StatusThe thesis was presented on the 17 March, 2021
Approved by NCAA on the 25 June, 2021
Abstract– 0.57 Mb / in romanian
3.82 Mb /
Thesis structure: introduction, 5 chapters with the synthesis of the obtained results, general conclusions and practical recommendations, list of references of 175 titles, 18 appendices, 120 pages of basic text, 19 figures, 30 tables. The obtained results are published in 11 scientific papers.
Aim: innocuity research, evaluation of the hepatoprotective and gastroprotective effects of coptizine bisulfate, elucidation of the possibilities of its use for hepato-biliary diseases.
Thesis objectives: Study of the innocuity of the CB to determine its safety limits; determination of the hepatoprotective action with the evaluation of the hepatic, hematological and biochemical indices at its administration in different doses; comparative assessment of the evolution of acute toxic hepatitis when administrated coptizine bisulphate and the reference substance berberine bisulphate in different doses; elucidation of its regenerative and gastroprotective aspects, depending on doses, in the therapy of experimental gastric ulcers, elucidation of aspects of its clinical application for the treatment of patients with hepato-biliary diseases.
Scientific novelty and originality: performing for the first time preclinical studies of coptizine bisulphate, establishing its innocuity; highlighting bioavailability study methods; performing the comparative study of coptizine bisulfate and berberine bisulfate and finding its beneficial influence on experimental acute toxic hepatitis with elucidation of the beneficial hepatoprotective action in correlation with dose, duration of administration and reference substance; demonstration of dose-dependent acceleration of regeneration of gastric ulcer under the action of coptizine bisulfate.
Solved scientific problem: The pharmacological and toxicological properties of CB have been investigated, that permits to expand and succeessfully find application in the hepatoprotective and cytoprotective drugs; it also allows to expand the knowledge and possibilities in the field of treatment of the liver and biliary tract disorders and it makes it possible to investigate some aspects of the regenerative therapy in the gastrointestinal tract disorders.
Theoretical significance: The complex research of a new indigenous drug substance – CB was performed for the first time. It has been served as a fundamental support in order to explain the specific properties that will allow the elaboration of the preclinical research dossier for the evaluation of the subsequent clinical studies.
Applicative value: The expanding of the arsenal of the indigenous drugs, used in the treatment of the liver and biliary tract disorders, gastric and duodenal ulcers and the elaboration of the monograph for the subsequent pharmaceutical forms.
Implementation of scientific results: The results of the study were implemented in the teaching process at the Departments of: pharmacology and clinical pharmacology, pharmacology and clinical pharmacy, drug technology and in the scientific process at the Laboratory of preclinical and clinical evaluation of the drug.