Reproductive toxicity of the lyophilized liposomal dosage form of the borchlorin
https://doi.org/10.17650/1726-9784-2017-16-2-50-59
Abstract
Introduction. The study investigates the embryotoxicity, teratogenicity and reproductive toxicity of lyophilized dosage form borchlorin on rats. Materials and methods. The research was conducted on 210 outbred female rats and 105 outbred male rats weighing 250-300 g. We used a lyophilized dosage form borated chlorin e6 called «Borchlorin liposomal, lyophilisates for dispersion for injection 2.5 mg». The drug was administered intravenously daily for 48 days (males) and 15 days (females) in 2 corresponding total doses for therapeutic dose in mice and rats based on the 10-therapeutic doses. As a control, intact rats were used, as well as rats - males and females who received intravenous 0.9 % sodium chloride solution into the mode corresponding to the mode of administration, and in the amounts corresponding to the maximum volume of the injected solution. Results of the study. To study the damaging effect of lyophilized liposomal formulation borchlorin on the generative function in rats - the identification of the possible negative effect of the drug on the progenesis stage (formation of male and female gametes). It was found that lyophilized liposomal formulation borchlorin has a damaging effect on the reproductive function of male and female and fetal deve lopment (embryotoxicity) rats on the index's ability to fertilization and conception and the index of postimplantation fetal loss. Postimplant death of the fetuses in most pronounced in females treated with a total dose of the drug, therapeutic doses corresponding to 10, coupled with intact males. The lyophilized liposomal formulation borchlorin pre-implantation does not cause the death of the fetus, has no teratogenic effects. Conclusion. The lyophilized dosage form borchlorin has a damaging effect on the reproductive function of male and female and fetal development (embryotoxicity) neinbrednyh rats on the index's ability to fertilization and conception and the index of postimplantation fetal loss. The lyophilized dosage form borchlorin pre-implantation does not cause the death of the fetus, has no teratogenic effects, effects on the physical development of the offspring, and the rate of maturation of the sensory-motor reflexes during the feeding of offspring.
About the Authors
O. I. Konyaeva
N.N. Blokhin Russian Cancer Research Center, Ministry of Health of Russia
Russian Federation
N. Yu. Kulbachevskaya
N.N. Blokhin Russian Cancer Research Center, Ministry of Health of Russia
Russian Federation
V. A. Chaley
N.N. Blokhin Russian Cancer Research Center, Ministry of Health of Russia
Russian Federation
N. P. Ermakova
N.N. Blokhin Russian Cancer Research Center, Ministry of Health of Russia
Russian Federation
A. A. Nikolina
N.N. Blokhin Russian Cancer Research Center, Ministry of Health of Russia
Russian Federation
T. I. Malova
LLC «VETA-GRAND»
Russian Federation
V. M. Bukhman
N.N. Blokhin Russian Cancer Research Center, Ministry of Health of Russia
Russian Federation
References
1. Методические рекомендации по доклиническому изучению репродуктивной токсичности фармакологических средств. Ведомости Фармакологического Комитета 1998;1:13-20.
2. Руководство по экспериментальному (доклиническому) изучению новых фармакологических веществ. Под ред. Р.У. Хабриева. М.: Медицина, 2005. С. 87-100.
3. Руководство по проведению доклинических исследований лекарствен ных средств. Часть первая. Под ред. А.Н. Миронова. М.: Гриф и К, 2012. С. 80-93.
For citations:
Konyaeva O.I.,
Kulbachevskaya N.Yu.,
Chaley V.A.,
Ermakova N.P.,
Nikolina A.A.,
Malova T.I.,
Bukhman V.M.
Reproductive toxicity of the lyophilized liposomal dosage form of the borchlorin. Russian Journal of Biotherapy. 2017;16(2):50-59.
(In Russ.)
https://doi.org/10.17650/1726-9784-2017-16-2-50-59
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