B. Kuzminov, T. S. Zazuljak, V. Turkina
Feb 28, 2016
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Quality indicators
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Abstract
The toxicological assessment of diazoline, the first- generation antihistaminic preparation, was carried out together with justification of the hygiene standard for permissible content ( (Tentative Safe Exposure Level-TSEL) of occupational air in production premises. It was found out that according to acute oral toxicity criterion, Diazoline refers to low hazardous substances. In the clinical picture of acute and sub-chronic intoxication, CNS involvement prevails. Diazolin has a weak local irritant effect in case of contact with mucous membranes, shows a strong cumulative activity. In case of intracutaneous sensitization, it influences indicators of the cellular and humoral component of innate and acquired immunity. TSEL of diazoline in occupational air is 1.0 mg/m . Toxicity effects of «Cigalin» and «Ferocit» lyophilizates used for formulation of the radiopharmaceutical preparation 68Ga-citrate were studied in animal organisms (rats, mice). Good tolerability, absence of pronounced intoxication symptoms, allergenic effects and animal deaths were noted in experiments using a recommended clinic dose of lyophilizates. «Cigalin» didn’t produce toxicity effects influencing on statistically significant changes in blood main hematological and biochemical parameters. Similar changes in case of «Ferocit» used in multiple doses were functionally reversible. The results permit to characterize 68Ga-citrate as safe for clinical applications in radionuclide diagnostics for PET imaging of inflammation and infection.