Journal of Research in Unani Medicine, Vol 4, Issue 1

Standard manufacturing procedure of Qurse Tabasheer - A herbo mineral Unani anti

diabetic formulation
Waris Ali, *Hamiduddin,AkhtarAli
Dept. of Ilmul Saidla (Unani pharmacy), National Institute of Unani Medicine (NIUM), Bangalore-91, Karnataka,
India
*CorrespondingAuthor
Email: drhamid2003@rediffmail.com

Abstract
Background and Objectives: Qurs (Tablet) is one of the most suitable dosage forms due to its easy portability,
stability and accuracy of dose etc. Unani tablets contain diverse crude drugs which require specific manufacturing
procedures for good quality of finished products to be maintained. In this work Qurse Tabasheer containing six
ingredients, Tabasheer (Siliceous concretions) , Gule Surkh (Rosa damascena Mill. flower), Gulnar (Punica
granatum Linn. flower), Tukhme kahu (Lactuca sativa Linn. seeds), Tukhme khurfa (Portulaca oleraceae Linn.
seeds ) and Gile Armani was taken up for study due to its important indication in diabetes, hummae hadda and
diarrhea . Objective of this study was to develop standard operating procedure (SOP) for its manufacturing stages.
Materials and Methods: Total 18 batches were generated for the optimum working process related to the powder
size, quantity of binder, granulation, temperature and duration for drying and compression on the basis of trial and
error. All the batches were assessed for friability, hardness and disintegration time and final ideal batch was selected
on the basis of normal set parameters. Ideal working condition was documented as SOP for manufacturing procedure
and final ideal batch was again repeated to check the reproducibility. Result was analyzed by calculating mean ± SEM
(Standard error of mean).
Results: Friability (%), hardness (kg/cm) and disintegration time (Minutes) of selected final ideal batch and repeated
final ideal batch was (0.0730±.01764, 0.09±0.0057), (4.10±.050, 4.03±0.087) and (26.16±0.5376, 25.57±0.4860)
respectively and it was found within the set limit. Pre-compression parameters were fine, weight of tablet was 793.7 ±
4.755 mg and weight variation was <5%.
Conclusions: This work may be of utility in improving the quality when comparing parameters as it shows
reproducible results. This SOP may be used for future reference for production of ideal Qurse Tabasheer quality wise.
Key-words: Standard manufacturing procedure, Qurse Tabasheer, Unani, Tablets

Introduction compiled1. There has been an exponential growth in

The traditional system of medicine is being practiced
in many countries of the world such as Chinese
medicine (TCM), Indian system of medicine (ISM)
(Ayurvedia, Unani and Sidha), African folklore etc.,
where the remedies are thoroughly documented and
herbal medicine in last few decades, due to natural
origin and lesser adverse effects 2. Majority of the
remedies of Indian system of medicine are based on
plants / plant products and few on animal and mineral
products. In manufacturing process, a lot of variation

51

is being observed for preparation of same formulation
from one company to another company, although they
start with similar raw materials . Process validation
1
and development of Standard Operating Procedures
(SOPs) of manufacturing procedure are very
necessary for Unani compound formulations, because
the classical description of various operations for
manufacturing procedure is not well defined in all
aspects as the principles developed relied on the
extensive experience. Thus art of manufacturing
contained visible elements of subjectivity. Nowadays
tablets are manufactured with contemporary
technology, detail of which is not mention in classical
Unani text and different Unani tablets contain
different types of crude drugs which require specific
and standard manufacturing procedures. Not
following the specific and correct procedure for tablet
production will lead to poor quality tablet of very
friable nature or extended disintegration time, and will
ultimately affect the efficacy and drug dosage
compliance by the patient. All the above mentioned
issues are to be taken care of to get good quality of
tablets and other Unani finished products which can
be safe and effective in various diseases for which
they are advocated. Hence the need of the hour is to
conduct standardization of Unani formulations with
respect to its manufacturing procedure i.e. SOPs
(quality), safety and efficacy validation and to re-
evaluate the standardization process in present global
scenario.
Therefore in the present study standard operating
procedure (SOP) of Qurse Tabasheer regarding
various steps of its manufacturing process such as
particle size , quantity of binder, temperature of
drying, and duration of drying was developed,
documentation of various process involve in the
Journal of Research in Unani Medicine, Vol 4, Issue 1
preparation of Qurse Tabasheer was done for
achieving optimum friability, hardness disintegration
time and other quality specifications. This particular
Qurse Tabasheer formulation is mentioned in
Bayaaze Kabeer, Kitabul Murakkabat Al Maroof
Makhzanul Murakkabat and Kitab Al Murakkabat, it
is used in the treatment of Dhayabitus (Diabetes),
Hummae Hadda (Acute fever) and Is'hal (Diarrhoea)
. Hypoglycemic or antihyperglycemic and related
3, 4, 5, 6
activities are reported in most of the individual
ingredient of Qurse Tabasheer and their extracts, and
directly on Qurse Tabasheer 7, Qurse Tabasheer
extract showed antihyperglycemic,
antihyperlipidemic activity in rats 8. Moreover this
formulation was selected due to its important
indication i.e. in diabetes and to overcome the
imperfect manufacturing procedure.
Materials and Methods
Collection of Drugs / Ingredients and its
identification: Gule Surkh (Rosa damascena Mill.
flower), Gulnar (Punica granatum Linn. flower),
Tukhme Kahu (Lactuca sativa Linn. seeds) and
Tukhme Khurfa (Portulaca oleraceae Linn. seeds )
were procured from A.B. General Store, Avenue
Road; Bangalore and identified by expert at FRLHT
(Foundation for Revitalization of Local Traditions)
Bangalore. Tabasheer (Siliceous concretions) was
procured from a raw drug dealer 'Herbo World
Associates', New Delhi and identified by expert.
Different samples of Gile Armani were purchased
from market and XRD was conducted at Department
of Material Engineering, Indian Institute of Sciences
Bangalore for its identification. The drug samples
were submitted in NIUM Drug Museum and voucher
specimen No. was collected: 22/IS/Res/2014. [Table
1]
52
 Journal of Research in Unani Medicine, Vol 4, Issue 1

Table1: Ingredients and excipients used in preparation of Qurse Tabasheer

Sr.No. Ingredient / excipients Role

1. Tabasheer (Siliceous concretions) Active drug

2. Gule Surkh (Rosa damascena Mill.) Flower Active drug

3. Gulnar (Punica granatum Linn.) Flower Active drug

4. Gile Armani (Armenian bole) Active drug

5. Tukhme Kahu (Lactuca sativa Linn.) Seeds Active drug

6. Tukhme Khurfa (Portulaca oleraceaeLinn.) Seeds Active drug

7. Gum Acacia Binder

8. Water (filtered / R.O.) For making Loab / lubdi

(wet massing)
9. Magnesium carbonate Glidant

10. Liquid paraffin Lubricant

Techniques used for process standardization: After
identification of the ingredients, the Aqurs (Tablets)
were prepared. Different batch of tablets was
generated by 120g powder in each batch for the
optimum working process related to the powder size,
binder, granulation, temperature and time for drying
and finally the compression of Qurs. Each batch was
assessed three times with the documentation of
various steps of manufacturing process. The method
mentioned in The Unani Pharmacopeia of India and
National Formulary of Unani Medicine was followed
for the preparation of Qurse Tabasheer with necessary
modification 9, 10
. Sil-Batta (wet grinder) was used 10.
Step1: Powdering and Sifting/Sieving of
ingredients of Qurse Tabasheer: Tabasheer, Gule
Surkh, Gulnar and Gile Armani, were powdered
separately by using super mixer-grinder. Sieve no. 80,
100 and 120 (B.S.S.) were used for Sieving of
powders. Powdering of Tukhme Kahu and Tukhme
khurfa was done separately. Initially dry grinding was
attempted and No. 80 mesh powder was obtained but
sieving through 100 and 120 no. mesh was not
possible so for attaining powder of these mesh size,
wet grinding was done as mention in NFUM (National
formulary of Unani medicine) for powdering of tough,
hard and fibrous drug, instead of Sil-Batta, electrical
Procedure of wet grinding: Tukhme Kahu was taken

53

and dried in sun for some time and then pound in iron
mortar, then the drug was put in wet grinder with water
for 6 hr. (time in which finely grinded mass was
achieved) This wet finely grinded mass was then
passed by the help of powder wiper through 100 no.
mesh sieve, this mass was dried first in hot air oven at
up to 60°C for 2 hrs then dried in shade under the fan
for 36 hrs. This dried mass was then put in mixer-
grinder for few minute; the powder obtained was
again passed through 100 no. mesh size. This sieved
powder was then preserved in air tight container for
further study. Similar procedure was followed for
obtaining powder of No. 120 mesh. Same procedure
was followed for Tukhme Khurfa but after wet
grinding and sieving, wet mass was dried for 32 hrs
under fan.
Step 2: Preparation of binder solution: Three
binders, water, corn starch and gum acacia were
initially tested for preparation of formulation but
finally on the basis of post-compression evaluation,
gum acacia (I.P. grade) was selected for final study in
different batches of Qurs Tabasheer. Binder S.A.
(Samaghe Arabi / Gum acacia) was taken in 10%,
15%, and 20% of the total w.t. of powder. Mucilage or
loab (binder solution / Loabe Samaghe Arabi) was
prepared with binder: water (filtered / R.O.), 4: 6 w/w
initially .
11
Step 3: Granulation:
Weighing of powdered drug and mixing: All six
drugs powder were taken in equal quantity as mention
in the formulation and weighing of powdered drug is
done by digital weighing machine. This separately
powdered and weighed drug was mixed properly in
mixer grinder.
Journal of Research in Unani Medicine, Vol 4, Issue 1
Preparation of lubdi (Wet massing): Lubdi was
prepared by adding binder solution to previously
mixed powder drug material with suitable amount of
water and then this mass was put in mixer grinder for
proper mixing of binder. Precaution was taken that
prepared lubdi should not be so hard and not so loose,
till the damp mass / Snow ball was achieved.
Preparation of Granules / Screening: 16 no. mesh
sized granules were prepared of obtained material by
using oscillating granulation machine, GMP model
(Cemach machinery Ltd., Ahmadabad SN. 1417).
Size of the granulator screen (mesh size) was decided
as per diameter of punches i.e. Tablet up to 7/32 to
5/16 inch in diameter = 16 mesh for granules 12.
Drying of granules: Prepared Granules were dried
for 30 minutes and 60 minutes at 60°C for all batches
in hot air oven 13 (Labline Mod. No. HO 6, 7).
Inclusion of lubricant and glidant: 1% liquid
paraffin as lubricant and 1% magnesium carbonates as
glidant of total wt. of powder were added slowly in
dried granules, quantity of glidant and lubricant was
selected on the basis of trial and error 14, 15.
Step 4: Compression: In this step blend of dried
granules, lubricant and glidant were subjected to
compression by multi-station rotary presses
(Tableting machine) GMP model (Cemach machinery
Ltd. Mod. No. CM-D-20) at 6 Tone pressure for all
batches, and calibrated to the weight of tablet
approximately for 800 mg / tablet.
Step 5: Drying of tablets: Prepared tablets were dried
for 30 minutes at 60°C for all batches in drier (Tray
drier) (GMP model) (Pharmac, mod. No. 24) for
removing additional moisture if any, and are then kept
in air tight container. [Figure 1]
54
 Journal of Research in Unani Medicine, Vol 4, Issue 1

Fig ure 1: Schematic pres entation of
manufacturing process
Tablets obtained from different batches as mention
above were evaluated for parameters such as friability,
hardness and disintegration time. Total 18 batches
were prepared for trial and error on the basis of
different powder size i.e. 80,100 and 120 no. mesh
size, binder Samaghe Arabi concentration 10%, 15%
and 20%, duration for drying of granules i.e. 30
minutes and 60 minutes at 60°C temperature and post-
compression drying 30 minutes at 60°C was done for
all batches, for preparation of SOP of manufacturing
process of Qurs Tabahseer, one final (ideal) batch was
selected on the basis of parameter mentioned above
from the 18 batches. [Table 2

Table 2: Description of Batches of Qurse tabasheer prepared

Batch Sieve Particle Binder Temperature Duration Post- Compression
No. No. size S.A. of drying of of compression pressure in
( µm ) (%) granules drying drying at tons
(°C) of 60°C
granules
1. 80 177 10% 60 °C 30 min 30 min 6
2. 80 177 10% 60 °C 60 min 30 min 6
3. 80 177 15% 60 °C 30 min 30 min 6
4. 80 177 15% 60 °C 60 min 30 min 6
5. 80 177 20% 60 °C 30 min 30 min 6
6. 80 177 20% 60 °C 60 min 30 min 6

55
 Journal of Research in Unani Medicine, Vol 4, Issue 1

7. 100 150 10% 60 °C 30 min 30 min 6

8. 100 150 10% 60 °C 60 min 30 min 6
9. 100 150 15% 60 °C 30 min 30 min 6
10. 100 150 15% 60 °C 60 min 30 min 6
11. 100 150 20% 60 °C 30 min 30 min 6
12. 100 150 20% 60 °C 60 min 30 min 6
13. 120 125 10% 60 °C 30 min 30 min 6
14. 120 125 10% 60 °C 60 min 30 min 6
15. 120 125 15% 60 °C 30 min 30 min 6
16. 120 125 15% 60 °C 60 min 30 min 6
17. 120 125 20% 60 °C 30 min 30 min 6
18. 120 125 20% 60 °C 60 min 30 min 6

Pre-compression parameter: Final selected batch
granules were also subjected to pre-compressions
parameter Bulk density, Tapped density,
Compressibility index, Hausner's ratio, [2,16, 18]
Angle of repose. [2, 17, 18]
Techniques used for Process Standardization
(Selection of ideal batch):
1. Friability test: Friability test apparatus Roche´s
friabilator (Labinda mod. no. 1020) was used for
determination of friability of tablet. This device
subject the tablet to the combined effect of abrasion
and shock in a public chamber revolving at 25 rpm and
dropping the tablets at a height of 6 inches in each
revolution. Tablets was placed in friabilator after
weighing and subjected for 100 revolutions. Tablet
de-dusted using a soft muslin cloth and reweighted.
The conventional compressed tablets that lose less
than 0.5 to 1% of their weight are generally considered
acceptable. The friability was calculated by following
[16]
formula: F = (W1¯W2/ W1) ×100
and W1= Initial weight of tablets, W2= Final weight of
tablets. Procedure was repeated three times for mean
friability value 2, 19.
2. Tablet Hardness test: Randomly three tablets was
pickup and they were individually tested for the
hardness by Monsanto hardness tester (Shital
scientific industries Sr. no. 11012010) in term of
kg/cm. the hardness of 4 kg is considered to be
minimum for a satisfactory tablet 2, 19.
3. Disintegration test: Disintegration testing
apparatus manufactured as per USP (TAB machine
mod. no. TD 20S) was used for determination of
disintegration time. In apparatus there was 6 glass
tube of length 3 inches, open at top and hold a 10 no.

56

mesh screen at bottom end of the basket rack
assembly. One tablet was placed in each tube of 2
basket rack assemblies of disintegration apparatus and
perforated plastic discs placed at top of the tablets and
impart an abrasive action of the tablets. Basket rack
was positioned in a one liter beaker filled with distilled
water at 37°c ±2°c. The procedure was started for
running disintegration time for uncoated tablets. At
last when tablets completely disintegrate and all
particles of tablet pass through 10 no. mesh, then time
of disintegration was noted. Uncoated USP tablets
have disintegration time standard minimum 5 min,
majority of the tablets have maximum disintegration
time of 30 min .
19
4. Weight variation: (USP weight variation test) 20
tablets were select randomly from batch and weighing
was done individually, average weight was calculated.
Individual weights were compared to average weight.
If not more than 2 tablets are outside the percentage
limit, then tablets meet the USP test. The weight
variation tolerance for uncoated tablet according to
USP is shown in table. Tested tablet was in more than
324 mg category. (Weight variation for average
weight of uncoated Tablets more than 324 mg was
Table 3: Pre-compressions parameters of ideal batch Qurse Tabasheer
Sr. Pre-compressions
No. parameters of granules
1. Bulk Density (gm/ml)
2. Tapped Density (gm/ml)
3. Compressibility index (%)
4. Hausner´s ratio
5. Angle of Repose θ
*F.P (Flow property)
Journal of Research in Unani Medicine, Vol 4, Issue 1
followed i.e. maximum percentage difference allowed
is 5%) 19.
Ideal final batch selected by above set parameters i.e.
friability, hardness, disintegration time was again
prepared to check the reproducibility.
Results
Identification: All the ingredients were authenticated
by the expert except Gile Armani. Gile Armani
(clay/mineral) sample were analyzed by XRD studies
for its authentication, XRD findings of Gile Armani
showed presence of Fe2O3-Hematite; Silica (SiO2)-
Quarts alpha; CaCO3- Calcite form and TiO2-
Titanium Oxide, Anatase. Its constituents resembled
Red Ochre (Geru).[20] This sample of Gile Armani was
taken in the study as it is the readily available market
sample. This sample was identified as Geru which is a
genuine substitute of Gile Armani in Unani text 21.
Yield of powders: Yields of powders by sieving it
with 80, 100 and 120 no. sieves for Tabasheer were
80%, 76% and 71% ; for Gule Surkh 91.4%, 86.8%
and 84.5%; for Gulnar 78.8%, 74.4% and 68%; for
Gile Armani 97.14%, 96% and 94.28%; for Tukhme
Khurfa 59.65%, 64% and 63% and for Tukhme Kahu
were 62%, 65% and 63% respectively. Pre-
compression parameter of final batch was found to be
good 2, 16, 17, 18. Table 3 summarises the compression
parameters.
Mean ± SEM Value Range
0.5084 ± 0.0 -----
0.5884 ± 0.006669 -----
13.56 ± 0.9786 up to 15 Good F.P.*
1.157 ± 0.01311 < 1.25 Good
29.98° up to 40° reasonable F.P.*
57
 Journal of Research in Unani Medicine, Vol 4, Issue 1
Friability, Hardness, Disintegration time of all batches of Qurse Tabasheer: The mean value of all 18 batches
mentioned in Table 4, Figure 2, Figure 3 and Figure 4.
Table 4: Results of all batches of Qurse Tabasheer
Sr. Sieve Partic S.A. Duration Post Friabilit Hardnes Disintegrati
No No. le size Binde of drying compressio y (%) s on time
(µm) r granules at n drying Mean ± (kg/cm2 ) (Minutes)
(%) 60°C time at SEM Mean ± Mean ±
60°C SEM SEM
1. 80 180 10% 30 min 30 min 0.723±0. 0.66±0.0 6.37±0.08
035 83
2. 80 180 10% 60 min 30 min 0.68±0.0 1.10±0.0 8.25±0.49
32 5
3. 80 180 15% 30 min 30 min 0.539±0. 1.833±0. 11.80±0.32
03 08333
4. 80 180 15% 60 min 30 min 0.463±0. 2.10±0.0 17.053±0.32
01 5
5. 80 180 20% 30 min 30 min 0.460±0. 1.966±0. 24.38±0.46
02 08333
6. 80 180 20% 60 min 30 min 0.336±0. 2.20±.02 25.18±0.56
10 887
7. 100 150 10% 30 min 30 min 0.446±0. 1.166±0. 13.96±0.22
02 08333
8. 100 150 10% 60 min 30 min 0.326±0. 1.75±000 14.96±0.20
05
9. 100 150 15% 30 min 30 min 0.19±0.0 2.50±0.1 16.54±0.85
2 443
10. 100 150 15% 60 min 30 min 0.096±0. 2.75±0.1 23.11±0.87
02 443
11. 100 150 20% 30 min 30 min 0.116±0. 3.916±0. 23.86±0.64
02 08333
12. 100 150 20% 60 min 30 min 0.0730±0 4.10±0.0 26.16±0.54
.02 5
13. 120 125 10% 30 min 30 min 0.75±0.0 1.916±0. 5.95±0.42
3 08333
14. 120 125 10% 60 min 30 min 0.41±0.0 2.33±0.0 7.29±0.49
2 8333
15. 120 125 15% 30 min 30 min 0.173±0. 2.916±0. 12.16±0.49
01 08333
16. 120 125 15% 60 min 30 min 0.16±0.0 3.10±0.0 15.56±0.27
1 5
17. 120 125 20% 30 min 30 min 0.107±0. 3.83±0.0 22.603±0.33

58
 Journal of Research in Unani Medicine, Vol 4, Issue 1

Figure 2: Friability of Qurse Tabasheer batches Figure 3: Hardness of batches of Qurse Tabasheer

Figure 4: Disintegration time of batches of Qurse Tabasheer

Friability, hardness, disintegration time, of final selected batch: Friability, hardness, disintegration time, of final
selected batch was 0.0730±.01764, 4.10±.050, 26.16±0.5376, respectively.
Average weight and weight variation: Average weight of tablets of final selected batch was 793.7 ± 4.755 mg and
weight variation was < 5%.
Comparison of ideal batch no. 12 and repeated ideal batch prepared following specification of ideal batch, shows
comparative friability, hardness and disintegration time [Table 5] Total time of preparation, quantity of tablet
obtained and residue left of final selected ideal batch and two repeated ideal batches is mentioned in [Table 6].
Standard preparation specification for Qurse Tabasheer after validation is summarized in [Table 7].

59
 Journal of Research in Unani Medicine, Vol 4, Issue 1
Table 5: Compression of ideal batch no. 12 and repeated ideal batch
Parameters Ideal batch Repeated ideal
no. 12 batch 1
Friability (%) 0.0730.01764 0.09±0.0057
Hardness (kg/cm2 ) 4.10±.05 4.03±0.087
Disintegrationtime (min.)
In aqueous medium (distilled water) 26.16±0.5376 25.57±0.4860
In simulated gastric fluid (dist. water with 0.1M HCl) 25.19±0.1110 24.72±0.1881

Table 6: Detail of Preparation of Qurse Tabasheer final batch

Sr. Parameters Batch I Batch II Batch III
No. (Ideal batch (Repeated (Repeated
no. 12) ideal batch 1) ideal batch 2)
1. Quantity of drugs powder (g) 120 120 120
2. Quantity of binder (g) (20 % of total wt. of 24 24 24
drug powder)
3. Quantity of lubricant (g) 1.2 1.2 1.2
4. Quantity of glidant (g) 1.2 1.2 1.2
5. Percentage of binder in Tablet 16.39% 16.39% 16.39%
6. Total time for preparation of tablets (hr) 48-50 48-50 48-50
7. Quantity of tablets obtained (g) 114 116 113
8. Quantity of tablets obtained (%) 77.97 79.18 77.13
9. Quantity of residue after making tablet (g) 18.5 16 19.5

Table 7: Standard specification of preparation for Qurse Tabasheer

Sr. no. Preparation procedure Standard specification forQurse Tabasheer
1. Grinding Dry grinding for all drug, and wet grinding for Tukhme
Kahu and Tukhme khurfa and then drying.
2. Powder size 100 no. mesh sieve
3. Binder and it’s concentration Gum acacia 20% of total w.t. of drug powder
(30% w/w solution in distilled / R.O water)
4. Granules size 16 no. mesh Sieve
5. Temperature and duration of drying of 60°C for 60 minutes
granules
6. Compression machine and pressure Multi-station rotary presses at 6 tons pressure
7. Post-compression (Tablets) temperature 60°C for 30 minutes
and duration of drying

60
 Journal of Research in Unani Medicine, Vol 4, Issue 1
Discussion
Process standardization of Qurse Tabasheer starts
from powdering of crude drugs, Quality of good
tablet also depends on the particle size of the
ingredients and attempt have been made to
maintain the uniform particle size in respect of
Sieve no. Some of the drugs in formulation were
very tough and fibrous such as Tukhme Khurfa and
Tukhme Kahu and particle size of 100 and 120
mesh sieve was achieved with the help of wet
grinding then drying of wet mass to prevent
growth of micro-organism, high yield was also
achieved by this method. Rest of the drugs easily
passes through no. 80,100 and 120 mesh sieve.
Maximum yield of powder was achieved for Gile
Armani.
Without lubricant and glidant good flow in granules
was observed in pilot batches but keeping in mind
industrial production in bulk, magnesium
carbonate and liquid paraffin were used as a
glidant and lubricant in 1% concentration . They
14
were added just before compression and mixed or
tumbled gently without breaking granules to fine
particle magnesium carbonate was first sieve
through 100 mesh to break the lump / agglomerate
(bolting) . Presence of clay and silica in large
12
quantity as a constituents in its ingredients such as
in Gile Armani and Tabasheer, may be working as
a disintegrant and glidants. No scratches and
fracture on edges of tablets or any other defect
were observed in the final batch. Different
excipients such as binders (PVP, gelatin, other
natural binders), glidant and lubricant can be tried
for future studies. High concentration of binder
Gum Acacia (16%) in final selected batch to
maintain the quality can be justifiable owing to its
probable role in diabetes with its hypoglycemic
activity, and might be further aiding in the
hypoglycemic activity of formulation 22. Binder is
added as solution in the powder for preparation of
granules as they are more effective in solution
form 19
. Some percentage of fines was also
observed in granules, care was taken in mixing of
binders and drying so that problem during
compression would be avoided. It was observed
that granules dried for 60 minutes at 60°C and
post-compression drying for 30 minute at 60° C
achieved better friability and hardness when
compared to the batch in which granules were
dried for 30 minutes. Drying is required in all wet
granulation procedure; in 60 minute drying
probably water was removed to the optimum level
of concentration within the granules helping to
attain control over microbial content. During
drying inter particulate bonds result from fusion or
re-crystallization and curing of the binding agent
(Van der Waals forces playing a significant role),
drying of wet granules was done soon after
preparation as natural gums are usually
contaminated with bacteria 19. Post-compression
drying was done to further overcome the moisture
and contamination issue. Decrease in friability
was noted on increase of binders in different
batches, and increase in binder concentration also
increase the hardness and it was also observed that
increasing in drying time i.e. up to 60 minute also
increase the hardness, efforts were made to
maintain hardness of 4kg to improve the strength
of tablet 12 as lesser hardness and excess friability is
commonly encountered in Unani tablets. Process
of compression of dried granules with lubricant
and glidant in tablet presses was uneventful and
61
 Journal of Research in Unani Medicine, Vol 4, Issue 1
smooth.
Batch no. 12 (100 no. mesh sieve powder) and 18
(120 no. mesh sieve powder) were found to be in
acceptance criteria meeting their quality attributes.
Friability, hardness and disintegration of batch no.
12 and 18 was 0.0730.01764, 4.10±.05,
26.16±0.5376 and 0.093±0.01453, 4.21±0.1485,
27.366±0.4767 respectively with 20% binder, and
60 minute granules drying time in both the
batches. Pre-compression parameter of batch no.
12 was good, Compressibility index was 13.56%
and up to 15% usually indicated good to excellent
flow property for achieving good quality of tablet
18
. Out of this, batch no. 12 was selected as final
batch on the basis of lowest friability, greater
hardness and good disintegration time and other
factors such as reference regarding mesh size
mention in NFUM and Unani Pharmacopoeia of
India (fine powder passed through no. 100 mesh
Sieve), 9,10
feasible process for industrial level
production regarding particle size reduction to no.
100 mesh sieve as it was observe that it is difficult
to obtain powder of 120 mesh no. due to tough
nature of some drug present in the formulation, to
increase the retention time of drug for intervention
/ local action in gut for glucose absorption if any in
comparison with particle size 120 mesh as surface
area of no.120 mesh powder will be more and
probably it will absorb faster than no. 100 mesh
size powder. Traditional / herbal medicines for
diabetes can act in four way as per mode of action:
act like insulin, act on insulin secreting beta cells,
act by modifying glucose utilization and act by
miscellaneous mechanisms (dietary fiber content,
reducing or slowing glucose / carbohydrate
absorption) [23,24]
there are many constituent in
Qurse Tabasheer which can exert above mention
mechanism such silica content in Tabasheer and
Gile Armani and fiber content in other drugs can
act locally and remaining in gut (small intestine) of
these ingredient for longer time where glucose
absorption take place can be beneficial and drug
like Punica granatum peel (rind) extract exert
action like protection of pancreas, stimulation of ß
cells, increase number of ß cells and subsequent
release of insulin.[25] Appearance, colour, smell,
taste and texture of final ideal batch were looking
acceptable. When final ideal batch was repeated to
check the reproducibility by following its
manufacturing specification it also demonstrated
results under the set parameters. Further detailed
pharmacodynamic and pharmacokinetic study of
Qurse Tabsheer is needed to establish proper
particle size with sophisticated mechanism.
Conclusion
The present study was undertaken to establish the
pharmacopeial standard of Unani formulation,
Qurse Tabasheer to some extent. This work may
be of utility in improving the quality when
comparing parameters as it shows reproducible
results. This SOP may be used for future reference
for production of ideal Qurse Tabasheer quality
wise.
Acknowledgment
The authors would like to express their
gratefulness to Prof. M.A Siddiqui, Director,
National Institute of Unani Medicine (NIUM)
Bangalore, for providing all the necessary
assistant and stimulation to work and to all the
Pharmacy staff of NIUM Pharmacy, also thankful
to Prof Dr. Satyam Suhas Incharge CCD facility,
IISc (Indian Institute of Sciences) Bangalore for
62

help in XRD analysis.
References
1. Abdin MZ, Abrol YP. (eds.) Traditional System of
Medicine. New Delhi: Narosa Publishing House;
2006. P. 114, 123, 13.
2. Manjula S, Shashidhara S, Anita S, Shilpa S.
Design Development and Evoluation of Herbal
Tablets Containing Andrographis paniculata and
Phylanthus amarus. Pharma Science Monitor An
International Journal of Pharmaceutical Science
2012;3(4):2352-2362.
3. Kabir al-Din, Hakim Muhammad [1894-
1976A.D.], Bayaz Kabeer. Vol 2, Hyderabad.
Hikmat Book Depot, 1955; 146.
4. Hafeez A. Qarabadeen Jadeed. New Delhi,
Central Council for Research in Unani Medicine;
2005. p. 167.
5. Rahman ZS. Kitab Al Murakkabat. Aligarh: Ibne
SinaAcadmy; 2010. p. 131-133.
6. Jeelani G. Kitabul Murakkabat Almaruf
Makhzanul Murakkabat. Delhi: Aijaz Publishing
House; 1995. p. 270.
7. Bano S, Javed K, Jafri MA. Effect of Qurse
Tabashir on Glucose tolerance test in Rats. In:
Abdin MZ, Abrol YP. (eds.) Traditional System of
Medicine. New Delhi: Narosa Publishing House;
2006. p. 304-307.
8. Ahmed D, Sharma M, Mukerjee A, Kant RK,
Kumar V. Antidiabetic, Anti-hyperlipidemic &
Hepatoprotective effect of a Polyherbal Unani
formulation "Qurs Tabasheer" in STZ-diabetic
wistar rats. BMC Complementary and Alternative
Medicine 2013;13(10)
9. The Unani Pharmacopeia of India. Part II. Vol.1st.
New Delhi: Ministry of Health & Family Welfare,
Department of Ayurveda, Yoga & Naturopathy,
Journal of Research in Unani Medicine, Vol 4, Issue 1
Unani, Siddha and Homoeopathy (AYUSH),
Govt. of India; 2007. p. 269, 278.
10. National Formulary of Unani Medicine. (Urdu
Edition). Part.III. Vol. 1st. New Delhi: Department
of AYUSH, Ministry of Health & Family Welfare,
Government of India; 2005. p. 7,141.
11.Waring EJ. Pharmacopeia of India. Delhi: Asiatic
Publishing House; 2005. p. 62.
12. Rudnic EM., Schwartz JB. Oral solid dosage
forms In: Troy BD. (eds), Remington the Science
and Practice of Pharmacy. Vol. Ist. 21th ed. London:
B. I. Publication; 2005. p. 898,892-93, 916.
13. Rasheed NMA, Gupta VC. Standardization of a
Compound Unani Herbal Formulation Qurse Luk
with Modern Techniques. Pharmacognosy
Research 2010;2(4):237-241.
14. Said HM. Hamdard Pharmacopeia of Eastern
Medicine. Pakistan: Hamdard Foundation; 1997.
p. 217-218.
15. Raymond CR, Paul JS, Marian EQ. Handbook of
Pharmaceutical Excipients. 6 t h ed. UK:
Pharmaceutical Press; 2009. p. 397.
16. General Chapters: <616> Bulk density and Tapped
density, 2011 The United States Pharmacopeial
Convention 2011[Cited on 2014 Feb 13] Available
from URL:
17. Musa A, Adamu BI, Teriyila SA and Musa I. Use of
Hydrophobic Fumed Silica and Selected Binders
in the Tablet Formulation of a Deliquescent Crude
Plant Extract: Vernonia Galamensis (Asteraceae).
Journal of Pharmaceutical and Biomedical
sciences 2011;6(13):2.
18. Marshall K. Compression and consolidation of
powdered solids In: Lachman L, Lieberman HA,
Kanig JL. The Theory and Practice of Industrial
Pharmacy. 3rd ed. Mumbai: Varghese Publishing
63

House; 1987. p. 77, 67.
19. Gilbert S. and Neil RA. Tablets In: Lachman L,
Lieberman HA, Kanig JL. The Theory and
Practice of Industrial Pharmacy. 3 ed. Mumbai:
rd
Varghese Publishing House; 1987. p. 295-320,
300, 320, 327.
20. Anonymous. The Ayurvedic Pharmacopeia of
India. Part I, Vol. 7th. ed. 1st. New Delhi: Ministry
of H & FW, Dept of AYUSH, Govt. of India; 2009.
p. 5-7.
21. Ghani N. Khazainul Advia. (reprint) New Delhi:
Idara Kitabus- Shifa; 2010. p. 1127.
22. Sharma RD. Hypoglycemic effect of Gum Acacia
in Healthy Human Subjects. Nutrition Research
Journal of Research in Unani Medicine, Vol 4, Issue 1
1985; 5(12):1437-1441.
23. Wadkar KA, Magdum CS, Patil SS and Naikwade
NS. Anti-diabetic Potential and Indian medicinal
plants. Journal of Herbal Medicine and
Toxicology 2008; 2(1)45-50.
24. Sharma RD. Effect of fenugreek seeds and leaves
on blood glucose and serum insulin responses in
human subjects. Nutr Res 1986; 6:1353-1364.
25. Enas AM, Khalil. Antidiabetic effect of an
aqueous extract of Pomegranate (Punica
granatum L.) peels in normal and alloxan diabetic
rats. The Egyptian Journal of Hospital Medicine
2004; 16:92-99.
64