Toxicological study of the new gel containing oak bark extract and aloe extract under long-term use
DOI:
https://doi.org/10.24959/ubphj.19.237Keywords:
gel, oak bark extract, aloe extract, prolonged toxicityAbstract
Topicality. The significant prevalence of destructive-inflammatory periodontal diseases and the imperfection of existing medicines determine the feasibility to develope new topical dosage forms with polymodal pharmacological activity and low toxicity. Scientists of NUPh developed a new gel, containing an oak bark extract and aloe extract with strong parodontoprotective effect.
Aim. To study the toxicity of a new gel containing an oak bark extract and aloe extract under the long-term use. This new gel is developed by the scientists of NUPh, under the direction of prof. N. V. Khokhlenkova, and is intended for treatment of oral cavity inflammatory diseases. In previous studies a pronounced membran-protective, antimicrobial, anti-inflammatory activity and parodont-protective activity were established for the new gel.
Materials and methods. Prior to the experiment, randomized samples were applied for the animal population taken in experimental groups and fixed averaged indicators of the initial state of animals organism. A new gel was applied on the skin.
Results and discussion. Animals that received the new gel did not differ from the animals of the control groups in appearance, behavior and attitude to food. During the experiment, there were no signs of inhibition of activity and development of aggressiveness in animals of comparable groups. The results of the study of weight ratios of both sex rat organs indicate the absence of test gel toxic effects in doses of 0.5 and 5 ml. The new gel does does’t reveal hepatotoxic effect. The results of lipid metabolism indices shows that there is no toxic effect in the studied doses.
Conclusions. It was established that a new gel, containing oak bark extract and aloe extract, does not exert a toxic effect on the functions of vital organs and systems of the organism of experimental animals at the conditions of prolonged application (1 month) at doses of 0.5 ml and 5 ml. Along with the previously established parodontprotective, antimicrobial and other activities, the absence of toxic effects of a new gel under the conditions of long-term use is the basis for in-depth preclinical studies to create a new drug with parodontprotective effect.
References
Ethical and Scientific Issues in Studying the Safety of Approved Drugs. (2012). Committee on Ethical and Scientific Issues in Studying the Safety of Apporoved Drugs; Board of Population Health and Public Health Practice; Institute of Medicine. Washington: The National Academies Press, 276.
Sou, H. (2010). EU Compassionate Use Programmes (CUPs). Pharmaceutical Medicine, 24 (4), 223–229. https://doi.org/10.1007/bf03256820
Liu, J. J., Davidson, E., & Sheikh, A. (2011). Achieving Ethnic Diversity in Trial Recruitment. Pharmaceutical Medicine, 25 (4), 215–222. https://doi.org/10.1007/bf03256863
Stefanov, O. V. (2001). Doklinichni doslidzhennia likarskykh zasobiv. Metodychni rekomendatsii. Kyiv : Avitsenna, 528.
Nakaz Ministerstva okhorony zdorovia Ukrainy vid 14 hrudnia 2009 roku № 944. (2009). Pro zatverdzhennia Poriadku provedennia doklinichnoho vyvchennia likarskykh zasobiv ta ekspertyzy materialiv doklinichnoho vyvchennia likarskykh zasobiv.
The Lancet. (2009). Phase 0 trials: a platform for drug development? The Lancet, 374 (9685), 176. https://doi.org/10.1016/s0140-6736(09)61309-x
Tsubanova, N. A., Hochlenkova, N. V., Zhurenko, D. S., Matthew, I. I. (2016). Ukraine Patent № 109792. Opys na korysnu model IPC A 61 K 36/49, A 61 K 36/889, A 61 K 129/00, A 61 P 1/02. Farmatsevtychna kompozytsiia u formi stomatolohichnoho heliu z parodontoprotektornoiu diieiu.
Zhurenko, D. S., Strilec, O. P., Hochlenkova, N. V., Matthew, І. І. (2016). Study of antimicrobial activity of “Аloedental” gel for treatment of periodontal diseases. Liky Ukrainy Plius, 3 (28), 34–36.
Tsubanova, N., Hohlenkova, N., Zhurenko, D., & Iroko, I. (2016). New research efficiency gel containing an extract of oak bark and extract of aloe under condition protamine periodontal. Ukraïns’kij bìofarmacevtičnij žurnal, 2(43), 27–31. https://doi.org/10.24959/ubphj.16.19
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).