[Preparation and Performance Study of a Novel Antibacterial Hemostatic Chitosan Sponge].

Objective: To create a novel chitosan antibacterial hemostatic sponge (NCAHS) and to evaluate its material and biological properties.

Methods: Chitosan, a polysaccharide, was used as the sponge substrate and different proportions of sodium tripolyphosphate (STPP), glycerol, and phenol sulfonyl ethylamine were added to prepare the sponges through the freeze-drying method. The whole-blood coagulation index (BCI) was used as the screening criterion to determine the optimal concentrations of chitosan and the other additives and the hemostatic sponges were prepared accordingly. Zein/calcium carbonate (Zein/CaCO) composite microspheres loaded with ciprofloxacin hydrochloride were prepared and added to the hemostatic sponges to obtain NCAHS. Scanning electron microscope was used to observe the microscopic morphology and porosity of the NCAHS. The water absorption rate, antibacterial susceptibility rate against () and (), coagulation performance, and hemocompatibility of NCAHS were examined. The coagulation performance of NCAHS was evaluated by using rabbit liver injury and rabbit auricular artery hemorrhageear models and commercial hemostatic sponge (CHS) was used as a control. The biocompatibility, including such aspects as cytotoxicity, skin irritation in animals, and acute toxicity, of the NCAHS extracts was examined by using as a reference the national standards for biological evaluation of medical devices.

Results: The NCAHS prepared with 1.5% chitosan (/), 0.01% STPP (/), 0% glycerol (/), 0.15% phenol-sulfonyl-ethylamine (/), Zein and CaCO at the mixing ratio of 5∶1 (/), Zein at the final mass concentration of 2.5 g/L, and ethanol at the final concentration of 17.5% (/) were fine and homogeneous, possessing a honeycomb-like porous structure with a pore size of about 200 μm. The NCAHS thus prepared had the lowest BCI value. The water absorption ([2362.16±201.15] % vs. [1102.56±91.79]%) and coagulation performance (31.338% vs. 1.591%) of NCAHS were significantly better than those of CHS (<0.01). Tests with the auricular artery hemorrhage model ([36.00±13.42] s vs. [80.00±17.32] s) and rabbit liver bleeding model ([30.00±0] s vs. [70.00±17.32] s) showed that the hemostasis time of NCAHS was significantly shorter than that of CHS (<0.01). NCAHS had significant inhibitory ability against and . In addition, NCAHS showed good and biocompatibility.

Conclusion: NCAHS is a composite sponge that shows excellent antimicrobial properties, hemostatic effect, and biocompatibility. Therefore, its extensive application in clinical settings is warranted.