| Objective:The possibility of clinical application of polyvinyl acetate(PVAC)and poly methyl vinyl ether-maleic anhydride(PMVE-MA)as the main component of the new polymer hydrogel denture stabilizer was preliminarily tested,through the preliminary examination of the adhesive properties and biological safety of the new polymer hydrogel denture stabilizer further to provide a reliable experimental basis for its application in the future.Methods:According to the national standard GB / T 16886,the national medicine industry standard YY/T and IS010993,the in vitro and in vivo experiments of the newly synthesized polymer hydrogel denture stabilizers were carried out in order of bond strength test,hemolysis test,in vitro cytotoxicity test,acute systemic toxicity test.These tests were conducted to prove whether the new polymer hydrogel denture stabilizer meet the requirements of biomaterials.1.Samples 1 and 2 of newly synthesized polymer hydrogel denture stabilizer were used as experimental group and the denture stabilizer sold in market as control group.They were divided into two groups immediately and immersed in artificial saliva for 1 hours.The bond strength of experimental group was tested by tensile test of universal material tester.2.The new synthetic polymer hydrogel denture stabilizer extract was mixed with 0.2 ml diluted rabbit blood.The simulated organism was incubated at37 ? for 60 min and centrifuged for 5 minutes with 2500 r / min.The supernatant was obtained.The absorbance value was measured by ultraviolet spectrophotometer.3.Intraperitoneal injection and oral administration respectively of the extracts from samples 1 and 2 in ICR mice.Two mice were injected.After 2 weeks,the mice were killed and the important organs were dissected for pathological analysis.Results:1.The TBS value of the two samples was higher than that of Polident(P < 0.05 after soaking immediately or in saliva for 1 hour,the value of No.2 TBS was higher than that of No.1 TBS,and the difference was statistically significant.2.In the negative control group and samples1,2 a layer of red sediment can be observed at the bottom of centrifuge tubes,while the upper liquid cleaning was colorless and transparent,indicating that the blood cells deposited on the bottom,However,there was no red blood cell sediment at the bottom of the centrifuge and the liquid color was pale red,indicating the hemolytic reaction.The hemolysis rate of the sample 1 was 1.97%,and the sample2 was 0.87%,both less than 5%.Two samples all meet the standard requirements.3.In the acute systemic toxicity test,the experimental mice were in good mental condition,normal defecation and urine,no obvious abnormal changes in vital signs were observed.And there were no obvious abnormal color,texture and morphology of the important organs of heart,liver,spleen,stomach and kidney.No obvious inflammatory changes and hyperemia were observed under microscope after tissue section staining.Conclusions:1.The bond strength results showed that the new polymer hydrogel denture stabilizer had better adhesion than Polident..2.The hemolysis test results showed that the hemolysis rate of 2 samples was less than 5%,and there was no hemolysis phenomenon,which accords with the biosafety requirements of materials.3.The results of acute systemic toxicity test showed that both the heart and the liver and the spleen and stomach were basically consistent with the normal organs of the control group,and the two samples had no systemic toxicity to the organism. |
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