Quality control of the “Flavosterol” emulgel for androgenic alopecia prevention and treatment
DOI:
https://doi.org/10.24959/uekj.20.4Keywords:
emulgel, androgenic alopecia, quality control, microbiological purityAbstract
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.
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