A safety evaluation of marbofloxacin was carried out following repeated intramuscular (5 mg/kg of body weight for 5 days) administration alone and piperine pretreated (10 mg/kg, P.O. for 5 days) rats. The blood samples were collected into sterile K 3 EDTA and non-heparinized test tube on 0 day (before treatment) a nd 6 th day (after treatment) monitored by estimation of va rious haemato-biochemical parameters.The average values of hematological parameters, viz., HB, PCV, TLC, TEC, DLC, MCV, MCH and MCHC were estimated before and after drug administration. The average values of blood biochemical (ALT, AST, Total protein, Albumin, Globulin, LDH, Creatinine, BUN, Bilirubin and AKP) parameters were measured before and after drug administration. The values of HB, PCV, eosinophil and monocytes were found be significant (p<0.05) when compared to before treated values. No significant alterations in mean values of all serum biochemical parameters were observed after treatment compared to (0 day) before treatment. All the rats were found no clinical signs and others adverse reactions.It is concluded that marbofloxacin following repeated intramuscular alone and piperine pretreated rats did not show major significant alterations in the haemato-biochemical parameters. Marbofloxacin was found sa fe and well tolerated antibacterial agents to be used against bacterial infections.
The present study was carried out to evaluate the effect of piperine pre-conditioning on the pharmacokinetics of marbofloxacin in Wistar rats. Marbofloxacin was administrated at a dose rate of 5 mg/kg body weight alone, and along with piperine pre-conditioning at a dose of 10 mg/kg of body weight, orally for 5 days in Wistar rats. The mean values of the half-life (t ½β), maximum drug concentration (C max) and area under the curve (AUC) were 1.19 ± 0.17 h, 2.71 ± 0.09 μg/mL and 12.25 ± 0.77 μg.h/mL, respectively, in piperine pretreated rats. The values were significantly higher than the values observed in rats administered with marbofloxacin alone (1.12 ± 0.31 h, 2.28 ± 0.20 μg/mL and 9.24 ± 0.59 μg.h/mL, respectively). The drug clearance (Cl B) in piperine pretreated rats was 0.04 ± 0.02 L/h/kg, which was significantly lower than the clearance rate of the drug (0.53 ± 0.03 L/h/kg) in the animals administered with marbofloxacin alone. The study reveals that piperine has a significant effect on the pharmacokinetics of marbofloxacin, which may be due to an increase in the drug absorption and inhibition of elimination of the drug in rats.
The present study was conducted to evaluate pathophysiological alterations after repeated oral administration of marbofloxacin alone and along with piperine pretreatment in rats. Blood samples were collected from treated animals at 6 th day. Hematological parameters (Hb, PCV, TLC, TEC, DLC, MCV, MCH and MCHC) and serum biochemical parameters (ALT, AST, total protein, albumin, globulin, LDH, creatinine, BUN, bilirubin and AKP) were estimated after five days treatment. Hematological and serum biochemical parameters were not found influenced after treatments and their mean values were not significantly altered (p>0.01) from corresponding control values. Moreover, no gross or microscopic changes were found in all major organs except liver of the treated rats. The histopathological changes in liver of treatment groups II (marbofloxacin alone) and III (marbofloxacin with piperine pretreatment) revealed mild degree of congestion and vacuolar degeneration in hepatocytes. It was concluded that piperine pretreatment for 5 th day in rats did not produce significant pathophysiological alterations in blood, serum biochemical parameters and microscopic changes in major organs with absence of clinical signs of side effects, following repeated oral administration of marbofloxacin.
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