The study of microbiological purity of ointment “Fitolan” during storage




mastopathy, microbiological purity, phytooil, semi-solid srug


Topicality. Mastopathy is a benign disease of the mammary glands, and it belongs to a number of hormone-dependent pathologies. The danger of mastopathy is not only in that it significantly reduces the quality of life of a woman, but also in the possibility of its rebirth and masking of the initial stage of breast cancer.
Aim. Studies of microbiological purity of the developed semi-solid medicine for epicutaneous application on the basis of phytooils of sea buckthorn, amaranth, parsley and tea tree under the conditional name “Fitolan”.
Materials and methods. The testing samples of semi-solid dosage form under the conditional name “Fitolan” was carried out at the Department of Biotechnology of NUPh in accordance with the requirements of the SPhU 2 ed. To test and eliminate the antimicrobial activity of the drug samples, dilutions 1 : 10 of the dosage form were used.
Results and discussion. Determination of the microbiological purity of the samples of the medicine “Fitolan” for epicutaneous application using the two-layer seeding method showed that the total number of viable aerobic microorganisms (TAMC) is 20 CFU/g and the total number of yeast and mold fungi (TYMC) does not exceed 10 CFU/g within 27 months of storage, it meets the requirements of SPhU [1].
Conclusions. According to the results of microbiological purity research of the studied samples of the semi-solid dosage form “Fitolan” using the double-layer agar method the ointment fully complies with the requirements of SPhU on the indicator “Microbiological purity of non-sterile drugs” within 27 months of storage.

Author Biographies

S. S. Zuіkina, National University of Pharmacy

Candidate of Pharmaceutical Sciences, Associate Professor of Department of Pharmaceutical Technology of Drugs

L. I. Vyshnevska, National University of Pharmacy

Doctor of Pharmaceutical Sciences, Professor, Head Department of Pharmaceutical Technology of Drugs

L. S. Strelnikov, National University of Pharmacy

Doctor of Pharmaceutical Sciences, Professor, Head of the Department of Biotechnology


Kovalev, A. A. (2017). Medychni aspekty zdorov’ia zhinky, 4 (109), 15–18.

Zuikina, S. S., Vyshnevska, L. I. (2017). Pivdennoukrainskyi medychnyi naukovyi zhurnal, 18, 46–49.

Zakon vid 23.12.2009 № 1794-VI. (2009). Pro zatverdzhennia Zahalnoderzhavnoi prohramy borotby z onkolohichnymy zakhvoriuvanniamy na period do 2016 roku. VR Ukrainy.

Vyshnevska, L. I., Zuikina, S. S. (2017). Farmakoterapiia mastopatii. Ekstemporalni propysy. Fitopreparaty ta homeopatychni likarski zasoby : metodychni rekomendatsii. Kharkiv : Vyd–vo IFNMU : NFaU, 44.

Siu, A. L. (2016). Screening for Breast Cancer : U.S. Preventive Services Task Force Recommendation Statement. Annals of Internal Medicine, 164 (4), 279.

Shekhavtcova, K. A., Zuikina, S. S. (2016). Oңtүstіk Kazaқstan memlekettіk farmatcevtika akademiiasy Khabarshysy, 4 (77), 19–21.

Derzhavna farmakopeia Ukrainy. (2015). Kharkiv: Ukrainskyi naukovyi farmakopeinyi tsentr yakosti likarskykh zasobiv, 1128.





Biopharmaceutical research