Biopharmaceutical and microbiological studies of hard gelatin capsules with multicomponent herbal dry extract




capsules, dry extract, biopharmaceutical studies, microbiological purity


Topicality. The statistical data indicate that surgical intervention is about 33.23 %. among the methods of genitourinary system treatment. Therefore, there is a problem to reduce their number by increasing the effectiveness of the conservative treatment results and reducing the drugs cost without quality deterioration. The prevalence of infectious and inflammatory diseases of kidneys, urinary tract and genital tract prompted us to find new ways for their treatment, development, production and introduction into effective original medicines practice. From these positions, medicinal herbs, in particular, essential oil plants play a certain important role.
Aim. To conduct biopharmaceutical and microbiological studies of hard gelatin capsules with dry multicomponent herbal extract of uroholum as an experimental substantiation of the developed medicinal product quality.
Materials and methods. Objects of study were hard gelatin capsules with a multicomponent dry extract, a dissolution test for which is one of the most important in the creation of new solid medicines. In the analysis of microbiological purity of the developed drug uroholum, the method of SPhU 2 ed. was used. (s. 2.6.12), according to which the examined samples of capsules should meet the criteria for acceptability of microbiological purity of non-sterile ready-made herbal drugs for oral use (category C).

Results and discussion. According to the results of the research, model samples of uroholum capsules in the conditions of the experiment showed the degree of dissolution of the polyphenolic compounds amount, in terms of gallic acid ≥ 90 %. The samples of the capsules did not detect the bacteria Escherichia coli and Salmonella, and the total number of viable aerobic microorganisms (TAMC) does not exceed 3.5 × 103 CFU / g (at a rate of 105 CFU/g) and the total number of yeast and mildew fungi (TYMC) does not exceed 4.3 × 102 CFU/g (at a rate of 104 CFU/g).
Conclusions. The experimental data obtained indicated the model samples of uroholum capsules meet the requirements of SPhU by the test parameters of “Dissolution” and “Microbiological purity”.

Author Biographies

L. I. Vyshnevska, National University of Pharmacy

Dr. Habil. of Pharmacy, professor, head of the Drug Technology Department 

O. O. Shmalko, National University of Pharmacy

Candidate of Sciences in Pharmacy, associate professor, candidate of Sciences degree seeking applicant


Onyshchuk, V. O., Bysaha, Ye. I., Vyshnevska, L. I. (2017). Suchasni dosiahnennia farmatsevtychnoi tekhnolohii ta biotekhnolohii: zbirnyk naukovykh prats, 2. Kharkiv: NFaU, 144–148.

Hozhenko, A. I., Kravchuk, A. V., Nykytenko, O. P., Moskolenko, O. M., Sirman, V. M. (2015). Funktsionalnyi nyrkovyi rezerv: monohrafiia. Odesa: Feniks, 180.

Vlietinck, A., Pieters, L., & Apers, S. (2009). Legal Requirements for the Quality of Herbal Substances and Herbal Preparations for the Manufacturing of Herbal Medicinal Products in the European Union. Planta Medica, 75(7), 683–688.

Derzhavna Farmakopeia Ukrainy. (2015). Derzhavne pidpryiemstvo «Ukrainskyi naukovyi farmakopeinyi tsentr yakosti likarskykh zasobiv». Kharkiv: Derzhavne pidpryiemstvo «Ukrainskyi naukovyi farmakopeinyi tsentr yakosti likarskykh zasobiv», 1, 1128.

Chubka, M. B., Vronska, L. B., Zarivna, N. O., Hroshovyi, T. A., Hureieva, S. M. (2012). Farmatsevtychnyi chasopys, 2, 165–168.

Dudok, T., Savaryn, V., Meyer, C., Cherpak, V., Fechan, A., Lychkovskyy, E., … Nastishin, Y. (2016). Lasing cholesteric capsules. Ukrainian Journal of Physical Optics, 17(4), 169.

All about hard gelatine capsules. (1994). Firm «Capsugel». Basel, Switzerland, 47.

Manufacturing of Gelatin Capsules. (1992). Capsule Technology International Ltd. Montreal, 17.

Cattoor, K., Dresel, M., De Bock, L., Boussery, K., Van Bocxlaer, J., Remon, J.-P., … Heyerick, A. (2013). Metabolism of Hop-Derived Bitter Acids. Journal of Agricultural and Food Chemistry, 61(33), 7916–7924.

Murachanian, D. (2010). Two-Piece Hard Capsules for Pharmaceutical Formulations. Journal of GXP Compliance, 14 (3), 31−42.





Biopharmaceutical research