Preclinical tests of Staphylococcus aureus somatic antigen as the basis for drugs for treatment of staphylococcal skin infections

AIM: To analyze results of conducted preclinical animal tests of ointment and gel preparations based on the somatic antigen ("Somatin") of Staphylococcus aureus. MATERIALS AND METHODS: Contents of ointment and gel as well as method of "Somatin" extraction from cytosomatin ointment are presented. Standard serum was obtained by immunization of rabbits by "Somatin". Tests for acute and chronic toxicity and sensitizing effect of cytosomatin ointment were performed. 1% gentamycin ointment was used for comparison with cytosomatin ointment and gel for treatment of pyodermia. Preparations were patented. RESULTS: Authenticity and specific activity of ointment and gel preparations were demonstrated. Animal tests for acute and chronic toxicity of cytosomatin ointment did not reveal inflammatory reaction of skin and sclera as well as influence on biochemical parameters of the blood or abnormalities of visceral morphological structure. Assessment of sensitizing effect of cytosomatin ointment did not reveal promotion of allergy. Advantages in treatment of staphylococcal skin infections and wounds with cytosomatin ointment and gel as compared with gentamycin ointment were established. CONCLUSION: The main immunogenic mechanism of "Somatin" substance was activation of complete phagocytosis. The character of immune response was specific. Selected optimal ratios of therapeutic doses for ointment and gel bases promote active permeation of the drug into skin that enhances its therapeutic effect. Duration of treatment with cytosomatin ointment was shortened on 5 days as compared with gentamycin ointment. Duration of treatment with cytosomatin gel was shortened on 8 days as compared with prototype.