"Orostim"--polymicrobial preparation for oral administration. I. "In vivo" determination of toxicity and of inborn resistance stimulation characteristic.

"Orostim" is a polymicrobial immunomodulator for oral administration, obtained from bacterial suspensions, disintegrated by ultrasonics and dried by atomization. The preparation was chemically characterized before and after atomization without presenting essential modifications. Orostim was not shown to be toxic in mice and rats by esophageal intubation, as long as 20 days. The animals presented normal evolution; hemoleukograms, serum proteins and alkaline phosphatase, in rats, did not present significant modifications in comparison with controls. Histopathologic examination of the organs, obtained from mice, treated for 20 days (liver, spleen, lung) did not emphasize modifications in comparison with controls. Circulating neutrophils phagocytosis in rabbits, orally treated with Orostim, was increased as compared to 0 time; serum complement values decreased compared to the initial ones for 0 time but turned to normal and reached even superior limits, 10 days after the treatment ending.

Study on possible deleterious effects induced in white mice and rabbits by prolonged administration of polidin in different concentrations.

There were investigated possible deleterious effects induced in white mice and rabbits by prolonged administration of polidin in different concentrations, as well as of polidin associated with membrane fraction of Klebsiella pneumoniae. In the experimental model used all the animals evolved normally presenting some transient blood modifications which occurred after administration of comparatively much higher doses than those usually administered in man. There were not noticed significant macroscopical and microscopical modifications at the level of the organs sampled from mice. The pregnant female mice treated along one month with doses, proportionally 1000 times higher than those used in human therapy, presented some pathological aspects, which disappeared on cessation of therapy with the biological. These animals were not affected by abortions and the experiment proved the absence of some teratogenic effects connected to polidin administration. The prolonged polidin administration also acted as an immunostimulant of the natural and acquired defense system.