Abstract
Aim. To examine an irritating effect, and the presence/absence of sensitizing effect of the «Oflinim» ointment, the acute toxicity has been studied to obtain toxicological specification of the remedy being developed.Methods. Toxicological specification of the «Oflinim» developed ointment has been studied by the “acute” experiment on warm-blooded animals – albino “Wistar” rats, albino mice, guinea pigs, “Chinchilla” rabbits according to the toxicological, biochemical and statistical methods. Considering the ointment is a drug for external use, its potential toxicological effect for different routes of administration in human’s organism according to the requirements has been studied. Due to the fact that the «Oflinim» ointment contains active pharmaceutical ingredients, which are used both in pharmacy and in medicine, every component is used in low doses, and terms of use is limited to several days, the carcinogenic activity of remedy has not been studied.To identify toxicological specification of the «Oflinim» developed ointment, determination of safety degree at its both gastrointestinal administration (single and multiple use), and administration through integuments has been examined. Irritating effect of the «Oflinim» ointment when applied to skin (single and multiple use), as well as upon contact with the eyes mucous membranes, has been determined.Results. It has been determined by pharmacological studies that median lethal dose (LD50) at single application to the skin is more than 2500.0 mg/kg. At single gastrointestinal administration, median lethal dose (LD50) for warm-blooded animals – albino rats and albino mice was more than 5000 mg/kg.Conclusion. Toxicological specification of the «Oflinim» ointment has been studied by conventional methods and in “acute” experiment on warm-blooded animals – albino rats and albino mice.It has been determined by pre-clinical trials that the developed dosage form can be estimated as toxicologically safe ((LD50>70 g/kg), and it does not show any allergenic and irritating effect on the eyes mucous membranes and skin
Highlights
Патоморфологичесие исследования органов животных при изучении острой токсичности лекарственного средства (ЛС) показали, що мазь «Офлиним» не вызывает патологических изменений во внутренних органах
Токсикометрия химических веществ загрязняющих окружающую среду [Текст]: пособие / под ред
Summary
Toxicological specification of the «Oflinim» ointment has been studied by conventional methods and in “acute” experiment on warm-blooded animals – albino rats and albino mice It has been determined by pre-clinical trials that the developed dosage form can be estimated as toxicologically safe ((LD50>70 g/kg), and it does not show any allergenic and irritating effect on the eyes mucous membranes and skin Keywords: pharmacological studies, wound process, ointment, median lethal dose, sensibilization, safety, toxicity. Экспериментальные исследования по проведению токсикологических исследований – определения степени опастности мази при разных путях влияния на организм (перорально, эпикутально, влияние на кожные покровы и слизистые оболочки глаз) проведены согласно общепринятым методикам (токсикологическим, биохимическим, статистическим) [4,5,6,7] и в соответствии требований нормативных документов и рекомендаций [8,9,10]. Таблица 1 Показатели токсического действия мази «Офлиним» при одноразовом поступлении в желудок мазь «Офлокаин»
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