Volume 03 Issue 11-2023
32
International Journal of Medical Sciences And Clinical Research
(ISSN
–
2771-2265)
VOLUME
03
ISSUE
11
P
AGES
:
32-37
SJIF
I
MPACT
FACTOR
(2021:
5.
694
)
(2022:
5.
893
)
(2023:
6.
184
)
OCLC
–
1121105677
Publisher:
Oscar Publishing Services
Servi
ABSTRACT
Lophantus anisatus Benth is a plant that grows in Europe and East Asia. In folk medicine, it is used as an anti-
inflammatory and bactericidal agent [1]. Tinctures and decoctions of Lophantus anisatus Benth are used in Tibetan
and Mongolian folk medicine as a general tonic, anti-inflammatory, anti-ulcer, and anti-cough agent [2].
Aqueous extracts from the leaves of this plant are prescribed for inflammatory processes in diseases of the
gastrointestinal tract, liver and urinary tract. The gel obtained from the leaves of Lophantus anisatus Benth has an
antifungal effect [3]. Lophantus anisatus Benth has been found to contain essential oil, flavonoids, tannins, triterpenic
acids, organic acids and ascorbic acids [4, 5-9]. Flowers and leaves contain food additives, apple, lemon and ascorbic
acid, phenol, flavanoid, alkaloid, vitamin B group.
KEYWORDS
The gastrointestinal tract, liver and urinary tract, triterpenic acids, organic acids and ascorbic acids.
INTRODUCTION
The toxicity of the dry extract obtained from the locally
grown Lophantus anisatus Benth plant was studied in
healthy animals quarantined for at least 10-14 days.
Experiments were conducted on 36 white mice of both
sexes weighing 18-22 g, then divided into 6 groups each
(5 experimental groups and one intact).
Research Article
STUDY OF THE ACUTE TOXICITY OF THE DRY EXTRACT FROM THE
SURFACE PART OF LOFANTHUS ANISATUS BENTH GROWN IN LOCAL
CONDITIONS IN LABORATORY CONDITIONS
Submission Date:
November 08, 2023,
Accepted Date:
November 13, 2023,
Published Date:
November 18, 2023
Crossref doi:
https://doi.org/10.37547/ijmscr/Volume03Issue11-05
Normurotova Maxfuza Murotboevna
Tashkent Pharmaceutical Institute, Department Of Pharmacology And Clinical Pharmacy, Uzbekistan
Journal
Website:
https://theusajournals.
com/index.php/ijmscr
Copyright:
Original
content from this work
may be used under the
terms of the creative
commons
attributes
4.0 licence.
Volume 03 Issue 11-2023
33
International Journal of Medical Sciences And Clinical Research
(ISSN
–
2771-2265)
VOLUME
03
ISSUE
11
P
AGES
:
32-37
SJIF
I
MPACT
FACTOR
(2021:
5.
694
)
(2022:
5.
893
)
(2023:
6.
184
)
OCLC
–
1121105677
Publisher:
Oscar Publishing Services
Servi
Experimental animals are kept in vivarium conditions in
accordance with the requirements specified in the
relevant
regulatory
documents.
Appropriate
microclimate parameters were maintained in the room
where the laboratory mice were kept. Animals were
fed complete extruded chow for laboratory animals;
Irrigation was carried out from standard drinking
bottles with prepared water.
The extract was administered to experimental animals
orally, in the form of a suspension, using a metal
atraumatic probe, in the following doses: 1000mg/kg
(0.1ml\20g), 2000mg/kg (0.2ml/20g), 3000mg/kg (0 .3
ml / 20 g), 4000 mg/kg (0.4 ml/20 g), 5000 mg/kg (0.5
ml/20 g) and 6000 mg/kg (0.6 ml/20 g) was sent.
According to the literature, the maximum volume for a
single oral administration is 0.5 ml/20 g and we used
the fractional administration method to administer the
dose of 6000 mg/kg. A substance of 0.6 ml / 20 g was
first injected with 0.1 ml / 20 g, then after 10 minutes 0.5
ml / 20 g.
The animals were then divided into groups and placed
in separate cages and monitored continuously for the
first hour, then hourly on the first day of the
experiment and once a day for the next 13 days (total
observation period 14 days).
For 14 days, daily monitoring was carried out for signs
of intoxication, such as: general condition and behavior
of animals, intensity and nature of motor activity,
presence and nature of seizures, coordination of
movements, skeletal muscle tone, reaction to stimuli
(tactile, sound, light), condition of fur and skin, color of
mucous membranes, amount and consistency of feces,
food and water consumption, changes in div weight,
probability of death. Changes in the div weight of the
experimental animals were recorded on the 1st, 3rd,
7th, 9th and 14th days.
Results of an acute toxicity study of the extract. The
successful introduction of new drugs into clinical
practice presupposes the proven safety of their use.
For this purpose, pre-clinical experimental studies are
important. When the safety of drugs is evaluated and
confirmed by scientific methods, a prerequisite for the
use of new drugs created for the first time in humans is
to conduct toxicological studies in laboratory animals
first. The more thoroughly the toxicity of the drug
under investigation is studied in animals (preclinical
studies), the fewer adverse reactions may occur during
clinical studies [10, 11, 12, 13].
However, preclinical studies traditionally begin with
acute toxicity studies, because acute toxicity studies
help determine the median lethal dose and determine
the safety class of the pharmacological drug being
studied, the most importantly, the data obtained
regarding death. Helps determine the range of dose
selection for studies on specific activities.
Volume 03 Issue 11-2023
34
International Journal of Medical Sciences And Clinical Research
(ISSN
–
2771-2265)
VOLUME
03
ISSUE
11
P
AGES
:
32-37
SJIF
I
MPACT
FACTOR
(2021:
5.
694
)
(2022:
5.
893
)
(2023:
6.
184
)
OCLC
–
1121105677
Publisher:
Oscar Publishing Services
Servi
Preclinical toxicological studies have been conducted
on Lofanthus anisatus Benth extract for enteral use.
The toxicity results of the extract after oral
administration are presented in Table 1.
Table 1 - Toxicity results after oral administration of the extract
Dose
results
1000 mg\kg
10 minutes after the administration of the
extract, a relative decrease in motor activity was
observed in all animals. 20 minutes after the
introduction of the drug, the animals
experienced a state of drowsiness. 1 hour after
the introduction of the extract, the condition of
the animals returned to normal, and no death of
the animals was observed during the entire
period of the experiment.
2000 mg\kg
10 minutes after the administration of the
extract, a decrease in motor activity was
observed in all animals. A state of dissociation
was observed in animals 20 minutes after the
introduction of the drug. 30 minutes after the
administration of the drug, the animals
experienced a state of somnolence. Animals sat
in corners. 1 hour after drug administration, all
animals fell asleep. After 2 hours, the animals
began to wake up, 3 hours after the introduction
of the drug, the condition of the animals
returned to normal, and no death of animals was
observed during the entire period of the
experiment.
3000 mg\kg
10 minutes after the administration of the
extract, a decrease in motor activity was
observed in all animals, hiccups appeared in 2
animals, which stopped 20 minutes after the
administration of the drug. The animals sat in the
corners of the cage 30 minutes after the
injection. 1 hour after drug administration, all
animals fell asleep. After 2 hours, the animals
began to wake up, 3 hours after the introduction
of the drug, the condition of the animals
returned to normal, and no death of animals was
observed during the entire period of the
experiment.
Volume 03 Issue 11-2023
35
International Journal of Medical Sciences And Clinical Research
(ISSN
–
2771-2265)
VOLUME
03
ISSUE
11
P
AGES
:
32-37
SJIF
I
MPACT
FACTOR
(2021:
5.
694
)
(2022:
5.
893
)
(2023:
6.
184
)
OCLC
–
1121105677
Publisher:
Oscar Publishing Services
Servi
4000 mg\kg
A significant decrease in motor activity was
observed in all animals 10 minutes after the
administration of the extract; the animals sat in
the corner two at a time. Half of the animals
developed hiccups, which resolved within a day
of drug administration. 40 minutes after the
drug was administered, the animals became
drowsy. On the 2nd day after the introduction of
the drug, the condition of the animals returned
to normal, and there was no death of the animals
during the entire period of the experiment.
5000 mg\kg
A significant decrease in motor activity was
observed in all animals 10 minutes after the
administration of the extract. The animals sat in
a row along the wall. 1 animal developed hiccups.
40 minutes after the drug was administered, the
animals became drowsy. On the 3rd day after the
introduction of the drug, the condition of the
animals returned to normal, and no death of
animals was observed during the entire period
of the experiment.
6000 mg\kg
A significant decrease in motor activity was
observed in all animals 10 minutes after the
administration of the extract. Animals sat
separately, alone. 5 animals developed hiccups,
which resolved within a day of drug
administration. 40 minutes after the drug was
administered, the animals became drowsy. 1
hour after drug administration, all animals fell
asleep. After 2 hours the animals started to wake
up. 5 days after the introduction of the drug, the
condition of the animals returned to normal, and
no death of the animals was observed during the
entire period of the experiment.
Preliminary data on the clinical presentation of
intoxication indicate that the main target systems are
the central nervous system, which is confirmed by the
drowsiness of experimental animals.
According to the classification described in the
methodological manual of pre-clinical research of
drugs edited by Stefanov A.V.(the classifier has six
levels of toxicity classification). According to GOST
12.1.007-76, substances with an average lethal dose of
Volume 03 Issue 11-2023
36
International Journal of Medical Sciences And Clinical Research
(ISSN
–
2771-2265)
VOLUME
03
ISSUE
11
P
AGES
:
32-37
SJIF
I
MPACT
FACTOR
(2021:
5.
694
)
(2022:
5.
893
)
(2023:
6.
184
)
OCLC
–
1121105677
Publisher:
Oscar Publishing Services
Servi
more than 5000 mg / kg, when entered into the
stomach, belong to the 4th class of "Low-hazardous
substances" (the classifier has four classifications for
the safety of substances contains) ).
Therefore, we chose a maximum dose of 6000 mg/kg
when choosing the maximum dose in the acute toxicity
study.
The data obtained on acute toxicity show that the
extract is very harmless when administered orally,
since the average lethal dose belongs to the fifth
toxicity class (practically non-toxic).
According to acute toxicity data, the maximum
permissible dose of LD is >6000 mg/kg. Therefore, in
future studies, we have fo
llowed the interval ≤ LD 0
when determining the therapeutic dose.
Thus, we can conclude that the acute toxicity of the
extract after oral administration was studied in white
mice. As a result, it was determined that the drug is
absolutely harmless, since the average lethal dose
belongs to the fifth toxicity class - "Practically non-
toxic". It should also be noted that the dose
dependence of the drug in the acute toxicity study was
determined at six oral dose levels. The obtained data
indicate that the study of the acute toxicity of the drug
for oral administration has been completed.
CONCLUSION
Acute toxicity data show that the extract is very
harmless (practically non-toxic) when administered
orally.
According to acute toxicity data, Lethal dose is >6000
mg/kg.
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