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ISSN: 2229-3701
_________________________________________Research Article
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ISSN: 2229-3701
Need of Standardization
The quality control of herbal crude drug &
formulation is important in justifying their
acceptability in modern system of medicines.
Standardization of synthetic drugs offers no
problem with very well defined parameters of
analysis. It is not uncommon to have as many as
five or more different herbal ingredients in one
single formulation. The batch to batch variation
starts from the collection of the raw materials itself
in absence of any reference standard for
identification.
WHO has emphasized the need to ensure quality
control of medicinal plants products by using
modern techniques and by applying suitable
standards and parameters.10-13
Standardized products and services are valuable
User 'confidence builders' being perceived as
safe
healthy
secure
high quality
flexible
Standardization brings important benefits to
business including a solid foundation upon which
to develop new technologies and an opportunity to
share and enhance existing practices.
Standardization also plays a pivotal role in assisting
Governments, Administrations, Regulators and the
legal profession as legislation, regulation and
policy initiatives are all supported by
standardization.
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735
Sample name
Ashwagandha churna
Biological name
Withania somnifera
Family
Solanaceae
Vernacular name
In English
In Hindi
In Bengali
In Malayalam
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
15,16
Evaluation
of
of Ashwagandha
PLAN OF WORK
Comparative standardisation of Ashwagandha
churna formulated by Dabour pharma. & Dhaka
ausadhalaya was planned to carry out development
of quality standards for the finished marketed
formulation.The method used for the comparative
standardization was planned to be carried out as
follows:
DEVELOPMENT OF STANDARDIZATION
PARAMETERS
FOR
ASHWAGANDHA
CHURNA
1 Study of organoleptic characters
i.
Colour
ii.
Odour
iii.
Taste
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a)
Compressibility index
it is the propensity of the powder to be
compressed.
Based on the apparent bulk density and tapped
density the percentage compressibility of the
powder can be determined using the following
formula.
Compressibility index=[(v0-vf)/v0] x 100,
Or
% compressibility=[(tapped density bulk
density)]/ tapped density] x 100
b)
Hausner ratio
it indicates the flow properties of the powder. The
ratio of tapped density to the bulk density of the
powder is called Hausner ratio.
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FLOW PROPERTIES
1
2
3
4
5
6
7
Excellent
Good
Fair
Possible
Poor
Very Poor
Very very
poor
ANGLE OF
REPOSE
25-30
31-35
36-40
41-45
45-46
55-56
>66
5 Determination of PH range
The powder sample of ashwagandha churna was
weighed to about 5g and immersed in 100 ml of
water in a beaker. The beaker was closed with
aluminum foil and left behind for 24 hour s in room
temperature. Later the supernatant solution was
decanted into another beaker and the pH of the
formulation was determined using a calibrated pH
meter.
6 TLC17
1.4 gm of sample was taken in 40 ml rectified spirit
(90%)
2.Shaking it for 18 hrs & boiled for 10 mins &
filtered.
COMPRESSIBILITY
INDEX (%)
<10
11-15
16-20
21-25
26-31
32-37
>38
HAUSNER
RATIO
1.00-1.11
1.12-1.18
1.19-1.25
1.26-1.34
1.35-1.45
1.46-1.59
>1.6
Observation
White ppt of cadmium hydroxide soluble in excess NH4 OH
White ppt of cadmium ferrocyanide.
Result
P/0 cadmium
P/0 cadmium
For Bismuth
Experiment
H2 S gass added in the sample solution
NH4 OH
Observation
Dark brown ppt soluble in hot dil. HNO3 but insoluble in NH4 S
white ppt insoluble in excess NH4 OH dissolved in dil. Hcl.
Result
p/o bismuth
p/o bismuth
For Lead
Experiment
Dil Hcl added in sample solution.
KI is added in sample solution.
Observation
of CaCl2 soluble in boiled
water & conc. Hcl.
Yellow ppt soluble in boiling water.
White ppt
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Result
p/o lead
p/o lead
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Yellowish white
Characteristics
Slightly bitter
SAMPLE
Ashwagandha Churna of Dhaka Ausadhalaya
Color
Odor
Test
Pale brown
Characteristics
Slightly bitter
% of ash values
Type of ash
(S.E.M)
1.
Total ash
4.7 % 0.115
2.
1.4 % 0.17
SAMPLE
Ashwagandha Churna of Dhaka Ausadhalaya
Serial no
Type of
% of ash values
ash
(S.E.M)
1.
Total ash
3.5% 0.115
2.
1.5 % 0.12
DISCUSSIONS
The total ash value is an indicative of total amount
of inorganic material after complete incineration
and the acid insoluble ash value is an indicative of
silicate impurities, which might have arisen due to
improper washing of drug. The loss on drying
value obtained is an indicative of amount of
moisture content present in the drug. The extractive
values names water soluble and alcohol soluble
indicates the amount of active constituent in given
amount of plant material when extracted with
respective solvent, values obtained supports the
fact that drug is unexhausted which is contrary to
lower extractive value.
3 Qualitative Analysis
S.No.
1
2
3
4
5
% Loss on drying
7.20% 0.115
% Loss on drying
13.6% 0.115
Extractive Values
Sample
Ashwagandha Churna of Dabour
S.No.
1
2
NAME OF THE
SOLVENT
WATER
ALCOHOL
EXTRACTIVE
VALUE(% w/w)
1.6% 0.115
0.6% 0.12
S.No.
1
S.No.
1
EXTRACTIVE
VALUE(% w/w)
2.4% 0.115
1.4% 0.12
Determination of Physical
Characteristics of Powder
Bulk Density & Tap Density
Sample
Ashwagandha Churna of Dabour
S.No.
BULLK DENSITY
(S.E.M)
0.45 0.011
TAP DDENSITY
(S.E.M)
0.52 0.0115
Sample
Ashwagandha Churna of Dhaka
AUSADHALAYA
SAMPLE
Ashwagandha Churna of Dhaka Ausadhalaya
NAME OF THE
SOLVENT
WATER
ALCOHOL
Sample
Ashwagandha Churna of Dhaka Ausadhalaya
S.No.
1
2
Alcohol Extract
++
4 Quantitative Estimation
Sample
Ashwagandha OF Dhaka Ausadhalaya
S.No.
Chemical Constituents
Alkaloids
Glycoside
Tannin
Saponin
Phyto sterol
DISCUSSIONS
The results of phytochemical tests were given in
the above table.
++ this indicates the presence of more amounts
of compounds.
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S.No.
1
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BULLK
DENSITY
(S.E.M)
0.35 0.01
TAP DDENSITY
(S.E.M)
0.44 0.01
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CARRS INDEX
HAUSNER RATIO
(S.E.M)
(S.E.M)
13.6 0.11
1.15 0.01
SAMPLE
Ashwagandha Churna of Both Dabour & Dhaka
Ausadhalaya.
For cadmium
Sample
Ashwagandha Churna of Dhaka
Ausadhalaya
CARRS INDEX
S.No.
1
HAUSNER RATIO
(S.E.M)
(S.E.M)
19.5 0.11
1.24 0.01
Angle of repose
Sample
Ashwagandha churna of dabour
S.No.
1
ANGLE OF REPOSE
34 1.15
SAMPLE
Ashwagandha Churna of Dhaka Ausadhalaya
S.No.
ANGLE OF REPOSE
38 1.15
DISCUSSIONS
From the all above values, it can be concluded that
the quality of ashwagandha churna of dabour is
GOOD & the quality of ashwagandha churna of
Dhaka Ausadhalaya is FAIR.
5
Determination of P H Sample
Ashwagandha Churna of Dabour
H
S.No
1
P (IN 1%)
8.4
P (IN 10%)
5.76
Sample
Ashwagandha Churna of Dhaka
Ausadhalaya
PH (IN 1%)
7.36
S.No.
1
PH (IN 10%)
6.40
CRUDE FIBER
(S.E.M)
3.8 0.115
SAMPLE
Ashwagandha Churna of Dhaka
Ausadhalaya
S.No.
1
Experiment
NH4 OH added in the
sample solution.
Potassium ferrocyanide
added.
Observation
White ppt is
absent.
White ppt is
absent.
Result
Absence
cadmium
Absence
cadmium
of
of
For bismuth
Experiment
H2S gas added in the
sample solution
NH4 OH
Observation
Dark brown ppt is
absent.
White
ppt
is
absent.
Result
Absence
bismuth
Absence
bismuth
of
of
For lead
Experiment
Observation
Result
Absence of
lead
Absence of
lead
DISCUSSION
From the heavy metal test it is concluded that both
the ashwagandha churna of dabour & dhaka
Ausadhalaya are free from heavy metals.
TLC VALUES
SAMPLE
Ashwagandha Churna of Dabour
Ashwagandha Churna of Dhaka
Ausadhalaya
DISCUSSION
The TLC profile of both the formulation showed a
bright fluorescence at 366 nm and their Rf values
were found to be 0.78 & 0.89 respectively .
CONCLUSION
From
the
present
investigation
various
standardization
parameters
such
as
physicochemical standards like total ash, acid
insoluble ash, water & alcohol soluble extractive
values, loss on drying, phyto-chemical analysis,
flow properties, TLC profile and safety evaluation
were carried out, it can be concluded that the
formulation of Ashwagandha churna contains all
good characters of an ideal churna and it was found
to be harmless, more effective, and economic. The
comparison between the two marketed samples
have been done on the basis of the above
mentioned parameters which shows satisfactory
results, but the efficacy of the products can only be
judged by doing the pharmacology of which is
suggested as future scope of R & D. The study
shows that the contents of formulation presents
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11
12
ACKNOWLEDGEMENT
Authors are very much grateful to BCDA College
of Pharmacy & Technology for providing
necessary facilities for completion of the research
work.
13
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