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8575-Article Text-15226-1-10-20210704
8575-Article Text-15226-1-10-20210704
15251 - 15261
Received 25 April 2021; Accepted 08 May 2021.
ABSTRACT
The herbal preparations standardization method is an important part to obtain the quality and
efficacy of the product that considered as the rate-limiting step of the Ayurvedic formulations.
The method comprehensively provides the data for the concentrations used in the formulation. In
this research standardization of sudnasak churna, a polyherbal medicine was done and their anti-
inflammatory action was determined. The preparation was done as per the formulary of
ayurvedic polyherbal in India. The organoleptic properties, physical properties, and
physiological characters were used for the standardization of marketed and in-house ayurvedic
medicinal preparations. The accurate and exact parameters were used to evaluate the churna
property and compare it with the reference standards for control and quality assurance in the
pharmaceutical labs.
Keywords: Physico-chemical, Polyherbal Formulation, Standardization, anti-inflammatory.
INTRODUCTION
The herbal drug standardization method is quite deep and wide. There is so much to study and
several contradictory theories were subjected to herbal medicines and their relation with human
physiology and mental function. [1]The research aims to standardize the herbal formulations and
nutraceuticals for deep knowledge of main herbs present in India and majorly use in the
Ayurvedic formulations for important work. In India herbs used are in a wide range for
medicinal purpose and their formulations are very important. India comes as a wider country for
playing an important role in producing and standardizing the therapeutic effects in the ayurvedic
formulations. India is exploring more in the field of herbal medicinal plants and this can be
achieved only by evaluation and analysis of herbal products by using a modern procedure of
standardization. [2]
WHO also mentioned the importance of medicinal plants in the field of public health care that
directly helps in the nation's development and origin of the guidelines for supporting the state
members for formulating national policies in the traditional medicine field for studying the
potential uses including evaluation, safety, and efficacy. [3]
The present work concerns the latest guidelines mentioned below including Good Manufacturing
Practices (GMP) for preparing the Ayurvedic formulations. Standardization guidelines need to be
followed for herbal formulations explained by international bodies such as the WHO European
Agency for the evaluation of Medicinal Products (EMEA) and the United States Pharmacopeia
(USP) have also been considered. [4]
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Annals of R.S.C.B., ISSN:1583-6258, Vol. 25, Issue 6, 2021, Pages. 15251 - 15261
Received 25 April 2021; Accepted 08 May 2021.
Biuret`s Test:
Copper sulfate solution was added to the polyherbalchurna and then the addition of sodium
hydroxide solution appearance of violet color precipitates confirms the protein in it.
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Annals of R.S.C.B., ISSN:1583-6258, Vol. 25, Issue 6, 2021, Pages. 15251 - 15261
Received 25 April 2021; Accepted 08 May 2021.
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Annals of R.S.C.B., ISSN:1583-6258, Vol. 25, Issue 6, 2021, Pages. 15251 - 15261
Received 25 April 2021; Accepted 08 May 2021.
around 25 ml of the filtrate to dryness in a tarred flat bottom shallow flask that was previously
dried at 1050C and weighed. The water-soluble extract value was calculated by taking the air-
dried drug as a reference. [13]
ii) Determination of Ethanol-soluble Extractive:
Air-dried plant material (around 5 gm) was macerated with the ethanol (100 ml) in a closed flask
and frequent shaking was done initially (up to 6 hr) then allow to stand for the next 18 hours
separately. Further filtration was done rapidly to prevent ethanol loss and evaporation done for
around 25 ml of the filtrate to dryness in a tarred flat bottom shallow flask that was previously
dried at 1050C and weighed. Ethanol soluble extractive value was calculated taking the air-dried
drug as reference. [14]
iii) Determination of Chloroform-solubleExtractive:
Air-dried plant material (around 5 gm) was macerated with the chloroform (100 ml) in a closed
flask and frequent shaking was done initially ( up to 6 hr) then allow to stand for the next 18
hours separately. Further filtration was done rapidly to prevent chloroform loss and evaporation
done for around 25 ml of the filtrate to dryness in a tarred flat bottom shallow flask that was
previously dried at 1050C and weighed. Chloroform soluble extractive value was calculated
taking the air-dried drug as reference. [15]
iv) Determination of Pet ether-soluble Extractive:
Air-dried plant material (around 5 gm) was macerated with the Pet ether (100 ml) in a closed
flask and frequent shaking was done initially ( up to 6 hr) then allow to stand for the next 18
hours separately. Further filtration was done rapidly to prevent Pet ether loss and evaporation
done for around 25 ml of the filtrate to dryness in a tarred flat bottom shallow flask that was
previously dried at 1050C and weighed. pet ether soluble extractive value was calculated taking
the air-dried drug as reference. [16]
v) Determination of Total Ash:
Dried powder of around 2-3 g was weighed accurately in tarred platinum or silica dish that was
earlier ignited and weighted. Scattering of powder drug on the dish bottom and incineration was
done by gradually increasing the heat that might not exceeds the dull red heat until free from the
carbon cooling down the ash and weighing was done. If carbon-free ash is not obtained via using
this method, exhaust the charred mass along with hot water and collection of the residue on the
ashless filter paper incinerates the residue and filter paper addition of filtrate and evaporation to
the dryness and ignition at low temperature. Calculation of % ash was done by taking air-dried
drugs as a reference. [17]
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Annals of R.S.C.B., ISSN:1583-6258, Vol. 25, Issue 6, 2021, Pages. 15251 - 15261
Received 25 April 2021; Accepted 08 May 2021.
25 ml of water was boiled with ash for 5 minute and collection of insoluble matter in a sintered
glass crucible or the ashless filter washing was done with the hot water and then ignition for 15
minutes at a temperature not rising more than 450 °c and subtraction of the weight of the residue
in mg from the weight of total ash. The content was calculated with reference to the air-dried
drug in mg/g. [18]
viii) Determination of pH:
pH was determined by using polyherbal solution (1%) in distilled water and by using a systronic
digital pH meter [19].
ix) Fluorescence analysis:
1mg of polyherbalchurna was taken for fluorescence analysis on the glass slide and treating the
churna with numerous samples such as FeCl3, Conc.HCl, HNO3, K2Cr2O7, NaOH, AgNO3,
Conc.H2SO4,Conc. HNO3, Br2 water, 5% H2O2, CCl4, Methanol, CH3COOH, Xylene, NH3,
I2 for determining the fluorescence character presence under the ultra-violet lamp. [20]
x) Determination of viscosity, surface tension and density:
Density, surface tension and viscosity were determined by using the aqueous solution (1%) of
polyherbalchurna. [21]
xi) Determination of Viscosity:
Ostwardvisometer was used for determining the viscosity of polyherbal formulation (1%).The
determination done for required time needed to the liquid flows due to gravity between the two
marks via vertically capillary tube. Viscosity calculated by comparing with the time of flow of
liquid (known viscosity, i.e. water). The viscosity of the sample liquid η1 is calculated with the
help of below mentioned equation [21]
P1 t1 × η2
η1 =
P2 t2
P1 = unknown liquid denesity
t1 = time of the flow ( unknown liquid)
P2= density (known liquid (density of water =0.9971g/ml))
t2= time of the flow (known liquid)
η2 = viscosity (known liquid (water =0.8937cps))
w3-w1
ʆL =
w2-w1
where,
ʆL = density of unknown liquid
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Annals of R.S.C.B., ISSN:1583-6258, Vol. 25, Issue 6, 2021, Pages. 15251 - 15261
Received 25 April 2021; Accepted 08 May 2021.
where :
ηH2O = drops of water (Average number)
dL1 = unknown liquid density
γH2O = Water Surface tension
ηL1 = unknown liquid (average number)
dH2O = Water density
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Annals of R.S.C.B., ISSN:1583-6258, Vol. 25, Issue 6, 2021, Pages. 15251 - 15261
Received 25 April 2021; Accepted 08 May 2021.
This is the propensity of the powder to be compressed depending upon the apparent bulk density
and tapped density. % compressibility of the powder is calculated by using the below formula.
[20]
Compressibility index/ Carr’s index = [(V0-Vf)/V0] × 100
Or
% Compressibility/ Carr’s Index = [(Tapped density – Bulk density)]/ Tapped
density] × 100
F) Hausner’s Ratio
For determining flow properties of powder Hausner’s ratio is used. Hausner’s ratio is the ratio of
tapped density to the bulk density of powder. [20]
Hausner’s ratio= Tapped density/bulk density
G) Angle of Repose
H) The angle of repose is defined as the angle between the powder pile surface and the
powder horizontal surface. The powder passes via a funnel and is fixed to the burette at a
height of 4 cm. The graph paper is placed below the funnel of the table and the height and
radius of the pile were measured. The calculation done by using below mentioned
formula. [20]
Angle of repose= tan-1(h/r)
I) Where,
J) h=height of the pile
K) r = radius of the pile.
RESULTS& DISCUSSION:
The polyherbal formulations were prepared as per the Indian Ayurvedic Formulary.[3]The
qualitative test was performed for polyherbal formulation for identification of class of
components such as Carbohydrates, Proteins, Alkaloids, Glycosides, Tannins, Saponins and
Flavanoids and results shown in Table 2. Organoleptic properties of polyherbal formulations are
shown in Table 3. Water soluble, alcohol-soluble extractive values,and ash values (total ash, acid
insoluble ashand water soluble ash) in Table 4. Samples ash value was carried out using the
procedure mentioned in WHO guidelines for plant materials. [4] pH values from 1% W/V
solution revealed that polyherbalformulation is nearly neutral (6.70). In Tables 5 the flourescent
analyses have been presented. The density, viscosity and surface tension of the polyherbal
formulation are shown in Table 6. The physical characteristics like bulk density, tapped density,
Carr’s index, Hausner ratio and angle of repose are shown in Table 7.
The Pharmacognostic properties estabilished for raw materials of polyherbal preparations could
be employed as QC, Standards for identifying and used in the routine analysis. Purity and
potency of raw materials and formulations follows the method for performing QC/QA laboratory
of pharmaceutical house.
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Annals of R.S.C.B., ISSN:1583-6258, Vol. 25, Issue 6, 2021, Pages. 15251 - 15261
Received 25 April 2021; Accepted 08 May 2021.
S. No. Parameter %
1. Watersolubleextractivew/w 43%
2. Alcoholsolubleextractivew/w 28%
3. Chloroformsolubleextractivew/w 16%
4. Petethersolubleextractivevalue w/w 3%
5. Ashcontentw/w 51.39%
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Annals of R.S.C.B., ISSN:1583-6258, Vol. 25, Issue 6, 2021, Pages. 15251 - 15261
Received 25 April 2021; Accepted 08 May 2021.
Determination of pH:
pH was evaluated by usingthepolyherbal solution (1%) in the distilled water and pH is
determined by using Systronic Digital pH meter that is 6.70
1. Density(1%) 0.94
2. Viscosity(1%) 1.123cps
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Annals of R.S.C.B., ISSN:1583-6258, Vol. 25, Issue 6, 2021, Pages. 15251 - 15261
Received 25 April 2021; Accepted 08 May 2021.
CONCLUSION
The numerous studies such as morphology, pharmacognostic, phytochemical and physio-
chemical studies of the sample were doneBy the above studies we can conclude that the
parameters defined for the standardization of powder formulations (Sudnasakchurna) are
efficient enough to consider for quality control department for ensuring the consistency of the
finished product from batch to batch is maintained.
Literature review concluded that all plants of polyherbalSudnasakchurna formulation exhibited
anti-inflammatory activities. So it was concluded that polyherbalchurna formulationshows strong
effect against anxiety and anxiety relatedbehavior.
More studies need to be done for finding of pharmacological and chemical characters finding to
know the accurate mechanism of action of the formulation for isolating the active principles
responsible for this type of actions.
ACKNOWLEDGEMENT:
My heartfelt thanks to Dr. kshitij Aggarwal and Dr. Arvind Kumar for funding myresearch
project and utilization for different instrumentsand equipment in Department of Pharmacognosy
andDepartment of Pharmacology, college of Pharmacy, SD College of Pharmacy and Vocational
studies Muzaffarnagar U.P.
REFERENCES
1. Meena, A. K., Mangal, A. K., Rao, M. M., Panda, P., Simha, G. V., Shakya, S. K., &Babu,
R. (2011). Evaluation of standardization parameters for SitopaladiChurna an Ayurvedic
formulation. Alcohol, 16, 4.
2. Sriwastava, N. K., Shreedhara, C. S., & Ram, H. A. (2010). Standardization of
Ajmodadichurna, a polyherbal formulation. Pharmacognosy research, 2(2), 98.
3. OrganisationMondiale De La Sante, Quality control methods for medicinal plant materials,
559, rev. 1. Original English, World Health Organisation; 1992. p. 159
4. Choudhary, N., &Sekhon, B. S. (2011). An overview of advances in the standardization of
herbal drugs. Journal of Pharmaceutical Education and Research, 2(2), 55.
5. Sahoo, N., Manchikanti, P., &Dey, S. (2010). Herbal drugs: standards and
regulation. Fitoterapia, 81(6), 462-471.
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Annals of R.S.C.B., ISSN:1583-6258, Vol. 25, Issue 6, 2021, Pages. 15251 - 15261
Received 25 April 2021; Accepted 08 May 2021.
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