Development of the composition of a dermatological product in the form of a cream with extracts of the aerial part of lespedeza bicolor

Authors

DOI:

https://doi.org/10.15587/2519-4852.2025.322855

Keywords:

aerial part of Lespedeza bicolor, phenolic compounds, dermatological cream, Lespedeza bicolor extracts, anti-inflammatory activity, drug technology

Abstract

The aim of the work: Justification of the composition of emulsion cream with extracts of Lespedeza bicolor.

Materials and methods: In the development of the emulsion base of the cream, corn oil (Ukraine), propylene glycol (Germany), purified water, emulsifiers: xyliance (France), prolipid 141 (USA) and lamecrem (France) were used. The composition of the emulsion base included oil and liquid alcohol extract of the above-ground part of Lespedeza bicolor, which were obtained from the above-ground part of Lespedeza bicolor, harvested in the Botanical Garden of the Ivan Franko National University of Lviv (Lviv, Ukraine) in the flowering phase. The studies used physicochemical (pH value, identification and quantitative content of BAS), pharmacotechnological (thermo- and colloidal stability, structural-mechanical properties and disperse analysis) research methods. The anti-inflammatory activity of the experimental samples was studied on a burn wound model in outbred sexually mature male rats. The following medicines were used as comparison drugs: Panthenol ointment, “Hemofarm”, AD, Serbia, series 138CLA and Calendula ointment, LLC “Pavlova Pharmacy”, Ukraine, series 23.0823.

Results. Experimental studies of the organoleptic, physicochemical and structural-mechanical properties of samples of emulsion bases showed their dependence on the concentration of the oil phase, the composition and concentration of complex emulsifiers xyliance, prolipid 141 and lamecrem. It was established that the emulsion base of the cream, which contains 15 % corn oil, 7 % of the complex emulsifier xyliance, 5 % propylene glycol and water purified to 100, has satisfactory structural-mechanical properties, the necessary dispersion and homogeneous distribution of particles of the oil phase in the aqueous dispersion medium, withstands the test for thermal and colloidal stability and can be used to develop a dermatological cream with Lespedeza extracts. It was shown that the introduction of extracts into the composition of the developed base does not affect the stability, structural-mechanical properties of the base and the content of BAS. Studies of the anti-inflammatory activity of a cream with a complex of biologically active compounds of the oily and alcoholic extracts of the terrestrial part of Lespedeza bicolor on a burn wound model showed a reduction in signs of inflammation without signs of the joining of an infectious process in laboratory animals with wound healing on the 26th day of the study.

Conclusions. The composition of the cream with oil and alcohol extract of Lespedeza, which, due to the BAS complex, has a wider spectrum of pharmacological activity, has been experimentally substantiated. The composition of the emulsion base of the cream with corn oil, xyliance emulsifier, propylene glycol and purified water has been developed. It has been shown that the introduction of extracts into the composition of the developed base does not affect its pharmacotechnological properties, and the quantitative content of biologically active compounds in the cream corresponds to their content in the extracts in terms of the concentration of extracts in SDF, which is a confirmation of the compatibility of BAS with excipients. It has been established that the cream containing the BAS complex of Lespedeza bicolor in terms of anti-inflammatory activity is at the level of the comparison preparations Panthenol ointment and Calendula ointment

Author Biographies

Kate Kiselyova, National University of Pharmacy

Postgraduate Student

Department of Pharmaceutical Technology of Drugs

Liliia Vyshnevska, National University of Pharmacy

Doctor of Pharmaceutical Science, Professor, Head of Department

Department of Pharmaceutical Technology of Drugs

Tetiana Yudkevych, National University of Pharmacy

Deputy Director for Research

Educational and Scientific Institute of Applied Pharmacy

Liubov Bodnar, National University of Pharmacy

Assistant

Department of Pharmaceutical Technology of Drugs

Mariia Skybitska, Botanical Garden of the Lviv National Ivan Franko University

PhD, Senior Researcher

Liudas Ivanauskas, Lithuanian University of Health Sciences

Doctor of Biomedical Sciences, Professor, Head of Department

Department of Analytical and Toxicological Chemistry

Olha Mykhailenko, National University of Pharmacy; Kiel University; UCL School of Pharmacy

Doctor of Pharmaceutical Sciences, Associate Professor

Department of Pharmaceutical Chemistry

Humboldt Research Fellow

Visiting Researcher

Pharmacognosy and Phytotherapy Group

Oleksandr Kukhtenko, National University of Pharmacy

Doctor of Pharmaceutical Sciences, Professor

Department of Industrial Technology of Drugs and Cosmetic Products

Victoriya Georgiyants, National University of Pharmacy

Doctor of Pharmaceutical Sciences, Professor, Head of Department

Department of Pharmaceutical Chemistry

References

  1. Yazarlu, O., Iranshahi, M., Kashani, H. R. K., Reshadat, S., Habtemariam, S., Iranshahy, M., Hasanpour, M. (2021). Perspective on the application of medicinal plants and natural products in wound healing: A mechanistic review. Pharmacological Research, 174, 105841. https://doi.org/10.1016/j.phrs.2021.105841
  2. Ahuja, A., Gupta, J., Gupta, R. (2021). Miracles of Herbal Phytomedicines in Treatment of Skin Disorders: Natural Healthcare Perspective. Infectious Disorders – Drug Targets, 21 (3), 328–338. https://doi.org/10.2174/1871526520666200622142710
  3. Ullah, S. (2017). Methanolic extract from Lespedeza bicolor: potential candidates for natural antioxidant and anticancer agent. Journal of Traditional Chinese Medicine, 37 (4), 444–451. https://doi.org/10.1016/s0254-6272(17)30150-4
  4. Kim, S. J., Kim, D. W. (2007). Antoxidative activity of hot water and ethanol extracts of Lespedeza cuneata seeds. Korean Journal of Food Preservation, 14, 332–335.
  5. Ren, C., Li, Q., Luo, T., Betti, M., Wang, M., Qi, S. et al. (2023). Antioxidant Polyphenols from Lespedeza bicolor Turcz. Honey: Anti-Inflammatory Effects on Lipopolysaccharide-Treated RAW 264.7 Macrophages. Antioxidants, 12 (10), 1809. https://doi.org/10.3390/antiox12101809
  6. Lee, S. J., Hossaine, M. D. A., Park, S. C. (2016). A potential anti-inflammation activity and depigmentation effect of Lespedeza bicolor extract and its fractions. Saudi Journal of Biological Sciences, 23 (1), 9–14. https://doi.org/10.1016/j.sjbs.2015.01.016
  7. Thuy, N. T. T., Lee, J.-E., Yoo, H. M., Cho, N. (2019). Antiproliferative Pterocarpans and Coumestans from Lespedeza bicolor. Journal of Natural Products, 82 (11), 3025–3032. https://doi.org/10.1021/acs.jnatprod.9b00567
  8. Nam, S. H. (2023) Evalution of the anti-caries effect of Lespedeza cuneata extract against Streptococcus mutans. Georgian Med News, 3 (38), 19–22.
  9. Hong, H.-J., Son, N.-R., Yang, W.-Y., Lee, J.-M., Kim, J.-H., Jang, S.-M., Nam, S.-H. (2018). Antibacterial and antifungal activities of Lespedeza cuneata extract against Candida albicans. Biomedical Research, 29 (20). https://doi.org/10.4066/biomedicalresearch.29-18-1080
  10. Woo, H. S., Lee, K. H., Park, K. H., Kim, D. W. (2024). Flavonoids Derived from the Roots of Lespedeza bicolor Inhibit the Activity of SARS-CoV Papain-like Protease. Plants, 13 (23), 3319. https://doi.org/10.3390/plants13233319
  11. Leti, M., Daunes-Marion, S., Leveque, M. (2020). WO2020020791A1; WIPO (PCT). Lespedeza capitata extract for use in the field of hair care. Available at: https://patents.google.com/patent/WO2020020791A1/en
  12. Seong, J. S., Xuan, S. H., Park, S. H., Lee, K. S., Park, Y. M., Park, S. N. (2017). Antioxidative and Antiaging Activities and Component Analysis of Lespedeza cuneata G. Don Extracts Fermented with Lactobacillus pentosus. Journal of Microbiology and Biotechnology, 27 (11), 1961–1970. https://doi.org/10.4014/jmb.1706.06028
  13. Deng, F., Chang, J., Zhang, J.-S. (2007). New flavonoids and other constituents from Lespedeza cuneata. Journal of Asian Natural Products Research, 9 (7), 655–658. https://doi.org/10.1080/10286020600979894
  14. Kiselyova, K. E., Bevz, N. Yu., Mykhailenko, O. O., Yaromiy, M. V., Vyshnevska, L. I. (2024). The substantiation of the choice of an extractant for obtaining extractions of the overground part of Lespedeza bicolor. News of Pharmacy, 107 (1), 58–65. https://doi.org/10.24959/nphj.24.126
  15. Kiselyova, K. E., Bevs, N. Yu., Mykhaylenko, O. O., Vishnevska, L. I.; Bessarabov, V., Lubenets, V. (Eds.) (2023). Justification of the conditions for obtaining the oil extract of Lespedecia bicolor. Chemical and biopharmaceutical technologies. Tallinn: Nordic Sci Publisher, 336–342.
  16. Kiselyova, K., Osolodchenko, T., Vishnevska, L. (2024). Study of the antibacterial action of Lespedecia bicolor extracts and cream based on them. Annals of the Mechnikov Institute, 2, 69–73. https://doi.org/10.5281/zenodo.11638092
  17. Kiselyova, K. E., Vishnevska, L. I. (2024). Study of the anti-inflammatory activity of extracts of Lespedecia bicolor. Industry 4.0: modern directions of development of the pharmaceutical industry. Kharkiv: Publishing House of the National Academy of Sciences, 51–53.
  18. Herbig, M. E., Evers, D.-H., Gorissen, S., Köllmer, M. (2023). Rational Design of Topical Semi-Solid Dosage Forms-How Far Are We? Pharmaceutics, 15 (7), 1822. https://doi.org/10.3390/pharmaceutics15071822
  19. Dragicevic, N., Maibach, H. I. (2021). Percutaneous Absorption: Drugs, Cosmetics, Mechanisms, Methods. Boca Raton: CRC Press, 1008. https://doi.org/10.1201/9780429202971
  20. Grégoire, S., Ribaud, C., Benech, F., Meunier, J. R., Garrigues-Mazert, A., Guy, R. H. (2009). Prediction of chemical absorption into and through the skin from cosmetic and dermatological formulations. British Journal of Dermatology, 160 (1), 80–91. https://doi.org/10.1111/j.1365-2133.2008.08866.x
  21. Dias, M., Hadgraft, J., Lane, M. (2007). Influence of membrane–solvent–solute interactions on solute permeation in skin. International Journal of Pharmaceutics, 340 (1-2), 65–70. https://doi.org/10.1016/j.ijpharm.2007.03.030
  22. Oliveira, G., Hadgraft, J., Lane, M. E. (2012). The influence of volatile solvents on transport across model membranes and human skin. International Journal of Pharmaceutics, 435 (1), 38–49. https://doi.org/10.1016/j.ijpharm.2012.05.037
  23. Herbig, M. E. (2022). Topical Drug Delivery and the Role of Excipients. Chimica Oggi-Chemistry Today, 40, 34–37.
  24. ST-N MOZU 42-3.0:2011 «Likarski zasoby. Farmatsevtychna rozrobka (ICH Q8)» (2011). Kyiv: Ministry of Health of Ukraine, 13.
  25. Lane, M. E., Hadgraft, J., Oliveira, G., Vieira, R., Mohammed, D., Hirata, K. (2012). Rational formulation design. International Journal of Cosmetic Science, 34 (6), 496–501. https://doi.org/10.1111/j.1468-2494.2012.00747.x
  26. Derzhavna Farmakopeia Ukrainy. Vol. 1 (2015). Kharkiv: DP «Ukrainskyi naukovyi farmakopeinyi tsentr yakosti likarskykh zasobiv», 1128.
  27. Stefanova, O. V. (Ed.) (2001). Doklinichni doslidzhennia likarskykh zasobiv. Kyiv: Avicenna, 528.
  28. Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposes (2010). Official Journal of the European Union, L276, 33–79.
  29. Medicines. Good laboratory practice (2009). Kyiv: Ministry of Health of Ukraine, 27.
  30. Yakovleva, L. V., Tkacheva, O. V., Butko, I. O., Larianovska, Yu. B. (2013). Experimental study of new drugs for local treatment of wounds. Kharkiv: NFaU Publishing House, 52.
  31. Trapella, C., Rizzo, R., Gallo, S., Alogna, A., Bortolotti, D., Casciano, F. et al. (2018). HelixComplex snail mucus exhibits pro-survival, proliferative and pro-migration effects on mammalian fibroblasts. Scientific Reports, 8 (1). https://doi.org/10.1038/s41598-018-35816-3
  32. Tkachova, O. V. (2014). Pharmacological study of new drugs developed on the basis of natural substances and intended for the local treatment of wound healing process. [Extended abstract of PhD thesis].
  33. Indrayan, A., Malhotra, K. R. (2018). Medical biostatistics. Boca Raton: CRC Press, 685.
  34. Roberts, M. S., Cheruvu, H. S., Mangion, S. E., Alinaghi, A., Benson, H. A. E., Mohammed, Y. et al. (2021). Topical drug delivery: History, percutaneous absorption, and product development. Advanced Drug Delivery Reviews, 177, 113929. https://doi.org/10.1016/j.addr.2021.113929
  35. Kukhtenko, H., GladukhIe, Y., Kukhtenko, O., Soldatov, D. (2017). Influence of Excipients on the Structural and Mechanical Properties of Semisolid Dosage Forms. Asian Journal of Pharmaceutics, 11 (3), 575–578.
  36. Bulyha, L. O., Chernykh, V. P., Shtryhol, S. Iu., Movchan, B. O., Butko, Ya. O. (2015). Eksperymentalne doslidzhennia ranozahoiuvalnoi dii heliu z nanochastynkamy sribla ta hliukozaminom. Pharmacology and medicinal toxicology, 2 (43), 49–54.
  37. Mayevsky, O. E., Mironov, E. V. (2015). Changes in the skin after thermal burns (literature review). Biomedical and biosocial anthropology, 25, 218–220.
Development of the composition of a dermatological product in the form of a cream with extracts of the aerial part of lespedeza bicolour

Downloads

Published

2025-02-28

How to Cite

Kiselyova, K., Vyshnevska, L., Yudkevych, T., Bodnar, L., Skybitska, M., Ivanauskas, L., Mykhailenko, O., Kukhtenko, O., & Georgiyants, V. (2025). Development of the composition of a dermatological product in the form of a cream with extracts of the aerial part of lespedeza bicolor. ScienceRise: Pharmaceutical Science, (1 (53), 26–40. https://doi.org/10.15587/2519-4852.2025.322855

Issue

Section

Pharmaceutical Science