Quality control of the “Flavosterol” emulgel for androgenic alopecia prevention and treatment

Authors

DOI:

https://doi.org/10.24959/uekj.20.4

Keywords:

emulgel, androgenic alopecia, quality control, microbiological purity

Abstract

The required step in the new drug development is standardization of the finished product. The quality of dosage forms with soft medium depends on many factors. Taking into account the abovestated, for the developed “Flavosterol” emulgel it is important to carry out organoleptic, physical and chemical, microbiological quality control methods.
Aim. To develop the quality control methods of the “Flavosterol” emulgel freshly prepared samples.
Results.The studied emulgel is a homogeneous, viscous mass of yellow-green creamy consistency with a distinctive scent of lavender essential oil. The tested samples met the requirements of colloidal and thermal stability. Qualitative reactions indicate the presence of flavonoids in themedicine, and the absorption spectrum confirms the presence of flavonoids, triterpenoids and steroid compounds. The quantitative content of flavonoids in terms of routine was (0.92 ± 0.019) mg / g of the medicine, and the content of the sum of triterpenoids and phytosterols in terms of β-amyrin was (2.16 ± 0.053) mg / g of the medicine. Structural viscosity (3980 ± 50) MPa · s and pH 5.3 ± 0.1 ensure good consumption properties of the emulgel. The samples contained no pathogens such as Enterobacteriaceae, S. aureus, P. aeruginosa and the total number of bacteria and fungi per 1 g of the emulgel were within the requirements of the State Pharmacopoeia of Ukraine (SPhU) 2.0 for medicines cutaneously applied.
Conclusions. It was worked out the quality control methods of the emulgel “Flavosterol” freshly prepared samples intended for androgenetic alopecia prevention and treatment. The quality of the emulgel met the requirements specified in the developed projectof Quality Control Methods and SPhU2.0.

References

Fedorovska, M. I. (2014). Fitoterapiia. Chasopys, 2, 40–44.

Сhatterjee, S., Agrawala, S. K. (2003). Saw palmetto (Serenoa repens) in androgenic alopecia. Natural Product Radiance, 2(6), 302–305.

Shram, N. A., Moshchits, V. F., & Dmytriievskyi, D. I. (2017). Farmatsevtychnyi Chasopys, (2). https://doi.org/10.11603/2312-0967.2017.2.7908

Yarema, I. O., Fedorovska, M. I., Sokolova, L. V. (2014). Aktualni pytannia farmatsevtychnoi i medychnoi nauky ta praktyky, 3(16), 106–110.

Bezrukavyi, Ye. A. (2013). Annals of Mechnikov Institute, 3, 28–33.

Derzhavna farmakopeya Ukrayiny. (2015). Derzhavne pidpryyemstvo «Ukrayins’kyy naukovyy farmakopeynyy tsentr yakosti likars’kykh zasobiv». Kharkiv: Derzhavne pidpryyemstvo «Ukrayins’kyy naukovyy farmakopeynyy tsentr yakosti likars’kykh zasobiv», 1, 1128.

DSTU 4765:2007. (2009). Kremy kosmetychni. Zahalni tekhnichni umovy. Vyd. ofits. Kyiv : Derzhspozhyvstandart Ukrainy, 11.

Glushchenko, A. V., Georgiiantc V. A., Bevz N. Iu. (2014). Nauchnye vedomosti Belgorodskogo gosudarstvennogo universiteta. Seriia: Meditcina. Farmatciia, 1((182)26/1)), 172–175.

Orlova, S. E., Zilfikarov, I. N. (2012). Farmatciia, 4, 16–17.

Qi, Y., Sun, A., Liu, R., Meng, Z., & Xie, H. (2007). Isolation and purification of flavonoid and isoflavonoid compounds from the pericarp of Sophora japonica L. by adsorption chromatography on 12% crosslinked agarose gel media. Journal of Chromatography A, 1140(1-2), 219–224. https://doi.org/10.1016/j.chroma.2006.12.002

Published

2020-03-02

Issue

Section

Quality, standardization and certification in pharmacy