DOI: https://doi.org/10.22263/2312-4156.2024.3.69
O.A. Sushinskaya, N.S. Golyak
The assessment of local irritant and skin-resorptive effect of liquid extract of wormwood and combined spray based on it
Belarusian State Medical University, Minsk, Republic of Belarus
Vestnik VGMU. 2024;23(3):69-78.
Abstract.
Objectives. To assess the safety of liquid extract of wormwood and combined spray based on it.
Material and methods. The objects of the study were liquid extract of wormwood (extractant – 70% ethanol) and combined spray for external use containing ibuprofen and liquid extract of wormwood 1:1. Tests to determine the local irritant and skin-resorptive effect were carried out in accordance with Instructions 1.1.11-12-35-2004 «Requirements for conducting experimental studies for primary toxicological assessment and hygienic regulation of substances». To assess the irritant and resorptive effect, the thickness of skin folds and their increase after single and multiple applications of the studied substances, changes in body weight of laboratory animals and mass coefficients of their internal organs, indicators of general and biochemical blood tests were determined.
Results. According to the results of quantitative assessment of the degree of erythema induction and edema of skin folds, the severity of local irritant properties for the groups of experimental animals was less than 1 point. There were no statistically distinguishable results in terms of body weight dynamics. The mass coefficients of all organs of the tested animals remained within the normal range. When assessing the majority of hematological parameters in all test groups, their values remained within the physiological norm, however, an increase in the level of total bilirubin was revealed in all test groups of females and the test group of males receiving the extract.
Conclusions. The results of the safety assessment made it possible to establish that the liquid extract of wormwood, as well as the combined spray, do not exhibit a locally irritating effect (neither in acute nor in subchronic experiments) and a toxic skin-resorptive effect.
Keywords: liquid extract, wormwood, ibuprofen, safety, local irritant effect, skin-resorptive effect.
The study was conducted within the frames of State Research Programs 2 (GPNI 2) – Chemical processes, reagents and technologies, bioregulators and bioorganic chemistry – of subprogram 2.2.3 – To get and standardize extraction dosage forms with an increased content of biologically active substances (№GR 20220401 of 30.03.2022).
References
1. Jurca T, Józsa L, Suciu R, Pallag A, Marian E, Bácskay I, Mureșan M, et al. Formulation of Topical Dosage Forms Containing Synthetic and Natural Anti-Inflammatory Agents for the Treatment of Rheumatoid Arthritis. Molecules. 2020 Dec;26(1):24. doi: http://dx.doi.org/10.3390/molecules26010024
2. Sushinskaya OA, Golyak NS. Anti-inflammatory activity of a spray based on ibuprofen and liquid extract of wormwood. Vestn Farmatsii. 2021;(3):73-8. (In Russ.)
3. Sushinskaya OA, Golyak NS. Prospects for the use of medicinal plant raw materials in external forms of anti-inflammatory action. Retsept. 2021;24(1):67-77. (In Russ.). doi: http://dx.doi.org/10.34883/PI.2021.24.1.006
4. Bhat RR, Rehman MU, Shabir A, Mir M, Ahmad A, Khan R, et al. Chemical Composition and Biological Uses of Artemisia absinthium (Wormwood). Plant Human Health. 2019;3:37-63. doi: http://dx.doi.org/10.1007/978-3-030-04408-4_3
5. Batiha GE-S, Olatunde A, El-Mleeh A, Hetta HF, Al-Rejaie S, Alghamdi S, et al. Bioactive Compounds, Pharmacological Actions, and Pharmacokinetics of Wormwood (Artemisia absinthium). Antibiotics (Basel). 2020 Jun;9(6):353. doi: http://dx.doi.org/10.3390/antibiotics9060353
6. Pred-Skin: Web App 3.0 [Internet]. Available from: http://predskin.labmol.com.br/. [Accessed 29th May 2024].
7. Borba JVB, Braga RC, Alves VM, Muratov EN, Kleinstreuer N, Tropsha A, et al. Pred-Skin: A Web Portal for Accurate Prediction of Human Skin Sensitizers. Chem Res Toxicol. 2021 Feb;34(2):258-67. doi: http://dx.doi.org/10.1021/acs.chemrestox.0c00186
8. Mironov AN, Bunyatyan ND, Vasilyev AN, Verstakova OL, Zhuravleva MV, Lepakhin VK, i dr. Guidelines for conducting preclinical studies of medicinal products. Ch 1. Moscow, RF: Grif i K; 2012. 944 р. (In Russ.)
9. On approval of sanitary rules and norms 2.1.2.12-18-2006 "Design, equipment and maintenance of experimental-biological clinics (vivariums)" [Internet]: postanovlenie Gl gos sanitar vracha Resp Belarus', 31 okt 2006 g, № 131. V: Ministerstvo zdravookhraneniya Respubliki Belarus': sait. Available from: https://minzdrav.gov.by/ru/dlya-spetsialistov/normativno-pravovaya-baza/baza-npa.php?ELEMENT_ID=332564. [Accessed 29th May 2024]. (In Russ.)
10. European Convention for the Protection of Vertebrate Animals used for Experimental and Other Scientific Purposes [Internet]. Available from: https://rm.coe.int/168007a67b. [Accessed 29th May 2024].
11. Directive 2010/63/EU of the European Parliament and of the Council of the European Union of September 22, 2010 on the protection of animals used for scientific purposes [Internet]. St. Petersburg; 2012. Available from: https://ruslasa.ru/wp-content/uploads/2017/06/Directive_201063_rus.pdf. [Accessed 29th May 2024]. (In Russ.)
12. On Approval of Instruction 1.1.11-12-35-2004 "Requirements for setting up experimental studies for primary toxicological assessment and hygienic regulation of substances" [Internet]: postanovlenie Gl gos sanitar vracha Resp Belarus', 14 dek 2004 g, № 131. Available from: https://minzdrav.gov.by/upload/lcfiles/text_tnpa/Инструкция_1.1.11-12-35-2004.pdf. [Accessed 29th May 2024]. (In Russ.)
Submitted 02.05.2024
Accepted 14.06.2024
Information about authors:
O.A. Sushinskaya – Master of Pharmaceutical Sciences, senior lecturer of the Chair of Pharmaceutical Technology, Belarusian State Medical University, https://orcid.org/0000-0002-6801-7285
e-mail: Этот адрес электронной почты защищён от спам-ботов. У вас должен быть включен JavaScript для просмотра. – Olga A. Sushinskaya;
N.S. Golyak – Candidate of Pharmaceutical Sciences, associate professor, head of the Chair of Pharmaceutical Technology, Belarusian State Medical University, https://orcid.org/0000-0002-4904-6523