as exercise
•Or applied on their own as a form of Complementary or
Alternative (CAM) treatment
Ayurveda – the Wisdom of Life
• Offers a proven guide for a life of
happiness, vitality, love and purpose.
• Human beings are not viewed as
mere thinking physical machines, but
• Rather as fields of intelligence in
dynamic exchange with the energy
and information of the environment.
Ayurveda – a holistic system
• A Comprehensive System with
equal emphasis on the body, mind
and spirit
• Strives to restore the innate
harmony of the individual
• It is not only about treating sickness
but – preventing disease and
enhancing health, longevity, vitality
and happiness.
Vedas
• It is the bedrock upon which Ayurveda rests
• Considered to be composed around 1500-
2000 BC
• Four Vedas
Rig-veda :contains hymns to be recited
Sam-veda : collection of hymns to be sung
Yajur-veda : entire sacrificial rite
Athar-veda : contains information on
health and sickness
EarliestTexts
• 760 BC
• 660 BC
: Charaka Samhita – herbal or plant
based pharmacopoeia
: Sushruta Samhita – Surgical
approaches
• 7thCentury : Ashtanga Sangraha of Vagbhata
– summary of previous two
•
•
AD 100
1331
: Nagarjuna – iatrochemistry
: Madhava Nidana by Madhava
– Ayurvedic Diagnosis
• 14thCentury :Sarangadhara Samhita
– Pulse diagnosis
Disciplines of Ayurveda
Ashtanga Ayurveda
1. Internal Medicine
2. Surgery
3. ENT, Ophthalmology
4. OBG & Pediatrics
5. Toxicology
6. Psychiatry
: Kayachikitsa
: Shalyatantra
: Shalakyatantra
: Kaumarabhritya
: Agadatantra
: Bhutavidya
7. Anti-aging &rejuvenation : Rasayana
8. Reproductive & aphrodisiac medicine
: Vajikarana
Ayurveda in 20th Century
• Ayurveda flourished till 12thcentury, till the Muslim
invasion
Not much progress from 12th to 17thcentury•
• British invasion : 1833 virtually all Ayurveda
schools closed, opening of British medical schools
•
•
•
•
1920 : a national revival and resurgence of
interest in traditional Indian culture and practices
1946 : Formal Govt. recognition and reacceptance
of Ayurveda and resurgence of research.
Currently, however it holds a secondary place in
medicine in India
India Govt. officially recognizes as legitimate:
Allopathy, Homoeopathy, Naturopathy, Unani
Tibb, Ayurveda, and its cousins Siddha and Yoga.
Ayurvedic Approach of Health
and Disease
Promotion
of
Health
Prevention
of
Disease
Ayurveda
Science of Longevity
with quality of life
Holistic
management
of disease
Dosha - 3 (Vata, Pitta, Kapha)
Agni
Dhatu
Mala
- 13 (Metabolic fire)
- 7 (Body tissues)
- 3 (Waste products)
Indriya - 5 (Sensory motor organs)
Manas - 1 (Mind)
Atma - Soul
Components
of
Health
Definition of Health
Physical &
Physiological
Psychological
Spiritual
One whose doshas, agni, functions of doshas and malas are in
state of equilibrium, who has cheerful atman, mind, intellect
and sense organs is designated as healthy.
The Four Components of Life
Health according to Ayurveda is perfect
balance between
• Body : Sharir
• Senses : Indriya
• Mind : Sattva
• Spirit (Soul) : Atma
INDRIYA (Senses & Functions):
• Gyan-Indriya (Senses) : Sight, Hearing,
Smell, Touch & Taste
• Karm-Indriya (Voluntary functions) :
MANAS (Mind) : Supreme Indriya that
controls all Indriyas
• Has three abstract qualities – ‘Sattva’,
‘Rajas’ and ‘Tamas’.
ATMA (Soul/Self/Spirit) :
• Param Atma : Supreme, immortal pure
has only Sattva, free of happiness or
sorrow.
• Jiv Atma : resides in living body
attached to Rajas and Tamas, witness
every function & emotion throughout the
life.
AYURVEDA
TRIDOSHA THEORY- 3 DOSHAS
PANCHAMAHABHUTA THEORY- 5 elements
VATA PITTA
PRITHVI
Earth
JALA
Water
AGNI
Fire
VAYU
Air
AKASH
Space
EQUILIBRIUM
of 3 DOSHAS
DISEQUILIBRIUM
of 3 DOSHAS
HEALTH DISEASE
SOULKAPHA +
Effecting Human Physiology
Space :
• In the human body, many spaces are
aspects of the Space element.
• The spaces in the mouth, nose,
tract,gastrointestinal tract, respiratory
abdomen, thorax, capillaries, etc.
Air :
• All movements involve Air as an
element.
• The nature of the elements themselves
determine the nature of physiology.
• With the human body Air is present in
the pulsations of the heart, lungs etc.
• Fire : The source of Fire and light in the
solar system is the sun.
• In the human body, the source of Fire is
metabolism.
• Fire works in the digestive system as well
as in the gray matter of the brain, where
Fire manifests as intelligence. Fire also
activates the retina to perceive light.
• Therefore body temperature, digestion,
thinking etc are all the functions of the
Fire.
Water:
• It manifests in the body as the
secretions of digestive juices, in the
mucous membranes and in plasma and
cytoplasm.
• Water is vital for the functioning of all the
systems of the body.
• For example, dehydration resulting from
diarrhea and vomiting is due to water
element.
Earth :
• The fifth element, is also present in the
microcosm of the human being.
• Life is possible on this planet because
the Earth holds all living and non-living
substances to its solid surface.
Tridosha
Ayurveda is based on 3 energies.
Their balanced state is health and
imbalance disease.
• VATA – the kinetic energy, movement,
division, growth, etc.
• PITTA – the thermal energy, heat
generation, intellect,sight, etc.
• KAPHA – the potential energy
• Tridoshas are Vata, Pitta & Kapha
• Tridosha concept is applicable in living organisms
• Tridoshas are biological entities responsible for
structure, function and behaviour dimensions of
all living organisms
• Therefore human body mind constitution
(Prakriti), diseases, Medicines and Food all has
been categorized in Vata type, Pitta type and
Kapha type.
• But nothing is absolute pure; every thing is
permutation and combination of Tridoshas
Doshas Function
Most fundamental Principle
“Prakriti Purusha Samya”
Prakriti (Nature): Governed by
•
•
•
Air
Sun and
Water
Purusha (Living body):
Regulated by 3 vital entities: “Doshas” –
•
•
•
Vata,
Pitta and
Kapha
Mind Body SoulTrinity:
Personality in Ayurveda
Soul
Mind
Body
PURUSH CONSCIOUS
(Living)
PRAKRITI Non-living Matrix
GeneticConstitution of Body
“Prakriti Purusha Samya”
Concept of Prakriti
(Body Mind Constitution and Temperament)
• Concept of Prakriti (human constitution) is related to
physiological attributes to health and disease.
• Prakriti is determined by relative predominance of
dosha in intra-uterine life of a fetus.
•
•
Prakriti is unchangeable throughout the life span, but
One can take remedial measures in diet and
behavior suitable to his/her prakriti to maintain health
and prevention of disease.
Significance of Prakriti in Clinical
Medicine
• For Promotive & Preventive Health
–
–
■ Know your prakriti and diseases susceptibility
■ Prakriti will tell the risk factors, course of disease,
complications and prognosis
■ – Follow your diet, behaviour, profession and life
style suitable to your prakriti to lead a healthy life.
• Curative Health
–
–
–
Select the drugs and dose as per prakriti
Drug body interaction and reaction pattern depend upon
the prakriti of individual & drug
Associated complications of a disease, prognosis and
their treatment can be improved as per prakriti of
disease & individual
Concept of Sapta Dhatus
( 7 Body Tissues)
Body is made up of Seven Tissues and their
function is to maintain the body matrix
1. Rasa
(Plasma)
3. Mansa
(Muscles)
4. Medas
(Fats)
5. Asthi
(Bones)
6. Majja
(Bone marrow)
7. Shukra
(Reproductive
tissues)
2. Rakta
(Blood)
Ojas
(Responsible for Immunity)
Causes of diseases…
• Man made activities -
Prajnaparadha
• Environmental factors
• Genetic factors
Psychological factors….
Diagnosis in Ayurveda
The two main pillars on which the diagnosis
•
•
History of Illness:
Examination of the Patient:
• a) General Examination or Ashta Vidha Pariksha:
Examination of the pulse (Naadi Pariksha), Tongue,
Urine and stool examination, Speech, Examination
by palpation and percussion, Gait (bodily
movement), General appearance of the patient, and
Examination of the constitution (Prakriti).
• b) Systemic Examination: This consists of
examination of the different systems, Skin and Hair,
and Eyes .
The factors responsible for prevention of
illness and promotion of health
Day regimen (Dinacharya)
Night regimen (Ratricharya )
Seasonal regimen (Rutucharya)
Seasonal Purification (Rutu
anusara Shodhana)
Treatment in
Ayurveda
Basic treatment modalities
Pacification Treatment Purification Treatment
Pacifies doshas locally Removes doshas from body
Comparatively of temporary Effect lasts for long
action.
Done in minimal or moderate
dosha and of minimal or
moderate strength
Done in profound dosha and of
profound strength
Does not interfere much with
tissues (dhatus)
Normalizes tissue (dhatu)
functions
Management Principles
 Internal Purification
 External treatment
modalities
 Internal medicines
 Holistic treatment
DrugTherapy in Ayurveda
• DRUG (AUSHADHA)
"One which ensures alleviation the disease but
does not give rise to any other disorders”
• PLANT origin
• MINERAL origin
• ANIMAL origin
• Single or Compound formulations of
above
• Employed as per ‘Yukti’ (planning).
Rasayana
• Rejuvenation Therapy
• Delays Aging
• Provide Immunity
• Improve Memory and
sensory perception
Traditional way to be EVER
GREEN
Personal Health is a BALANCE
of -
• Good Food
• Good Regimen
• Good emotions
• Good Environment
Food inAyurveda
Quantity and Quality well defined….
Food Combinations are important
Natural food are highlighted…
Regimen and Ayurveda
• Exercise
• Sleep
• Sex
Seasonal Regimens
• Different Regimens in different seasons
• Improves immunity
• Fight against infectious diseases
• Prevents seasonal diseases
Social Health
• Healthy Societies….
• Pollution free air, water, land etc…..
• Good Health education
Caring the Nature
• Protection of Ecosystem
• Cultivation of medicinal plants
• Prevents massive exploitation of
natural resources
• Preventing pollution….
Benefits of Ayurveda
Physical Benefits
The basic constitution represents
the individual’s psychological and
physical nature, distinctly.
Non-invasive diagnostic Ayurvedic treatments are
beneficial for chronic diseases such as diabetes,
heart ailments and cancer.
Difficult diseases like asthma and tumor growths
(gulmas) are managed effectively.
A discerning diet according to one’s dosha type, and well
regulated life (dinacharya) helps strengthen one’s
natural immune system.
•Detoxification methods like Panchakarma and other herbal remedies
make the body more responsive to medicines and treatment.
•It hastens the healing process.
•Yogasanas achieve the twin purpose of strengthening body-parts such
as bone, muscle and vital organs like heart, liver, stomach, intestine as
well as
•Keeping out blood circulation and psychological conditions strong and
resilient.
Psychological Benefits:
It is said that the condition of body and mind are
integral to the overall health of an individual.
Ayurvedic massages, inhalation of herbal (Aromatherapy)
preparations, panchakarma (nasya) besides much-tested
yogasanas and meditation leave a calming effect on the
nerves.
Spiritual Benefits:
The treatment methods, diet and lifestyle regimen in
Ayurveda are meticulously planned to heal the body
as well enrich the mind
So that each can improve from their own levels to
the higher goal of realizing the full self-potential.
It was with Ayurveda that the unique longevity and
rejuvenating method of rasayana was born for
mankind to progress in the path of spirituality.
• Ayurveda is not only treatment, it is a way of life
• Has no side effects
• Gives happy, healthy disease free long life
• Makes you Tension Free
• Relaxes mind
• Provides knowledge about life
• Tells about good and bad dietary effects to life
• Tells the way for life goals, with keeping good
health status
Summary of Benefits of Ayurveda
AYURVEDIC FORMULATION:
CHURNA
Definition
General Method of
preparation
Characteristics and
preservation
Note
Examples
AYURVEDIC FORMULATION:
KWATH
Definition
Method of preparation
Characteristics and
preservation
Note
AYURVEDIC FORMULATION:
GUTIKA
Definition
Method of preparation
Characteristics and
preservation
Examples
AYURVEDIC FORMULATION:
AVALEHA
Definition
Method of preparation
Characteristics
Preservation and Storage
Examples
AYURVEDIC FORMULATION:
ASAVA,ARISTA
Definition
Method of preparation - Aristas
Method of preparation - Asavas
General Precautions
Characteristics
Preservation
Note
Examples
AYURVEDIC FORMULATION:
BHASMA
Definition
Method of preparation
Characteristics and
preservation
Examples
AYURVEDIC FORMULATION:
PISTI
Definition
Method of preparation
Characteristics and
preservation
Examples
AYURVEDIC FORMULATION:
TAILA
Definition
General Method of
preparation
Characteristics
Preservation
Method of use
Note
Examples
AYURVEDIC FORMULATION:
GHRITA
Definition
General method of
preparation
Characteristics
Preservation
Method of use
Note
Examples
EVALUATION OF
YURVEDIC FORMULATIONS
Macroscopic study
• Visual inspection provides the simplest and quickest
means by which to establish identity, purity and quality.
• Macroscopic identity of medicinal plant materials is
based on shape, size, colour, surface characteristics,
texture, fracture characteristics and appearance of the
cut surface.
Microscopic study
• Detail of cell structure and arrangement of the
cells useful for differentiating similar species.
• Select a representative sample of the material & If it is
dried parts of a plant than it may require softening before
preparation for microscopy, preferably by being placed in
a moist atmosphere, or by soaking in water.
• Any water-soluble contents can be removed from the cells
by soaking in water. Starch grains can be gelatinized by
heating in water.
• Histochemical detection
• Starch grains
• Aleurone grains
• Fats, fatty oils, volatile oils and resins
• Calcium oxalate/carbonate crystals
• Lignified cell wall
• Cellulose cell wall
• Mucilage
• Tannin
• Measurement of specimen
• Stomatal number
• Stomatal index
• Palisade ratio
• Vein-islet number
• Vein termination number
• Lycopodium spore method
Foreign organic matter
• Parts of the medicinal plant material or
materials other than those named with the
limits specified for the plant material
concerned;
• Any organism, part or product of an
organism, other than that named in the
specification and description of the plant
material concerned;
• Mineral admixtures that is adhering to the
medicinal plant materials, such as soil, stones,
sand, and dust.
Foreign matter: NMT 2%w/w
Ash value
• It involves non-volatile inorganic components.
• High ash value is the indicative of contamination, substitution,
adulteration or carelessness in preparing the crude drugs.
Total ash
• Total ash is designed to measure the total amount of material
produced after complete incineration of the drug material at as
low temperature as possible (about 450°C) to remove all the
carbons.
• Total ash usually consists of carbonates, phosphates, silicates
and silica.
• IP and USP: 675±25°C
• BP : 600±25°C
• WHO: 500-600°C
Acid insoluble ash
• Ash insoluble in HCl is the residue obtained after
extracting the total ash with HCl. It gives idea about the
earthy matter
•
•
•
•
IP method: 25mL 2M HCL solution
USP method: 25mL 3N HCL solution
BP method: 15mLwater and 10mLHCL
WHO method: 25 ml of hydrochloric acid (~70g/l)
Water soluble ash
• Total ash content which is soluble in water. It’s good
indicator of presence of previous extraction of water soluble
salts in the drug or incorrect preparation or amount of inorg.
matter
• Carbonated ash: Ash is treated with ammonium carbonate.
• Nitrated ash: Ash is treated with dilute nitric acid.
Extractive value
• Amount of the active constituents present in crude drug
material when extracted with specific solvent.
• There are following
Methods for determin-
-nation of Extractive
value.
a) Cold method
b) Hot method
c)Soxhlet method
• Volatile ether soluble
extractive value:
Anhydrous ether-
continuous extraction for
20hours
• Nonvolatile ether soluble
extractive value:
Drugs having lipid content,
fixed oils eg.Colocynth
fruits : NMT 3% (Pulp-
medicinal value)
• Water soluble extractive
value
• Alcohol soluble extractive
value: Solvent strength: 20-
95% v/v
• Solvent Hexane soluble
extractive value: Continuous
extraction for 20 hours
eg.Phyllanthus amarus: NLT
3%
Insoluble matter:
• Presence of woody matter or vegetable debris or pieces of
bark materials.
• Eg. In catechu
Water insoluble matter: NMT 33%
Alcohol insoluble matter: NMT 30%
Total solid content
• The residue obtained when prescribed amount of preparation
is dried to constant weight under the specified condition
(Residue on evaporation)
• Powdered extract: NLT 95%
• Semisolid extract: NLT 70%
Water Content
• Loss on drying (Gravimetric determination)
• Volumetric Azeotropic distillation (toluene distillation)
method
• Titrimetric Karl fisher method
• Gas chromatographic method
Volatile oil content
• Volatile oils are the liquid components of the plant cells,
immiscible with water, volatile at ordinary temperature and
can be steam distilled at ordinary pressure
• Many herbal drugs contain volatile oil which is used as
flavourig agent.
• E.g. Clove: NLT 15%v/w
Bitterness value
• Medicinal plant materials that have a strong bitter taste
("bitters") are employed therapeutically, mostly as appetizing
agents. Their bitterness stimulates secretions in the
gastrointestinal tract, especially of gastric juice.
• The bitter properties of plant material are determined by
comparing the threshold bitter concentration of an extract of
the materials with that of a dilute solution of quinine
hydrochloride.
• The bitterness value is expressed in units equivalent to the
bitterness of a solution containing 1g of quinine hydrochloride
R in 2000 ml.
• Bitterness value calculated in units per g using the
following formula:
Where,
a= the concentration of the stock test solution (ST) (mg/ml),
b = the volume of test solution ST(in ml) in the tube with the
threshold bitter concentration,
c = the volume of quinine hydrochloride R (in mg) in the tube
with the threshold bitter concentration.
Haemolytic activity
• Many medicinal plant materials, of the families
Caryophyllaceae, Araliaceae, Sapindaceae, Primulaceae,
and Dioscoreaceae contain saponins.
• The most characteristic property of saponins is their
ability to cause haemolysis; when added to a suspension
of blood, saponins produce changes in erythrocyte
membranes, causing haemoglobin to diffuse into the
surrounding medium.
• The haemolytic activity of plant materials, or a
preparation containing saponins, is determined by
comparison with that of a reference material, saponin R,
which has a haemolytic activity of 1000 units per g.
Serial dilution for the
preliminary test
• Calculate the haemolytic activity of the medicinal plant
material using the following formula:
1000 ×a/b
Where,
1000 = the defined haemolytic activity of saponin R in relation to ox
blood,
a = quantity of saponin R that produces total haemolysis (g)
b = quantity of plant material that produces total haemolysis (g)
Determination of tannins
• Tannins (or tanning substances) are substances capable of
turning animal hides into leather by binding proteins to
form water-insoluble substances that are resistant to
proteolytic enzymes.
• This process, when applied to living tissue, is known as an
"astringent" action and is the reason for the therapeutic
application of tannins.
• Chemically, tannins are complex substances; usually occur
as mixtures of polyphenols that are difficult to separate and
• Calculate the quantity of tannins as a percentage using the
following formula:
where w = the weight of the plant material in grams
T1= Weight of material extracted in water
T2= Weight of material not bound to hide powder
T0= Weight of hide powder material soluble in water
Determination of swelling
index
• The swelling index is the volume in ml taken up by the
swelling of 1 g of plant material under specified
conditions.
• Its determination is based on the addition of water or a
swelling agent as specified in the test procedure for each
individual plant material (either whole, cut or pulverized).
Determination of foaming
index
• Many medicinal plant materials contain saponins that can
cause a persistent foam when an aqueous decoction is shaken.
• The foaming ability of an aqueous decoction of plant materials
and their extracts is measured in terms of a foaming index.
Calculate the foaming index using the following formula:
foaming index =
where a = the volume in ml of the decoction used for
preparing the dilution in the tube where foaming to a
height of 1 cm is observed.
Determination of pesticide
residues
• Not more than 1%
• An ARL (in mg of pesticide per kg of plant material) can be
calculated on the basis of the maximum acceptable daily intake
of the pesticide for humans (ADI), as, recommended WHO,
and the mean daily intake (MDI) of the medicinal plant
material.
ADI = maximum acceptable daily intake of pesticide (mg/kg of body weight);
E = extraction factor, which determines the transition rate of the pesticide from
the plant material into the dosage form;
MDI = mean daily intake of medicinal plant product.
Some example of Pesticides :
• Chlorinated hydrocarbons and related pesticides: BHC, DDT
• Chlorinated phenoxyalkanoic acid herbicides: 2,4-D; 2,4,5-T
• Organophosphorus pesticides: malathion, methyl parathion, parathion
• Carbamate insecticides: carbaryl (carbaril)
• Dithiocarbamate fungicides: ferbam, maneb, nabam, thiram, zineb
• Inorganic pesticides: calcium arsenate, lead arsenate
• Miscellaneous: ethylene dibromide, ethylene oxide, methyl bromide
• Pesticides of plant origin: tobacco leaf and nicotine; pyrethrum flower,
pyrethrum extract and pyrethroids; derris root and rotenoids.
Determination of arsenic and
heavy metals
• Contamination of medicinal plant materials with arsenic
and heavy metals can be attributed to many causes
including environmental pollution and traces of pesticides.
• Limit test for arsenic
• Limit test for cadmium and lead
• The contents of lead and cadmium may be determined by
inverse voltametry or by atomic emission
spectrophotometry.
• The following maximum amounts in dried plant materials,
which are based on the ADI values, are proposed:
▫ lead, 10 mg/kg;
▫ cadmium, 0.3 mg/kg.
Determination
of microorganisms
Test strains and culture media for use in validating the
tests for specific microorganisms
-
Limits for microbial contaminants in finished products & Raw materials
Aflatoxins Content
• Aflatoxins are naturally occuring mycotoxins produced
mainly by Aspergillus flavus and Aspergillus parasiticus.
• The presence of aflatoxins can be determined by
chromatographic methods using standard aflatoxins B1,
B2, G1, G2 mixtures.
• IP method: NMT 2 µg/kg of aflatoxins B1& Total aflatoxins 4 µg/kg
• USP method: NMT 5ppb of aflatoxins B1& Total aflatoxins 20ppb
Radioactive contamination
• The range of radionuclides that may be released into the
environment as the result of a nuclear accident might include
long-lived and short-lived fission products, actinides, and
activation products.
• Microbial growth in herbals is usually avoided by irradiation.
This process may sterilize the plant material but the
radioactivity hazard should be taken into account.
• The nature and the intensity of radionuclides released may
differ markedly and depend on the source (reactor,
reprocessing plant, fuel fabrication plant, isotope production
unit, etc.).
• The radioactivity of the plant samples should be checked
accordingly to the guidelines of International Atomic
CHROMATOGRAPHY OF HERBAL DRUG
• Seperation, identification, impurity detection
and assay of herbal drug in the formulation or
in the extract are carried out by following
methods :-
a)TLC
b)HPTLC
c)HPLC/Densitometric chromatography
d)GLC
Evaluation of Ayurvedic
formulation: ASAVAS, ARISTA
1. Organoleptic Parameters
a) Colour of sample
b) Odour of sample
c) Taste of sample
d) Determination of pH of sample
2. Physical Parameters
a) Determination of foreign organic matter
b) Determination of ash value
 Total ash value
 Acid insoluble ash
 Water soluble ash
 Sulphated ash
c) Determination of extractive value
 Alcohol soluble extractive value
 Water soluble extractive value
d) Determination of moisture content
e) Determination of physical constant
 Melting point
 Boiling point
 Refractive index
 Optical rotation
f) Determination of specific gravity
g) Determination of solid content
h) Determination of alcohol content
3. Chemical tests
a) Alkaloids – Dragandroffs test
b) Glycosides – Molish test
c) Flavonoids – Shinoda test
d) Phenolic – Lead acetate test
e) Tannins – Ferric chloride test
f) Steroids – Salkowski reaction
g) Amino acids – Ninhydrine test
h) Carbohydrates – Fehling’s test, Benedict test
4. Toxicological parameters
a)Pesticides residue
b) Heavy metal
c) Microbial contamination
Evaluation of Ayurvedic
formulation:TAILA, GHRITA
 Colour
 Smell
 Appearance
 Touch Oily
 Clarity
 Specific gravity
 Acid value mg/gm
 Saponfication value
 Iodine value gm/100gm
Evaluation of Ayurvedic
formulation: BHASMA, PISTI
1. organoleptic characters
 Sound : The Bhasma should have
imperceptible sound
 on grinding the Bhasma between teeth.
 Colour : depends
 Touch - Soft ~ Imperceptible coarseness in the
Bhasma
 Taste - should be tasteless
 Odour -should be odourless
2. Physico-chemical parameters
 pH :
 Ash Value (AV):
 Acid Insoluble Ash (AIA) :
 Particle Size Distribution
 X-ray Diffraction
 Inductively Coupled Plasma – Emission Spectroscopy
 UV-Visible Spectrophotometry
Evaluation of Ayurvedic
formulation: CHURNA,
KWATH1 Study of organoleptic characters
 i. Colour
 ii. Odour
 iii. Taste
2 Determination of physico-chemical parameters
 Moister content, Total ash
 Acid insoluble ash, Water soluble ash
 Water soluble extractive, Alcohol soluble extractive
 Crude fiber contents
3 Quantitative estimation of selected phyto- constituents
 Total alkaloids
4 Evaluation of Churna
 Powder fineness
 Bulk density
 Tap density
 Angle of repose
 Compressibility
 Hausner ratio
5 Determination of Ph
6 Establishing the safety pertaining to Heavy metals &
Microbial load
Evaluation of Ayurvedic
formulation: GUTIKA
1. Organoleptic Parameters :
Colour
Odour
2. Physico-chemical Evaluation
Reducing sugar
Total sugar
3. Phytochemical assessment
4. Physical evaluation:
• Ash value
• Acid insoluble ash
• Water insoluble ash
• Alcohol soluble extractive
• pH
• Volatile oil
• Melting temperature
• Loss on drying
5. Pharmaceutical parameters
• Hardness
• Uniformity in weight
• Uniformity in diameter
• Friability test
• Dissolution time
• Disintegration time
Evaluation of Ayurvedic
formulation: AVALEHA
1. Organoleptic Evaluation
2. Physico-chemical Evaluation
• Reducing sugar
• Total sugar
3. Analytical Evaluation
• Chromatography
4. Biological Evaluation
• Test for heavy metals
• Microbial contamination
• Shelf life
5. Physical evaluation
• Loss on drying at 105°c
• Total ash
• Acid insoluble ash
• pH
• Specific gravity
• Total solid contents
• Fat contents
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Concept_of_Ayurveda_Ayurvedic_Formulations_and_their_Quality_Control

  • 1. CONCEPT OF AYURVEDA, AYURVEDIC FORMULATIONSAND THEIR QUALITY CONTROL DR. SIDDHI UPADHYAY H.O.D. & ASSOCIATE PROFESSOR Dept. of Pharmacognosy and Phytochemistry SIGMA INSTITUTE OF PHARMACY
  • 2. CONTENT ■ The holistic concept of Ayurvedic system of medicine. ■ A study on different types ofAyurvedic formulations like Churna, Kwath, Gutika,Taila,Ghrita,Avaleha,Asavas,Arista, Bhasma and Pisti. ■ Evaluation of Ayurvedic formulations
  • 3. THE HOLISTIC CONCEPT OF AYURVEDIC SYSTEMOF MEDICINE
  • 4. Ayu + Veda LIFE: The unified State of Body, Mind & Soul SCIENCE (Knowledge) Ayurveda = Science of Life
  • 5. What is Ayurveda? •Is a system of traditional medicine native to the Indian Subcontinent •Practiced in other parts of the world like USA, Europe, Australia, New Zealand, Singapore, Malaysia etc as a form of complementary and alternative medicine •Involves use of herbs, therapies and Yoga as exercise •Or applied on their own as a form of Complementary or Alternative (CAM) treatment
  • 6. Ayurveda – the Wisdom of Life • Offers a proven guide for a life of happiness, vitality, love and purpose. • Human beings are not viewed as mere thinking physical machines, but • Rather as fields of intelligence in dynamic exchange with the energy and information of the environment.
  • 7. Ayurveda – a holistic system • A Comprehensive System with equal emphasis on the body, mind and spirit • Strives to restore the innate harmony of the individual • It is not only about treating sickness but – preventing disease and enhancing health, longevity, vitality and happiness.
  • 8. Vedas • It is the bedrock upon which Ayurveda rests • Considered to be composed around 1500- 2000 BC • Four Vedas Rig-veda :contains hymns to be recited Sam-veda : collection of hymns to be sung Yajur-veda : entire sacrificial rite Athar-veda : contains information on health and sickness
  • 9. EarliestTexts • 760 BC • 660 BC : Charaka Samhita – herbal or plant based pharmacopoeia : Sushruta Samhita – Surgical approaches • 7thCentury : Ashtanga Sangraha of Vagbhata – summary of previous two • • AD 100 1331 : Nagarjuna – iatrochemistry : Madhava Nidana by Madhava – Ayurvedic Diagnosis • 14thCentury :Sarangadhara Samhita – Pulse diagnosis
  • 10. Disciplines of Ayurveda Ashtanga Ayurveda 1. Internal Medicine 2. Surgery 3. ENT, Ophthalmology 4. OBG & Pediatrics 5. Toxicology 6. Psychiatry : Kayachikitsa : Shalyatantra : Shalakyatantra : Kaumarabhritya : Agadatantra : Bhutavidya 7. Anti-aging &rejuvenation : Rasayana 8. Reproductive & aphrodisiac medicine : Vajikarana
  • 11. Ayurveda in 20th Century • Ayurveda flourished till 12thcentury, till the Muslim invasion Not much progress from 12th to 17thcentury• • British invasion : 1833 virtually all Ayurveda schools closed, opening of British medical schools • • • • 1920 : a national revival and resurgence of interest in traditional Indian culture and practices 1946 : Formal Govt. recognition and reacceptance of Ayurveda and resurgence of research. Currently, however it holds a secondary place in medicine in India India Govt. officially recognizes as legitimate: Allopathy, Homoeopathy, Naturopathy, Unani Tibb, Ayurveda, and its cousins Siddha and Yoga.
  • 12. Ayurvedic Approach of Health and Disease Promotion of Health Prevention of Disease Ayurveda Science of Longevity with quality of life Holistic management of disease
  • 13. Dosha - 3 (Vata, Pitta, Kapha) Agni Dhatu Mala - 13 (Metabolic fire) - 7 (Body tissues) - 3 (Waste products) Indriya - 5 (Sensory motor organs) Manas - 1 (Mind) Atma - Soul Components of Health Definition of Health Physical & Physiological Psychological Spiritual One whose doshas, agni, functions of doshas and malas are in state of equilibrium, who has cheerful atman, mind, intellect and sense organs is designated as healthy.
  • 14. The Four Components of Life Health according to Ayurveda is perfect balance between • Body : Sharir • Senses : Indriya • Mind : Sattva • Spirit (Soul) : Atma
  • 15. INDRIYA (Senses & Functions): • Gyan-Indriya (Senses) : Sight, Hearing, Smell, Touch & Taste • Karm-Indriya (Voluntary functions) : MANAS (Mind) : Supreme Indriya that controls all Indriyas • Has three abstract qualities – ‘Sattva’, ‘Rajas’ and ‘Tamas’.
  • 16. ATMA (Soul/Self/Spirit) : • Param Atma : Supreme, immortal pure has only Sattva, free of happiness or sorrow. • Jiv Atma : resides in living body attached to Rajas and Tamas, witness every function & emotion throughout the life.
  • 17. AYURVEDA TRIDOSHA THEORY- 3 DOSHAS PANCHAMAHABHUTA THEORY- 5 elements VATA PITTA PRITHVI Earth JALA Water AGNI Fire VAYU Air AKASH Space EQUILIBRIUM of 3 DOSHAS DISEQUILIBRIUM of 3 DOSHAS HEALTH DISEASE SOULKAPHA +
  • 18. Effecting Human Physiology Space : • In the human body, many spaces are aspects of the Space element. • The spaces in the mouth, nose, tract,gastrointestinal tract, respiratory abdomen, thorax, capillaries, etc.
  • 19. Air : • All movements involve Air as an element. • The nature of the elements themselves determine the nature of physiology. • With the human body Air is present in the pulsations of the heart, lungs etc.
  • 20. • Fire : The source of Fire and light in the solar system is the sun. • In the human body, the source of Fire is metabolism. • Fire works in the digestive system as well as in the gray matter of the brain, where Fire manifests as intelligence. Fire also activates the retina to perceive light. • Therefore body temperature, digestion, thinking etc are all the functions of the Fire.
  • 21. Water: • It manifests in the body as the secretions of digestive juices, in the mucous membranes and in plasma and cytoplasm. • Water is vital for the functioning of all the systems of the body. • For example, dehydration resulting from diarrhea and vomiting is due to water element.
  • 22. Earth : • The fifth element, is also present in the microcosm of the human being. • Life is possible on this planet because the Earth holds all living and non-living substances to its solid surface.
  • 23. Tridosha Ayurveda is based on 3 energies. Their balanced state is health and imbalance disease. • VATA – the kinetic energy, movement, division, growth, etc. • PITTA – the thermal energy, heat generation, intellect,sight, etc. • KAPHA – the potential energy
  • 24. • Tridoshas are Vata, Pitta & Kapha • Tridosha concept is applicable in living organisms • Tridoshas are biological entities responsible for structure, function and behaviour dimensions of all living organisms • Therefore human body mind constitution (Prakriti), diseases, Medicines and Food all has been categorized in Vata type, Pitta type and Kapha type. • But nothing is absolute pure; every thing is permutation and combination of Tridoshas
  • 26. Most fundamental Principle “Prakriti Purusha Samya” Prakriti (Nature): Governed by • • • Air Sun and Water Purusha (Living body): Regulated by 3 vital entities: “Doshas” – • • • Vata, Pitta and Kapha
  • 27. Mind Body SoulTrinity: Personality in Ayurveda Soul Mind Body PURUSH CONSCIOUS (Living) PRAKRITI Non-living Matrix
  • 29. Concept of Prakriti (Body Mind Constitution and Temperament) • Concept of Prakriti (human constitution) is related to physiological attributes to health and disease. • Prakriti is determined by relative predominance of dosha in intra-uterine life of a fetus. • • Prakriti is unchangeable throughout the life span, but One can take remedial measures in diet and behavior suitable to his/her prakriti to maintain health and prevention of disease.
  • 30. Significance of Prakriti in Clinical Medicine • For Promotive & Preventive Health – – ■ Know your prakriti and diseases susceptibility ■ Prakriti will tell the risk factors, course of disease, complications and prognosis ■ – Follow your diet, behaviour, profession and life style suitable to your prakriti to lead a healthy life. • Curative Health – – – Select the drugs and dose as per prakriti Drug body interaction and reaction pattern depend upon the prakriti of individual & drug Associated complications of a disease, prognosis and their treatment can be improved as per prakriti of disease & individual
  • 31. Concept of Sapta Dhatus ( 7 Body Tissues) Body is made up of Seven Tissues and their function is to maintain the body matrix 1. Rasa (Plasma) 3. Mansa (Muscles) 4. Medas (Fats) 5. Asthi (Bones) 6. Majja (Bone marrow) 7. Shukra (Reproductive tissues) 2. Rakta (Blood) Ojas (Responsible for Immunity)
  • 32. Causes of diseases… • Man made activities - Prajnaparadha • Environmental factors • Genetic factors Psychological factors….
  • 33. Diagnosis in Ayurveda The two main pillars on which the diagnosis • • History of Illness: Examination of the Patient: • a) General Examination or Ashta Vidha Pariksha: Examination of the pulse (Naadi Pariksha), Tongue, Urine and stool examination, Speech, Examination by palpation and percussion, Gait (bodily movement), General appearance of the patient, and Examination of the constitution (Prakriti). • b) Systemic Examination: This consists of examination of the different systems, Skin and Hair, and Eyes .
  • 34. The factors responsible for prevention of illness and promotion of health Day regimen (Dinacharya) Night regimen (Ratricharya ) Seasonal regimen (Rutucharya) Seasonal Purification (Rutu anusara Shodhana)
  • 36. Basic treatment modalities Pacification Treatment Purification Treatment Pacifies doshas locally Removes doshas from body Comparatively of temporary Effect lasts for long action. Done in minimal or moderate dosha and of minimal or moderate strength Done in profound dosha and of profound strength Does not interfere much with tissues (dhatus) Normalizes tissue (dhatu) functions
  • 37. Management Principles  Internal Purification  External treatment modalities  Internal medicines  Holistic treatment
  • 38. DrugTherapy in Ayurveda • DRUG (AUSHADHA) "One which ensures alleviation the disease but does not give rise to any other disorders” • PLANT origin • MINERAL origin • ANIMAL origin • Single or Compound formulations of above • Employed as per ‘Yukti’ (planning).
  • 39. Rasayana • Rejuvenation Therapy • Delays Aging • Provide Immunity • Improve Memory and sensory perception Traditional way to be EVER GREEN
  • 40. Personal Health is a BALANCE of - • Good Food • Good Regimen • Good emotions • Good Environment
  • 41. Food inAyurveda Quantity and Quality well defined…. Food Combinations are important Natural food are highlighted…
  • 42. Regimen and Ayurveda • Exercise • Sleep • Sex
  • 43. Seasonal Regimens • Different Regimens in different seasons • Improves immunity • Fight against infectious diseases • Prevents seasonal diseases
  • 44. Social Health • Healthy Societies…. • Pollution free air, water, land etc….. • Good Health education
  • 45. Caring the Nature • Protection of Ecosystem • Cultivation of medicinal plants • Prevents massive exploitation of natural resources • Preventing pollution….
  • 46. Benefits of Ayurveda Physical Benefits The basic constitution represents the individual’s psychological and physical nature, distinctly. Non-invasive diagnostic Ayurvedic treatments are beneficial for chronic diseases such as diabetes, heart ailments and cancer. Difficult diseases like asthma and tumor growths (gulmas) are managed effectively.
  • 47. A discerning diet according to one’s dosha type, and well regulated life (dinacharya) helps strengthen one’s natural immune system. •Detoxification methods like Panchakarma and other herbal remedies make the body more responsive to medicines and treatment. •It hastens the healing process. •Yogasanas achieve the twin purpose of strengthening body-parts such as bone, muscle and vital organs like heart, liver, stomach, intestine as well as •Keeping out blood circulation and psychological conditions strong and resilient.
  • 48. Psychological Benefits: It is said that the condition of body and mind are integral to the overall health of an individual. Ayurvedic massages, inhalation of herbal (Aromatherapy) preparations, panchakarma (nasya) besides much-tested yogasanas and meditation leave a calming effect on the nerves.
  • 49. Spiritual Benefits: The treatment methods, diet and lifestyle regimen in Ayurveda are meticulously planned to heal the body as well enrich the mind So that each can improve from their own levels to the higher goal of realizing the full self-potential. It was with Ayurveda that the unique longevity and rejuvenating method of rasayana was born for mankind to progress in the path of spirituality.
  • 50. • Ayurveda is not only treatment, it is a way of life • Has no side effects • Gives happy, healthy disease free long life • Makes you Tension Free • Relaxes mind • Provides knowledge about life • Tells about good and bad dietary effects to life • Tells the way for life goals, with keeping good health status Summary of Benefits of Ayurveda
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  • 121. Macroscopic study • Visual inspection provides the simplest and quickest means by which to establish identity, purity and quality. • Macroscopic identity of medicinal plant materials is based on shape, size, colour, surface characteristics, texture, fracture characteristics and appearance of the cut surface.
  • 122. Microscopic study • Detail of cell structure and arrangement of the cells useful for differentiating similar species. • Select a representative sample of the material & If it is dried parts of a plant than it may require softening before preparation for microscopy, preferably by being placed in a moist atmosphere, or by soaking in water. • Any water-soluble contents can be removed from the cells by soaking in water. Starch grains can be gelatinized by heating in water.
  • 123. • Histochemical detection • Starch grains • Aleurone grains • Fats, fatty oils, volatile oils and resins • Calcium oxalate/carbonate crystals • Lignified cell wall • Cellulose cell wall • Mucilage • Tannin
  • 124. • Measurement of specimen • Stomatal number • Stomatal index • Palisade ratio • Vein-islet number • Vein termination number • Lycopodium spore method
  • 125. Foreign organic matter • Parts of the medicinal plant material or materials other than those named with the limits specified for the plant material concerned; • Any organism, part or product of an organism, other than that named in the specification and description of the plant material concerned; • Mineral admixtures that is adhering to the medicinal plant materials, such as soil, stones, sand, and dust. Foreign matter: NMT 2%w/w
  • 126. Ash value • It involves non-volatile inorganic components. • High ash value is the indicative of contamination, substitution, adulteration or carelessness in preparing the crude drugs.
  • 127. Total ash • Total ash is designed to measure the total amount of material produced after complete incineration of the drug material at as low temperature as possible (about 450°C) to remove all the carbons. • Total ash usually consists of carbonates, phosphates, silicates and silica. • IP and USP: 675±25°C • BP : 600±25°C • WHO: 500-600°C
  • 128. Acid insoluble ash • Ash insoluble in HCl is the residue obtained after extracting the total ash with HCl. It gives idea about the earthy matter • • • • IP method: 25mL 2M HCL solution USP method: 25mL 3N HCL solution BP method: 15mLwater and 10mLHCL WHO method: 25 ml of hydrochloric acid (~70g/l)
  • 129. Water soluble ash • Total ash content which is soluble in water. It’s good indicator of presence of previous extraction of water soluble salts in the drug or incorrect preparation or amount of inorg. matter • Carbonated ash: Ash is treated with ammonium carbonate. • Nitrated ash: Ash is treated with dilute nitric acid.
  • 130. Extractive value • Amount of the active constituents present in crude drug material when extracted with specific solvent. • There are following Methods for determin- -nation of Extractive value. a) Cold method b) Hot method c)Soxhlet method
  • 131. • Volatile ether soluble extractive value: Anhydrous ether- continuous extraction for 20hours • Nonvolatile ether soluble extractive value: Drugs having lipid content, fixed oils eg.Colocynth fruits : NMT 3% (Pulp- medicinal value) • Water soluble extractive value • Alcohol soluble extractive value: Solvent strength: 20- 95% v/v • Solvent Hexane soluble extractive value: Continuous extraction for 20 hours eg.Phyllanthus amarus: NLT 3%
  • 132. Insoluble matter: • Presence of woody matter or vegetable debris or pieces of bark materials. • Eg. In catechu Water insoluble matter: NMT 33% Alcohol insoluble matter: NMT 30%
  • 133. Total solid content • The residue obtained when prescribed amount of preparation is dried to constant weight under the specified condition (Residue on evaporation) • Powdered extract: NLT 95% • Semisolid extract: NLT 70%
  • 134. Water Content • Loss on drying (Gravimetric determination) • Volumetric Azeotropic distillation (toluene distillation) method • Titrimetric Karl fisher method • Gas chromatographic method
  • 135. Volatile oil content • Volatile oils are the liquid components of the plant cells, immiscible with water, volatile at ordinary temperature and can be steam distilled at ordinary pressure • Many herbal drugs contain volatile oil which is used as flavourig agent. • E.g. Clove: NLT 15%v/w
  • 136. Bitterness value • Medicinal plant materials that have a strong bitter taste ("bitters") are employed therapeutically, mostly as appetizing agents. Their bitterness stimulates secretions in the gastrointestinal tract, especially of gastric juice. • The bitter properties of plant material are determined by comparing the threshold bitter concentration of an extract of the materials with that of a dilute solution of quinine hydrochloride. • The bitterness value is expressed in units equivalent to the bitterness of a solution containing 1g of quinine hydrochloride R in 2000 ml.
  • 137. • Bitterness value calculated in units per g using the following formula: Where, a= the concentration of the stock test solution (ST) (mg/ml), b = the volume of test solution ST(in ml) in the tube with the threshold bitter concentration, c = the volume of quinine hydrochloride R (in mg) in the tube with the threshold bitter concentration.
  • 138. Haemolytic activity • Many medicinal plant materials, of the families Caryophyllaceae, Araliaceae, Sapindaceae, Primulaceae, and Dioscoreaceae contain saponins. • The most characteristic property of saponins is their ability to cause haemolysis; when added to a suspension of blood, saponins produce changes in erythrocyte membranes, causing haemoglobin to diffuse into the surrounding medium. • The haemolytic activity of plant materials, or a preparation containing saponins, is determined by comparison with that of a reference material, saponin R, which has a haemolytic activity of 1000 units per g.
  • 139. Serial dilution for the preliminary test
  • 140. • Calculate the haemolytic activity of the medicinal plant material using the following formula: 1000 ×a/b Where, 1000 = the defined haemolytic activity of saponin R in relation to ox blood, a = quantity of saponin R that produces total haemolysis (g) b = quantity of plant material that produces total haemolysis (g)
  • 141. Determination of tannins • Tannins (or tanning substances) are substances capable of turning animal hides into leather by binding proteins to form water-insoluble substances that are resistant to proteolytic enzymes. • This process, when applied to living tissue, is known as an "astringent" action and is the reason for the therapeutic application of tannins. • Chemically, tannins are complex substances; usually occur as mixtures of polyphenols that are difficult to separate and
  • 142. • Calculate the quantity of tannins as a percentage using the following formula: where w = the weight of the plant material in grams T1= Weight of material extracted in water T2= Weight of material not bound to hide powder T0= Weight of hide powder material soluble in water
  • 143. Determination of swelling index • The swelling index is the volume in ml taken up by the swelling of 1 g of plant material under specified conditions. • Its determination is based on the addition of water or a swelling agent as specified in the test procedure for each individual plant material (either whole, cut or pulverized).
  • 144. Determination of foaming index • Many medicinal plant materials contain saponins that can cause a persistent foam when an aqueous decoction is shaken. • The foaming ability of an aqueous decoction of plant materials and their extracts is measured in terms of a foaming index. Calculate the foaming index using the following formula: foaming index = where a = the volume in ml of the decoction used for preparing the dilution in the tube where foaming to a height of 1 cm is observed.
  • 145. Determination of pesticide residues • Not more than 1% • An ARL (in mg of pesticide per kg of plant material) can be calculated on the basis of the maximum acceptable daily intake of the pesticide for humans (ADI), as, recommended WHO, and the mean daily intake (MDI) of the medicinal plant material. ADI = maximum acceptable daily intake of pesticide (mg/kg of body weight); E = extraction factor, which determines the transition rate of the pesticide from the plant material into the dosage form; MDI = mean daily intake of medicinal plant product.
  • 146. Some example of Pesticides : • Chlorinated hydrocarbons and related pesticides: BHC, DDT • Chlorinated phenoxyalkanoic acid herbicides: 2,4-D; 2,4,5-T • Organophosphorus pesticides: malathion, methyl parathion, parathion • Carbamate insecticides: carbaryl (carbaril) • Dithiocarbamate fungicides: ferbam, maneb, nabam, thiram, zineb • Inorganic pesticides: calcium arsenate, lead arsenate • Miscellaneous: ethylene dibromide, ethylene oxide, methyl bromide • Pesticides of plant origin: tobacco leaf and nicotine; pyrethrum flower, pyrethrum extract and pyrethroids; derris root and rotenoids.
  • 147. Determination of arsenic and heavy metals • Contamination of medicinal plant materials with arsenic and heavy metals can be attributed to many causes including environmental pollution and traces of pesticides. • Limit test for arsenic • Limit test for cadmium and lead • The contents of lead and cadmium may be determined by inverse voltametry or by atomic emission spectrophotometry. • The following maximum amounts in dried plant materials, which are based on the ADI values, are proposed: ▫ lead, 10 mg/kg; ▫ cadmium, 0.3 mg/kg.
  • 148. Determination of microorganisms Test strains and culture media for use in validating the tests for specific microorganisms -
  • 149. Limits for microbial contaminants in finished products & Raw materials
  • 150. Aflatoxins Content • Aflatoxins are naturally occuring mycotoxins produced mainly by Aspergillus flavus and Aspergillus parasiticus. • The presence of aflatoxins can be determined by chromatographic methods using standard aflatoxins B1, B2, G1, G2 mixtures. • IP method: NMT 2 µg/kg of aflatoxins B1& Total aflatoxins 4 µg/kg • USP method: NMT 5ppb of aflatoxins B1& Total aflatoxins 20ppb
  • 151. Radioactive contamination • The range of radionuclides that may be released into the environment as the result of a nuclear accident might include long-lived and short-lived fission products, actinides, and activation products. • Microbial growth in herbals is usually avoided by irradiation. This process may sterilize the plant material but the radioactivity hazard should be taken into account. • The nature and the intensity of radionuclides released may differ markedly and depend on the source (reactor, reprocessing plant, fuel fabrication plant, isotope production unit, etc.). • The radioactivity of the plant samples should be checked accordingly to the guidelines of International Atomic
  • 152. CHROMATOGRAPHY OF HERBAL DRUG • Seperation, identification, impurity detection and assay of herbal drug in the formulation or in the extract are carried out by following methods :- a)TLC b)HPTLC c)HPLC/Densitometric chromatography d)GLC
  • 153. Evaluation of Ayurvedic formulation: ASAVAS, ARISTA 1. Organoleptic Parameters a) Colour of sample b) Odour of sample c) Taste of sample d) Determination of pH of sample
  • 154. 2. Physical Parameters a) Determination of foreign organic matter b) Determination of ash value  Total ash value  Acid insoluble ash  Water soluble ash  Sulphated ash c) Determination of extractive value  Alcohol soluble extractive value  Water soluble extractive value d) Determination of moisture content e) Determination of physical constant  Melting point  Boiling point  Refractive index  Optical rotation f) Determination of specific gravity g) Determination of solid content h) Determination of alcohol content
  • 155. 3. Chemical tests a) Alkaloids – Dragandroffs test b) Glycosides – Molish test c) Flavonoids – Shinoda test d) Phenolic – Lead acetate test e) Tannins – Ferric chloride test f) Steroids – Salkowski reaction g) Amino acids – Ninhydrine test h) Carbohydrates – Fehling’s test, Benedict test 4. Toxicological parameters a)Pesticides residue b) Heavy metal c) Microbial contamination
  • 156. Evaluation of Ayurvedic formulation:TAILA, GHRITA  Colour  Smell  Appearance  Touch Oily  Clarity  Specific gravity  Acid value mg/gm  Saponfication value  Iodine value gm/100gm
  • 157. Evaluation of Ayurvedic formulation: BHASMA, PISTI 1. organoleptic characters  Sound : The Bhasma should have imperceptible sound  on grinding the Bhasma between teeth.  Colour : depends  Touch - Soft ~ Imperceptible coarseness in the Bhasma  Taste - should be tasteless  Odour -should be odourless
  • 158. 2. Physico-chemical parameters  pH :  Ash Value (AV):  Acid Insoluble Ash (AIA) :  Particle Size Distribution  X-ray Diffraction  Inductively Coupled Plasma – Emission Spectroscopy  UV-Visible Spectrophotometry
  • 159. Evaluation of Ayurvedic formulation: CHURNA, KWATH1 Study of organoleptic characters  i. Colour  ii. Odour  iii. Taste 2 Determination of physico-chemical parameters  Moister content, Total ash  Acid insoluble ash, Water soluble ash  Water soluble extractive, Alcohol soluble extractive  Crude fiber contents
  • 160. 3 Quantitative estimation of selected phyto- constituents  Total alkaloids 4 Evaluation of Churna  Powder fineness  Bulk density  Tap density  Angle of repose  Compressibility  Hausner ratio 5 Determination of Ph 6 Establishing the safety pertaining to Heavy metals & Microbial load
  • 161. Evaluation of Ayurvedic formulation: GUTIKA 1. Organoleptic Parameters : Colour Odour 2. Physico-chemical Evaluation Reducing sugar Total sugar 3. Phytochemical assessment
  • 162. 4. Physical evaluation: • Ash value • Acid insoluble ash • Water insoluble ash • Alcohol soluble extractive • pH • Volatile oil • Melting temperature • Loss on drying
  • 163. 5. Pharmaceutical parameters • Hardness • Uniformity in weight • Uniformity in diameter • Friability test • Dissolution time • Disintegration time
  • 164. Evaluation of Ayurvedic formulation: AVALEHA 1. Organoleptic Evaluation 2. Physico-chemical Evaluation • Reducing sugar • Total sugar 3. Analytical Evaluation • Chromatography 4. Biological Evaluation • Test for heavy metals • Microbial contamination • Shelf life
  • 165. 5. Physical evaluation • Loss on drying at 105°c • Total ash • Acid insoluble ash • pH • Specific gravity • Total solid contents • Fat contents