Pharmaceutico-analytical standardization and preclinical safety evaluation of herbomineral formulation (Sameerpanag Ras) in rats

Sameerpannag Ras (SPR) is a complex herbomineral formulation widely used in Ayurveda for stiffness in joints, cough, fever, headache, and respiratory symptoms like dyspnea. The metallic constituents of the formulation pose public health concerns; therefore, the current study was designed to evaluate the safety of the SPR in rats. In the present study, systematic preparation, characterization, and subacute oral toxicity of Sameerpannag Ras were performed. The formulation was prepared as per a standard protocol prescribed in the classical Ayurveda texts. The drug obtained was greenish-black with typical physicochemical properties. Energy-dispersive X-ray analysis (EDX) identified the sample with the presence of arsenic (As), sulphur (S), carbon (C), and mercury (Hg) predominantly. The subacute oral toxicity study of the formulation was conducted at different doses (6, 12, and 25 mg/kg BW) for 28 days on rats. No clinical signs and mortality were observed at any of the three doses in rats. The body weight, haematological, and biochemical parameters were comparable to the control animals. The histopathological examination revealed no significant pathological lesion in the vital organ except for mild changes in the intestinal villi of few rats at medium and higher doses. Overall, the study concluded that the formulation has no significant adverse effect and safe to use at the prescribed doses.