ABSTRACT
Se realizó el estudio de estabilidad de una jalea de idoxuridina para el tratamiento de la gingivo estomatitis herpética aguda, mediante una técnica de análisis específica por cromatrografía líquida de alta resolución, con la que se puede cuantificar el contenido de idoxuridina en presencia de sus productos de degradación. Las muestras se almacenaron a diferentes temperaturas y se analizaron de acuerdo con el diseño previamente establecido. se demostró que la formación es estable químicamente y que la reacción de degradación hidrolitíca de la idoxuridina en la jalea es de primer orden; se plantea para este producto una fecha de vencimiento de 5 años, si se almacena a temperatura de refrigeración
Subject(s)
Drug Stability , Stomatitis, Herpetic/drug therapy , Gels , Hydrolysis , Hypothermia, Induced , Idoxuridine/analysis , Idoxuridine/chemistry , Drug StabilityABSTRACT
1. SB-73, a magnesium ammonium phospholinoleate anhydride aggregate, exhibited antiviral action in vitro in the concentration range of 50 to 100 µg/ml against herpes simplex type 1, stomatitis vesicular virus, adenovirus type 5, and in vivo in the dose range of 0.7 to 1.3 mg/Kg against canine parvovirus distemper virus. 2. The lethal dose (LD50) was 2.71 ñ 1.55 g/Kg body weight in mice inoculated intraperitoneally. Oral ingestion of the aggregate up to 30 g/Kg body weight by mice had no lethal effects during the 14 days of observation. 3. In in vitro cytotoxicity experiments with fibroblasts (V-79 Chinese hamster cell line), no toxic effects were observed with SB-73 concentrations (120 µg/ml) having antiviral activity. 4. In a cellular proliferation experimental using hamster V-79 cells, we observed 72% proliferation after treatment of the cells with a high concentration (500 µg/ml) of SB-73. 5. Compound SB-73 showed no genotoxicity for human lymphocytes at concentrations of 100 µg/ml. 6. When the cytoxicity and genotoxicity of SB-73 wee compared with those of acyclovir, idoxuridine and AZT at 500µg/ml concentration the compound was found to have effects similar to those of acyclovir