Гелевые и гидрогелевые повязки с антибактериальными и репаративными свойствами на основе материалов животного сырья: фармацевтико-технологические и регистрационные аспекты (обзор)

Введение. Хронические, ожоговые, послеоперационные и инфицированные раны требуют раневых покрытий, которые не только поддерживают влажную среду, но и помогают контролировать бактериальную обсемененность, воспаление, экссудацию и регенерацию тканей. Гелевые и гидрогелевые повязки на основе биополимеров животного происхождения представляют особый интерес для фармацевтической отрасли, поскольку их свойства можно регулировать за счет выбора сырья, метода сшивки, состава матрицы и различных модификаций.

Текст. В обзоре рассмотрены шесть биополимерных платформ: коллаген, желатин, хитозан, гиалуроновая кислота, кератин и шелковый фиброин. Основное внимание уделено не только их антибактериальным и репаративным свойствам, но и технологическим параметрам, которые определяют возможность практического применения: молекулярной массе, степени модификации, времени гелеобразования, набуханию, механической прочности, адгезии к влажной ткани, профилю высвобождения, биодеградации, стерильности, стабильности и цитосовместимости. Отдельно рассмотрены методы сшивки, подходы к стандартизации сырья, выбор метода стерилизации, контроль качества, а также регистрационные особенности медицинских изделий и комбинированных продуктов.

Заключение. Перспективность гидрогелевой повязки определяется не только биологической активностью материала, но и воспроизводимостью ее критических показателей качества. Наиболее значимыми для дальнейшей разработки являются платформы, в которых состав, технология получения, стерилизация, высвобождение активных компонентов, безопасность и предполагаемое клиническое применение связаны уже на этапе проектирования изделия.

1. Sen C. K. Human wound and its burden: updated 2022 compendium of estimates. Advances in Wound Care. 2023;12(12):657–670. https://doi.org/10.1089/wound.2023.0150

2. Martinengo L., Olsson M., Bajpai R., Soljak M., Upton Z., Schmidtchen A., Car J., Järbrink K. Prevalence of chronic wounds in the general population: systematic review and meta-analysis of observational studies. Annals of Epidemiology. 2019;29:8–15. https://doi.org/10.1016/j.annepidem.2018.10.005

3. desJardins-Park H. E., Gurtner G. C., Wan D. C., Longaker M. T. From chronic wounds to scarring: the growing health care burden of under- and over-healing wounds. Advances in Wound Care. 2022;11(9):496–510. https://doi.org/10.1089/wound.2021.0039

4. Eriksson E., Liu P. Y., Schultz G. S., Martins-Green M. M., Tanaka R., Weir D., Gould L. J., Armstrong D. G., Gibbons G. W., Wolcott R., Olutoye O. O., Kirsner R. S., Gurtner G. C. Chronic wounds: treatment consensus. Wound Repair and Regeneration. 2022;30(2):156–171. https://doi.org/10.1111/wrr.12994

5. Surowiecka A., Strużyna J., Winiarska A., Korzeniowski T. Hydrogels in burn wound management – a review. Gels. 2022;8(2):122. https://doi.org/10.3390/gels8020122

6. Jia B., Li G., Cao E., Luo J., Zhao X., Huang H. Recent progress of antibacterial hydrogels in wound dressings. Materials Today Bio. 2023;19:100582. https://doi.org/10.1016/j.mtbio.2023.100582

7. Butenko S., Nagalla R. R., Guerrero-Juarez C. F., Palomba F., David L.-M., Nguyen R. Q., Gay D., Almet A. A., Digman M. A., Nie Q., Scumpia P. O., Plikus M. V., Liu W. F. Hydrogel crosslinking modulates macrophages, fibroblasts, and their communication, during wound healing. Nature Communications. 2024;15:6820. https://doi.org/10.1038/s41467-024-50072-y

8. Yu Q., Yan Y., Huang J., Liang Q., Li J., Wang B., Ma B., Bianco A., Ge S., Shao J. A multifunctional chitosan-based hydrogel with self-healing, antibacterial, and immunomodulatory effects as wound dressing. International Journal of Biological Macromolecules. 2023;231:123149. https://doi.org/10.1016/j.ijbiomac.2023.123149

9. Zhao J., Qiu P., Wang Y., Wang Y., Zhou J., Zhang B., Zhang L., Gou D. Chitosan-based hydrogel wound dressing: from mechanism to applications, a review. International Journal of Biological Macromolecules. 2023;244:125250. https://doi.org/10.1016/j.ijbiomac.2023.125250

10. Yang Y., Ma Y., Wang H., Li C., Li C., Zhang R., Zhong S., He W., Cui X. Chitosan-based hydrogel dressings with antibacterial and antioxidant for wound healing. International Journal of Biological Macromolecules. 2024;280:135939. https://doi.org/10.1016/j.ijbiomac.2024.135939

11. Zhao X., Wu H., Guo B., Dong R., Qiu Y., Ma P. X. Antibacterial anti-oxidant electroactive injectable hydrogel as self-healing wound dressing with hemostasis and adhesiveness for cutaneous wound healing. Biomaterials. 2017;122:34–47. https://doi.org/10.1016/j.biomaterials.2017.01.011

12. Guo W., Ding X., Zhang H., Liu Z., Han Y., Wei Q., Okoro O. V., Shavandi A., Nie L. Recent advances of chitosan-based hydrogels for skin-wound dressings. Gels. 2024;10(3):175. https://doi.org/10.3390/gels10030175

13. Watson A. L., Eckhart K. E., Wolf M. E., Sydlik S. A. Hyaluronic acid-based antibacterial hydrogels for use as wound dressings. ACS Applied Bio Materials. 2022;5(12):5608–5616. https://doi.org/10.1021/acsabm.2c00647

14. Yang K., Yang J., Chen R., Dong Q., Yang H., Gu S., Zhou Y. Antibacterial hyaluronic acid hydrogels with enhanced self-healing properties via multiple dynamic bond crosslinking. International Journal of Biological Macromolecules. 2024;256(Pt 2):128320. https://doi.org/10.1016/j.ijbiomac.2023.128320

15. He C., Bi S., Zhang R., Chen C., Liu R., Zhao X., Gu J., Yan B. A hyaluronic acid hydrogel as a mild photothermal antibacterial, antioxidant, and nitric oxide release platform for diabetic wound healing. Journal of Controlled Release. 2024;370:543–555. https://doi.org/10.1016/j.jconrel.2024.05.011

16. Zhai M., Xu Y., Zhou B., Jing W. Keratin-chitosan/n-ZnO nanocomposite hydrogel for antimicrobial treatment of burn wound healing: characterization and biomedical application. Journal of Photochemistry and Photobiology B: Biology. 2018;180:253–258. https://doi.org/10.1016/j.jphotobiol.2018.02.018

17. Shang Y., Wang P., Wan X., Wang L., Liu X., Yuan J., Chi B., Shen J. Chlorhexidine-loaded polysulfobetaine/keratin hydrogels with antioxidant and antibacterial activity for infected wound healing. International Journal of Biological Macromolecules. 2023;242(1):124754. https://doi.org/10.1016/j.ijbiomac.2023.124754

18. Han X., Yang R., Wan X., Dou J., Yuan J., Chi B., Shen J. Antioxidant and multi-sensitive PNIPAAm/keratin double network gels for self-stripping wound dressing application. Journal of Materials Chemistry B. 2021;9(31):6212–6225. https://doi.org/10.1039/D1TB00702E

19. Ren Y., Yu X., Li Z., Liu D., Xue X. Fabrication of pH-responsive TA-keratin bio-composited hydrogels encapsulated with photoluminescent GO quantum dots for improved bacterial inhibition and healing efficacy in wound care management: in vivo wound evaluations. Journal of Photochemistry and Photobiology B: Biology. 2020;202:111676. https://doi.org/10.1016/j.jphotobiol.2019.111676

20. Liu R., Bi S., Zhang L., Li X., Dai K., Wang H., Zhang Z., Gu J. Flexible and antibacterial conductive hydrogels based on silk fibroin/polyaniline/AgNPs for motion sensing and wound healing promotion under electrical stimulation. Journal of Materials Chemistry B. 2024;12(40):10346–10356. https://doi.org/10.1039/D4TB01505C

21. González-Restrepo D., Zuluaga-Vélez A., Orozco L. M., Sepúlveda-Arias J. C. Silk fibroin-based dressings with antibacterial and anti-inflammatory properties. European Journal of Pharmaceutical Sciences. 2024;195:106710. https://doi.org/10.1016/j.ejps.2024.106710

22. Wang S.-L., Zhuo J.-J., Fang S.-M., Xu W., Yu Q.-Y. Silk sericin and its composite materials with antibacterial properties to enhance wound healing: a review. Biomolecules. 2024;14(6):723. https://doi.org/10.3390/biom14060723

23. Li J., Zhai Y.-N., Xu J.-P., Zhu X.-Y., Yang H.-R., Che H.-J., Liu C.-K., Qu J.-B. An injectable collagen peptide-based hydrogel with desirable antibacterial, self-healing and wound-healing properties based on multiple-dynamic crosslinking. International Journal of Biological Macromolecules. 2024;259(Pt 1):129006. https://doi.org/10.1016/j.ijbiomac.2023.129006

24. Liang C., Wang H., Lin Z., Zhang C., Liu G., Hu Y. Augmented wound healing potential of photosensitive GelMA hydrogel incorporating antimicrobial peptides and MXene nanoparticles. Frontiers in Bioengineering and Biotechnology. 2023;11:1310349. https://doi.org/10.3389/fbioe.2023.1310349

25. Sabolinski M. L., Archambault T. Real-world data analysis of bilayered living cellular construct and fetal bovine collagen dressing treatment for pressure injuries: a comparative effectiveness study. Journal of Comparative Effectiveness Research. 2024;13(4):e230109. https://doi.org/10.57264/cer-2023-0109

26. Theodorakopoulos G., Armstrong D. G. Collagen-ORC versus standard treatment in diabetic foot ulcers: a systematic review and meta-analysis of randomised trials. International Wound Journal. 2025;22(11):e70782. https://doi.org/10.1111/iwj.70782

27. Wang X., Zhao D., Li Y., Zhou X., Hui Z., Lei X., Qiu L., Bai Y., Wang C., Xia J., Xuan Y., Jiang P., Wang J. Collagen hydrogel with multiple antimicrobial mechanisms as anti-bacterial wound dressing. International Journal of Biological Macromolecules. 2023;232:123413. https://doi.org/10.1016/j.ijbiomac.2023.123413

28. Lin X., Yang X., Li P., Xu Z., Zhao L., Mu C., Li D., Ge L. Antibacterial conductive collagen-based hydrogels for accelerated full-thickness wound healing. ACS Applied Materials & Interfaces. 2023;15(19):22817–22829. https://doi.org/10.1021/acsami.2c22932

29. Brooker C., Tronci G. A collagen-based theranostic wound dressing with visual, long-lasting infection detection capability. International Journal of Biological Macromolecules. 2023;236:123866. https://doi.org/10.1016/j.ijbiomac.2023.123866

30. Gharibi R., Shaker A., Rezapour-Lactoee A., Agarwal S. Antibacterial and biocompatible hydrogel dressing based on gelatin- and castor-oil-derived biocidal agent. ACS Biomaterials Science & Engineering. 2021;7(8):3633–3647. https://doi.org/10.1021/acsbiomaterials.1c00706

31. Karamanlioglu M., Yesilkir-Baydar S. Characterization of gelatin-based wound dressing biomaterials containing increasing coconut oil concentrations. Journal of Biomaterials Science, Polymer Edition. 2024;35(1):16–44. https://doi.org/10.1080/09205063.2023.2265624

32. Hoque J., Prakash R. G., Paramanandham K., Shome B. R., Haldar J. Biocompatible injectable hydrogel with potent wound healing and antibacterial properties. Molecular Pharmaceutics. 2017;14(4):1218–1230. https://doi.org/10.1021/acs.molpharmaceut.6b01104

33. Bakadia B. M., Lamboni L., Ahmed A. A. Q., Zheng R., Boni B. O. O., Shi Z., Song S., Souho T., Mukole B. M., Qi F., Yang G. Antibacterial silk sericin/poly (vinyl alcohol) hydrogel with antifungal property for potential infected large burn wound healing: systemic evaluation. Smart Materials in Medicine. 2023;4:37–58. https://doi.org/10.1016/j.smaim.2022.07.002

34. Chopra H., Bibi S., Kumar S., Khan M. S., Kumar P., Singh I. Preparation and evaluation of chitosan/PVA based hydrogel films loaded with honey for wound healing application. Gels. 2022;8(2):111. https://doi.org/10.3390/gels8020111

35. Sayyar Z., Mahdavinia G. R., Khataee A. Dual-drug (Curcumin/Ciprofloxacin) loading and release from chitosan-based hydrogels embedded with magnetic Montmorillonite/Hyaluronic acid for enhancing wound healing. Journal of Biological Engineering. 2023;17:66. https://doi.org/10.1186/s13036-023-00385-1

36. Khaliq T., Sohail M., Minhas M. U., Mahmood A., Munir A., Qalawlus A. H. M., Jabeen N., Kousar M., Anwar Z. Hyaluronic acid/alginate-based biomimetic hydrogel membranes for accelerated diabetic wound repair. International Journal of Pharmaceutics. 2023;643:123244. https://doi.org/10.1016/j.ijpharm.2023.123244

37. Şalva E., Akdağ A. E., Alan S., Arısoy S., Akbuğa F. J. Evaluation of the effect of honey-containing chitosan/hyaluronic acid hydrogels on wound healing. Gels. 2023;9(11):856. https://doi.org/10.3390/gels9110856

38. Guo Z., Yan L., Zhou B., Zhao P., Wang W., Dong S., Cheng B., Yang J., Wang X., Li B. In situ photo-crosslinking silk fibroin based hydrogel accelerates diabetic wound healing through antibacterial and antioxidant. International Journal of Biological Macromolecules. 2023;242(3):125028. https://doi.org/10.1016/j.ijbiomac.2023.125028

39. Sheybanikashani S., Zandi N., Hosseini D., Lotfi R., Simchi A. A sustainable and self-healable silk fibroin nanocomposite with antibacterial and drug eluting properties for 3D printed wound dressings. Journal of Materials Chemistry B. 2024;12(3):784–799. https://doi.org/10.1039/D3TB02363J

40. Shu W., Wang Y., Zhang X., Li C., Le H., Chang F. Functional hydrogel dressings for treatment of burn wounds. Frontiers in Bioengineering and Biotechnology. 2021;9:788461. https://doi.org/10.3389/fbioe.2021.788461

41. Ning S., Zhang T., Lyu M., Wing J., Lam Y., Zhu D., Huang Q., Tang B. Z. A type I AIE photosensitiser-loaded biomimetic nanosystem allowing precise depletion of cancer stem cells and prevention of cancer recurrence after radiotherapy. Biomaterials. 2023;295:122034. https://doi.org/10.1016/j.biomaterials.2023.122034

42. Baniasadi H. State-of-the-art in natural hydrogel-based wound dressings: design, functionalization, and fabrication approaches. Advances in Colloid and Interface Science. 2025;342:103527. https://doi.org/10.1016/j.cis.2025.103527

43. Caló E., Khutoryanskiy V. V. Biomedical applications of hydrogels: a review of patents and commercial products. European Polymer Journal. 2015;65:252–267. https://doi.org/10.1016/j.eurpolymj.2014.11.024