Biological Evaluation Of Oxidative Regenerated Cellulose Biodegradable Materials And Their Degradation Products

Oxidative regenerated cellulose biodegradable materials have avoided the damage caused by secondary surgery due to their bioabsorbable ability.They were widely applied in clinical practice,especially in surgery.The commonly used oxidative regenerated cellulose biodegradable materials is Surgicel? made by Johnson & Johnson corporation in the United States at present.With its clinical application,adverse reactions often has been occurred.As a result,the safety of oxidative regenerated cellulose biodegradable materials is increasingly valued by the relevant departments,physicians and patient.Therefore,it is necessary to carry out the biological evaluation of such products.In addition,the analysis of the degradation products of oxidative regenerated cellulose biodegradable materials and the biological evaluation of degradation products in current are still lack of systematic evaluation.Therefore,the degradation products of oxidative regenerated cellulose biodegradable materials has analyzed,the biosafety of oxidative regenerated cellulose biodegradable materials and their degradation products were evaluated in this subject,which was intended to provide reference for the clinical application of this kind of biological materials.1.The method of HILIC combined with ELSD was established to analyze the degradation products.The chromatographic column was a hydrophilic column named X-Amide and the columnar temperature was 30?.The mobile phase was acetonitrile and 5mmol/L ammonium formate buffer(pH 5.50)at a rate of 53:47 with a flow rate of 1mL/min.The parameter of ELSD as follows: the drift tube temperature was 45?,the gain was 1 and the flow rate of nitrogen was 1.5L/min.The results showed that the oxidative degradation products of Surgicel? contained glucose and cellobiose.2.The cytocompatibility of oxidative regenerated cellulose biodegradable materials and their degradation products were evaluated by cytotoxicity assays in vitro.The effects of Surgicel?,Yingjieer and Taikeling on the proliferation of L929 fibroblasts and the cytotoxicity were evaluated by MTT colorimetric assay,cell morphology analysis,agar diffusion method and membrane diffusion method.MTT colorimetric assay combined with cell morphology analysis showed that there was no obvious cytotoxicity of the extracts of Yingjieer,and no significant cytotoxicity was observed when the concentration of Surgicel? and Taikeling extract made by 50.00mg/mL was less than 25.00%.Agar diffusion method and membrane diffusion method showed that there was no obvious cytotoxicity of Yingjieer,and Surgicel? and Taikeling had cytotoxicity.It can be seen that three different materials had different cell compatibility.It is important to select the appropriate evaluation method.For the degradation products,the cytotoxicity of the Surgicel? and Yingjieer degradation products was evaluated by MTT colorimetry.It showed that the concentration of degradation product of Surgicel? less than 5.00mg/mL had no cytotoxicity,and the concentration of degradation product of Yingjieer was less than 0.63mg/mL so did.3.The hemocompatibility of oxidative regenerated cellulose biodegradable materials and their degradation products was evaluated by hemolysis in vitro.The results of hemolysis of Surgicel?,Yingjieer and Taikeling showed that the different material caused different degrees of hemolysis.No hemolysis occurred when the extracts of Surgicel? and Taikeling was diluted to 0.10mg/mL and so did the extract of Yingjieer was diluted to 10.00mg/mL.The hemolysis of the degradation product of Surgicel? showed no hemolysis when the concentration was less than 0.05mg/mL.4.The effects of Surgicel? and its degradation products on animal body reactions were evaluated by animal experiments,including acute systemic toxicity,skin irritation,intradermal reactions and sensitization experiments.0.100g/mL material extract showed no acute systemic toxicity,skin irritation and sensitization,but with intradermal reaction.0.010g/mL degradation product extract with acute systemic toxicity,skin irritation and intradermal reaction,but no sensitization.By means of the analysis of the degradation products of oxidative regenerated cellulose biodegradable materials and the biosafty evaluation of the material and its degradation products in vitro and in vivo,it provides some basic data for the safe application of this kind of materials,which can be used as a reference for clinical application.