ABSTRACT
INTRODUCTION: Aluminum (Al) is a toxic element which may contaminate pharmaceutical products used as individual components to prepare total parenteral nutrition mixtures (TPN). OBJECTIVES: 1) to determine Al levels in the individual components used to prepare TPN mixtures; 2) to compare detected Al levels with those imposed by international regulations (FDA); 3) to calculate the total amount of Al administered to adult and children receiving those typical TPN mixtures. METHODS: Al was determined by Inductively Coupled Plasma- Atomic Emission Spectrometry (ICP-OES) (Perkin Elmer OPTIMA 5100 DV) in 44 individual products, from different labs and lots, belonging to 16 components available in Argentina: dextrose and amino acids for adult formulas and for pediatric formulas: lípids; potassium chloride; sodium chloride, magnesium sulfate; sodium phosphate; calcium gluconate; sodium glycerophosphate, zinc sulfate; multitrace elements; steril water (ampoules and great volume presentations). RESULTS: Al levels were detected in 43 of the 44 the studied components, except sterile water. The components of large volume presented between 249 y 1,580 µg Al/ L, between 4 and 180 times FDA established levels (25 µg Al/ L). Small volume components presented Al levels between 85 y 4,909 g/ L, not declared in labels. CONCLUSIONS: The highest amounts of Al were detected in calcium gluconate, sodium phosphate and multitrace elements. 2) Usually prescribed TPN mixtures would have higher Al levels than those accepted by FDA regulation; 3) The highest aluminum concentration was provided by dextrose, amino acids and lipids in adult TPN mixtures. In neonate TPN mixtures, Al highest amounts were provided by dextrose and calcium gluconate. The calculated concentration of Al in TPN mixtures was higher than those stipulated by international regulation (5 µg Al/kg (body weight)/ d). It would be advisable for manufacturers to declare the content of aluminum in the label, with the aim of avoiding toxicities which would compromise the critical patients' evolution.
Introducción: aluminio (Al) es un elemento tóxico que puede ser contaminante de productos farmacéuticos utilizados para preparar mezclas de nutrición parenteral (NP). Objetivos: 1) determinar la concentración de Al en componentes individuales utilizados para preparar mezclas de NP; 2) comparar las cantidades detectadas con los límites de la regulación internacional (FDA); 3) calcular la cantidad de Al administrada en fórmulas habituales de NP para neonatos, niños y adultos. Materiales y métodos: El Aluminio fue determinado por Espectroscopía de Emisión Atómica-Plasma-Inductivo de Argón (Perkin Elmer 5100 DV) en 44 productos comerciales, de diferentes laboratorios y lotes, correspondientes a 16 componentes individuales: dextrosa; aminoácidos para adultos y pediátricos; lípidos; cloruro de potasio; cloruro de sodio, sulfato de magnesio; fosfato de sodio; gluconato de calcio; glicerofosfato de sodio; sulfato de zinc; elementos multitraza; agua estéril en ampollas y de gran volumen. Resultados: Todos los componentes de gran volumen, excepto el agua, contenían entre 249 y 1.580 µg/L, superando entre 4 y 180 veces mas que los niveles establecidos por la FDA (25 µg/L). Los componentes de pequeño volumen contenían entre 85 y 4.909 µg/L, no declarados en los rótulos. Conclusiones: 1) La mayor cantidad de aluminio se encontró en el gluconato de calcio, fosfato de sodio y elementos multitraza. 2) Las mezclas de uso habitual para NP presentan niveles de Al mayores al límite de FDA. Los componentes que aportan mayor cantidad de aluminio en las mezclas de NP para adultos son: glucosa, aminoácidos y lípidos, pero en las de neonatos, el mayor aporte proviene de la dextrosa y gluconato de calcio. 3) En las mezclas de NP para neonatos, niños y adultos la cantidad de aluminio administrado por kg de peso supera la recomendación de FDA (5 µg/kg de peso /día). Los productos comerciales deberían declarar el contenido de Al para no comprometer la evolución de los pacientes graves.
Subject(s)
Aluminum/analysis , Parenteral Nutrition Solutions/analysis , Parenteral Nutrition Solutions/standards , Adult , Argentina , Child , Humans , Infant, Newborn , Legislation, Drug , Spectrophotometry, Atomic , United States , United States Food and Drug AdministrationABSTRACT
Introducción: aluminio (Al) es un elemento tóxico que puede ser contaminante de productos farmacéuticos utilizados para preparar mezclas de nutrición parenteral (NP). Objetivos: 1) determinar la concentración de Al en componentes individuales utilizados para preparar mezclas de NP; 2) comparar las cantidades detectadas con los límites de la regulación internacional (FDA); 3) calcular la cantidad de Al administrada en fórmulas habituales de NP para neonatos, niños y adultos. Materiales y métodos: El Aluminio fue determinado por Espectroscopía de Emisión Atómica-Plasma-Inductivo de Argón (Perkin Elmer 5100 DV) en 44 productos comerciales, de diferentes laboratorios y lotes, correspondientes a 16 componentes individuales: dextrosa; aminoácidos para adultos y pediátricos; lípidos; cloruro de potasio; cloruro de sodio, sulfato de magnesio; fosfato de sodio; gluconato de calcio; glicerofosfato de sodio; sulfato de zinc; elementos multitraza; agua estéril en ampollas y de gran volumen. Resultados: Todos los componentes de gran volumen, excepto el agua, contenían entre 249 y 1.580 µg/L, superando entre 4 y 180 veces más que los niveles establecidos por la FDA (25 µg/L). Los componentes de pequeño volumen contenían entre 85 y 4.909 µg/L, no declarados en los rótulos. Conclusiones: 1) La mayor cantidad de aluminio se encontró en el gluconato de calcio, fosfato de sodio y elementos multitraza. 2) Las mezclas de uso habitual para NP presentan niveles de Al mayores al límite de FDA. Los componentes que aportan mayor cantidad de aluminio en las mezclas de NP para adultos son: glucosa, aminoácidos y lípidos, pero en las de neonatos, el mayor aporte proviene de la dextrosa y gluconato de calcio. 3) En las mezclas de NP para neonatos, niños y adultos la cantidad de aluminio administrado por kg de peso supera la recomendación de FDA (5 µg/kg de peso /día). Los productos comerciales deberían declarar el contenido de Al para no comprometer la evolución de los pacientes graves (AU)
Introduction: Aluminum (Al) is a toxic element which may contaminate pharmaceutical products used as individual components to prepare total parenteral nutrition mixtures (TPN). Objectives: 1) to determine Al levels in the individual components used to prepare TPN mixtures; 2) to compare detected Al levels with those imposed by international regulations (FDA); 3) to calculate the total amount of Al administered to adult and children receiving those typical TPN mixtures. Methods: Al was determined by Inductively Coupled Plasma- Atomic Emission Spectrometry (ICP-OES) (Perkin Elmer OPTIMA 5100 DV) in 44 individual products, from different labs and lots, belonging to 16 components available in Argentina: dextrose and amino acids for adult formulas and for pediatric formulas: lípids; potassium chloride; sodium chloride, magnesium sulfate; sodium phosphate; calcium gluconate; sodium glycerophosphate, zinc sulfate; multitrace elements; steril water (ampoules and great volume presentations). Results: Al levels were detected in 43 of the 44 the studied components, except sterile water. The components of large volume presented between 249 y 1,580 µg Al/ L, between 4 and 180 times FDA established levels (25 µg Al/ L). Small volume components presented Al levels between 85 y 4,909 g/ L, not declared in labels. Conclusions: The highest amounts of Al were detected in calcium gluconate, sodium phosphate and multitrace elements. 2) Usually prescribed TPN mixtures would have higher Al levels than those accepted by FDA regulation; 3) The highest aluminum concentration was provided by dextrose, amino acids and lipids in adult TPN mixtures. In neonate TPN mixtures, Al highest amounts were provided by dextrose and calcium gluconate. The calculated concentration of Al in TPN mixtures was higher than those stipulated by international regulation (5 µg Al/kg (body weight)/ d). It would be advisable for manufacturers to declare the content of aluminum in the label, with the aim of avoiding toxicities which would compromise the critical patients evolution (AU)
Subject(s)
Humans , Parenteral Nutrition/methods , Parenteral Nutrition Solutions/pharmacology , Aluminum/isolation & purification , Argentina , Food, Formulated/standards , Drug Compounding/standards , Legislation, Food , Legislation, DrugABSTRACT
The use of Eriochrome Black T in an alkaline, 40% methanol solution was found to be appropriate as post-column reagent for the determination of rare earths by ion chromatography. Detection of individual lanthanides and lanthanum was carried out at 512 nm and 650 nm after separation by dynamic cation exchange chromatography with gradient elution on C18 column and employing a solution containing alpha-hydroxyisobutiric acid/sodium octanesulfonate at pH 3.8 as eluent. The effect of the presence of micelles in the post-column reagent was studied. Sensitivities obtained by the addition of the cationic surfactants cetylpyridinium chloride (CPC) and hexadecyltrimethylammonium bromide (CTAB) were lower than those measured without surfactant addition. In some cases, the signal was totally suppressed. No change in sensitivity was observed with non-ionic (Triton X-100) or anionic (sodium dodecylsulphate, SDS) surfactants but a slight improvement in the baseline noise was observed with the SDS. An evaluation of the influence of chemical and operational variables on the post column reaction (PCR) reagent was carried out either by spectrophotometric tests or by chromatographic experiments. A comparison was performed between three PCR reagents: Eriochrome Black T and xylenol orange in the presence of a cationic surfactant and arsenazo III. Calibration response was linear up to an analyte concentration of 5.0 micrograms ml-1. Absolute detection limits lower than 7 and 17 ng were obtained at the detection wavelengths of 650 nm and 512 nm respectively, for all the natural lanthanides and lanthanum.
Subject(s)
Azo Compounds/chemistry , Chromatography, Liquid/methods , Indicators and Reagents/chemistry , Metals, Rare Earth/analysis , Ions , Sensitivity and Specificity , Spectrum AnalysisABSTRACT
Artificial extension of the duration of nocturnally secreted circulating melatonin with exogenous injections produces a short day effect in the reproductive status of mammals, and this paradigm has been applied to Japanese quail to test the hypothesis that birds are similar to mammals in this respect. Male quail reared on non-stimulatory short days (8L:16D) were switched to mildly stimulatory 12L:12D and given daily melatonin injections at dusk (10 micrograms 2 h before dusk and 10 micrograms at dusk) or at dawn (10 micrograms 2 h before dawn and 10 micrograms at dawn) for about 3 weeks. Although assay of circulating melatonin suggested that injections had extended the melatonin signal, there was no short day effect, i.e. reproductive stimulation was not prevented. This reinforces the view that, unlike mammals, birds do not read the duration of the melatonin signal to measure scotoperiod. Paradoxically, however, the injections resulted in a small but significant stimulation. The results are discussed in view of the postulated role for melatonin as an internal Zeitgeber, which is coupled to the external photic Zeitgeber, to regulate the circadian system.
Subject(s)
Circadian Rhythm/physiology , Coturnix/physiology , Melatonin/pharmacology , Animals , Circadian Rhythm/drug effects , Darkness , Drug Implants , Injections, Intramuscular , Light , Male , Melatonin/administration & dosage , Melatonin/blood , Reference Values , Time FactorsABSTRACT
We have developed and tested a radiation protection material that provides similar attenuation for diagnostic x-ray spectra to that of conventional Pb apron materials with approximately 30% reduced weight. By combining a number of elements with different K absorption energies, such as Ba, W, and Pb, energy attenuation for given spectra can be optimized with respect to total cross-sectional mass loading. Alternatively, garments with much higher protective factors at equivalent weight to conventional garments could be produced. The reduction in the amount of Pb used also reduces problems associated with the toxicity of the material during manufacture and disposal. Back strain can be reduced for personnel performing special radiological procedures that require wearing protective garments for long periods of time.
