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PRECLINICAL STUDY OF THE EFFICACY AND SAFETY OF WOUND HEALING GEL CONTAINING CHITOSAN, TAURINE AND ALLANTOIN

Introduction: The paper deals with the problem of wound healing, which is considered to remain one of the most pressing challenges of the modern medicine, despite a large variety of wound healing preparations. This results from a high level of domestic and military traumatism of the population, and the fact that many registered medications do not meet the requirements for modern wound healing preparations. Objectives: To develop gel containing chitosan, taurine, allantoin, and to experimentally investigate its wound healing properties in pre-clinical studies on laboratory animals. Methods: The methodological approach was based on a range of theoretical, pharmacological, toxicological, histological, statistical, physico-chemical, biopharmaceutical, rheological methods, which ensured the development of an optimal, safe and effective wound healing preparation in the gel dosage form. Results: The developed chitosan gel containing taurine and allantoin meets the major modern requirements for wound and burn care. Physico-chemical compatibility of the chitosan gel components with taurine and allantoin were proved in the experimental studies. When applied either singly or repeatedly on the skin, the developed gel is reported to be of low toxicity; in case of linear wounds, it demonstrates wound-healing properties, ensuring the increase of wound-disruption strength 1.5 times more in comparison with the control; in case of planar full-thickness skin wounds, it provides earlier complete healing (4 days earlier than in the control) and full epithelium recovery in the area of a wound defect. The given gel possesses burn-treating properties exceeding the efficiency of the "Solcoseryl" gel and reducing the half-healing period by 28%. When applied topically, the chitosan gel containing taurine and allantoin reveals anti-inflammatory and capillary-protective properties of moderate degree. Conclusion: It is possible to use 1.0% chitosan gel with 4.0% taurine and 0.5% allantoin to accelerate healing and provide epithelization without cosmetic defects of conditionally aseptic wounds and thermal skin burns up to IIIa degree to 1% of the body surface area; the gel should be applied 1-3 times a day locally, 0.5 g directly to the wound surface.

Иллюстрации

Fig. 1. The research design.

Fig. 2. Infrared specters of taurine, allantoin, chitosan and their mixture.

Fig. 3. Rheograms of the gel flows.

 Fig. 4. Dynamics of  taurine and allantoin release.

Table 1.  Comparative evaluation of the wound-healing activity of the chitosan gel with taurine and allantoin and its components, “Solcoseryl” gel, “Levomekol” ointment on the model of planar full-thickness wound.

Note: * - Р<0.05; ** - Р<0.01 – statistical significance in comparison with the control;+ - Р<0.05; ++ - Р<0.01 – statistical significance in comparison with the 1.0% chitosan gel ; ● – Р<0.05; ●● – Р<0.01 – statistical significance in comparison with the “ Solcoseryl” gel.

Fig. 5. Half-healing period of planar experimental wounds.

Note: * - P<0.05 – statistical significance in comparison with the control.

Table 2. Morphometric parameters of planar full-thickness wounds.

Note: * - Р<0.05 – statistical significance in comparison with the intact group; - Р<0.05 – statistical significance in comparison with the control.


Fig. 6A. A histological picture of the epidermis of the skin of the control group mice.

Note: staining of hematoxylin-eosin. inc. × 200. Cells of all layers of the skin have multidirectional sizes and shapes, papillary dermis layer is smoothed.

Fig. 6B. A histological picture of the epidermis of the skin of mice after the action of the gel "Solcoseryl".

Note: staining of hematoxylin-eosin. inc. × 200. There is no exudation and edema.

Fig. 6C. A histological picture of the epidermis of the skin of mice after exposure to the chitosan gel with taurine and allantoin.

Note: staining of hematoxylin-eosin. inc. × 200. Fibroblasts and fibrocytes predominate over other types of cells, complete restoration of the epidermis is observed, collagen fibers have formed beams of various thicknesses and directions.

Fig. 7. Wound-tensiometric findings of the linear skin wound.

Note: * - P<0.05 – statistical significance in comparison with the control; - Р<0.05 – statistical significance in comparison with the reference preparation.

Table 3. Comparative evaluation of wound-healing activity of the chitosan gel with taurine and allantoin, the “Solcoseryl” gel on the model of a linear skin wound.

Note: * - Р<0.05 – reliability of the differences in comparison with the control; - Р<0.05 – reliability of the differences in comparison with comparison drug.

Fig. 8A. Histological picture of the epidermis of the skin of the control group rats.

Note: staining of hematoxylin-eosin. inc. × 160. There is a network of "young" fibroblasts.

 Fig. 8B. A histological picture of the skin epidermis of rats after the action of the gel "Solcoseryl".

Note: staining of hematoxylin-eosin. Uv. × 160. In the field of view there are single blood-filled vessels of different calibers.

 Fig. 8C. A histological picture of the epidermis of rat skin after exposure to chitosan gel with taurine and allantoin.

Note: staining of hematoxylin-eosin. Uv. × 160. Recovered epidermal shaft developing from the edges of the wound defect fills the damaged skin area.

Fig. 9. Comparative evaluation of the anti-inflammatory activity of the ChTA gel, “Voltaren Emulgel”, “Solcoseryl” gel, 4.0% taurine solution, 0.5% allantoin solution, 1.0% chitosan gel on the model of formalin test (a swollen rat leg).

Note: * - P<0.05; ** - Р<0.01 – statistical significance in comparison with the control.

Table 4. Impact of “Troxevasin” gel, ChTA gel, taurine and allantoin solution in the mono-composition on the reduction of vascular permeability in mice.

Note: * - P<0.05, ** - P<0.01 – statistical significance in comparison with the control.

DOI: 10.18413/2313-8971-2017-3-2-14-28
Количество просмотров: 1560 (смотреть статистику)
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