Assessment of The Toxicological Profile of The New Dioxidine Dosage Form (Solution for Topical and External Use, 0.025%)
The general toxicity was studied with an assessment of local tolerability, immunotoxicity, and pharmacological safety of the new medicine Dioxidine®, a solution for topical and external use, 0.25 mg/ml (0.025%) for the treatment of acute tonsillopharyngitis (JSC «Valenta Pharm», Russia). The experim...
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LLC "Publishing House OKI"
2022-11-01
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| Series: | Антибиотики и Химиотерапия |
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| Online Access: | https://www.antibiotics-chemotherapy.ru/jour/article/view/944 |
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| author | M. V. ZHURAVLEVA E. A. ROSHCHINA C. A. LOSEVA A. V. GUROV |
| author_facet | M. V. ZHURAVLEVA E. A. ROSHCHINA C. A. LOSEVA A. V. GUROV |
| author_sort | M. V. ZHURAVLEVA |
| collection | DOAJ |
| description | The general toxicity was studied with an assessment of local tolerability, immunotoxicity, and pharmacological safety of the new medicine Dioxidine®, a solution for topical and external use, 0.25 mg/ml (0.025%) for the treatment of acute tonsillopharyngitis (JSC «Valenta Pharm», Russia). The experiment included 48 rabbits (divided in equal proportion by sex) randomized into 3 groups (n=16 in each group), whose back wall of the pharynx was irrigated with the studied substances for 28 days. Group 1 — control (aqueous solution of NaCl 0.9% for infusions at a daily dose of 4.0 ml/animal); group 2 — dioxidine (1.8 ml/animal); group 3 — dioxidine (4.0 ml/animal). The animals were observed for the entire period of drug administration — up to the 28th day of the experiment, as well as during the delayed observation period — up to the 58th day. The following indicators were recorded: lethality, daily monitoring of general condition and behavior, weight, feed and water consumption, respiratory rate, heart rate, blood pressure, electrocardiogram, mass coefficients of internal organs. Immunotoxicity, poisoning symptoms, adrenal insufficiency, as well as animal autopsy results were assessed. Clinical and biochemical blood tests, blood coagulation system analysis, urine analysis, macroscopic and histological examination of internal organs were performed. The absence of statistically significant differences in all evaluated indicators between the group of animals receiving dioxidine solution for topical and external use, 0.25 mg/ml (0.025%) at a dose of 1.8 ml/animal (equivalent to 15 therapeutic doses for humans), the group receiving dioxidine at a dose of 4.0 ml/animal (equivalent to 35 therapeutic doses for humans) and the control group allowed us to draw conclusions concerning the absence of signs of general toxicity, including toxic effects on the adrenal glands, cardiotoxicity, immunotoxicity, and toxic effects on other organs and organ systems, as well as local irritant and toxic effects after repeated irrigation of dioxidine on the back wall of the pharynx in rabbits for 28 days and during the period of delayed observation. |
| format | Article |
| id | doaj-art-c8659fac751641ea8793bb88d7e524d2 |
| institution | Kabale University |
| issn | 0235-2990 |
| language | Russian |
| publishDate | 2022-11-01 |
| publisher | LLC "Publishing House OKI" |
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| series | Антибиотики и Химиотерапия |
| spelling | doaj-art-c8659fac751641ea8793bb88d7e524d22025-08-20T03:37:09ZrusLLC "Publishing House OKI"Антибиотики и Химиотерапия0235-29902022-11-01677-8243210.37489/0235-2990-2022-67-7-8-24-32855Assessment of The Toxicological Profile of The New Dioxidine Dosage Form (Solution for Topical and External Use, 0.025%)M. V. ZHURAVLEVA0E. A. ROSHCHINA1C. A. LOSEVA2A. V. GUROV3I. M. Sechenov First Moscow State Medical University (Sechenov University)JSC RMC «Home of Pharmacy»JSC RMC «Home of Pharmacy»Pirogov Russian National Research Medical University of the Ministry of Health of the Russian Federation; Sverzhevsky Research Clinical Institute of OtorhinolaryngologyThe general toxicity was studied with an assessment of local tolerability, immunotoxicity, and pharmacological safety of the new medicine Dioxidine®, a solution for topical and external use, 0.25 mg/ml (0.025%) for the treatment of acute tonsillopharyngitis (JSC «Valenta Pharm», Russia). The experiment included 48 rabbits (divided in equal proportion by sex) randomized into 3 groups (n=16 in each group), whose back wall of the pharynx was irrigated with the studied substances for 28 days. Group 1 — control (aqueous solution of NaCl 0.9% for infusions at a daily dose of 4.0 ml/animal); group 2 — dioxidine (1.8 ml/animal); group 3 — dioxidine (4.0 ml/animal). The animals were observed for the entire period of drug administration — up to the 28th day of the experiment, as well as during the delayed observation period — up to the 58th day. The following indicators were recorded: lethality, daily monitoring of general condition and behavior, weight, feed and water consumption, respiratory rate, heart rate, blood pressure, electrocardiogram, mass coefficients of internal organs. Immunotoxicity, poisoning symptoms, adrenal insufficiency, as well as animal autopsy results were assessed. Clinical and biochemical blood tests, blood coagulation system analysis, urine analysis, macroscopic and histological examination of internal organs were performed. The absence of statistically significant differences in all evaluated indicators between the group of animals receiving dioxidine solution for topical and external use, 0.25 mg/ml (0.025%) at a dose of 1.8 ml/animal (equivalent to 15 therapeutic doses for humans), the group receiving dioxidine at a dose of 4.0 ml/animal (equivalent to 35 therapeutic doses for humans) and the control group allowed us to draw conclusions concerning the absence of signs of general toxicity, including toxic effects on the adrenal glands, cardiotoxicity, immunotoxicity, and toxic effects on other organs and organ systems, as well as local irritant and toxic effects after repeated irrigation of dioxidine on the back wall of the pharynx in rabbits for 28 days and during the period of delayed observation.https://www.antibiotics-chemotherapy.ru/jour/article/view/944general toxicitylocal irritant effectadrenal insufficiencydioxidinepharmacological safety |
| spellingShingle | M. V. ZHURAVLEVA E. A. ROSHCHINA C. A. LOSEVA A. V. GUROV Assessment of The Toxicological Profile of The New Dioxidine Dosage Form (Solution for Topical and External Use, 0.025%) Антибиотики и Химиотерапия general toxicity local irritant effect adrenal insufficiency dioxidine pharmacological safety |
| title | Assessment of The Toxicological Profile of The New Dioxidine Dosage Form (Solution for Topical and External Use, 0.025%) |
| title_full | Assessment of The Toxicological Profile of The New Dioxidine Dosage Form (Solution for Topical and External Use, 0.025%) |
| title_fullStr | Assessment of The Toxicological Profile of The New Dioxidine Dosage Form (Solution for Topical and External Use, 0.025%) |
| title_full_unstemmed | Assessment of The Toxicological Profile of The New Dioxidine Dosage Form (Solution for Topical and External Use, 0.025%) |
| title_short | Assessment of The Toxicological Profile of The New Dioxidine Dosage Form (Solution for Topical and External Use, 0.025%) |
| title_sort | assessment of the toxicological profile of the new dioxidine dosage form solution for topical and external use 0 025 |
| topic | general toxicity local irritant effect adrenal insufficiency dioxidine pharmacological safety |
| url | https://www.antibiotics-chemotherapy.ru/jour/article/view/944 |
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