Novel Granular Formulation of Solanum nigrum and Cichorium intybus Leaf Juice Hepatoprotective Effects Against Paracetamol-Induced Toxicity in Rats

Introduction: Liver disorders are a significant global health concern, often resulting from drug-induced toxicity, infections, and metabolic dysfunctions. Traditional Unani medicine has utilized Murawwaqain, a hepatoprotective leaf juice derived from Solanum nigrum L. and Cichorium intybus L., for managing liver ailments. However, its liquid form presents challenges related to stability, shelf life, and patient compliance. This study was conducted to develop and evaluate a novel granular formu-lation of S. nigrum and C. intybus leaves juice (SCJ) for its hepatoprotective potential. Specifically, this research focuses on conducting phytochemical profiling to identify bioactive compounds, assessing the anti-oxidant activity, and evaluating the formulation';s effectiveness in mitigating liver damage induced by paracetamol-induced hepatotoxicity. The findings aim to provide insights into the therapeutic poten-tial of this formulation as a natural remedy for liver protection. Methods: S. nigrum and C. intybus juice (SCJ) were lyophilized and granulated using carboxymethyl cellulose (CMC) and starch as excipients. The phytochemical composition of both SCJ and its granules (SCG) was analyzed to quantify tannins, phenolics, flavonoids, alkaloids, esculetin, and diosgenin. An-ti-oxidant activity was assessed using DPPH, ABTS, and FRAP assays to determine free radical scav-enging potential. For hepatoprotective evaluation, Wistar albino rats were divided into control, parace-tamol-induced, and treatment groups receiving SCGJ or SCG. Liver function markers, including SGOT, SGPT, ALP, and bilirubin, were analyzed, and histopathological examination of liver tissue was conducted to assess structural damage, necrosis, and inflammation. Results: Phytochemical analysis revealed that the granular formulation retained and enhanced bioactive compounds, including tannins (176.17±1.8 µg vs. 93.57±0.34 µg in extract), phenolics (22.2±1.3 mg vs. 15.62±0.52 mg), flavonoids (350.6±1.43 µg vs. 181.04±2.25 µg), alkaloids (302.6±1.65 µg vs. 108.6±0.65 µg), esculetin (8.47±0.38 mg vs. 2.01±0.08 mg), and diosgenin (0.46±0.03 mg vs. 0.11±0.01 mg). Both forms exhibited strong anti-oxidant activity, with IC50 values of 0.318 and 0.136 for DPPH, and 0.288 and 0.12 for ABTS. In hepatotoxicity-induced rats, both formulations significant-ly reduced elevated liver enzyme levels (SGOT, SGPT, ALP, and bilirubin) and improved histopatho-logical features, showing reduced necrosis, inflammation, and hepatocellular damage compared to the control group. Discussion: The anti-oxidant and hepatoprotective activities observed in Murawwaqain and its granules may be attributed to the presence of bioactive compounds. The formulation process did not compromise therapeutic efficacy, indicating that converting the juice into granules offers a viable approach to over-come the limitations of the liquid dosage form. Conclusion: The study demonstrates the successful development of a granular formulation of S. nigrum and C. intybus juice with preserved and enhanced hepatoprotective properties. The findings support its potential use as a stable and effective natural remedy for managing liver disorders and warrant further standardization and clinical investigation.