Abstract

Over the years, the issues of clinical course and seborrheic dermatitis treatment in children and adults are actual. This is evidenced by numerous publications of domestic and foreign scientists. Seborrheic dermatitis occurs in 20-25 % of the population aged 16 to 35 years, the disease is more common in men than in women, which is associated with androgenic stimulation of the sebaceous glands. The cause of seborrheic dermatitis is the fungus Malassezia , and factors that contribute to the development of this disease are: endocrine pathology, neurological diseases, immunodeficiency, genetic predisposition, hyperhidrosis, vitamin deficiency, the effects of alkaline detergents on the skin and other. The correction of seborrheic dermatitis of the scalp is a complex process that must be comprehensive: to eliminate not only the symptoms, but also to effect on the causes of the disease. In the pharmaceutical market ofUkraine, the number of combined drugs used for the treatment and prevention of seborrheic dermatitis is quite limited. Because of that it is important to develop a new drug in the form of shampoo for the prevention and treatment of this hair disease. Aim. To study the toxicological characteristics and pharmacological activity of a new drug in the form of shampoo. Materials and methods. One of the most important requirements for drugs is their health safety. The study of toxicological properties of the new drug for the prevention and treatment of seborrheic dermatitis has been carried out according to the guidelines of the State Pharmacological Center of Ukraine. The study included the identification of possible toxic effects with a single injection, as well as application in the form of skin applications and «conjunctival test». The study of pharmacological activity included the research of antialterative effect on a model of linear wounds, as well as reparative effect on a model of a linear cut wound in rats. Results. The results of the study indicated the absence of toxic effects of the new drug under acute experimental conditions on two types of laboratory animals with two ways of administration. According to the classification of K. K. Sidorov, the studied agent belongs to the IV class of toxicity – low-toxic substances (LD > 2810 mg/kg). It has been found that this drug has no local irritant effect on contact with the skin and mucous membranes of the eye. During the study of antialterative activity of a new drug in the form of shampoo, it has been found that the expressive activity showed a sample with the following components: octopyrox – 0.5 %; α-lipoic acid – 0.5 %; urea – 5.0 % and the rate of wound healing on the 15th day of the experiment was not inferior to the reference drug «PhysiObebe Mustela Bebe». It has been confirmed that in the model of a linear cut wound in rats, the new drug in the form of shampoo shows a pronounced reparative activity and exceeds the same indicator of the comparison drug «PhysiObebe Mustela Bebe». Conclusions. The results of the study indicated the absence of toxic effects of the new drug (according to the classification of K. K. Sidorov belongs to the IV class of toxicity – low-toxic substances), as well as local irritation in the applied to the skin and mucous membranes of the eye. The new drug in the form of shampoo under the conditions of model pathology showed pronounced antialterative and reparative activity.

Highlights

  • The cause of seborrheic dermatitis is the fungus Malassezia, and factors that contribute to the development of this disease are: endocrine pathology, neurological diseases, immunodeficiency, genetic predisposition, hyperhidrosis, vitamin deficiency, the effects of alkaline detergents on the skin and other

  • The study of toxicological properties of the new drug for the prevention and treatment of seborrheic dermatitis has been carried out according to the guidelines of the State Pharmacological Center of Ukraine

  • The results of the study indicated the absence of toxic effects of the new drug under acute experimental conditions on two types of laboratory animals with two ways of administration

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Summary

Introduction

Результати дослідження свідчать про відсутність токсичного впливу нового лікарського засобу за умов гострого експерименту на двох видах лабораторних тварин при двох шляхах введення. При вивченні антиальтеративної активності нового ЛЗ у вигляді шампуню встановлено, що виразну активність проявив зразок з наступними складовими: октопірокс – 0,5 %; α-ліпоєва кислота – 0,5 %; сечовина – 5,0 % та за показником швидкості загоєння ран на 15-у добу експерименту не поступався референс-препарату «PhysiObebe Mustela Bebe». Результати проведеного дослідження свідчать про відсутність токсичного впливу нового ЛЗ The issues of clinical course and seborrheic dermatitis treatment in children and adults are actual. This is evidenced by numerous publications of domestic and foreign scientists. Because of that it is important to develop a new drug in the form of shampoo for the prevention and treatment of this hair disease

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