Technologycal study of preparing tablet formulations from hepaclin-4 prescription

Abstract

Background: As of 2024, digestive system diseases rank fourth among the causes of mortality in Mongolia. Among these, hepatocellular carcinoma (liver cancer) accounted for 20,501 deaths, leading in total mortality rates. In Traditional Mongolian Medicine, Scutellaria baicalensis Georgi is used to cool blood heat, clear internal heat, and regulate imbalances; Saussurea amara L. is used for its antibacterial, anti-infective, and anti-inflammatory properties; Carthamus tinctorius L. serves for disinfection, pain relief, fever reduction, and detoxification; and Chiazospermum erectum L. is used to eliminate toxic heat and febrile conditions. Studies have confirmed that the Hepaclin-4 formulation exhibits antioxidant, membrane-stabilizing, hepatoprotective, anti-necrotic, detoxifying activities, and reduces the accumulation of harmful byproducts from excessive peroxidation. Therefore, developing a solid dosage form from the raw herbal materials of Scutellaria baicalensis Georgi, Saussurea amara L., Carthamus tinctorius L., and Chiazospermum erectum L.in the Hepaclin-4 formula forms the basis of our research. Aim: To formulate and develop a tablet dosage form based on the compound prescription of Hepaclin-4 Materials and Methods: The raw materials of Scutellaria baicalensis Georgi, Saussurea amara L., Carthamus tinctorius L., and Chiazospermum erectum L.were weighed at a 1:1:1:1 ratio and extracted with 40% ethanol at a 1:10 ratio using the remaceration method. Ethanol was evaporated using a vacuum evaporator to obtain a thick extract, and quality indicators were determined. From the obtained thick extract, granules were prepared using two types of excipients through the wet granulation method, and their quality characteristics were studied. Based on the most suitable granules, tablet and capsule dosage forms were prepared and standardized according to the methods outlined in the Mongolian National Pharmacopoeia. Results: The Hepaclin-4 tablets were found to be round, well-formed, smooth, with intact edges, a slight characteristic odor, no unpleasant taste, and light yellow in color. The friability resistance of the 0.5 g tablet was 99.6±0.08%, hardness was 1.07±0.12 MPa, weight variation ranged from -2.6% to +3.9%, all within the acceptable 5% limit. The disintegration time was 4.23±0.05 minutes, and dissolution was 95.4±0.47%, meeting the permissible standards. When flavonoids in the tablets were detected by Thin Layer Chromatography (TLC), brownish-yellow spots appeared at Rf values identical to standard quercetin (Rf=0.94) and rutin (Rf=0.48). The total flavonoid content, determined by Spectrophotometric Method (SPM), was 0.165±0.01%. Conclusion:Tablets were successfully developed from the thick extract of the Hepaclin-4 herbal compound. Upon evaluation, the tablets met all the required technical specifications.