Background: Tamra bhasma (TB) is copper based herbo-metallic preparation which is used extensively by Ayurvedic practitioners. Tamra bhasma is endorsed for different disorders of liver, abdominal pain, heart disease, colitis, tumors, anemia, loss of appetite, tuberculosis, as well as eye problems. Objective: Our aim is to characterize 5 commercial TB preparations from 5 different manufacturers by using modern scientific techniques and to study there bioavailability in Wistar rats. Materials and Methods: Tamra bhasma was characterized by X-ray diffraction (XRD), Scanning electron microscope (SEM), Energy Dispersive X-ray analysis (EDAX), Nanoparticle tracking analyzer (NTA), Inductively coupled plasma optical emission spectroscopy (ICP-OES). Bioavailability of Tamra bhasma was studies using non compartmental rat model with daily dose of 6.45mg/kg according to their body weight. Results: The colour of one of the TB preparation was different from other 4 TB samples. The chemical phase and particle size is significantly different for all the 5 TB’s. Pharmacokinetic model confirms difference in various PK parameters such as peak concentration (Cmax), half-life (t1/2) and terminal elimination slope (λz) for all 5 TB’s. TB-A showed highest Cmax (82.21 mg/L), whereas TB-E showed lowest Cmax (48.69 mg/L). The highest bioavailability of TB is may be due to specific chemical moiety and morphology. Based on XRD and elemental analysis, it was found that manufacturing route followed for one of the preparation is not as per ayurvedic text reference. Conclusions: The morphology as well as chemical phase of the five TB’s studied were different from each other, which might be responsible for different pharmacokinetic profiles in Wistar rat model.
Objectives: This study aimed to assess the adverse effects of Rasaraj Rasa tablets after repeated oral administration for 180 days in Wistar rats. Methods: Wistar rats were divided into five groups, of which three were treated with 54, 162, and 270 mg/kg body weight of Rasaraj Rasa, respectively, which correspond to one, three, and five times the proposed human therapeutic dose, for 180 days consecutively. The fifth group (satellite) also received 270 mg/kg body weight of Rasaraj Rasa for 180 days. Body weight and food intake were measured weekly. At the end of the study, all rats were sacrificed, and their blood, serum, and organs were collected and examined using hematology, serum biochemistry, gross pathology, and histopathology tests. In contrast, the satellite group was kept for 4 weeks after treatment. Results: No significant treatment-related toxicological findings were observed in the clinical features, body weight, laboratory findings, and pathological findings of the high-dose treated groups, when compared to those of the control group. Conclusion:The no-observed-adverse-effect-level for Rasaraj Rasa in Wistar rats is set at 270 mg/kg body weight.
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