Antidiabetic and hepatoprotective activity of a novel polyherbal preparation against streptozotocin-induced diabetes rats and its formulation into a tablet dosage form

Abstract

Context: Diabetes is estimated to affect 79.4 million individuals in India by 2030. Aim: A polyherbal mixture containing hydroalcoholic extracts of Cinnamomum zeylanicum (CZ) bark, Eugenia jambolana (EJ) seed, Vinca rosea (VR) entire plant, and Gymnema sylvestre (GS) leaves was tested for anti-diabetic and hepatoprotective properties in different proportions. Materials and Methods: In normal and diabetic rats, the anti-diabetic and hepatoprotective efficacy was evaluated. Male and female Albino Wistar rats weighing 150–200 g were utilized in the experiment. Streptozotocin (60 mg/kg, i.p.) was used to induce diabetes. Group 1 acts as a normal control, Group 2 as a diabetic control, and Group 3 as a standard control, all animals of Group 3 were given Glibenclamide at a dose of 5 mg/kg p. o. Diabetic rats in groups 4–7 and 8–11 were given polyherbal preparations (PHPs) containing a combination of the above-mentioned plants in different proportions at doses of 200 and 400 mg/kg body weight, respectively, for dosage optimization and to determine the most efficacious and safe dose. The treatments were administered for a total of 28 days. Blood was drawn on the 7th, 14th, 21st, and 28th days to determine diabetic and hepatoprotective indicators such as body weight, blood glucose (BGL) levels, liver glycogen, total protein, urea, creatinine, serum glutamic oxaloacetic transaminase, and serum glutamic pyruvic transaminase. On the 28th day of the research, rats were sacrificed, and the pancreas examined for histological results. Results: BGL levels and serum liver enzymes were significantly reduced when a polyherbal mixture including CZ: EJ: VR: GS: 2: 1: 2: 2 at 400 mg/kg was administered. The optimum PHP ratio was then translated into tablet formulations (F1-F9) and tested for quality control characteristics. The weight, hardness, thickness, friability, and disintegration time of polyherbal tablets were all found to be within acceptable pharmacopeial parameters. Formulation F8, which included 20% sodium starch glycolate, had a disintegration time of 291 s. Formulation F8 was further tested for description, hardness, friability, and disintegration time during a 3-month accelerated stability testing. The results of a short-term stability investigation were likewise positive and comparable to the original formulation. Conclusion: As a result, the produced polyherbal formulation F8 may be utilized as a solid dosage form that is stable, patient-friendly, and cost-effective.