Preclinical study

Results of Preclinical study of “Kyzyl may” polyherbal oil.

Kuzdembaeva R. S., Minseitova S.R.,Mavliudova N.M., ElemesovaM.Sh.,Chukanova G.N.
State Medical Institute, Aktiubinsk

Dynamic pattern of environmental situation on the planet, in whole and in particular different regions, is a reason of substantiated scientists warning. Environment is refilled by newly synthesized factors of physical, chemical and biological nature yearly, possessing mutagenic, carcinogenic , toxic and allergic properties. The above mentioned properties of newly synthesized substances should be determined by hygiene regulation. Particular attention should be focused on the problem of the environmental factors influence on human genetic apparatus, as genetic changes which appear in some time and do not have an effect threshold can lead to increase of congenital defect in human populations .

In connection with this, test for genotoxicity, since the mid 70-s, became a part of the basics of hygiene regulation ( along with, for example, test for toxicity or allergenicity ) harmful environmental factors. It is important to note, that all new medications are tested totally for genotoxicity, while there is no such rules for other substances (industrial, agricultural, nutritional and other). Hygienic rating should include assessment of genetic effects within the experiments using different test systems, among which tests Eim with microorganism indicator strain, micronucleus test, cytogenetic methods, Drosophilla melanogaster test and others have the most spread in different scientific laboratories. (Ames В. N. and McCanu J PNAS, 72, 1975: Ilijnskih N.N. and other. Micronucleated analysis and cytogenetic instability. Tomsk, 1992 ). Last time the interest to medications, produced with medicinal plants, significantly increased. Among them, a special place is occupied by domestic medications, in particular the new herbal medicinal product, which is presented in form of medicinal plants oily extract – polyherbal oil “Kyzyl may”. Based on pharmacological trials, it can be used as anti-inflammatory agent and immunostimulative drug. However, preclinical safety studies of this drug and possibility of using the drug as a corrector of the harmful effects of environmental factors performed insufficiently. The aim of this research was to study general toxic and genotoxic effects , allergenic and irritant properties of polyherbal oil “Kyzyl may”. Experiments for studying general toxic effects were performed using 260 nonlinear healthy white mice, with initial body mass  18,0-20,0±2,0 g, separately for males and females (winter-spring period). Dosage are selected based on average daily dose, which are recommended for clinical usage. The duration of drug injection was determined by average use of it in clinical unit – 8-15 days, which is appropriate for one month- period of experimental studies. (“Requirements to preclinical study of general toxic effects of new pharmacological substances” MZ USSR, M., 1985)

Animals were treated with 1, 2, 4 drops of polyherbal oil during 1, 2 and 6 months.

Throughout the experiment all the animals were under daily observation on general vivarium diet under standard conditions, corresponding to sanitary rules concerning animal management and vivarium equipment.

To assess general damaging action, feed consumption, water and hair-covering condition and mucous membranes were noted daily.

Regularly (once in 10 days) the animals were weighted, frequency and respiratory rhythm, heartbeats, body temperature (see Table 1) were registered, and also behavioral reactions (affectability, responsiveness, apprehensive attitude, combativeness/ aggression, jitteriness), myoneuralexitability (tale position, contact reaction, general tonus of skeletal muscles); reflexes (corneal, acoustic meatus) were observed.

At the end of experiment, part of animals in each group was sacrificed and performed gross examination of organs state, tissues, inner organs weighting.

Results of experiments were analyzed by method of variation statistics (M.L.Belenkiy Elements of quantity assessment of pharmacological effect – L., 1963. – 149 p.).All registered data of laboratory animals in the setting of herbal formulation “Kyzyl may” in mentioned dosage range were similar to data of control groups, data differences are statistically invalid.

Genotoxic effect of polyherbal oil”Kyzylmay” was studied on 100 white nonlinear mice with initial body mass 18,0-20,0±2,0 g. As a comparison sea-buckthorn seed oil, which is characterized by absence of genotoxic effect, was taken. Both sea-buckthorn seed oil andpolyherbal oil were given to animals in dosage of 1, 2, 4 drops daily during one month. Genotoxicity was determined by micronucleus test of normochromatic erythrocytes in peripheral blood (Illinskih N.I., Cytology and genetics, v. 22, 1988).

Results of experiments are presented in Table 2. As you can see in table polyherbal oil “Kyzyl may” in mentioned dosage doesn’t possess genotoxicity.

One set of experiments was devoted for studying local irritative, allergenic effect of the preparation “Kyzyl may” using method of multiple (10-14) epikutannuh applications of test substance on different skin areas. Skin area which was covered by polyherbal oil was similar to surrounding skin. Therefore, performing laboratory tests on general toxicity and genotoxic effect; local irritative, allergenic effect of polyherbal oil «Kyzyl may» did not find out any of mentioned effect of examined herbal product, which can be recommended to wide use in clinical practice.

Conclusion:

  1. It is established that polyherbal oil “Kyzyl may” in examined dosage, treated by animals during 1, 2, 6 months, did not provide general toxic effect on body of experimental animals.
  2. Herbal product “Kyzyl may” treated by similar dosage during one month did not provide genotoxic effect.
  3. Local irritative , allergenic effect of the studied preparation was not found.

 LITERATURE

  1. Ames В, N. and McCanu J.PNAS 72, 1975.
  2. Belenkiy M.L.Elements of quantity assessment of pharmacological effect – L., 1963. – 149 p
  3. Illinskih N.N., Illinskih I. N., Nekrasov V.N. Using of micronucleus test in screening and monitoring of mutagens. Cytology and genetics, v. 22, №1, 1988, p. 67-72.
  4. Illinskih N.N., Novitskiy V.V.,Vanchugova N.N., Illinskih I. N. Micronucleated analysis and cytogenetic instability. Tomsk, 1992, 271 p.
  5. Minseitova S.R., Bakiev I.S. Protective role of herbal preparations in mutagenesis of Drosophilla melanogasterhexavalent chromium. Collection of brief scientific reports “Ekogen 2” Tomsk medical university, 1992, 2, 2, 9 (in English and Russian languages).
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