RESUMO
The aim of the evaluation was to establish bioequivalence between two oral 3.0 g sachet forms of L-ornithine-L-aspartate (LOLA). It was designed as randomised, two-way crossover study with a 1-week washout interval. Blood samples were collected throughout a 12 h period after administration of reference and test product to 12 fasting healthy male volunteers. Plasma were analyzed by sensitive, reproducible, accurate and rapid capillary electrophoresis (CE) method with UV detection. Many pharmacokinetic parameters including AUC0-t, AUC0-infinity, Cmax, Tmax, T1/2 and Kel were determined from plasma concentration. First three of them after log-transformation of data were examined for bioequivalence. Based on ANOVA with 90% confidence level no significant difference was found. All of tested parameters were found to be within the bioequivalence acceptance range of 80-125%. Based on these and other statistical tests it was concluded that Hepatil is bioequivalent to Hepa-Merz granulate.
Assuntos
Química Farmacêutica , Dipeptídeos/farmacocinética , Administração Oral , Adulto , Disponibilidade Biológica , Eletroforese Capilar , Humanos , Masculino , Valores de Referência , Espectrofotometria UltravioletaRESUMO
A rapid capillary electrophoresis method for routine determination of two amino acids, L-ornithine and L-aspartic acid, in human plasma is reported. The method runs automatically, requires a minimum of sample preparation and moreover includes no extensive extraction and no gradient or derivatization procedure. Analyses were performed on an uncoated silica capillary using buffer solution composed with 10 mM sodium tetraborate and 1 M sodium hydroxide (pH=10.0). A capillary electrophoresis P/ACE system equipped with UV detection (200 nm), an automatic injector, a fluid cooled cartridge and System Gold data station was used in this study. The total analysis time under these conditions was 8.0 min. The calibration curve was linear in the range 10-280 microg mL-1 for L-aspartic acid and 20-280 microg mL-1 for L-ornithine (for both amino acids, r=0.999). The method was validated by inaccuracy (bias) and precision (RSD) studies by analysing samples. The method was successfully applied to the quantitative determination of L-ornithine-L-aspartate in human plasma and could be useful for clinical and bioavailability investigations.
Assuntos
Ácido Aspártico/sangue , Dipeptídeos/sangue , Eletroforese Capilar/métodos , Ornitina/sangue , Estabilidade de Medicamentos , Congelamento , Humanos , Reprodutibilidade dos Testes , Sensibilidade e EspecificidadeRESUMO
Resection of the obturator nerve in hip joint arthritis can eliminate or decrease pain depending on the obturator nerve share in the hip joint innervation. From 1986 to 1988 34 obturator neurectomies were performed in painful hip arthritis patients with temporary or permanent contraindications for hip arthroplasty. In 21 from 30 patients followed-up at least 3 months partial or total relief of pain was found. Extrapelvic obturator neurectomy technique and indications for this procedure were presented.