RESUMEN
Se desarrolló y validó un método analítico para la determinación cuantitativa de bacitracina zinc al 15 por ciento y bacitracina metilen disalicilato al 11 por ciento, por el método de cilindro en placa (difusión en agar), con el fin de ser usado en el control de calidad de las materias primas y productos farmacéuticos. Se evaluaron los parámetros de especificidad, selectividad, linealidad del sistema, y del método, exactitud, límite de cuantificación y precisión. Mediante el diseño experimental y la evaluación estadística de los resultados, se demostró que el método analítico es específico, selectivo, lineal, preciso (CV< 5 por ciento) y exacto (sesgo< 3 por ciento, Gexp< Gtab y t exp< t tab) en el intervalo de las concentraciones estudiadas. El límite de cuantificación y de detección fue de 0,02 y 0,005 UI/mL respectivamente. Las características de desempeño analítico cumplen con los requisitos para la aplicación analítica propuesta.
An analytical method was developed and validated for quantitative determination of 15 percent zinc bacitracine and 11 percent disalicylate methylene-bacitracine by the plate-cylinder method (agar diffusion) to be used in quality control of raw products and pharmaceutical products. Specificity, selectivity, system and method linearity, accuracy, quantification and precision parameters were assessed. By the experimental design and the statistic evaluation of results, it was demonstrated that the analytical method is specific, selective, linear, precise (CV< 5 percent) and exact (bias < 3 percent, Gexp< Gtab< t exp< t tab) during the study concentrations. The quantification and detection limit was of 0.02 and 0.005 Ul/mL, respectively. The analytical performance characteristics fulfill the requirement for the proposal analytical implementation.
RESUMEN
BACKGROUND AND AIMS. The present research project has been made mainly with the idea of comparing the tensile strength values and histological answers of three types of colon anatomises: sutured with silk and sutureless anastomoses with 2-octylcyanocrylate and N-butyl-2-cyanoacrylate. METHODS. 112 Wistar rats distributed into three groups of 35 animals and a last control group of 7 have been used for this. Group 1: silk, group 2: 2-octyl-cyanocrylate, group 3: N-butyl-2-cyanoacrylate, group 4: Control group. The following surgical interventions were practiced on them: A cross section of the colon, followed by: group 1: an end-to-end discontinuoussuture anastomoses with Silk; group 2: sutureless anastomoses with 2-octyl-cyanocrylate; group 3: sutureless anastomoses with N-butyl-2-cyanoacrylate. On the 10th, 20th, 30th, 40th and 50th days we proceeded to measure the anastomoses' tensile strength value for each series. In the same period of time we carried out the following anatomic-pathological determinations: a) sharp inflammation; b) oedema; c) non-specific chronic inflammatory infiltrate; d) granulomatous inflammatory infiltrate to foreign bodies; e) fibrosis. RESULTS. The results obtained indicate a greater anastomoses' tensile strength for group 2 and 3. The anatomic-pathological values show a better response to anastomoses with adhesives than with conventional sutures. CONCLUSIONS. All these experimental results lead us to conclude that the cyanocrilates used to carry out sutureless anastomoses may be an alternative to the handmade conventional anastomoses. Moreover they are easy to be implemented (AU)
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