Document Type : Research Paper
Authors
- Marjan Daeihamed 1
- Edris Mahdavi Fikjvar 2
- Sedigheh Naghipour 3
- Leila Mohtashami 4
- Maryam Haddadi 3
- Maryam Naseri 5
1 Department of Pharmaceutics, School of Pharmacy, Guilan University of Medical Sciences, Rasht, Iran
2 Medical Biotechnology Research Center, School of Paramedical Sciences, Guilan University of Medical Sciences, langrud, Iran.
3 Student research committee, School of Pharmacy, Guilan University of Medical Sciences, Rasht, Iran
4 Department of Pharmacognosy, School of Pharmacy, Mashhad University of Medical Sciences, Mashhad, Iran
5 Department of Traditional Pharmacy, School of Persian Medicine, Iran University of Medical Sciences, Tehran, Iran
Abstract
Introduction and background: Primula macrocalyx Bunge. which belongs to primulaceae family grows in the highlands of Guilan province. This plant has long been used in traditional medicine to treat various diseases such as pneumonia, bronchitis and colds. However, no medicinal product has been produced from this plant in Iran so far. Therefore, in the present study, the preparation of liquid oral formulation of this plant was investigated and the physicochemical properties of the prepared formulation were measured.
Methods: After collecting plant in June 2020 from “Ulasbelangah” region in Guilan province, ethanolic extract of leaves, Flower and roots of the plant was prepared by maceration method. Then, the plant components were examined for the amount of water, total and acid insoluble ash, and qualitative tests were performed to identify the active compounds and the amounts of total phenols and flavonoids in the plant components were determined. During pre-formulation studies, the solubility of plant component extracts and the appropriate dosage and excipients of the formulation were evaluated, and based on this, the syrup formulation was prepared from this plant. Then, the prepared formulation was evaluated for appearance and organoleptic properties, pH, antimicrobial protection, sediment formation and locking the lid of the container.
Results: The extraction efficiency of cowslip in Flower, leaves and roots was 19.04%, 25.17%, and 21.12%, respectively. The amount of water was 13% in Flower and roots of the plant, and 12% in leaves. The amount of total ash in Flower, leaves and roots of the plant was equal to 6%, 11%, and 9.5% and the amount of acid insoluble ash was equal to 2%, 3.5%, and 3%, respectively. The leaves of the studied plant contained flavonoids, saponins and tannins, the flowers of the plant contained flavonoids and tannins, and the roots contained saponins and tannins. The percentage of total polyphenols in terms of gallic acid in roots, leaves and flowers was 41.44, 81.05, and 125.896, respectively. The percentage of total flavonoids in terms of isoquercitroside in the flowers and leaves of the plant was 2.88 ± 0.081 and 2.26 ± 0.041, respectively. Foaming index was 333, 250 and less than 100 in leaves, roots, and flowers respectively. In the pre-formulation studies of cowslip syrup, the solubility of the plant extract components, the appropriate dosage and excipients of the formulation, and the appropriate base for preparing the product were investigated. Accordingly, all plant extract components showed appropriate solubility in pure water, and the addition of propylene glycol and glycerin as co-solvents helped to better dissolve the extracts.
The formulation of the syrup prepared from the plant was accepted in terms of organoleptic properties, pH, viscosity, efficiency of the preservative, no sedimentation, and no locking of the lid.
Discussion and conclusion: Due to the presence of flavonoids and saponins in Primula macrocalyx and the acceptability of the formulation prepared from this plant in terms of organoleptic properties, pH, The way the formulation flows from the container (as a measure of the formulation's viscosity), efficiency of the preservative and no sediment, this formulation can be suggested as an herbal product in the treatment of respiratory diseases.
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