| Abstract [eng] |
Master’s thesis by Diana Bumbulytė “Production technology and evaluation of qualitative properties of semi-solid pharmaceutical forms with burdock root extract.” Scientific supervisor: assistant Dr. R. Kalėdaitė; Vilnius University, Faculty of Medicine, Institute of Biomedical Sciences, Center for Pharmacy and Pharmacology, Vilnius, 2026. Aim of the study: To produce stable semi-solid pharmaceutical forms with burdock root extract, to investigate and evaluate their qualitative properties. Objectives: • To collect suitable medicinal plant raw material for extract production and to prepare a liquid ethanolic extract by maceration for the development of semi-solid pharmaceutical forms. • To evaluate the antioxidant activity of the prepared extracts using the DPPH method and to determine the total phenolic content using the Folin–Ciocalteu method. • To formulate semi-solid pharmaceutical forms using ethanolic extracts of burdock roots and to assess their quality properties (pH, viscosity, stability, and emulsion type). Methods: Liquid ethanolic extract of burdock roots was prepared by maceration using appropriately comminuted medicinal plant raw material. The total phenolic compound content of the prepared burdock root extract was determined by the Folin-Ciocalteu method, while antioxidant activity was evaluated using the DPPH assay. Semi-solid pharmaceutical formulations were developed and evaluated for emulsion type (creams), pH, viscosity at different temperatures (4 °C, 22 °C, and 40 °C), and stability. Statistical analysis was performed using R Commander and Microsoft Excel. Research results: Suitable excipients were selected and 15 semi-solid cream formulations (K1-K15) and 6 ointment formulations (T1-T6) were developed. After preparing plant extracts using three different ethanol concentrations, their antioxidant activity and total phenolic content in the plant material were determined. The prepared creams and ointments were evaluated for kinetic and visual stability, emulsion type, pH, and viscosity. Conclusions: 1. A. lappa roots were collected, properly dried, and comminuted. A 70% ethanolic extract was prepared from the processed raw material by the maceration method. 2. It was determined that the total phenolic compound content of all extracts was similar, ranging approximately from 2.308 ± 0.049 to 2.456 ± 0.043 mg GAE/g, with the highest amount obtained using 50% ethanol as the solvent. The antioxidant activity of all extracts was also found to be similar, varying approximately from 10.142 ± 0.214 to 10.755 ± 0.060 mg TE/g, with the highest value determined in extracts prepared using 50% ethanol as the solvent. No statistically significant correlation was found between the total phenolic compound content determined by the Folin–Ciocalteu method and the antioxidant activity determined by the DPPH method. 3. A total of 21 semi-solid pharmaceutical formulations were developed. The qualitative properties of the prepared creams and ointments were determined: • The prepared creams were oil-in-water emulsions. • During the kinetic stability study, all samples remained stable except for cream formulations coded K6 and K8, which contained a higher amount of the aqueous phase, and K14 and K15, which contained a higher amount of the aqueous phase together with a lower amount of emulsifier. • The pH of the prepared creams ranged from 6.11 to 7.4. The pH of the prepared ointments ranged from 5.15 to 6.94. • The viscosity results of the creams showed that the viscosity of all samples decreased with increasing temperature. The highest viscosity values were determined at 4 °C (approximately 5400–11633 mPa·s), while the lowest values were observed at 40 °C (approximately 2200–5000 mPa·s). The viscosity results of the ointments also showed a decrease in viscosity with increasing temperature. At 22 °C, viscosity ranged from 4067 ± 665 to 9333 ± 850 mPa·s, whereas at 40 °C it ranged from 1800 ± 283 to 3200 ± 0 mPa·s. |
