Background: The task to develop new drugs containing metals of variable valence requires systematization of our knowledge, experimental and clinical studies. The aim of the study: To investigate the mechanisms of the effectiveness of the mineral complex containing metals of variable valence in the treatment of respiratory diseases, to conduct preclinical trials and clinical testing of a new inhalation mineral solution. Materials and methods: The ability of cerium (III) ions to exhibit reducing properties was demonstrated by carrying out chemical reactions of cerium (III) chloride and sulfate with potassium permanganate in the presence of sodium hydroxide or sulfuric acid (respectively). Preclinical studies of acute toxicity were carried out on laboratory mice and rats in accordance with the rules of bioethics and with generally accepted ethical standards for the treatment of animals, based on the standard operating procedures of the university, which comply with the rules adopted by the European Convention for the Protection of Vertebrate Animals used for research and other scientific purposes (Strasbourg, 1986). Clinical testing of two forms of the mineral complex for inhalation (1. Inhalation solution for nebulizer – Renerium; 2. intranasal spray) was carried out on 6 groups of volunteers in compliance with human rights and the principles of conducting medical research involving a person as a subject, declared on the 18th General Assembly of the World Medical Association (Helsinki, Finland), voluntary informed consent, approved by the local ethical committee. Results: Mineral preparation for inhalation therapy of patients with acute respiratory diseases does not show acute toxicity in preclinical studies on laboratory animals. The mechanism of action of the drug is most likely associated with the regulation of redox reactions at the level of the cell membrane, mitochondria and cell nucleus, which is manifested by anti-inflammatory and regenerative activity in the mucous membrane of the respiratory tract and alveolar apparatus. Both forms of the drug are well tolerated. A pronounced clinical efficacy of the drug Renerium in the form of inhalation through a compressor inhaler was noted in the case of a 5-day course of treatment, 5 ml once a day. Conclusion: Experimental and clinical data have demonstrated pronounced anti-inflammatory and regenerative properties of a new mineral complex based on cerium (III), the mechanism of which is due to the regulation of redox reactions
Background: The task to develop new drugs containing metals of variable valence requires systematization of our knowledge, experimental and clinical studies. The aim of the study: To investigate the mechanisms of the effectiveness of the mineral complex containing metals of variable valence in the treatment of respiratory diseases, to conduct preclinical trials and clinical testing of a new inhalation mineral solution. Materials and methods: The ability of cerium (III) ions to exhibit reducing properties was demonstrated by carrying out chemical reactions of cerium (III) chloride and sulfate with potassium permanganate in the presence of sodium hydroxide or sulfuric acid (respectively). Preclinical studies of acute toxicity were carried out on laboratory mice and rats in accordance with the rules of bioethics and with generally accepted ethical standards for the treatment of animals, based on the standard operating procedures of the university, which comply with the rules adopted by the European Convention for the Protection of Vertebrate Animals used for research and other scientific purposes (Strasbourg, 1986). Clinical testing of two forms of the mineral complex for inhalation (1. Inhalation solution for nebulizer – Renerium; 2. intranasal spray) was carried out on 6 groups of volunteers in compliance with human rights and the principles of conducting medical research involving a person as a subject, declared on the 18th General Assembly of the World Medical Association (Helsinki, Finland), voluntary informed consent, approved by the local ethical committee. Results: Mineral preparation for inhalation therapy of patients with acute respiratory diseases does not show acute toxicity in preclinical studies on laboratory animals. The mechanism of action of the drug is most likely associated with the regulation of redox reactions at the level of the cell membrane, mitochondria and cell nucleus, which is manifested by anti-inflammatory and regenerative activity in the mucous membrane of the respiratory tract and alveolar apparatus. Both forms of the drug are well tolerated. A pronounced clinical efficacy of the drug Renerium in the form of inhalation through a compressor inhaler was noted in the case of a 5-day course of treatment, 5 ml once a day. Conclusion: Experimental and clinical data have demonstrated pronounced anti-inflammatory and regenerative properties of a new mineral complex based on cerium (III), the mechanism of which is due to the regulation of redox reactions
The authors would like to thank Professor, Doct. Sci. (Pharmacy) Galina P. Vdovina for conducting and describing the results of preclinical studies involving laboratory animals, as well as Renerium LLC for the manufacture of Renerium and Renerium A preparations, providing the necessary reagents and a laboratory for performing part of the chemical experimental studies