PHYTOCHEMICALS SCREENING AND PHARMACOLOGICAL ANALGESIC AND ANTIPYRETICEVALUATIONOFFICUSRACEMOSALINN.LEAVESEXTRACTS

Abstract

ABSTARCT The present invention provides a method for the phytochemical and pharmacological evaluation of Ficus racemosa L. leaves extracts for analgesic and antipyretic applications. Ficus racemosa L. leaves were extracted using a Soxhlet apparatus with petroleum ether and chloroform solvents in increasing polarity. The resulting petroleum ether extract (PEE) and chloroform extract (CE) yielded 7.63% and 8.02%, respectively. Qualitative phytochemical analysis confirmed the presence of alkaloids, saponins, carbohydrates, and terpenoids in the extracts. Quantitative analysis revealed that PEE contained saponins (6.53±0.53 mg/100 g), carbohydrates (7.48±0.23 mg/100 g), and terpenoids (12.96±0.58 mg/100 g), while CE contained alkaloids (5.63±0.56 mg/100 g). High-performance thin-layer chromatography (HPTLC) fingerprint analysis at 366 nm revealed 13 peaks for PEE and 10 peaks for CE, indicating unique phytochemical profiles. In vivo oral toxicity studies (OECD 420) showed no signs of toxicity in experimental animals. Pharmacological evaluation demonstrated significant analgesic and antipyretic effects of Ficus racemosa L. extracts, with PEE (400 mg/kg) showing the most potent response. This invention presents a natural, safe alternative for pain and fever management.

Specification

Description:FIELD OFINVENTION
The present invention relates to the field of pharmaceutical science and phytochemistry.
Specifically, the disclosure provides Phytochemicals Screening and Pharmacological
analgesic and antipyretic evaluation of Ficus racemosa Linn. Leaves Extracts
BACKGROUND
Pain and fever are prevalent symptoms associated with a wide range of diseases and
inflammatory conditions. Traditionally, synthetic drugs like non-steroidal anti-inflammatory
drugs (NSAIDs) are prescribed to manage these symptoms. However, prolonged use of
these drugs often leads to adverse effects, including gastrointestinal irritation, cardiovascular
risks, and renal complications. Consequently, there is an increasing interest in natural
alternatives, particularly from medicinal plants, that may offer analgesic and antipyretic
effects with potentially lower risks of side effects.
Ficus racemosa Linn., commonly known as the cluster fig, is a plant widely distributed in
tropical regions, particularly in Asia. Known for its use in traditional medicine, various parts
of this plant, such as the bark, fruits, and roots, have been historically used to treat
conditions like diarrhea, diabetes, and inflammatory ailments. Preliminary studies have
suggested that Ficus racemosa leaves may contain bioactive phytochemicals with potential
therapeutic benefits. However, the pharmacological effects of the leaf extracts, particularly
concerning analgesic and antipyretic properties, remain underexplored.
The following active chemical constituents have been reported inFicus racemosa and
their structures are shown in Table 1.
Table 1 Important Phytoconstituents of Ficus racemosa L.
Phytoconstituents
Structure
2
3
ß-Sitosterol
Stigmasterol
Lanosterol
4
Tiglicacid
Gallicacid
Campesterol
Euphol
Phytochemical screening of plant extracts provides valuable insights into their medicinal
potential. Phytochemicals such as flavonoids, alkaloids, tannins, and saponins are known to
exert biological activities, including anti-inflammatory, analgesic, and antipyretic effects.
Despite the promising traditional usage of Ficus racemosa, there is a lack of systematic
research on the presence of specific phytochemicals in the leaf extracts and their correlation
with analgesic and antipyretic activities.
US20060189512A1 relates to compositions which contain therapeutically effective amounts
of phlorizin extract for effecting modification of blood glucose and insulin, for facilitating
weight loss, preventing weight gain and for providing beneficial effects in the aging process.
Methods of treating animals with phlorizin extract compositions to treat the aforementioned
conditions of the body are also disclosed.
CA3054270A1 relates to Herbo-mineral formulation for prevention, treatment and
management of Diabetes and method of preparing the same. The disclosed herbo-mineral
formulation includes herb and mineral elements which facilitate in treating Diabetes and
Diabetes associated complications. Further the disclosed formulation has been observed to
exhibit hypoglycemic, hypolipidemic, and pancreatic cell regenerative properties.
This invention seeks to address this gap by identifying and evaluating the phytochemical
constituents of Ficus racemosa leaves and examining their analgesic and antipyretic
properties through in vitro and in vivo methods. By providing a natural alternative with
clinically relevant efficacy, this invention aims to contribute to the field of pain and fever
management with the development of safer, plant-based pharmacological agents
SUMMARY
This summary is provided to introduce a selection of concepts in a simplified format that is
further described in the detailed description of the invention. This summary is neither
intended to identify key or essential inventive concepts of the invention and nor is it
intended for determining the scope of the invention.
A variety of organic compounds known as "secondary metabolites" or "natural products"
are present in plants. From old age, human beings rely on natural flora for their healthy life.
5
Flora is the main source of biologically active compounds. Now a days, plants are
considered as very important natural source according to phytopharmacologists for
discovering new pharmaceutical products having therapeutic benefits with no side effects.
Number of Herbal drugs are known to treat various ailments.
In present investigation, objective of the study was to extract the Ficus racemosa L.
leaves and evaluate its phytochemical and pharmacological parameters. The ailments which
were covered are pain and pyrexia.
Pain is a multidimensional experience that is essential for the maintenance and
preservation of an individual. It warns of the danger of bodily harm and alerts to trauma and
injury. Pain is a specific enteroceptive sensation; it can be perceived as arising from a
particular portion of the body, its temporal properties can be detailed, it can be differentiated
qualitatively (for example, as stinging, pricking, burning, throbbing, dull or aching), and it
involves dedicated subsets of peripheral and central neurons. The experience of pain has a
distinctly unpleasant character, that is, an affective or motivational aspect that can be
distinguished from its discriminative sensory aspects and from the long-term emotional
experience of 'suffering'.
Fever is a common medical symptom associated primarily with elevation of body
temperature and is often accompanied by certain sickness-related behavioural features such
as sleepiness, lethargy, hyper-algesia, anorexia, etc. In other words we can say that pyrexia
or fever is caused as a secondary impact of infection, malignancy or other diseased states.
Several synthetic drugs are available to cure these diseases but these drugs also have
serious side effects. To overcome this difficulty researcher have surveyed flora literature.
After a detailed survey researcher have decided to use Ficus racemosaL. leaves to
scientifically prove the usefulness of leaves of "gular fig" to cure these ailments with no side
effects.
Dried leaves were crushed using mixer grinder avoiding elevation of temperature
above 40°C. Powdered leaves were weighed and kept in air tight container for further use.
Powdered leaves were extracted using solvents: Petroleum ether, chloroform using soxhelet
apparatus andsuccessive extraction method. Extracts were dried using vaccum-dryer.
Extracts obtained were subjected to preliminary phytochemical tests. Qualitative
6
phytochemical tests confirmed the presence of alkaloids, saponins, carbohydrates and
terpenoids in Ficus racemosa L. leaves extracts.
Quantitative estimation of phytochemicals revealed the presence of saponins,
carbohydrates and terpenoids in some amount in PEE. Alkaloids was found to be present in
CEof Ficus racemosa L. leaves.
The HPTLC fingerprint study of PEE and CE of Ficus racemosa L. leaves showed
13 peaks and 10 peaks at 366 nm respectively.
Both the extracts were subjected to acute oral toxicity studies. OECD guideline No.
420 (Annexure 2d) method of CPCSEA was adopted for toxicity studies. The extracts were
administered in doses of 5, 50, 300 and 2000 mg/kg p.o. to different groups of rats each
containing 6 animals and after 24 h, mortality was not observed. The extracts of Ficus
racemosa L. leaves were devoid of mortality of animals at dose of 2000 mg/kg in male
albino swiss rats by p.o. route and hence >2000 mg/kg was taken as LD50 cut off value and
1/10th of the same i.e. 200 mg/kgwas selected for screening dose for further studies.
These findings suggested that oral administration of Ficus racemosa L.leaves
extracts produced no toxic effects in the test animals. All these findings of the present study
could stand as an assurance for the safe medicinal use of this plant as a pharmacological
agent.
PEE and CE were subjected to analgesic activity. Two methods were used: Hot Plate
method and Tail immersion method.
By Hot Plate method, it was concluded that PEE (400 mg/kg) showed most potent
analgesic activity. The reaction time (in sec) after 120 min was maximum in group of rats
treated with PEE (400 mg/kg). There was no significant difference between reaction time of
group of rats treated with PEE (400 mg/kg) and group of rats treated with standard drug
aspirin (100 mg/kg).
Similar results were obtained by tail immersion method, PEE (400 mg/kg) was found
to be the most potent one.
PEE and CE were subjected to antipyretic activity. Brewer's yeast pyrexia model
was used to scientifically prove the usefulness of both the extracts of Ficus racemosa L.
leaves in comparison to control.
PEE and CE at the dose of 200 mg/kg and 400 mg/kg body weight significantly
attenuated hyperthermia in rats in 1 h observation (??< 0.005) and lowering of temperature
7
was even more significant (??< 0.001) from 2 h to 4 h observation period in comparison to
control. Among them, PEE (400 mg/ kg) was the most potent one. Standard drug
paracetamol also significantly inhibited pyrexia (??< 0.05 and ??< 0.001) in early and later
hours of observationtime intervals. The different treatment extracts of Ficus racemosa
L.leavesand paracetamol lowered the rectal temperature in timedependent manner. There
was no significant difference between PEE (400 mg/kg b.w) and Paracetamol in inhibiting
pyrexia.
To further clarify the advantages and features of the present invention, a more particular
description of the invention will be rendered by reference to specific embodiments thereof,
which is illustrated in the appended figures. It is appreciated that this figure depicts only
typical embodiments of the invention and are therefore not to be considered limiting of its
scope. The invention will be described and explained with additional specificity and detail
with the accompanying figure.
OBJECTSOFTHEINVENTION
The present invention has been developed in response to the present state of the art, and in
particular, in response to the problems and needs in the art that have not yet been fully
solved by currently available techniques and processes.
Accordingly, the present invention has been developed to provide a cost-effective method of
quantifying organic carbon in soil.
Therefore, the current invention successfully overcoming all of the above-discussed
shortcomings present in the art.
1. It is an object of the invention to develop a process for obtaining an analgesic and
antipyretic composition from Ficus racemosa L. leaves through solvent extraction,
utilizing a Soxhlet apparatus with solvents in increasing order of polarity,
specifically petroleum ether and chloroform, to obtain petroleum ether extract (PEE)
and chloroform extract (CE) with % yields of 7.63% and 8.02%, respectively.
2. It is another object of the invention to subject Ficus racemosa L. leaves extracts to
qualitative phytochemical screening to confirm the presence of bioactive compounds
8
including alkaloids, saponins, carbohydrates, and terpenoids, which are expected to
contribute to the analgesic and antipyretic properties of the composition.
3. It is an object of the invention to quantify specific phytochemicals in the petroleum
ether extract (PEE) to verify the presence of saponins, carbohydrates, and terpenoids
in amounts of approximately 6.53±0.53 mg/100 g, 7.48±0.23 mg/100 g, and
12.96±0.58 mg/100 g, respectively, thus enabling consistency in composition and
efficacy.
4. It is an object of the invention to quantify the alkaloid content in the chloroform
extract (CE) at approximately 5.63±0.56 mg/100 g, supporting the pharmacological
potency of the extract in the analgesic and antipyretic formulation.
5. It is an object of the invention to create a natural analgesic and antipyretic
composition comprising PEE and CE of Ficus racemosa L. leaves that demonstrates
significant efficacy in reducing pain and fever at an optimal dosage of approximately
400 mg/kg, providing a natural alternative to synthetic analgesic and antipyretic
drugs.
6. It is an object of the invention to establish the petroleum ether extract (PEE) as a
particularly potent analgesic and antipyretic agent at a dosage of 400 mg/kg,
outperforming control groups in efficacy as validated by in vivo pharmacological
studies.
7. It is an object of the invention to develop a method for producing an HPTLC (High
Performance Thin Layer Chromatography) fingerprint of Ficus racemosa L. leaf
extracts, specifically PEE and CE, which exhibits 13 peaks and 10 peaks,
respectively, at 366 nm, providing a unique phytochemical profile for authentication
and quality control.
8. It is an object of the invention to confirm the safety of the developed composition for
human use by conducting in vivo oral toxicity studies in compliance with OECD
9
guidelines 420, ensuring no observed toxicity at therapeutic dosages in experimental
animals.
9. It is an object of the invention to offer a natural, effective, and safe alternative for
managing pain and fever in patients, thereby addressing the demand for herbal-based
analgesic and antipyretic treatments with fewer side effects compared to synthetic
drugs.
How the foregoing objects are achieved will be clear from the following brief
description. In this context, it is clarified that the description provided is non-limiting
and is only by way of explanation. Other objects and advantages of the invention will
become apparent as the foregoing description proceeds, taken together with the
accompanying drawings and the appended claims.
BRIEF DESCRIPTIONOFFIGURES
These and other features, aspects, and advantages of the present invention will become
better understood when the following detailed description is read with reference to the
accompanying figures in which like characters represent like parts throughout the
figures, wherein:
Figure 1, illustrates a view of a TLC images of PEE and CE at 366 nm for the present
invention.
Figure 2, illustrates a view of a HPTLC Chromatogram of PEE at 366 nm for the present
invention.
Figure 3, illustrates a view of analgesic effect of PEE, CE by Hot Plate method for the
present invention.
Figure 4, illustrates a view of Analgesic effect of PEE, CE by Tail Immersion method
for the present invention.
Figure 5, illustrates a view of a HPTLC Chromatogram of CE at 366 nm for the present
invention.
10
Further, skilled artisans will appreciate that elements in the figures are illustrated for
simplicity and may not have been necessarily been drawn to scale. For example, the
flowcharts illustrate the method in terms of the most prominent steps involved to help to
improve understanding of aspects of the present invention. Furthermore, in terms of the
construction of the device, one or more components of the device may have been
represented in the figures by conventional symbols, and the figures may show only those
specific details that are pertinent to understanding the embodiments of the present
invention so as not to obscure the figures with details that will be readily apparent to
those of ordinary skill in the art having benefit of the description herein.
DETAILEDDESCRIPTION:
For the purpose of promoting an understanding of the principles of the invention,
reference will now be made to the embodiment illustrated in the figures and specific
language will be used to describe the same. It will nevertheless be understood that no
limitation of the scope of the invention is thereby intended, such alterations and further
modifications in the illustrated system, and such further applications of the principles of
the invention as illustrated therein being contemplated as would normally occur to one
skilled in the art to which the invention relates.
It will be understood by those skilled in the art that the foregoing general description and
the following detailed description are exemplary and explanatory of the invention and
are not intended to be restrictive thereof.
Reference throughout this specification to "an aspect", "another aspect" or similar
language means that a particular feature, structure, or characteristic described in
connection with the embodiment is included in at least one embodiment of the present
invention. Thus, appearances of the phrase "in an embodiment", "in another
embodiment" and similar language throughout this specification may, but do not
necessarily, all refer to the same embodiment.
The terms "comprises", "comprising", or any other variations thereof, are intended to
cover a non-exclusive inclusion, such that a process or method that comprises a list of
11
steps does not include only those steps but may include other steps not expressly listed
or inherent to such process or method. Similarly, one or more devices or systems or
elements or structures or components proceeded by "comprises... a" does not, without
more constraints, preclude the existence of other devices or other systems or other
elements or other structures or other components or additional devices or additional
systems or additional elements or additional structures or additional components.
Unless otherwise defined, all technical and scientific terms used herein have the same
meaning as commonly understood by one of ordinary skill in the art to which this
invention belongs. The system, methods, and examples provided herein are illustrative
only and not intended to be limiting.
The terms "a" and "an" herein do not denote a limitation of quantity, but rather denote the
presence of at least one of the referenced items.
The terms "having", "comprising", "including", and variations thereof signify the presence
of a component.
Now the present invention will be described below in detail with reference to the following
embodiment.
Example 1: The leaves of plant Ficus racemosa were powdered. Drug was successively
extracted separately beginning with non-polar and gradually proceeding to polar solvents.
Extraction done by successive hot continuous extraction (soxhlet apparatus) by using
solvents: Petroleum ether and chloroform respectively. The powdered drug was extracted by
the Soxhlet apparatus with successively different solvents, in increasing order of polarity.
Each extract was concentrated by distilling off the solvent and then evaporating the solvent
to dryness in a vacuum dryer. The extract obtained with the solvent was weighed. Its
percentage yield was calculated in terms of the air-dried weight of the plant material.
12
Example-2
PEE and CE were subjected to preliminary phytochemical screening with an aim to
access the presence of various phytoconstituents including alkaloids, glycosides,
terpenoids, volatile oils Presence of alkaloids was confirmed by dragendorff's test,
mayer'stest, hager'stest and wagner's test. Presence of carbohydrates were confirmed by
some basic chemical tests which included molisch's test, fehling's test, benedict's test,
barfoed's test. For Saponins, frothing test and haemolytic tests were conducted. Standard
tests for terpenoids were performed (Table 2).
Table 2: Qualitative phytochemical screening of Ficus racemosa L. leaves extract
Secondary
Metabolites
Petroleum Ether Extract
(PEE)
Chloroform Extract
(CE)
13
Alkaloids
Glycosides
Flavonoids
Saponins
Amino acids
Proteins
Carbohydrates
Phenolic compounds
Proteins
Terpenoids
Tannins
Example-3--
+--
+--
+
+----------
Quantitative determination of secondary metabolites concludes that terpenoids were present
in major amount and alkaloids were present in minimum amount in Ficus racemosa Linn.
Leaves (Table 3).
Table 3: Total extraction yield and Quantitative phytochemical estimation of Ficus
racemosa L. leaves.
Extracts Extraction
Yield (%)
PEE
Alkaloids
(mg/100 g)
Saponins
(mg/100 g)
Carbohydrates
(mg/100 g)
7.63- 6.53±0.53 7.48±0.23
CE
8.02
Terpenoids
(mg/100 g)
12.96±0.58
5.63±0.56--
Example-4
The solvent system developed was Chloroform: Methanol (3:5)for PEE. The HPTLC
fingerprint study of PEE of Ficus racemosaL. leaves showed 13 peaks at 366 nm (Figure
3.6.). The photo documentation of PEE was done and the TLC images captured at 366 nm
isshown in Figure 3.5. The Rf value, height, area of peak, area % formed of PEE is given in
Table 4.
Table 4: HPLTC Finger Print Profile of Petroleum ether Extract of Ficus racemosa L. at
366 nm
14
15
Peak Start
Position
Start
Height
Max
Position
Max
Height
End
Position
EndHeight Area Area%
1 0.01Rf 3.7 0.00Rf 739.7 0.05Rf 12.9 17812.2 29.64
2 0.10Rf 83.0 0.12Rf 162.2 0.15Rf 49.5 5098.9 8.48
3 0.21Rf 50.7 0.23Rf 62.2 0.25Rf 50.9 2259.8 3.76
4 0.26Rf 48.2 0.30Rf 54.7 0.33Rf 36.4 1829.2 3.04
5 0.33Rf 40.9 0.36Rf 58.3 0.41Rf 44.9 3429.1 5.71
6 0.41Rf 44.8 0.43Rf 60.7 0.43Rf 57.4 953.2 1.59
7 0.45Rf 56.9 0.48Rf 96.4 0.52Rf 51.4 5121.2 8.52
8 0.53Rf 51.4 0.56Rf 195.2 0.61Rf 49.8 8632.9 14.37
9 0.61Rf 49.4 0.64Rf 99.6 0.66Rf 33.5 3393.7 5.65
10 0.66Rf 83.9 0.69Rf 209.2 0.72Rf 49.1 7112.2 11.83
11 0.72Rf 49.2 0.73Rf 51.4 0.78Rf 21.3 1917.9 3.19
12 0.78Rf 20.4 0.80Rf 37.9 0.82Rf 24.7 904.5 1.51
13 0.82Rf 25.6 0.84Rf 51.9 0.88Rf 2.7 1630.5 2.71
Example-5
AnalgesicActivity
Malealbinoswissratswereusedtoevaluateanalgesiceffect.Atotalofsixgroupswere
madefordividinganimals.Firstgroupreceivedvehicle,next twogroupsi.esecondand
thirdreceivedPEE(200&400mg/kg), fourthandfifthgroupreceivedCE(200&400
mg/kg).ThesixthgroupreceivedtheAspirinasstandarddrug.
HotPlateMethod
Therats (n=6)wereplacedinEddy'shotplatekept at a temperatureof55±0.5°C.A
cutofftimeof30swasfixedtoavoiddamagetothepaw.Reactiontimeofresponsewas
recordedusingastopwatch.Controlanimalsweretreatedwithvehicle(10%Tween80,
oral)andtestgroupswerepretreatedwith200and400mg/kgofPEEandCEonceaday
for 5 consecutive days. Aspirin (100mg/kg, p.o.)was administered as a standard.
Experimentswereperformed1hafterlastdoseoftestorstandarddrug(Table5).
Table5:AnalgesiceffectofPEE,CEbyHotPlatemethod
16
Drug Dose Reactiontimeafteradministration(s)
0min 30min 60min 90min 120min
Control 10
mL/k
g
3.640±0.000 3.785±0.003 4.035±0.004 4.052±0.011 4.081±0.002
Standar
d
100
mg/kg
6.605±0.002 10.117±0.006 12.122±0.007 20.150±0.004 21.172±0.005
PEE 200
mg/kg
5.077±0.002**
*
8.140±0.009*** 10.115±0.008**
*
15.163±0.005**
*
18.092±0.019**
*
PEE 400
mg/kg
6.1334±0.008
***
10.315±0.008**
*
12.152±0.003**
*
20.160±0.011**
*
21.112±0.004**
*
CE 200
mg/kg
5.150±0.000**
*
8.212±0.010*** 10.105±0.003**
*
13.153±0.002**
*
17.153±0.002**
*
CE 400
mg/kg
5.000±0.000**
*
8.588±0.011*** 10.873±0.006**
*
13.553±0.007**
*
17.571±0.003**
*
TailImmersionMethod
Thetailwithdrawal responsewasdeterminedbyimmersingthelower3.5cmof the
animals tail into a cup freshly filledwithwater froma large bath at a constant
temperature of 50 °Cuntil the typical responsewas observed. A25 s cutoffwas
imposedtoavoidtaildamagebyheat.Acontrolgroupreceivedvehicle(10%Tween
80,oral)andPEE(200and400mg/kgp.o.)wasgiventoGroupII,IIIandCE(200and
400 mg/kg p.o.) was given to Group IV,Vwhile the aspirin 100 mg/kg; p.o.
administeredtoGroupVI.Analgesicactivitywasmeasuredat0,30,60,90,120min
afteradministrationofPEE,CE,Tween80,Aspirin(Table6).
Table6:AnalgesiceffectofPEE,CEbyTailImmersionmethod
Drug Dose Reactiontimeafteradministration(s)
0min 30min 60min 90min 120min
Control 10
mL/k
g
3.641±0.005 3.796±0.004 4.048±0.004 4.069±0.011 4.080±0.002
Standar
d
100
mg/kg
6.610±0.003 10.121±0.002 12.126±0.004 20.153±0.006 21.152±0.006
PEE 200
mg/kg
5.075±0.001**
*
8.146±0.010*** 10.118±0.007**
*
15.164±0.006**
*
18.090±0.020**
*
PEE 400
mg/kg
6.131±0.007
***
10.328±0.009**
*
12.159±0.002**
*
20.169±0.013**
*
21.119±0.005**
*
CE 200
mg/kg
CE 400
mg/kg
Example-6
5.156±0.001**
*
5.005±0.001**
*
Antipyretic Activity
8.216±0.011***
8.596±0.012***
10.109±0.001**
*
10.871±0.004**
*
13.158±0.005**
*
13.559±0.004**
*
17.159±0.001**
*
17.562±0.002**
*
Male albino swiss rats were used to evaluate antipyretic effect. A total of six groups
weremade for dividing animals. First group received vehicle, next two groups i.e. second
and third received PEE (200 & 400 mg/kg), fourth and fifth group received CE (200 &
400 mg/kg). The sixth group received the Paracetamol as standard drug.
Brewer's yeast induced pyrexia model
The antipyretic activity was evaluated with fever induced by Brewer's yeast
following the established method in rats with some modifications. At 0 h, the basal
rectal temperature of each rat was recorded using clinical digital thermometer. Pyrexia
was induced by subcutaneous injection of 20% w/v suspension of Brewer's yeast in
distilled water at a dose of 10 mL/kg body weight. After 18 h of Brewer's yeast
injection the rise in rectal temperature was recorded and only animals showing an
increase in temperature of at least 0.6 0C (or 10F) were selected for the study. The
animals were randomly divided into six groups, each group containing six rats. Group I
received 10% Tween-80 in normal saline orally. Group II was given standard drug
paracetamol at the dose of 100 mg/kg per orally. Groups III and IV received PEE at oral
dose of 200 mg/kg and 400 mg/kg. Groups V and VI received CE at dose of 200 mg/kg
and 400mg/kg orally. After the treatment, the temperature of all the rats in each group
was recorded at 0 h, 1 h, 2 h, 3 h, and 4 h (Table 7).
Table 7: Antipyretic effect of PEE and CE of Ficus racemosa L. leaves with brewer's yeast
induced pyrexia in rats.
Treatm
ent
Dose Basal
Temperature
°F
Rectal Temperature
0 h
( af
ter
18
1 h 2h 3h 4h
17
18
Control 10
mL/k
g
98.94
h)
10
0.8
2±
0.4
12
100.75±0.
465
100.62±0.
319
100.61±0.
275
100.60±0.
207
Standar
d
100
mg/kg
98.61 10
0.5
8±
0.4
19
99.45±0.1
57***
99.10±0.1
53*
98.52±0.1
95*
98.48±0.1
10*
PEE 200
mg/kg
98.90 10
0.2
0±
0.2
67
99.80±0.1
68**
99.53±0.1
70*
99.05±0.1
23*
99.00±0.1
38**
PEE 400
mg/kg
98.77 10
0.3
8±
0.1
09
99.69±0.1
62**
99.26±0.1
20*
98.99±0.1
36*
98.40±0.1
13*
CE 200
mg/kg
98.76 10
0.2
8±
0.3
15
100.10±0.
102*
99.85±0.1
29*
99.55±0.1
85*
99.35±0.1
11*
CE 400
mg/kg
98.60 10
0.1
7±
0.2
48
99.95±0.1
55**
99.54±0.1
46*
99.17±0.1
36*
99.10±0.1
31**
ThePEE,CEat thedoseof200mg/kgand400mg/kgbodyweightsignificantlyattenuated
hyperthermia inrats in1hobservation(??<0.005)andloweringof temperaturewaseven
moresignificant (??<0.001) from2hto4hobservationperiodincomparisontocontrol.
AmongthemPEE(400mg/kg)was themostpotentone.Standarddrugparacetamol also
significantly inhibited pyrexia (??< 0.05 and ??< 0.001) in early and later hours of
observationtimeintervals. PEEofFicusracemosaL.leavesandparacetamol loweredthe
rectal temperature in time dependent manner. There was no significant difference between
PEE (400 mg/kg b.w) and Paracetamolin inhibiting pyrexia in experimental animals.
While the invention has been described with respect to specific composition which include
presently preferred modes of carrying out the invention, those skilled in the art will
appreciate that there are numerous variations and permutations of the above described
embodiments that fall within the spirit and scope of the invention. It should be understood
that the invention is not limited in its application to the details of construction and
arrangements of the components set forth herein.
Variations and modifications of the foregoing are within the scope of the present
invention. Accordingly, many variations of these embodiments are envisaged within the
scope of the present invention.
The foregoing descriptions of specific embodiments of the present invention have been
presented for purposes of description. They are not intended to be exhaustive or to limit
the present invention to the precise forms disclosed, and obviously many modifications
and variations are possible in light of the above teaching.
The embodiments were chosen and described in order to best explain the principles of the
present invention and its practical application, and to thereby enable others skilled in the art
to best utilize the present invention and various embodiments with various modifications as
are suited to the particular use contemplated. It is understood that various omissions and
substitutions of equivalents are contemplated as circumstances may suggest or render
expedient, but such omissions and substitutions are intended to cover the application or
implementation without departing from the spirit or scope of the present invention. , Claims:WECLAIM:
1. A process for obtaining an analgesic and antipyretic composition from Ficus racemosa L.
leaves, comprising:
· extracting Ficus racemosa L. leaves using a Soxhlet apparatus with solvents in
increasing order of polarity, wherein the solvents comprise petroleum ether and
chloroform;
· yielding a petroleum ether extract (PEE) and a chloroform extract (CE), wherein the
percentage yields are 7.63% and 8.02%, respectively;
· subjecting the extracts to qualitative phytochemical screening to confirm the
presence of alkaloids, saponins, carbohydrates, and terpenoids.
2. The process as claimed in Claim 1, wherein the quantitative phytochemical composition
of the petroleum ether extract (PEE) comprises saponins, carbohydrates, and terpenoids in
amounts of approximately 6.53±0.53 mg/100 g, 7.48±0.23 mg/100 g, and 12.96±0.58
mg/100 g, respectively.
3. The process as claimed in Claim 1, wherein the quantitative phytochemical composition
of the chloroform extract (CE) comprises alkaloids in an amount of approximately
5.63±0.56 mg/100 g.
4. An analgesic and antipyretic composition comprising petroleum ether extract (PEE) and
chloroform extract (CE) of Ficus racemosa L. leaves as obtained by the process claimed in
Claim 1, wherein said composition exhibits significant analgesic and antipyretic effects
when administered at a dosage of approximately 400 mg/kg.
5. The composition as claimed in Claim 4, wherein the petroleum ether extract (PEE) at a
dosage of approximately 400 mg/kg exhibits a potent analgesic and antipyretic response
when compared to the control in in-vivo studies.
6. A method for producing an HPTLC fingerprint of Ficus racemosa L. leaf extracts,
comprising:
20
· analyzing the petroleum ether extract (PEE) and chloroform extract (CE) at 366 nm
wavelength, wherein the HPTLC fingerprint of the PEE extract shows 13 distinct
peaks and the CE extract shows 10 distinct peaks.
7. The composition as claimed in Claim 4, wherein the composition is safe for
administration, as demonstrated by in vivo oral toxicity studies conducted according to
OECDguidelines 420, indicating no signs of toxicity in experimental animals.
8. The composition as claimed in Claim 4, wherein the composition provides a natural
analgesic and antipyretic alternative, suitable for managing pain and fever in subjects in
need thereof.

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