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A Detail Physicochemical Investigation of A Polyherbal Formulation - Cutisora Tablet
A Detail Physicochemical Investigation of A Polyherbal Formulation - Cutisora Tablet
, 3(3), 142-148
ISSN: 2231-010X
www.ijrpp.pharmascope.org Research Article
ABSTRACT
In order to have a good coordination between quality of raw materials, in process materials and the final prod-
ucts, it is essential to have reliable, specific and sensitive quality control methods. The quality of herbal drugs is
the sum of all factors, which contribute directly or indirectly to the safety, efficacy and acceptability of the prod-
uct. Standardization of drugs means confirmation of its identity and determination of its quality and purity. Cutiso-
ra tablet, a polyherbal formulation is used for the treatment of psoriasis. Raw materials as well as finished product
were standardized using standard parameters such as organoleptic parameters, physico-chemical parameters,
Comparative High Performance Thin Layer Chromatographic study (HPTLC), Microbial and Heavy metal analysis.
The investigation data revealed the status of standardization at the level of raw materials and finished product.
The obtained results were used to establish overall quality of the final product.
Keywords: Polyherbal formulation; Cutisora Tablet; Standardization; HPTLC study
INTRODUCTION analytical methods, which can reliably profile the phy-
tochemical composition, including quantitative analys-
Ancient Indian literature comprises a remarkably broad
es of marker/ bioactive compounds and other major
definition of medicinal plants and considers all plant
constituents, is a major challenge to scientists. Stan-
parts to be potential source of medicinal substances.
dardization minimizes batch-to-batch variation; assures
However, key obstacle, which has hindered the accep-
safety, efficacy, quality and acceptability of the poly-
tance of the alternative medicines in the developed
herbal formulations (Ahmad et al, 2006).
countries, is the lack of documentation and standardi-
zation. There is a real need for documentation on re- The present study was carried out with specific aim to
searches, which have been so far carried out on tradi- establish standards for Cutisora tablet. Cutisora tablet
tional medicines. With this backdrop, it become ex- contains following ingredients which having known
tremely important to make an effort towards standar- effect against skin disorders like psoriasis.
dization of plant based medicines.
Wrightia tinctoria extract has Anti-inflammatory activi-
Standardization is a system that ensures a predefined ty, Anti-fungal activity (Elumalai et al) Tinospora cordi-
amount of quantity, quality & therapeutic effect of folia anti inflammatory, analgesic and immunosuppres-
ingredients in each dose (Zafar et al, 2005). No medi- sive activity (Anonymous, 1998). Azadirachta Indica is
cine including Herbal product can be considered scien- main ingredient of poly herbal formulation &it is useful
tifically valid if the drug tested has not been authenti- in all skin conditions especially in burning sensation
cated and characterized in order to ensure reproduci- (Anonymous, 2000). Adhatoda vasica bacterial antisep-
bility in the manufacturing of the product. Moreover, tic and it is used in various skin infections (Anonymous,
many dangerous and lethal side effects have recently 2004). Trichosanthes dioica is effective in skin disease
been reported, including direct toxic effects, allergic including Pruritus (Anonymous, 2000). Solanum xan-
reactions, effects from contaminants, and interactions thocarpum has antifungal activity (Anonymous, 1998).
with herbal drugs (Vaidya et al, 2007). Therapeutic ac- Plumbago zeylanica has anti inflammatory and anti
tivity of an herbal formulation depends on its phyto- microbial activity (Anonymous, 2008). Acacia catechu
chemical constituents. The development of authentic has characteristic of Kushthaghna and Kandughna. So it
is used in all skin disease and intense itching (Anonym-
* Corresponding Author ous, 2000). Curcuma longa remarkable anti inflamma-
Email: vidhi@vasuresearch.com tory activity .It also has anti ulcer and anti bacterial
Contact: +91-9227788565, 0265 2657701/02 property (Anonymous, 1998). Kaishor Guggulu powder
Received on: 22-04-2013 formulation made using more than 10 different ingre-
Revised on: 17-08-2013 dients which are useful in treatment of psoriasis (Ano-
Accepted on: 18-08-2013 nymous, 2004).
142 ©JK Welfare & Pharmascope Foundation | International Journal of Research in Phytochemistry & Pharmacology
Hitesh Gohel et al., (2013) Int. J. Res. Phytochem. Pharmacol., 3(3), 142-148
analyzed by using these standard curves. The permissi- Staphylococcus aureus (ATCC 6358) were obtained
ble limit for Heavy metal in herbal drugs is consider as from NCIM Pune. The media used for the microbial
per describe limit given by Department of Ayush. limit test were of HiMedia Pvt. Ltd.
Table 2: Organoleptic character of all ingredients of Comparative Organoleptic characters of the extracts
Cutisora Tablet (Raw materials) and powder used in tablet formulation are as tabulated
in Table 2.
Name of In- Description
gredient Colour Odour Taste Physicochemical parameters such as moisture (by
Wrightia tinc- LOD), Water soluble extractive value, Total ash, Acid
Brown Characteristic Astringent
toria insoluble ash, Water soluble ash, and pH were deter-
Tinospora Light mined in raw materials. These values are mentioned in
Characteristic Bitter
cordifolia Brown Table No. 3, which shows that most of the raw mate-
Azadirachta Greenish rials do not have considerable amount of acid insoluble
Characteristic Bitter
indica brown
ash and water soluble ash. Other than physicochemical
Adhatoda vasi-
Brown Characteristic Bitter parameters, average weight, hardness, thickness, di-
ca
ameter and disintegration time in 3 different batches
Trichosanthes Dark
Characteristic Bitter of Cutisora Tablet were carried out. The results are as
dioica Brown
Solanum Dark tabulated in Table No. 4
Characteristic Bitter
xanthocarpum Brown Phytochemical constituents like alkaloid and bitter by
Plumbago
Brown Characteristic Characteristic gravimetric method, tannin by titrimetric method and
zeylanica
curcuminoids by spectrometry were determined in raw
Acacia catechu Brown Characteristic Astringent
Curcuma longa Yellow Aromatic Bitter
materials and Cutisora Tablet (Table No. 5).
Kaishor Dark HPTLC analysis
Characteristic Characteristic
Guggulu brown
In HPTLC analysis, the sample shows comparison of
Microbial Limit Test: Microbial analysis was carried individual extract & Powder with finished product. The
out for all the extracts as per procedure of Indian visualization of TLC plates was carried out in all 3 dif-
pharmacopoeia 2007. It included Total bacterial count, ferent wavelengths ie, 254nm, 366nm and 540 nm.
Total Fungal Count, Presence of Escherichia coli, Sal- From this only the best visualization result was se-
monella spp, Pseudomonas aeruginosa, and Staphylo- lected and included in our study along with its 3D im-
coccus aureus. Pure culture of Escherichia coli (NCIM: age. The Rf value thus found during this study indicates
2065; ATCC: 8739), Salmonella abony (NCIM: 2257 the prominent presences of raw material in the fi-
NCTC: 6017), Pseudomonas aeruginosa (ATCC 9027),
Table 3: Physicochemical Parameters for Cutisora Tablet (Raw materials)
Physicochemical Parameters
Sr. Name of ingre-
No dient M/C by LOD
WSE (%) pH TA (%) AIA (%) WSA (%)
(%)
1. W.tinctoria 96.24±0.05 4.62±0.04 3.32 ± 0.06 6.53±0.03 1.86±0.04 3.58±0.02
2. T. cordifolia 76.48±0.52 5.70±0.02 1.91 ± 0.05 9.00±0.05 1.52±0.06 3.89±0.03
3. A. indica 97.52±0.44 5.35±0.01 2.29 ± 0.02 6.65±0.01 2.59±0.01 3.86±0.04
4. A. vasica 92.80±0.66 7.03±0.02 3.62 ± 0.03 11.30±0.06 4.12±0.07 5.28±0.02
5. T. dioica 95.20±0.10 6.19±0.04 3.36±0.07 9.98± 0.04 3.68±0.08 4.67±0.05
6. S.xanthocarpum 88.72±0.26 5.31±0.05 1.06 ± 0.06 8.94± 0.03 4.26±0.01 5.60±0.06
7. P. zeylanica 94.32±0.76 4.57±0.05 2.89± 0.09 4.59± 0.02 2.18±0.09 1.94±0.05
8. A. catechu 96.88±0.05 4.36±0.04 2.43 ± 0.01 6.48± 0.07 2.59±0.04 3.95±0.02
9. C. longa 21.52±0.028 4.08±0.01 2.91 ± 0.08 1.99± 0.05 0.62±0.09 0.83±0.07
10. Kaishor Guggulu 35.12±1.026 2.46±0.03 4.78 ± 0.01 9.80± 0.01 4.27±0.01 5.28±0.06
3.54±0.05(LOD)
11. Cutisora Tablet 64.08±0.08 5.38±0.05 16.62±0.07 5.07±0.06 5.97±0.04
1.09 ±0.06 (KF)
* Results indicated in Mean + SEM, where n=3.
WSE – Water soluble extractive, M/C – Moisture content, LOD – Loss on drying, KF – Karl Fischer, TA –
Total Ash, AIA – Acid insoluble ash, WSA - Water soluble ash
W.tinctoria - Wrightia tinctoria, T. cordifolia - Tinospora cordifolia, A. indica - Azadirachta indica, A. vasica
- Adhatoda vasica, T. dioica - Trichosanthes dioica, S.xanthocarpum- Solanum xanthocarpum, P. zeylanica
- Plumbago zeylanica, A. catechu - Acacia catechu, C. longa - Curcuma longa
144 ©JK Welfare & Pharmascope Foundation | International Journal of Research in Phytochemistry & Pharmacology
Hitesh Gohel et al., (2013) Int. J. Res. Phytochem. Pharmacol., 3(3), 142-148
Parameters Result
Batch
Batch 1 Batch 2
3
Colour Purple Purple Purple
Shape Round Round Round
Film Film
Coating Film coated
coated coated
Standardization Parameters Figure 1: A) HPTLC finger printing of extract of Wrigh-
Average tia tinctoria. Track 1and 2: 8 μg/ml of Methanol extract
644.51±0.08mg
weight
of leaves of extract W.tinctoria Track 3 and 4: 8 μg/ml
Diameter 12.90±0.06
of Methanol extract of Cutisora tablet. Under UV 366
Thickness 5.11±0.04
Hardness 3.5 kg/cm
2 nm raw materials showed specific Rf values 0.25, 0.63
Disintegration and 0.80. From that Rf value 0.63 showed prominent
48 min 19 sec
time presences in finished product. B) HPTLC finger printing
of extract of Tinospora cordifolia (UV 366 nm). Track
* Results indicated in Mean + SEM, where n=3.
1and 2: 8 μg/ml of Methanol extract of leaves of ex-
Table 5: Quantitative determination of Actives tract Tinospora cordifolia. Track 3 and 4: 8 μg/ml of
Name
Methanol extract of Cutisora tablet. Under UV 366 nm
Alkaloid Bitter Tannin Curcuminoids
of
(%) (%) (%) (%)
raw materials showed specific Rf values 0.06, 0.11,
Ingredients
0.16, 0.25 and 0.30. From that Rf values 0.06 and 0.11
1.14
W.tinctoria NA NA NA showed prominent presences in finished product.
±0.06
2.98
T. cordifolia NA NA NA
±0.04
3.70
A. indica NA NA NA
±0.03
0.61
A. vasica NA NA NA
±0.09
1.96
T. dioica NA NA NA
±0.02
2.52
S.xanthocarpum NA NA NA
±0.05
0.16
P. zeylanica NA NA NA
±0.01
23.69
A. catechu NA NA NA
±0.04
7.20
C. longa NA NA NA
±0.08
5.02 9.40 Figure 2: A) HPTLC finger printing of extract of Azadi-
Kaishor Guggulu NA NA
±0.01 ±0.07
0.74 3.44 7.09 0.39 rachta indica. Track 1 and 2: 8 μg/ml of Methanol ex-
Cutisora Tablet
±0.06 ±0.04 ±0.07 ±0.14 tract of leaves of extract A.indica. Track 3 and 4: 8
* Results indicated in Mean + SEM, where n=3. NA: Not μg/ml of Methanol extract of Cutisora tablet. Under UV
applicable 254 nm raw materials showed specific Rf values0.60
and 0.74. These both Rf values showed prominent pre-
Discussion
sences in finished product. B) HPTLC finger printing of
All ingredients used in Cutisora Tablet are standardized extract of Adhatoda vasica. Track 1and 2: 8 μg/ml of
on the basis of organoleptic parameters, physico-
Methanol extract of leaves of extract A.vasica. Track 3
chemical parameters and different assays of their ac-
tives including HPTLC analysis. Moisture content/LOD and 4: 8 μg/ml of Methanol extract of Cutisora tablet.
value of all ingredient and Cutisora tablet were found Under UV 254 nm raw materials showed specific Rf
in their minimum range that indicates ingredients were values 0.09, 0.18, 0.28 and 0.80. From that Rf values
of good quality and thus will not deteriorate. Equally 0.28 and 0.80 showed prominent presences in finished
important in the evaluation of crude drugs, is the ash product.
value and acid insoluble ash value determination. The
©JK Welfare & Pharmascope Foundation | International Journal of Research in Phytochemistry & Pharmacology 145
Hitesh Gohel et al., (2013) Int. J. Res. Phytochem. Pharmacol., 3(3), 142-148
©JK Welfare & Pharmascope Foundation | International Journal of Research in Phytochemistry & Pharmacology 147
Hitesh Gohel et al., (2013) Int. J. Res. Phytochem. Pharmacol., 3(3), 142-148
148 ©JK Welfare & Pharmascope Foundation | International Journal of Research in Phytochemistry & Pharmacology