The study of microbiological purity of ointment “Fitolan” during storage
DOI:
https://doi.org/10.24959/ubphj.19.223Keywords:
mastopathy, microbiological purity, phytooil, semi-solid srugAbstract
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.
References
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. https://doi.org/10.7326/m15-2886
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.
Downloads
Published
Issue
Section
License
Copyright (c) 2019 National University of Pharmacy
This work is licensed under a Creative Commons Attribution 4.0 International License.
Authors who publish with this journal agree to the following terms:- Authors retain copyright and grant the journal right of first publication with the work simultaneously licensed under a Creative Commons Attribution License that allows others to share the work with an acknowledgement of the work's authorship and initial publication in this journal.
- Authors are able to enter into separate, additional contractual arrangements for the non-exclusive distribution of the journal's published version of the work (e.g., post it to an institutional repository or publish it in a book), with an acknowledgement of its initial publication in this journal.
- Authors are permitted and encouraged to post their work online (e.g., in institutional repositories or on their website) prior to and during the submission process, as it can lead to productive exchanges, as well as earlier and greater citation of published work (See The Effect of Open Access).