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DETERMINATION OF THE SPECIFIC ACTIVITY OF “VAIDAZ” GEL
D. T. Gaibnazarovа
Cand. Pharm. Sci., Associate Professor Tashkent Pharmaceutical Institute,
Tashkent, Republic of Uzbekistan
D. B. Kasimova
Assistant Eurasian Medical University, Tashkent, Republic of Uzbekistan
https://doi.org/10.5281/zenodo.14711374
Abstract:
The study investigated the specific activity and antimicrobial properties of
“Vaidaz” gel - 15% (Sample 01, Shelf Life 3 years), developed at the Department of
Pharmaceutical Production Organization and Quality Management of Medicines at Tashkent
Pharmaceutical Institute. The research demonstrated that the drug possesses anti-
inflammatory and minor antibacterial effects. The research results are documented in a
scientific report on research work in accordance with the requirements of GOST and O’zDSt
2762:2018 “Good Laboratory Practice,” Tashkent 2018.
Keywords:
Specific activity, gel, “Vaidaz”.
Relevance of the problem:
The problem of drug provision, rational and safe
pharmacotherapy has become one of the most pressing tasks for the activities of clinicians and
pharmacists. This is due, on the one hand, to the constantly growing drug market and the
volume of scientific information, and on the other hand, to the need to determine the most
sought-after groups and classes of drugs. In the context of existing healthcare resources,
rational use of high-quality, effective, safe drugs and the creation of new drugs by combining
previously known drugs with an innovative approach is a priority task for pharmacy.
Objective of the study:
Determination of the specific activity of “Vaidaz” gel.
Materials and methods of the study:
“Vaidaz” drug - 15% gel, biological and
microbiological methods.
Objective of the study:
To study the specific activity of the “Vaidaz” drug - 10% gel
(Sample 01, Shelf Life 3 years), developed at the Department of Pharmaceutical Production
Organization and Quality Management of Medicines at Tashkent Pharmaceutical Institute in an
experiment on white rats.
Results and Discussion:
The anti-inflammatory effect of the gel was studied using the “histamine edema” method
on 18 white rats weighing 180-200 g of both sexes, compared with the “Fastum gel” drug
produced by A. Menarini Manufacturing Logistics and Services S.r.L, Italy. The paw volume of
the rats was measured in the norm beforehand. The compared drugs were applied once
topically in a thin layer 1 time a day before histamine administration and every hour during the
experiment.
[4]
For the experiment, the rats were divided into groups of 6 individuals each.
The drugs were administered as follows: 1st group (control) - 0.1 ml of 1% histamine
solution; 2nd group (experimental) - “Vaidaz” drug in a thin layer + 0.1 ml of 1% histamine
solution. 3rd group (experimental) - “Fastum gel” drug produced by A. Menarini Manufacturing
Logistics and Services S.r.L, Italy in a thin layer + 0.1 ml of 1% histamine solution.
An acute inflammatory reaction (edema) was reproduced by subplantar (between the 1st
and 2nd toes of the left hind paw) administration of 0.1 ml of 1% histamine solution. The
severity of the inflammatory reaction was assessed 1, 2, and 3 hours after the induction of
inflammation by measuring the paw volume using a plethysmograph.
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The anti-inflammatory effect (AE) was calculated using the following formula:
AE = (Vexp - Vcont / Vcont) x 100, where
Vexp – edema volume in the experimental group; Vcont – edema volume in the control
group.
The results were processed using the method of variation statistics.
[2]
The results
obtained when studying the anti-inflammatory effect of the compared drugs showed that in rats
of the control group, the paw volume after dextran solution administration increased by 62.8%
after 1 hour, by 59.5% after 2 hours, and by 48.8% after 3 hours compared to the initial paw
volume. With the prophylactic use of “Vaidaz” gel, the paw volume after drug administration
was 25.8% less after 1 hour, 33.6% less after 2 hours, and 30.5% less after 3 hours compared
to the control indicators. The AE in rats was 53.5-75.2%.
Similar data was obtained when studying the anti-inflammatory activity of the “Fastum
gel” drug produced by A. Menarini Manufacturing Logistics and Services S.r.L, Italy. With drug
administration, the paw volume after drug administration was 16.2% less after 1 hour, 30.5%
less after 2 hours, and 30% less after 3 hours compared to the control indicators. The AE in rats
was 24.8-68.5%.
Thus, the obtained results show that “Vaidaz” drug, developed at the Department of
Pharmaceutical Production Organization and Quality Management of Medicines at Tashkent
Pharmaceutical Institute, possesses anti-inflammatory activity and is not inferior in activity to
the “Fastum gel” drug in an experimental aseptic arthritis in rats. The results of the experiment
are presented in Table 1.
Table 1. Study of the anti-inflammatory effect of the drug “Vaidaz”
Group
Increase in paw weight, ml
Anti-inflammatory effect in %
Baseline
1 hour
2
h
our
3 hour
Control
1,21±0,05
1,97±0,13ˣ 1,93±0,13ˣ
1,80±0,11ˣ
“Vaidaz” (drug)
1,10±0,04
1,46±0,08ˣ
ˠ
53,5%
1,28±0,06ˣ
ˠ
75,1%
1,25±0,05ˣˠ
75,2%
“
“Fastum gel” (drug)
”
1,08±0,04
1,65±0,05ˣ
24,8%
1,34±0,03ˣ
ˠ
63,0%
1,26±0,02ˣˠ
68,5%
Note: ˣ - significance of differences compared to initial values at P < 0.05; ˠ - significance
of differences compared to the control group values at P < 0.05.
The antimicrobial activity of the gel was determined by the agar diffusion method on a
dense nutrient medium by comparing the sizes of the zones of inhibition of the growth of test-
microbes formed during the testing of solutions of certain concentrations of the standard
sample and the test drug.
[6]
Sterile Petri dishes with a flat bottom and the same diameter were used for the analysis.
20 ml of a nutrient medium of a certain composition infected with an 18-20-hour culture of the
test strain (St. Aureus) were poured into the dishes placed on a horizontal table. Corresponding
nutrient media were used for the studies.
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Inoculum preparation: To prepare the inoculum, pure daily cultures of microorganisms
grown on dense nutrient media were used. Several identical, clearly isolated colonies were
selected. Using a loop, a small amount of material was transferred from the tops of the colonies
to a tube with a sterile 0.9% NaCl solution, bringing the density of the inoculum exactly to 0.5
according to the MacFarland standard. The inoculum was used within 15 minutes after
preparation.
Analysis: To conduct the test, a solution of the standard sample C1 from the drug
“Oflomed” 250 mg / 5 ml produced by Innothera Chouzy, France, and a solution of the test
sample I1 from the Vaidaz gel developed at the Department of Pharmaceutical Production
Organization and Quality Management of Medicines at Tashkent Pharmaceutical Institute, were
prepared. On the solidified agar surface, wells were made in the center with a glass cylinder.
The tested drugs were introduced into the wells at the specified concentrations in six Petri
dishes.
Incubation: The dishes were placed in a thermostat at a temperature of (36 ± 1) ° C for
18-24 hours.
After incubation in the thermostat, the zones of inhibition of the growth of
microorganisms formed by the solutions of the compared drugs were measured with a
microbiological ruler with an accuracy of 1 mm. The antimicrobial activity of the compared
drugs was assessed based on the size of the zones.
The obtained data were statistically processed using the STATISTICA program for
Windows 95.
After incubation in the thermostat, the zones of inhibition of the growth of
microorganisms formed by the solutions of the compared drugs were measured with a
microbiological ruler with an accuracy of 1 mm. The antimicrobial activity of the compared
drugs was assessed based on the size of the zones.
The obtained data show that the size of the zones of inhibition of the growth of
microorganisms under the influence of the tested gel is 2.35 times less compared to the
“Oflomelida” drug. The results of the experiment are presented in Table 2.
Table 2.
Zones of inhibition of the growth of microorganisms under the influence of the tested
Vaidaz gel
Preparations
Solution
Concentratio
n
Zones of growth inhibition
of microorganisms, mm
St. aureus
Vaidaz gel
I1
17,0 ± 0,4
Oflomelida
С1
40,0
Conclusions:
Thus, the study of the specific activity of the drug “Vaidaz” - 15% gel
(Sample 01, Shelf Life 3 years), developed at the Department of Pharmaceutical Production
Organization and Quality Management of Medicines at Tashkent Pharmaceutical Institute,
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shows that the drug possesses anti-inflammatory effects. The research results are documented
in a scientific report on research work in accordance with the requirements of GOST and O’zDSt
2762:2018 “Good Laboratory Practice,” Tashkent 2018. The study of the antimicrobial activity
of the drug “Vaidaz” - 15% gel (Sample 01, Shelf Life 3 years), developed at the Department of
Pharmaceutical Production Organization and Quality Management of Medicines at Tashkent
Pharmaceutical Institute, shows that the drug possesses anti-inflammatory and minor
antibacterial effects.
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