Chemistry, Physics and Technology of Surface, 2024, 15 (2), 268-279.

Production, physico-chemical and biomedical study of hemostatic powder composition based on nanosized silica



DOI: https://doi.org/10.15407/hftp15.02.268

I. I. Gerashchenko, O. M. Chepliaka, K. O. Stepanyuk, E. M. Pakhlov, T. V. Krupska

Abstract


Blood loss is one of the main causes of death, especially in war and natural disasters. At the beginning of the full-scale Russian-Ukrainian war we established the laboratory and later the industrial production of a powdered topical hemostatic composition based on nanosilica which is intended for providing first pre-medical aid. The composition contains nanosized silica A-300 and sodium alginate as two active ingredients in a mass ratio of 4:1. The aim of the work was to develop the optimal technological process for the production of a hemostatic composition and carry out physico-chemical and medical-biological studies of semi-finished products and the final product.

Bulk density measurements, optical microscopy, IR spectroscopy method and microbiological research were used to study the initial materials, intermediate products as well as the final product. The effectiveness of the hemostatic effect of the composition was checked on the model of parenchymal bleeding from the liver of a rat, using the time to stop bleeding (min) as a criterion.

As a result of the research, a two-stage method of manufacturing the composition is proposed: at the first stage, certain parts of the initial materials are treated in a ball mill, obtaining the semi-finished product "A-300/sodium alginate"; at the second stage, this semi-finished product is mixed with nanosilica and sodium alginate, obtaining the final product. It is shown that the bulk density serves as a useful technological parameter to control of which helps to produce a structurally homogeneous final product. In the IR spectra of the semi-finished product and the finished product, only the absorption bands of silica and sodium alginate are observed, that is, foreign substances are not formed during technological process. The microbiological purity of the composition meets the pharmacopoeial requirements for drugs of this category. An experimental study of the topical hemostatic effect of the composition revealed its significant advantage compared to the inorganic hemostatic substance kaolin, which acts according to a similar adsorption mechanism.


Keywords


hemostatic composition; adsorption; nanosilica; sodium alginate; manufacturing process; bulk density; optical microscopy; IR spectroscopy; microbiological purity; parenchymal bleeding

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References


1. Tarasyuk V.S., Matviychuk M.V., Palamar I.V., Polyarush V.V., Korolyeva N.D., Podolyan V.M. First emergency and tactical medical aid at the pre-hospital stage. (Kyiv: VSV "Medycyna", 2021). [in Russian].

2. Karpyuk U.V., Kyslychenko V.S. Analysis of the assortment of drugs of hemostatic action. Med. Clin. Chem. 2017. 19(2): 53. [in Ukrainian].

3. Paul W., Sharma P. Chandra. Advances in Wound Healing Materials: Science and Skin Engineering. In: Smithers Rapra Technology Ltd Shawbury, Shrewsbury, Shropshire, SY4 4NR. (UK: ©Smithers Information Ltd., 2015).

4. Martynyuk O.O., Sukhodub L.B., Sukhodub L.F. Nanocomposite materials based on hydroxyapatite and sodium alginate: synthesis and characteristics. Biophys. Visnyk. 2015. 1(33): 48. [in Ukrainian].

5. Holban A., Grumezescu A.M. Materials for Biomedical Engineering: Hydrogels and Polymer-Based Scaffolds. In: Elsevier. (Netherlands, UK, USA: Copyright© 2019, Elsevier Inc., 2019).

6. Zhong Yu., Hu H., Min N., Wei Yu., Li X., Li X. Application and outlook of topical hemostatic materials: a narrative review. Ann. Transl. Med. 2021. 9(7): 577. https://doi.org/10.21037/atm-20-7160

7. Sukhodub L.F., Sukhodub L.B., Litsis O., Prylutskyy Yu. Synthesis and characterization of hydroxyapatite-alginate nanostructured composites for the controlled drug release. Mater. Chem. Phys. 2018. 217: 228. https://doi.org/10.1016/j.matchemphys.2018.06.071

8. Strutynska N., Livitska O., Vovchenko L., Zhuravkov A., Prylutskyy Yu., Slobodyanik N. Novel Nanostructured Na+, Cu2+(Zn2+), CO32−-HAP/Alginate Composite Scaffold: Fabrication, Characterization and Mechanical Properties. Chem. Select. 2019. 4(39): 11435. https://doi.org/10.1002/slct.201902034

9. Strutynska N., Malyshenko A., Tverdokhleb N., Evstigneev M., Vovchenko L., Prylutskyy Yu., Slobodyanik N., Ritter U. Design, characterization and mechanical properties of new Na+, CO32−-apatite/alginate/C60 fullerene hybrid biocomposites. J. Korean Ceram. Soc. 2021. 58: 422. https://doi.org/10.1007/s43207-020-00107-z

10. Ponsen A.-Ch., Proust R., Soave S., Mercier-Nomé F., Garcin I., Combettes L, Lataillade J.-J., Uzan G. A new hemostatic agent composed of Zn2+-enriched Ca2+ alginate activates vascular endothelial cells in vitro and promotes tissue repair in vivo. Bioact. Mater. 2022. 18: 368. https://doi.org/10.1016/j.bioactmat.2022.01.049

11. Pan M., Tang Z., Tu J., Wang Zh., Chen Q., Xiao R., Liu H. Porous chitosan microspheres containing zinc ion for enhanced thrombosis and hemostasis. Mater. Sci. Eng. C. 2018. 85: 27. https://doi.org/10.1016/j.msec.2017.12.015

12. Gubsky Yu.I. Biological Chemistry. (Kyiv-Ternopil: Ukrmedknyha, 2000). [in Ukrainian].

13. Margolis J. The effect of colloidal silica on blood coagulation. Aust. J. Exp. Biol. Med. Sci. 1961. 39(3): 249. https://doi.org/10.1038/icb.1961.25

14. Medicinal chemistry and clinical use of silicium dioxide / Ed. A.A. Chuiko. (Kyiv: Naukova dumka, 2003). [in Russian].

15. Eur. Patent PCT/EP2019/052021. Gerashchenko I., Chepliaka O. Hydrophilic/hydrophobic pharmaceutical composition and method of its production and use. 2019.

16. Turov V.V., Chehun V.F., Krupskaya T.V., Barvinchenko V.N., Shehun S.V., Ugnivenko A.P., Prylutskyy Yu.I., Scharff P., Ritter U. Effect of small addition of C60 fullerenes on the hydrated properties of nanocomposites based on highly dispersed silica and DNA. Chem. Phys. Lett. 2010. 496(1-3): 152. https://doi.org/10.1016/j.cplett.2010.07.001

17. Turov V.V., Prylutskyy Y.I., Krupskaya T.V., Schur D.V., Evstigneev M.P., Kartel M.T., Ritter U. Clustering of hydrochloric acid on the surface of C60/C70 fullerite and its composites with nanosilica. Mater. Sci. Eng. Techol. 2016. 47(2-3, Special Issue: Physics and Chemistry of Nanostructures and Nanobiotechnology): 172. https://doi.org/10.1002/mawe.201600459

18. Standard (GOST 14922-77). Aerosil. Technical conditions. [in Russian].

19. State Pharmacopoeia of Ukraine. SE "Scientific Expert Pharmacopoeia Center". - 1st ed. Suppl. 1. (Kharkiv: RIREG, 2004). [in Ukrainian].

20. State Pharmacopoeia of Ukraine. SE "Scientific Expert Pharmacopoeia Center". - 1st ed. (Kharkiv: RIREG, 2001). [in Ukrainian].

21. Jaiswal A.K., Chhabra H., Narwane S., Rege N., Bellare J.R. Hemostatic efficacy of nanofibrous matrix in rat liver injury model. Surg. Innov. 2017. 24(1): 23. https://doi.org/10.1177/1553350616675799

22. Patent UA 141355. Kravchenko A.A., Gerashchenko I.I., Turov V.V., Krupska T.V., Gudzenko N.V., Yanchuk P.I., Komarov I.V., Shtanova L.Ya., Vovkun T.V., Veselskyi S.P. Hemostatic composite material. 2020. [in Ukrainian].

23. Biletsky V.S. Small mining encyclopedia. V. 2. (Donetsk: Donbas, 2007). [in Ukrainian].

24. Shenoy P., Viau M., Tammel K., Innings F., Fitzpatrick J., Ahrne L. Effect of powder densities, particle size and shape on mixture quality of binary food powder mixtures. Powder Technol. 2015. 272: 165. https://doi.org/10.1016/j.powtec.2014.11.023

25. Markelov D.A., Nytsak O.V., Gerashchenko I.I. Comparative study of the adsorption activity of medical sorbents. Khim.-Pharm. J. 2008. 42 (7): 30. [in Russian]. https://doi.org/10.1007/s11094-008-0138-2




DOI: https://doi.org/10.15407/hftp15.02.268

Copyright (©) 2024 I. I. Gerashchenko, O. M. Chepliaka, K. O. Stepanyuk, E. M. Pakhlov, T. V. Krupska

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